Showing posts with label Stack Attack. Show all posts
Showing posts with label Stack Attack. Show all posts

Tuesday, November 9, 2010

no baseline for Canada/Europe patent and pharmaceutical trade negotiations

So, last Friday - actually, two weeks ago Friday, where does the time go? - I participated in Foreign Affairs’ briefing phone call regarding the Canada-European free trade negotiations.  Overall, the negotiators are reportedly making progress - “better than the two sides had anticipated.” 

But, on the patent and pharmaceutical topics that I am interested in, the issues are described as “difficult”, with discussions ongoing but no particular progress.  This is unsurprising - since there is no normative or other baseline on which to base discussions or converge on a position, the best the negotiators can do is to define positions (for example, agree on some alternative texts) and present these to the politicians, who will have to make the hard calls regarding trade-offs. 



Cue the lobbying  ;)

One reason that patent law and pharmaceuticals are a big deal in this negotiation - pharmaceuticals are one of Europe’s largest exports to Canada, at about $5 billion per year.

An interesting point is that it is the provinces that will have to deal with the fallout from any potential patent/pharmaceutical deal via their health care programs.  The provinces are being actively consulted by the federal negotiators.

As noted in this article in the National Post, lobbyists are therefore busy lobbying the provincial governments as well as federal officals, and the innovative pharma companies have garnered some support from the Alberta, Quebec and New Brunswick governments.

But to get back to the point that there is no underlying normative baseline on these issues - focus on the reported Alberta position


Alberta decided to write a letter of support in July after the brand sector raised the issue with Premier Ed Stelmach, said George Samoil, director of operations in the Premier’s office.
He said the fact he had himself earlier been manager of government relations for AstraZeneca had nothing to do with the province’s stance.
Quebec and New Brunswick also sent letters of support to Tony Clement, the federal Industry Minister.
“It seems pretty straightforward that if Canada wants to be in line with one of its major trading partners, that its intellectual property protection policies be in line also,” Mr. Samoil said.
I have no problem with that as one underlying principle - heck, its one of the main points in my (shameless plug alert ;) ) book on international patent law cooperation coming out next year.

But I don't think it gets you anywhere in this case.  Among other things, which major trading partner is Canada supposed to be getting in line with - the U.S. or Europe?

For example, the US has a "linkage system" - approval to market generic pharmaceuticals from a health perspective is linked to addressing potentially relevant patents held by the innovative or brand-name drug company. 

In line with the US, Canada also has a similar linkage system.  In fact, Canada arguably goes beyond the protection the US provides by allowing patent holders two shots at stopping generic competition - once via a PM(NOC) application and again via a patent infringement case - while the US system just has one patent infringement action.

Europe does not have this linkage protection for innovator pharma companies.

So, Europe must be satisfied with this - Canada is granting higher protection to patent-holders than Europe itself grants.  Right?

Wrong.      

Europe is pressing for an additional right of appeal to be added for patent-holders in the PM(NOC) process.  Europe is asking Canada to agree in a treaty to strengthen patent protection in a system Europe doesn't adopt itself. 

So much for reciprocity.  ;)

In light of this, Mr. Samoli's statement of principle doesn't make very much sense as a baseline.   Presumably, if Canada wanted to get in line with Europe, it would eliminate the PM(NOC) regulations altogether.  But then it would be out of line with the US.  There's no baseline here.  Its just a non-reciprocal demand.

To put it another way - there really isn’t common ground on these issues - there is an EU position and a Canadian position.  At some point there will be a trade-off on political grounds between EU and Canadian positions across a whole range of issues, including patent law and pharmaceuticals. 

And that's about it.  


 

Friday, September 10, 2010

USPTO Data: CIPO?

Those of you who know me well know that in the past I have harped on patent office statistics like pendency and backlogs.  I think they are important - central, critical even - to understanding how patent law functions in a country. 

Well, the USPTO has certainly taken the idea of transparency in such matters to heart.  Check THIS out.

So, CIPO...  when can we expect a similar level of disclosure?  ;) 


(adding a comparison of CIPO stats to USPTO stats for corresponding applications would be nice too...)

Wednesday, August 11, 2010

Trade-driven changes coming to Canadian patent and data-protection laws?

I have published an article on the Canada - European Union trade negotiations - the Comprehensive Economic and Trade Agreement - in the latest issue of the Food and Drug Law Institute's Update magazine.

Here is a link to the article.  Please note that this is distributed with the permission of Update magazine of the FDLI.

Monday, August 9, 2010

Canadian provinces team up on drug purchases

Interesting though perhaps not surprising development on the drug purchasing front: the Canadian provinces have "teamed up" to purchase drugs for their respective provincial drug plans.

Globe and Mail article

"The premiers unveiled plans on Friday to set up a national agency that would be responsible for purchasing $10-billion in prescription drugs a year as well as medical supplies and equipment.

Having one entity responsible for drug purchases for all 13 provinces and territories would lower costs on a major contributor to the growing tab for health care.

Rising health-care costs dominated the premiers’ two-day annual meeting in Winnipeg. For the first time as a group, the premiers tackled the question of whether the country can sustain a system many Canadians appear to take for granted."

Easier said than done, I suppose - but its maybe inevitable. A) if purchasing power lowers drug prices, presumably more purchasing power can lower them further, and B) this can eliminate two problems: beggar-thy-neighbour provincial drug policies, and changes in one province's policies having unintended negative results in other provinces (i.e. negative externalities, for the economically-inclined ;) ).

A long term concern, however, is whether this will stifle policy and regulatory innovation. With parallel provincial programs comes the opportunity for one province to take the initiative and try something new - maybe it works, maybe it doesn't but at least something new was tried. And if it worked, then all the other provinces could copy it. With a national program, however, there is less scope for experimentation (i.e. Canada can only run one "experiment" at a time), and an innovation might need to gain wider acceptance before actually ever being implemented. This may not make any difference in a 2-3 year timeframe, but over a 20 year timeframe? This may end up not being a good idea in the long run.

Wednesday, June 9, 2010

IP a big issue in Canada/EU trade talks

A short but interesting note: The Spanish ambassador to Canada gave an interview last week where he said the prospects for an agreement are positive, but he highlighted three sticking points: agriculture, government contracts (specifically provincial government contracts), and intellectual property.

One article here: http://www.canadianbusiness.com/markets/headline_news/article.jsp?content=b3524582

Its a bit hard to know what to make of this. The text proposed by the EU would have an incredibly wide-ranging impact on Canadian intellectual property laws. It could be that this is the hold-up - simply the huge number of small to large changes on the table. The Canadians and Europeans might have difficulty getting their heads around the implications of so many changes. Intellectual property has historically been a very difficult thing to negotiate in these free trade deals - mainly because it demands a level of detail and specificity not demanded by other trade topics.

But, its also likely that specific items are contentious - but if so, which ones? One strong possibility is copyright - that's been in the news a lot - but the Canadian government is moving to implement new legislation. (a side question - is the government's new copyright legislation connected to the EU/CA trade negotiations? It wouldn't be the first time that the Canadian government changed IP laws ahead of an international agreement to try to smooth the trade agreement negotiations.)

Another possibility is border measures. Another is geographical indications. Both are big issues to Europe.

I would like to think that the proposed patent and pharmaceutical related issues are being given significant (and from my personal point of view, appropriate) weight in these negotiations.

In any case, it certainly highlights how intertwined intellectual property law and international economic law in general have become.

Sunday, March 21, 2010

Intellectual Property and the Canada/EU Free Trade Agreement: time to pay attention

Canada and the European Union are negotiating a free trade agreement ( CETA ), and I don’t think the Canadian IP community has been paying enough attention. After all, how often does Canada negotiate an intellectual property treaty with a giant partner that cares about Canada’s IP systems? There’s the potential for significant impact on Canada’s IP regime – perhaps greater than the TRIPs Agreement (which was largely anticipated in Canada by the CUSFTA and NAFTA negotiations and Agreements).

The EU’s draft chapter on intellectual property rights – presumably the EU’s starting negotiating position – has been leaked. It came to my attention via Michael Geist's blog, who has mainly focused on copyright issues; but there are several other interesting points in the patent and trade-mark areas.

It should be kept in mind that this is a draft position, not a final document. For all I know, the entire chapter will be scrapped when the final draft treaty comes out. Although I doubt that – official documents over several years including the “scoping exercise” have highlighted intellectual property as a core part of the agreement. IP chapters now seem to be firmly entrenched in the archetype for free trade deals. I could see the two sides digging in their heels on any number of points, however.

From another viewpoint, it is interesting to observe how Canada’s intellectual property laws are influenced by lobbying and through international treaties. When I’ve mentioned this draft to some people, their reaction is “wait a minute – in the US, provision X was balanced out by provision Y – you can’t have X without Y! These things have to balance!” Others ask “is there any reason to think that Canada’s laws on X need to be fixed? Any evidence?”
I think this reflects a lobbying mindset – i.e. that laws are set largely through lobbying by interested groups, which often circle around trade-offs and can be bolstered through argument or evidence of effects. But laws are also influenced by treaties – and yes, the perceived self-interest of states in negotiations is probably set by interest groups, but the context of engagement is different. Specifically, one gets a different set of trade-offs – instead of, for example, trading off the interests of generic versus innovative pharma groups, there might be a trade-off between Canada’s position on intellectual property for pharmaceuticals versus agricultural issues. Also, different people are doing the negotiating – trade negotiators will bring a trade-law mindset to negotiations as opposed to an IP-mindset or pharmaceutical-mindset. More bluntly, the years of lobbying person X at Health Canada might be futile when person Y at the Department of Foreign Affairs and International Trade is the person making the important decisions (and he thinks that pesky person X is pushing a narrow-view agenda compared to the important project of Constructing the International Trade System… etc. etc. )

Suffice it to say I find this all fascinating, but I won’t bore you with an endless diatribe (for that, see my hypothetical book… assuming it ever appears ;) ).

Speaking of the perceived self interest of states and interest groups… it seems that Canadian officials have been disappointed with the lack of commentary and input from Canadians, and are still actively seeking feedback although the official deadline for consultations has passed. This leaked document is a big insight into a (regrettably?) opaque process - maybe now is a good time to speak up before positions are hardened.

Meanwhile, here are the specific points I find interesting (largely ignoring copyright).

1) Data protection for pharmaceuticals

Most importantly, the EU position is that data protection should apply to “data submitted for the purpose of obtaining an authorization to put a pharmaceutical product on the market.” Canada grants data protection only for pharmaceuticals that are “innovative drugs”, and in the mid-2000’s there was a storm of lobbying about the meaning of innovative drugs. The EU position would get rid of all that fussing about with innovative drugs, and just grant data protection widely.

The EU also wants to extend Canada’s data protection regime to 8+2 years rather than the present 6+2 – i.e. no filing an application relying on someone else’s data for 8 years, and no granting an authorization that relies on the data for 10 years.

The EU position is also to extend the period to 11 years if the holder of the basic authorization obtains another authorization for new therapeutic indications of significant clinical benefit compared to existing therapies.

2) Patent term extension

Unsurprisingly, the EU would like Canada to implement patent term extension.

Whatever one thinks of this, the proposed mechanism seems unrealistic – “the period that elapses between the filing of the application for a patent and the first authorization to place the product” on the market minus five years. There is no mention of the actions of the pharmaceutical company in here – i.e. did they move promptly to get marketing approval, or sit on it for ten years? There have been cases in Canada where the marketing approval comes after the expiration of the first relevant patent. This seems to be a free pass for applicants to dawdle.

3) Data protection for plant protection products

Personally, I was unfamiliar with the term “plant protection products” or the idea of granting data protection for related “test or study reports”. A quick google search suggests that plant protection products is a European term which basically means pesticides and herbicides –

“Plant protection products: these are products consisting of, or containing, active substances, safeners or synergists, intended for one of the following uses:
• protecting plants or plant products against all harmful organisms or preventing the action of such organisms, except if they are mainly designed for reasons of hygiene rather than protection of vegetables or vegetable products;
• influencing the life processes of plants, other than as a nutrient (e.g. plant growth regulators);
• preserving plant products, in so far as such substances or products are not subject to Community provisions on preservatives;
• destroying undesirable plants, or parts thereof, with the exception of algae;
• checking or preventing undesired growth of plants, except algae.”


My quick read is that this does not apply to genetically modified organisms (GMOs), although it would apply to pesticides and herbicides designed to be applied to GMOs.

In any case, if a test or study report is necessary for the marketing authorization of the plant protection product, the EU would like a ten year period of data protection to apply starting at the date of first authorization in Canada, to be extended to 13 years for “low risk” plant protection products.

3) Copyright for industrial designs

The EU would like industrial designs to be eligible for copyright protection. This is the opposite of Canada’s present law, which states that copyright cannot be enforced if 50 articles are produced to which the design is applied.

4) Patent Law Treaty

The EU wants Canada to comply with Articles 1 to 16 of the Patent Law Treaty (Geneva, 2000). Canada signed the treaty, but I believe has not implemented it. I don’t think the Patent Law Treaty is particularly contentious – it focuses on the formalities and procedures to obtain a patent – but it might be embarrassing for Canada to implement it while ignoring various copyright treaties that are similarly signed but not implemented.

5) Legal procedures and remedies

The EU draft chapter also has a lengthy section setting out minimum standards for courts and enforcement – i.e. who is entitled to enforce IP, discovery obligations, anton piller and mareva orders, the availability of costs, interlocutory injunctions, what looks like a new legal tool to force disclosure of the distribution networks of infringing goods, the recall from the channels of commerce and destruction of infringing goods, permanent injunctions, the calculation of damages (including elements other than economic factors, such as “the moral prejudice” caused to the right holder), the publication of judicial decisions, border measures, and the standards applicable to administrative procedures.

This section probably has parts that have bite in terms of changing Canadian laws – but I suspect that a big motivation here for the EU and perhaps for Canada is to set precedents for use in other contexts with other countries.


6) Geographical Indications

What would a discussion of European intellectual property concerns be without a reference to geographical indications? Prepare for more fussing about Parma, (C)cheddar and Roquefort cheese, (C)champagne and Newcastle Brown Ale.

Tuesday, March 9, 2010

Bidding war for ratiopharm

Interesting news item: Pfizer and Teva and Actavis are in a three-way bidding war to purchase ratiopharm.

Teva and Actavis are generic drug companies, so its not surprising that they want to buy ratiopharm, which is also a generic drug company. Its interesting that Pfizer would like to buy ratiopharm.

Its another reflection of the blending of "innovative" or "brand name" pharmaceutical companies. (I had a discussion about this with Jocelyn Mackie this morning, so what follows is her thoughts as well as mine)

Innovative companies have been moving into the generic space for a while. One common way to do so is to do what Pfizer is trying to do - buy an established generic drug manufacturer. Another way is for a innovator company to license a generic manufacturer to begin production of a generic product even while the innovator company is still supplying a patent-protected (and more expensive) version - i.e. authorized generics. Or, the brand name company can produce a second version of their product, separately branded and at a lower cost point, then their more-expensive version. Or, most dramatically, as they see their patent protection about to expire, they can reduce their prices for their brand-name product to generic levels and refuse to concede the post-patent market to the generic drug companies.

At the end of the day, the industry is evolving so there is not not as much difference between "innovative" and "generic" drug companies - there may just be pharmaceutical drug companies with different strengths in different product areas and marketing capabilities. Company A may be strongly "innovative" (i.e. lots of patent protection) in one sector and simultaneously compete as a generic in another sector. A more resilient distinction may be in their marketing capabilities - some (innovative) companies have built large sales forces to sell to individual doctors, while other (generic) companies have developed strengths in dealing with pharmacies and governments which does not involve as large a sales force or the same capabilities.

This challenges many fundamental assumptions about public policy in the pharmaceutical arena. Generally, in the past it was easy to assume that innovative and generic companies are fundamentally different, and never the twain shall meet. That assumption is going a bit by the wayside.

This would affect, for example, provincial governments deciding which drugs to place on the formulary and what price to pay for pharmaceuticals. It affects tendering schemes and other price control schemes, which I've written about before. It affects the antitrust analysis of patent settlements in the pharma area. It affects the working of Hatch-Waxman and the PM(NOC) Regulations. It also raises questions about future interest-group lobbying - the commonality of interest between certain groups of companies is eroding. And it is heavily affects consideration of biologics and second-entry biologics - in fact, biologics is probably accelerating the blending of the traditional innovative and generic pharma markets.

Note that I linked to ratiopharm's Canadian website. ratiopharm is a significant player in the Canadian generic marketplace - this 2007 Competition Bureau report states that in 2006, ratiopharm was the fourth largest Canadian generic company measured by sales. Teva, which owns Novopharm, was number two.

Saturday, February 13, 2010

Privilege extended to American patent attorneys

Here is an article I recently published on Lexology (about a motion I argued).

There is apparently a rule against the word "silly" appearing in a legal publication; however, the present Canadian situation on privilege and Canadian patent prosecution is silly (for the reasons I cleverly describe as "odd" and "startling" ;) ). Just to be clear: the court reached the correct decision in DataTreasury, but the overall situation for Canadian patent agents and patent agent/lawyers is, err, less than ideal.



The Canadian Federal Court recently held that in appropriate circumstances, communications between an inventor and an American patent attorney regarding drafting a patent application and prosecution are privileged. It provides important lessons for American and other foreign patentees who wish to assert privilege in Canada.


In DataTreasury v. Royal Bank of Canada et al. (decision dated November 6, 2009, as yet unreported), a Canadian patent case, the defendants sought to compel the patentee DataTreasury to produce documents from the files of the U.S. lawyers who drafted, filed and prosecuted the corresponding U.S. application. These documents included drawings prepared by the inventor to explain his invention to his lawyers, drafts of the patent application, and correspondence. The defendants argued that such documents were relevant to identifying the true inventors of the DTC patent and the possibility of inequitable conduct in patent prosecution.

Instead, the court ruled that such documents were privileged, relying on common law privilege principles as well as the doctrine of comity. This article explains the decision, and outlines how foreign patentees can position themselves to claim privilege over communications with their patent professionals. The lessons from DataTreasury are particularly relevant to American patentees, who often wish to assert their Canadian patent in the context of North American litigation.

Background: Privilege in the Domestic Canadian Context

In Canada, lawyers (who are licensed to practice law) and patent agents (who are licensed to practice in the Canadian patent office) are separate professions. Client communications with lawyers related to legal matters are covered by solicitor-client privilege, and cannot be disclosed in litigation without the permission of the client. However, following old United Kingdom case law (such as Moseley v. Victoria Rubber Co. (1886) 3 R.P.C. 351 (High Court of Justice, Chancery Division)), the Federal Court of Appeal has held that communications between Canadian clients and Canadian patent agents are not covered by solicitor-client privilege, notwithstanding that many legitimate activities of patent agents may involve giving legal advice:

It is clear that, in this country, the professional legal privilege does not extend to patent agents. The sole reason for that, however, is that patent agents as such are not members of the legal profession. That is why communications between them and their clients are not privileged even if those communications are made for the purpose of or giving legal advice or assistance.


This has left Canadian courts, when considering privilege for communications regarding patent drafting and prosecution between clients and professionals who are both lawyers and patent agents, in a difficult position. Case-law states that courts should assess whether the professional was acting as a patent agent or lawyer before deciding whether the communication is privileged. Given the almost indistinguishable difference between “patent agent work” and “legal advice or assistance”, it is unsurprising that courts have reached a confusing mix of decisions. It is generally difficult to predict whether privilege will apply to communications regarding patent drafting and prosecution with Canadian patent lawyers.


Foreign Patent Agents and Lawyers

An additional layer of complexity exists when Canadian Courts consider privilege for foreign patent professionals. Foreign companies and lawyers are often surprised to learn that the simple fact that such communications are protected by privilege under the law in their home country may not be sufficient to have equivalent protection granted by a Canadian court.

For example, in the 2006 Lilly Icos LLC v. Pfizer Ireland Pharmaceuticals case, privilege for communications in the United Kingdom between an inventor and his U.K. Patent Agents was considered by the Federal Court of Canada. Under U.K. law, communications between a person and his patent agent are “privileged from disclosure in legal proceedings in England, Wales, or Northern Ireland in the same way as communications between a person and his solicitor…”.

Nevertheless, the Court held that such communications were not privileged under Canadian law and were required to be produced in the Canadian litigation. Ominously for foreign patentees, Phelan J. of the Federal Court wrote:

The law in this country does not recognize this [the U.K.] patent agent-client privilege and there is no reason to create such a privilege on an ad hoc basis. Judicial comity between countries does not require Canada to recognize a privilege not established in Canada. This is so particularly for a privilege which has been advocated for but never adopted by legislation.

Pfizer chose to market their products in Canada and therefore take both the benefits and burdens of the Canadian legal regime when they sue or are sued in this country.


This case was settled prior to the hearing of an appeal.

Nevertheless, the Lilly Icos case left open the possibility of privilege being extended to communications between inventors and foreign patent agents if such communications qualify for common law privilege under the Canadian application of the doctrine. This issue, and others, were considered in the recent DataTreasury decision.


The DataTreasury Case – Wigmore and Comity


In DataTreasury, Claudio Ballard, the inventor of the patent at issue and a resident of the United States, engaged the American law firm of Pennie & Edmonds LLP to draft, file and prosecute his patent application. The professionals who dealt with the inventor were patent attorneys: lawyers also called to the U.S. Patent Bar as “patent agents”. The defendants, in litigation involving the corresponding Canadian patent, demanded production of communications between the inventor and the Pennie & Edmonds “patent agents” regarding the drafting and filing of the initial U.S. patent application. They argued that under Canadian law the Pennie & Edmonds professionals were clearly acting as patent agents, not lawyers, and under the Lilly Icos case communications with patent agents, domestic or foreign, were not privileged.

Prothonotary Aalto instead ruled that the communications were privileged, under both the common law “Wigmore” test, and as a matter of comity.

Wigmore’s four part test

Under common-law principles, communications are held as confidential on a case-by-case basis if they satisfy the following four “Wigmore” criteria:

(1) The communications must originate in a confidence that they will not be disclosed;

(2) This element of confidentiality must be essential to the full and satisfactory maintenance of the relation between the parties;

(3) The relation must be one which in the opinion of the community ought to be sedulously fostered; and

(4) The injury that would inure to the relation by the disclosure of the communications must be greater than the benefit there by gained for the correct disposal of litigation.

DataTreasury was able to satisfy Prothonotary Aalto that these four criteria were met.

Critically, DataTreasury was able to point to testimony taken during discovery from the inventor that he was careful not to disclose his invention, that he approached Pennie & Edmonds because they were lawyers and he wanted to obtain confidential, and legal, advice. This satisfied the first criteria. Based upon this, the Court was able to find that the relationship in this particular case was an attorney-client relationship. In turn, this cemented the relevance of related U.S. cases on attorney-client privilege, such as Spalding Sports Worldwide and Knogo. This factual finding underpins the other three Wigmore criteria.

Unlike in the Lilly Icos case, in DataTreasury the foreign patent professionals were lawyers as opposed to patent agents. As a result, the relation between the client and professional was an American attorney-client relationship. Canadian courts are quite familiar with the American concept of attorney-client privilege and its basis in ensuring full and frank communication between clients and attorneys, satisfying the second Wigmore criteria.

Attorney-client or solicitor-client privilege is one which both American and Canadian legal systems believe should be sedulously fostered, satisfying the third Wigmore criteria.

The fourth Wigmore criteria was not explicitly dis-cussed in the decision, although implicit in the recognition of attorney-client privilege is the notion that great injury would inure to the client/attorney relationship if confidentiality is breached.

Comity

Prothonotary Aalto also grounded his decision in the notion of comity. He noted that comity – Canadian courts recognizing the laws of another jurisdiction – is grounded in a concern to be fair to a party that operates and arranges their affairs in accord with a foreign system:

In this case, comity also requires that this Court consider and give effect to the established expectation in the U.S. regarding privilege. The Knogo case, supra, supports the proposition that privilege attaches to communications between inventors and their counsel who are also patent agents. Here, the communications between Mr. Ballard and his U.S. lawyers originate in the confidence that they will not be disclosed. That is supported by the questions and answers referred to on the examination of Mr. Ballard. In the U.S. litigation, this information would not be compelled to be disclosed and, in my view, the same position should obtain in the Canadian litigation.


This last point - “in the U.S. litigation, this informa-tion would not be compelled to be disclosed and, in my view, the same position should obtain in the Ca-nadian litigation” - may be the most interesting part of the DataTreasury decision. While the court in Lilly Icos was hostile to the notion that Canadian courts should take into account foreign laws when making privilege decisions (stating that if patentees want to enforce patents in Canada, they need to play by Canada’s rules), the DataTreasury decision instead reflects a willingness to consider whether a particular privilege ruling is fair to foreign parties before the Canadian court.


The Canadian Position after DataTreasury

Oddly, the DataTreasury decision leaves Canadian patent agents, and Canadian patent agent/lawyers, at a disadvantage under Canadian law compared to foreign patent agents and foreign patent agent/lawyers. A Canadian patentee who uses Canadian patent professionals to draft and file a priority application may be unable to claim privilege under Canadian law, depending on whether a court judges the communication to fall under a “patent agent” purpose. Meanwhile, a foreign patentee who uses foreign patent professionals may be able to claim privilege under Canadian law as a matter of comity or common-law privilege.

While this is entirely consistent with international economic law, where countries typically reserve the privilege of treating their own nationals less favourably than foreign entities, it is startling to see this arise in an industrialized country in an area as important as patent law. The DataTreasury decision may give an impetus to Canadian efforts to change this situation.


Lessons to Draw from the DataTreasury Decision

The DataTreasury decision lays out a roadmap to be followed in future motions by patentees who wish to keep their discussions with their foreign patent professionals privileged. Success on the motion will be determined by the quality of evidence on the following points:

a) Was the inventor seeking “legal advice” when approaching the foreign patent professional?

b) Did the inventor regard the confidence of communications with the foreign patent professional as important when establishing the relationship or making the communication?

c) Are communications between the patent professional and inventor covered by privilege in the foreign jurisdiction?

d) What is the reasoning behind granting the privilege? Would denying privilege in Canada frustrate the reasoning behind granting the privilege in the foreign country?

e) Can the privilege in the foreign jurisdiction be characterized as attorney-client or solicitor-client privilege?

These points will generally be easier to establish for communications between an American patentee and professional than for communications in other countries. Most importantly, communications between a U.S. inventor and a U.S. lawyer/patent agent are formally covered by attorney-client privilege as opposed to some other privilege, which has a clear and highly protected counterpart under Canadian law. The U.S. inventor can thus usually sidestep the thorny issue of whether a particular communication was to the U.S. patent attorney as agent or lawyer.

The general familiarity Canadian courts have with American law and decisions make it easier to prove to a Canadian court that American attorney-client privilege applies to the specific communications at issue. Canadian courts will be more comfortable reading American cases such as Florida Bar v. Sperry, Spalding Sports Worldwide and Knogo than foreign legislation or cases establishing privilege for patent agents. The similarity of professional desig-nations between Canada and the U.S. – where professionals are separately qualified as a lawyer and to practice before the patent office – also assists in making the Court comfortable with ruling on privilege.

The difference between the successful patentee in DataTreasury and the unsuccessful patentee in Lilly Icos largely circles around the superior evidence in DataTreasury on these critical points. Even in the case of communications with an American patent attorney, it seems that evidence from the inventor as to who they sought advice from and his/her expectations is central to the success of asserting privilege. When conducting litigation in Canada, it would be prudent for a foreign patentee to consider how to prove these points at an early point in the litigation and lay the evidentiary groundwork for success in a privilege motion. From a broader and earlier point of view, inventors (particularly repeat patentees) should consider always consulting “lawyers” for patent drafting and prosecution advice to enhance the likelihood that such communications will be considered privileged in foreign litigation.

Please note that Gilbert’s LLP represented Data-Treasury in the decision discussed in this article. This article should not be taken as the views of DataTreasury or of Gilbert’s LLP.

Thursday, October 1, 2009

Canadian courts confirm differential profits approach to Accounting of Profits cases

Just catching up on things. I wrote this for Lexology a little while ago. Thanks to Art Renaud for bringing these cases to my attention.

Two recent Federal Court of Canada cases held that when calculating an accounting of profits in patent cases the “differential profits” approach - comparing the profits actually made with those that would have been made using the best non-infringing option – must be applied. These decisions, combined with the Supreme Court of Canada’s decision in Monsanto v. Schmeiser, are important precedent for the application of the accounting of profits remedy in patent cases in Canada and the Commonwealth.


The two cases, both decided by Zinn J., are Monsanto v. Rivett, 2009 FC 317 and Monsanto v. Janssens, 2009 FC 318.

“Actual profits” vs. “differential profits”: what’s at stake?

The accounting of profits is the dominant monetary remedy for patent infringement in Canada. Unlike damages, which measures the amount of the remedy by the loss of the successful plaintiff, the accounting of profits award forces the defendant to disgorge the profits attributable to the infringement. In Commonwealth countries, successful patent plaintiffs often can choose the accounting of profits instead of a damages award, and in fact generally do so, for strategic reasons (it is easier to protect sensitive information in an accounting of profits inquiry than a damages inquiry) and/or because of an expectation that the accounting of profits award will be larger than a damages award.

There are two competing theories on how to calculate the size of an accounting of profits award:

• subtract costs from the gross revenue attributable to the infringement – the “actual profits” approach

• subtract the profits that would have been made using the best non-infringing option from the actual profits made – the “differential profits” approach

These have been much debated in the case-law since the accounting of profits remedy was revived in the early 1980s. Since the actual profits approach will usually generate a larger award on the facts in the cases where an accounting of profit has been sought, the plaintiffs typically support this approach, with the defendants proposing the differential profits approach.

Until 2004, the results in the cases were fairly one-sided, with several decisions explicitly rejecting the differential profits doctrine in favour of the actual profits doctrine, and no case clearly adopting the differential profits approach.

As a practical matter, these approaches can lead to very different sizes of award. For example, in the Schmeiser case, the application of the differential profits approach reduced the plaintiff’s monetary award to zero. In the Rivett and Janssens cases, the application of the differential profits approach decreased the plaintiff’s monetary awards by 69%.

Debate: the innocent infringer and the
Supreme Court of Canada decision in Schmeiser


The debate between the actual and differential profits approaches took a dramatic turn in 2004 in the Supreme Court of Canada case of Monsanto v. Schmeiser. In that case, the defendant Percy Schmeiser was found to have deliberately raised and sold a crop of genetically modified canola and liable for infringing a Monsanto patent. The trial judge awarded an accounting of profits, and using the actual profits approach awarded Monsanto $20,000. The Supreme Court instead applied the differential profits approach, finding that the defendant’s profits “were precisely what they would have been had they planted and harvested ordinary canola. … The appellants' profits arose solely from qualities of their crop that cannot be attributed to the invention." Hence, there was no difference between the defendant’s profits with and without the infringement, and the Supreme Court held that no profits at all were to be awarded.

Nevertheless, the Supreme Court’s treatment of the issue led to further debate. If the Supreme Court was mandating a causation based approach to the accounting of profits remedy resulting in the differential profits approach, this was the portion of the Schmeiser decision with the greatest practical impact. However, the section dealing with the accounting of profits remedy was a scant five paragraphs long, and did not discuss any of the twenty years of case law it was supposedly overruling. While many practitioners embraced the Schmeiser decision as making the differential profits approach as a new “rule of law”, others saw Schmeiser as a signal that the differential profits approach should be used when appropriate, but that courts were free to apply the actual profits or differential profits approach as appropriate based upon the facts and equities of the case before them.

Clouding the issue is the possibility that the Supreme Court was determined to issue a ruling applying the differential profits approach to accounting of profits for a reason not directly before the Court - the “innocent infringer” problem. With the patenting of genetically engineered crops arises the possibility of the “innocent infringer” – exemplified by a person who unknowingly cultivates genetically modified crops with a patented gene after seed blows onto their land. Since patent infringement does not require knowledge either of the patent or that the impugned acts might infringe a patent, the “innocent infringer” is still infringing a patent. Although the amount of damages in such a situation is likely to be small, under the actual profits approach to the accounting of profits the innocent infringer could be liable to disgorge the entire profits from the sale of the tainted crop.

Such a result seems unfair on its face, and led to calls in Canada by expert commissions for changes to patent law, including special innocent infringer exceptions and rules. In reply, legal experts (primarily Professor Norman Siebrasse of the University of New Brunswick) answered that such changes were unnecessary and counterproductive, since a proper application of well-established principles of causation in remedial awards from general tort law in the patent context would lead to the differential profits approach. Under a differential profits approach, the “innocent infringer” would not have gained any particular profits beyond the best non-infringing option (the use of unpatented seed), and any monetary award against an innocent infringer would be modest at best.

On the actual facts of the Schmeiser case, the defendant was not an innocent infringer. Nevertheless, the Schmeiser case did involve genetically modified plants, and the writings of Professor Siebrasse were specifically cited by the Supreme Court. It is certainly arguable that the Supreme Court only applied the differential profits test in response to concern over the innocent infringer problem, and did not intend that the differential profits approach should always be applied when calculating an accounting of profits.

The recent decisions of Zinn J. in Rivett and Janssens

This was the state of affairs until the cases of Monsanto v. Janssens and Monsanto v. Rivett, were released in March 2009. These cases, heard together before Zinn J. of the Federal Court, both were factually similar to the Schmeiser case: all of the defendants were found to have deliberately planted, harvested and sold genetically modified soybeans, thus infringing a Monsanto patent. The plaintiffs elected an accounting of profits remedy, and urged Zinn J. to apply an actual profits approach. The defendants took the position that, following Schmeiser, Zinn J. was bound to apply the differential profits approach.

Given the factual similarity between the Schmeiser, Janssens and Rivett cases, it is unsurprising that Zinn J. followed the Supreme Court’s lead and applied the differential profits approach.

What is more interesting, and a strong signal to the patent bar in general, is that Zinn J. was clearly of the view that the ruling in Schmeiser set a new legal rule, and the differential profits approach should be applied in all future accounting of profits cases.

Noting that the Supreme Court “relied heavily on and arguably adopts Professor Siebrasse’ analysis of an accounting of profits”, Zinn J. argued that the Supreme Court had established that a causal link must be found between the profits awarded and the invention that is protected. This causation requirement necessarily results in the application of the differential profits approach.

Zinn J. hastened to add that the differential profits approach could still be reconciled with much of the existing case law. In many cases, there was no “best non-infringing option”, resulting in the actual profit and differential profit approaches becoming identical. In other cases, the courts first calculated an amount using the actual profits method, but then performed an apportionment in an attempt to limit the award to the profits actually earned from the use of the invention – essentially, an attempt to reach a causation-based result without the benefit of a causation-tailored approach.

Zinn J. summarized the steps required under the differential profits approach as follows:

a) Is there a casual connection between the profits made and the infringement?’ if there is none, then there are no profits that require an accounting.

b) If there is a causal connection, then what were the profits made by the infringer as a result of the infringement? This amount I shall describe as the Gross profits of Infringement.

c) Is there a non-infringing option that the infringer could have used?

d) If there is no non-infringing option, then the Gross Profits of Infringement are to be paid over to the patentee.

e) If there is a non-infringing option, then what profit would the infringer have made, had he used that option? This amount I shall describe as the Gross Profit of Non-Infringement.

f) Where there was a non-infringing option available, the amount to be paid over to the patentee is the difference between the Gross Profits of Infringement and the Gross Profits of Non-Infringement. This sum is the profit that is directly attributable to and that results from the infringement of the invention.

Zinn J. then proceeded to apply this analysis in the cases at hand. In both cases, the application of the differential profits approach instead of the actual profits approach lowered the award by 69%. The defendants were ordered to disgorge $40,137 in the Rivett case and $11,363 in the Janssens case.

Existence of a non-infringing comparator

Zinn J. had little difficulty in finding that the appropriate non-infringing comparator was “soybean seed that has none of the plaintiff’s invention” – i.e. conventional soybean seed. He rejected the suggestion of the defendants that the comparator should be the price of buying seed from Monsanto and thus obtaining a license.

A difficulty arose as the evidence before the Court was that conventional soybean – i.e. soybean seed not containing the patented genes – was not available on the market, or at least not available at the local co-op. Arguing that the fundamental purpose of the accounting of profits remedy was to “discover the value that the invention has brought to the product”, Zinn J. held that the market availability of the best non-infringing option is not determinative. “If one uses a comparator only if it is actually physically available for use, but not when it exists but is physically unavailable, the fact that the resulting crop has a value apart from the invention will be ignored.”

The accounting of profits remedy going forward

It will be interesting to see if the clear adoption of the differential profits approach as a rule of law by Zinn J. will be followed in other courts, particularly in the United Kingdom and Australia.

In some quarters, the accounting of profits remedy has acquired a reputation as being more difficult to administer than a damages award. Since the accounting of profits award is an equitable remedy and its award is always in the discretion of the court, some courts have taken the position that the plaintiffs need to justify the choice of an accounting remedy instead of being given a free choice. While it may be appropriate for plaintiffs to provide the court with reasons why they should receive an accounting of profits award, the differential profits approach underlies the parallel nature (and difficulty) of the damages and accounting of profits awards. Damages seeks to return the plaintiff to the position they would occupy if there was no infringement; accounting of profits seeks to return the defendant to the position they would occupy if there was no infringement. There is no reason in principle why one remedy should be more difficult to apply than the other.

The adoption of the differential profits approach will often result in lower accounting of profits awards. However, plaintiffs often make their choice of remedies for reasons other than the size of the monetary award, and in some cases the differential profits approach will give a larger accounting of profits award than the actual profits approach. While we may see more damages cases coming out of patent cases in the Canadian courts, it is unlikely that the accounting of profits award will become unused. Successful plaintiffs will need to seriously consider their choice between the damages and accounting of profits remedies in light of these decisions.

Thursday, July 16, 2009

Damages Calculations in Intellectual Property Cases in Canada (2007)
Norman Siebrasse, Alexander Stack, and the Cole & Partners IP Litigation Support Group
(2008) Vol 24 No. 2 Canadian Intellectual Property Review, pp 153-188


This is an update of an article we (members of Cole & Partners and I) first published in 2001. As with our recent article on accounting of profits, a big change is the addition of Norman Siebrasse as a co-author. Norman certainly bring a new level of vigor and rigorous thinking to these issues, which I think is reflected in the final article.

This is an update - and the fundamental law of damages has not changed since 2001. However, there is a greater emphasis in recent case-law - and in the article - on the remedial basis for the remedy, and on grounding patent law (including remedies) in fundamental common law tort principles. This leads to some interesting questions - for example, is the commonly stated rule from United Horse Shoe (1888, House of Lords) that damages are calculated assuming the infringer had never entered the market, or that it is not relevant that the plaintiff would have been equally hurt had the defendant produced a non-infringing product, good law? My suspicion is that it is not.

As with the Accounting of Profits article, the CIPR version of the article is heavily cut from the version available on the Cole & Partners website .

Monday, April 20, 2009

FCA: basis for a sound prediction must be in application

Also of interest – an FCA decision which supports the necessity of providing the facts to support a sound prediction in the patent application (the opposing position being that it is sufficient to have the facts at the time of the application, but that it is not necessary to put them in the application).

[10] Based on the foregoing, it is clear that the invention was based on a prediction. Although the rat studies were positive, only a prediction could allow for the proposition that raloxifene had the same effect on women, let alone estrogen deficient post-menopausal women who suffered from bone loss. In other words, the claimed utility required for patentability was not demonstrated but predicted based on the information provided in the ‘356 Patent.


[11] The appellant further argues that the Federal Court Judge erred in holding that the ‘356 Patent lacks adequate disclosure. In this respect, the appellant essentially alleges that there is no requirement that the underlying data supporting a sound prediction be disclosed in the patent. It contends that the Federal Court Judge misconstrued recent judicial pronouncements on the issue of sound prediction.



[12] In making this argument, the appellant at the hearing accepted for purposes of the appeal the conclusion reached by the Federal Court Judge at paragraphs 155 and 156 of his reasons that the Hong Kong study was required in order to turn the prediction on which the ‘356 Patent was predicated into a sound one. According to the Federal Court Judge, the Hong Kong abstract of the study conducted by the appellant on 251 post-menopausal women which concluded that “raloxifene show[ed] promise as a skeletal anti-resorptive” would have been a sufficient factual basis upon which a sound prediction of utility for raloxifene could have been made as of the filing date. However, this study was not disclosed in the ‘356 Patent with the result that the underlying factual basis for the prediction and the sound line of reasoning that grounded the inventors’ prediction were not disclosed.



[13] The importance of the disclosure obligation in applying for a patent has been emphasized by the Supreme Court of Canada on a number of occasions in recent years (Pioneer Hi Bred Ltd. v. Canada (Commissioner of Patents), [1989] 1 S.C.R. 1623 at paragraph 23; Cadbury Schweppes Inc. v. FBI Foods Ltd., [1999] 1 S.C.R. 142 at paragraph 46; Free World Trust v. Électro Santé Inc. 2000 SCC 66, [2000] 2 S.C.R. 1024 at paragraph 13; Apotex Inc. v. Wellcome Foundation Ltd., 2002 SCC 77, [2002] 4 S.C.R. 153 at paragraph 37 (commonly referred to as AZT and hereinafter referred to as such)).



[14] The decision of the Supreme Court in AZT is particularly significant to the disposition of this appeal. According to AZT, the requirements of sound prediction are three-fold: there must be a factual basis for the prediction; the inventor must have at the date of the patent application an articulable and sound line of reasoning from which the derived result can be inferred from the factual basis; and third, there must be proper disclosure (AZT, supra, at paragraph 70). As was said in that case (para. 70): “the sound prediction is to some extent the quid pro quo the applicant offers in exchange for the patent monopoly”. In sound prediction cases there is a heightened obligation to disclose the underlying facts and the line of reasoning for inventions that comprise the prediction.



[15] In my respectful view, the Federal Court Judge proceeded on proper principle when he held, relying on AZT, that when a patent is based on a sound prediction, the disclosure must include the prediction. As the prediction was made sound by the Hong Kong study, this study had to be disclosed.
Eli Lilly Canada v. Apotex (another one! - case names get repetitive in this area) 2009 FCA 97

Costs: straight talk by Justice Hughes

I don’t think this says anything new, but costs in NOC proceedings were dealt with pretty straightforwardly by Justice Hughes in Eli Lilly Canada v. Apotex, 2009 FC 320. Apotex was successful in fending off Lilly’s request for a prohibition order. Note the comment regarding allegations of fraud:


[67] Apotex costs are to be assessed in accordance with the middle of Column IV. Two counsel, a senior and a junior, are allowed for at the hearing and, if in attendance, in conducting cross-examination. One counsel, a senior, is allowed in defending a cross-examination. No costs or disbursements are allowable for any other lawyers, in house or out house counsel, paralegals, students, clerical persons or any other persons other than the expert witnesses that I shall name whose evidence was made of record.

[68] The fees and disbursements actually paid by Apotex or its solicitors to Dr. McClelland and Dr. Williard are allowed provided that they are not disproportionately larger than those charged by the Applicant’s experts. No fees or disbursements allowed in respect of any other witness.

[69] As in some other proceedings of this kind, Apotex raised an allegation in its Notice of Allegation as to section 53 of the Patent Act, an allegation that is close to an allegation of fraud. This allegation remained in play at least until it did not appear in Apotex’s Memorandum of Argument. At the hearing Apotex’s counsel formally acknowledged that it did not rely on this allegation. Apotex’s counsel also assured the Court that the format of its more recent Notices of Allegation was changed to eliminate section 53 allegations. Nonetheless, Apotex’s counsel did not at any early stage in these proceeding notify the Applicant that it would not rely on section 53, a simple enough matter that could have been done by a letter. Therefore I will again direct that the fees and disbursements recoverable by Apotex shall be reduced by twenty-five percent having regard to the section 53 allegation.

Also, another plea for PM (NOC) reform:

[19] I endorse the sentiments expressed by Harrington J. of this Court in Lundbeck Canada Inc. v. Canada (Minister of Health), 2009 FC 146 at paragraph 74 where he wrote that we really do not have evidence by way of actual persons or even “talking heads” in proceedings such as this, we simply have words on pieces of paper. Other than in the most exceptional cases, a Court is not in a position to come to any conclusions as to whether certain witnesses were evasive, or acted as advocates or acted in other ways urged by counsel so as to encourage the Court to take a dim view as to demeanour of any other party’s witnesses. I add my voice to those crying in the wilderness for improvements in the process.

Wednesday, December 3, 2008

Competition Bureau Report on the Generic Drug Industry

Grade: Incomplete ;)


As noted below, last Thursday (November 25), the Competition Bureau came out with “Benefiting from Generic Drug Competition in Canada: The Way Forward”. This was the second report in an ongoing advocacy effort by the Competition Bureau to encourage governments to adopt policies that will increase competition in the generic drug industry (see http://www.competitionbureau.gc.ca/epic/site/cb-bc.nsf/en/h_02704e.html, which discusses the Bureau’s health industry efforts).

Inevitably, this sort of report always contains lots of grounds for criticism, and I have little doubt that criticisms will appear in print (and, of course, behind the scenes) in the near future. But when I read this report, one big comment leaps to mind. (and I think its a whale*)

This report ignores the role of generic drug companies in making drugs “generic” in the first place. As a result, it risks recommending measures that might decrease the cost of generic drugs but increase the cost of pharmaceuticals to Canadians overall. It also misses the opportunity to investigate which measures might best decrease the cost of generic drugs to consumers while maintaining the pipeline of drugs moving to a generic, multisource market.

“Brand name” drugs are drugs protected by patents held by the producing company. As with patents in all industries, some patents issued in the pharmaceutical industry are invalid (i.e. never should have been issued in the first place) or issued with claims that are too broad. In most industries, a company that sees a competitor with patents that it thinks are invalid or too broad may choose to simply launch its product and see if the competitor wishes to risk its (weak?) patent position in a lawsuit.

The pharmaceutical industry is different. Under the PM (NOC)** regulations, a generic company that wants to bring a product to the marketplace that is nominally protected by a patent must notify the patent owning brand name company. Under the regulations, the brand company can then begin a proceeding for a non-binding determination of whether the generic company’s products would infringe the patent – and obtain an automatic 24 month injunction forbidding Health Canada from giving permission to the generic company to market a generic version of the drug. Meanwhile, if the generic loses the non-binding, summary proceeding (a proceeding with only limited evidence and argument), Health Canada is permanently forbidden to allow the generic product on the market until the final expiry of the patent. On the other hand, if the brand name company loses, it still can get a second kick at the can by suing the generic for patent infringement.

In other words, pharmaceutical patents by government regulation pose greater barriers to entry than patents in other industries. Generic companies must surmount these hurdles before bringing their less expensive medicines to the public.

And this costs money.

The PM(NOC) system rests, as a matter of policy, on generic drug companies with the capability and interest in supporting patent challenges. This may be looked at in two ways: are the Canadian markets for generic drugs profitable enough to justify a generic company spending money to challenge patents via the PM(NOC) process?; and do the generic drug companies interested in the Canadian market have enough reliable profits to fund the risky endeavour of challenging questionable patents?

In other words, reducing the profitability of generic drug companies that supply the Canadian market – for example, in the pursuit of lower prices for the paying public – comes at a cost of reducing challenges to pharmaceutical patents in the future. Given the high expense of pharmaceutical drugs, and a typical drop of some 80% in costs for a medicine after it becomes generic, the costs to consumers of delaying the move of even a few drugs to a generic status via patent challenges – i.e. maintaining higher prices for presently-patented drugs - could easily outweigh the benefits of lower generic drug prices. For example, one year of Lipitor freed of patent protection and supplied at generic rather than brand name prices would be word hundreds of millions of dollars alone. Recall that generic drugs are already off-patent, and thus relatively inexpensive.

This is a key trade-off in health policy in respect of pharmaceutical pricing. The generic and patented drug markets are directly connected in Canada, and their effects on consumer welfare cannot be coherently analyzed in isolation.

However, there is no mention of this trade-off in the latest Competition Bureau report – and scarce mention in the previous report in 2007. The latest report seems to assume that drugs become generic following patent expiry, and simply goes on to discuss how competition may be improved in the already-generic drug market.

This lack of attention is particularly worrisome, since the Competition Bureau report finds that competition among generic drug companies is already fierce – suggesting that policy changes that further squeeze the profitability of generic drug companies may have a meaningful and negative impact on these companies’ ability to fund future patent challenges.

Undoubtedly, this is a difficult trade-off, and really needs to be addressed through empirical investigation. Of course, this is easier said than done – for example, the European Competition Commission report on the pharmaceutical industry in Europe*** is admirably empirical, but obviously a huge undertaking (the results are not directly applicable in Canada, since Europe does not have a PM(NOC)-style linkage system).

However, the Competition Bureau is presumably motivated by consumer welfare – and when making policy analyses and recommendations in an industry, it should at least raise the more obvious routes through which the industry being studied affects consumer welfare, even if only to clearly state that its recommendations are limited by a lack of empirical knowledge on a particular point.

The absence of discussion on this point in the Competition Bureau’s report is unfortunate, as there is no necessary conflict between the goals of lowering generic drug prices for consumers and maintaining the incentives and ability of generic drug makers to challenge pharmaceutical patents. There are many players involved in the generic drug market other than generic drug manufacturers, and the Competition Bureau report itself has several suggestions to lower the cost of generic drugs to the public that would not meaningfully affect the profitability of generic drug companies.

Even if one considers measures aimed specifically at achieving lower drug prices from the generic drug companies, such measures could be designed to maintain an incentive for generic drug companies to challenge patents. For example, one could temporarily allow the first generic to successfully challenge a patent to temporarily be the only generic in the market – say, for six months, as is done under equivalent legislation in the United States. Similarly, provinces could implement progressively more aggressive pricing strategies over time starting from a successful PM(NOC) challenge, thus maintaining some reward for challenging patents.

Personally, I hope to see issues like this highlighted in the next Competition Bureau study.



* In keeping with my recent focus on harpooning whales, not minnows ;)
**Patented Medicines (Notice of Compliance)
*** http://ec.europa.eu/comm/competition/sectors/pharmaceuticals/inquiry/index.html

Monday, December 1, 2008



I have published an article on the Ontario tendering situation in the latest issue of the Food and Drug Law Institute's Update magazine.

I will post a link to the actual article here if I can figure out how to do so ;).

Thursday, November 6, 2008

New this morning: SCC decision approving selection patents, plus tests for anticipation and obviousness

Today was a hectic day at work. Not only have we just come off the madness of the three-day summer student recruitment period (meaning no one has done any legal work the last three days), but the Supreme Court of Canada released the highly-anticipated decision in Apotex v. Sanofi-Sythelabo. This case was closely watched because Apotex challenged the basic validity of all selection patents as a matter of law. Perhaps unsurprisingly, the Supreme Court affirmed selection patents in principle. However, the Court also went on to establish general tests for anticipation and obviousness that will apply to all Canadian patents.

In response, we quickly created and fired off a newsletter to our clients quickly outlining the case, and promising a more in-depth analysis to come. Here is the quick analysis.


This morning, the Supreme Court of Canada released a decision addressing the doctrine of selection patents and the tests for anticipation and
obviousness.


Selection patents are of considerable importance in Canadian patent law, particularly in the area of pharmaceuticals. This is the first decision of the Supreme Court to directly approve of selection patents. The Court’s statements on anticipation and obviousness also extend to all patents, selection or not.

Our preliminary analysis is that while Apotex lost this particular case, the Supreme Court has not given a green light to every selection patent. The validity of Canadian selection patents will very much depend on whether the claims are something special and inventive above the known prior art.

Apotex Inc. v. Sanofi-Synthelabo Canada Inc., 2008 SCC 61

Procedural History:

Sanofi-Synthelabo Canada Inc. is the owner of Ca-nadian Patent No. 1,336,777 (the “777 Patent”). Sanofi had previously obtained Canadian Patent No. 1,194,875 (the “875 Patent” or the “genus patent’) which covered a large class of compounds useful in the treatment of coronary artery, peripheral vascular and cerebral vascular diseases. The 777 Patent covered a subclass of compounds that were previously disclosed in the 875 Patent, including clopidogrel bisulfate, a particular compound with properties superior to the compounds generally disclosed in the 875 Patent. Sanofi commenced NOC proceedings against Apotex, who wished to launch their own clopidogrel bisulfate product, and Sanofi won at the FC and FCA level on the basis that Apotex’ product would infringe Sanofi’s 777 patent. Apotex appealed to the SCC on the basis that this selection patent was invalid on the grounds of anticipation, obviousness and double patenting.

The Decision:

Justice Rothstein, writing for a unanimous court, dismissed Apotex’ appeal on all grounds.

The Court accepted selection patents in principle. Rothstein J. cited the UK In re I.G. Farbenindustrie case to find that a selection of compounds from those described in general terms and claimed in a fist or genus patent may be claimed in a second patent if:

1. There is a substantial advantage to be se-cured or disadvantage to be avoided by the use of the selected members;

2. The whole of the selected members (subject to “a few exceptions here and there”) possess the advantage in question; and

3. The selection must be in respect of a quality of a special character peculiar to the selected group. If further research revealed a small number of unselected compounds possessing the same advantage, that would not invalidate the selection patent. However, if research showed that a larger number of unselected compounds possessed the same advantage, the quality of the compound claimed in the selection patent would not be of a special character.

The Court emphasized that selection patents still must meet the standards of anticipation and obviousness.

Anticipation:

In order to determine whether a patent has been anticipated, a two-step approach should be taken. First, did the prior art disclose subject matter which, if performed, would necessarily (without trial and error) infringe the patent? Second, the person skilled in the art (PSITA) must be enabled by the prior art to perform the invention without undue bur-den. A question at the enablement stage is how much trial and error or experimentation is permitted.

In the case of selection patents, the Court interpreted the disclosure test as whether the first patent dis-closed the special advantages of the invention covered in the second patent. In the case at hand, the Court found that the 777 patent was not anticipated because the 875 Patent did not disclose the special advantages of clopidogrel bisulfate disclosed in the 777 Patent.

Obviousness:

The obviousness test adopted by the SCC followed a four-step approach derived from the UK case of Windsurfing International Inc. v. Tabur Marine (Great Britain) Ltd.

• First, the PSITA and his / her relevant general knowledge is determined.

• Second, the inventive concept of the claim in question is determined.

• Third, differences between the “state of the art” and the inventive concept of the claim must be identified.

• Fourth, the court decides whether the differences are obvious or would have required any degree of inventiveness.

The fourth step is done without any consideration of the alleged invention as claimed.

In the analysis of inventiveness, the court adopted an “obvious to try” approach in which routine experimentation does not make the patent inventive. Rather, some testing is explicitly permitted without rendering the invention non-obvious. The analysis requires looking at four factors:

(a) is it self-evident that what is being tried ought to work, and is the number of predictable solutions finite?

(b) how much effort is required to achieve the invention?

(c) is there a motive provided to find the solution the patent addresses?

(d) perhaps considering the evidence of the actual course of conduct (a long and expensive or short and inexpensive effort?) which resulted in the making of the invention.

However, Rothstein J. cautioned against over-application of the “obvious to try” test, writing that it is “not a panacea for alleged infringers.” Notably, the test is not a simple conclusion that if X is obvious to try, then X is obvious. Even if X is obvious to try, X may still be non-obvious if it succeeds only after difficult or expensive experimentation.

In this case, the Court found that the invention was not self-evident from the prior art, and most importantly that Sanofi had spent “millions of dollars and several years developing [the racemate] up to the point of preliminary human clinic trials” before the discovery that the invention of the 777 Patent was superior to other compounds disclosed in the 875 Patent. Therefore, the 777 Patent is not obvious.

Double patenting:

The Court found that there is no inherent conflict be-tween the doctrines of double patenting and selection patents. The SCC acknowledged that evergreening is problematic, but left that concern to be addressed through the tests for anticipation, obviousness and double patenting. The Court stated that there is a valid general concern about double patenting, but selection patents can play an impor-tant role in encouraging improvements over the original genus patent.

We will be completing a more fulsome analysis of the case in the coming days. In the meantime, please feel free to contact us.

Emily Kettel (Student-at-law)
Alexander Stack
Sara Zborovski

Gilbert's LLP

Monday, August 11, 2008

Ontario Formulary Moves Towards Tendering

Here's a topic that occupied a bit of my time earlier this month. (Then, I went on holiday, and left my colleagues holding the bag ;) ) Its a bit out of date and a bit rough, but still gets the main points across...


ONTARIO FORMULARY MOVES TOWARDS TENDERING


The Ontario government recently announced a new tendering program for the listing of generic pharmaceutical products as benefits on the Ontario Drug Benefit (“ODB”) formulary. This program promises to radically change the way multi-source drugs are sold in the $7.6 billion Ontario pharmaceutical market.

A move towards tendering on the ODB formulary is a critical public policy issue, connecting the cost of pharmaceuticals to the public, the cost of administering the ODB programs to the Ontario government, Federal patent and pharmaceutical policy, revenue streams for pharmacies, and the future structure and health of the generic pharmaceutical industry. The resolution of these questions will have significant long-term results, and will also reflect the Ontario government’s ability to generate and implement good public policy. This presents strong challenges – both immediate and long term – for the generic pharmaceutical industry, and may also have a significant long-term impact on the brand-name industry in Canada.

The Ontario Drug Market

To market pharmaceuticals in Canada, a company must first obtain a Notice of Compliance (NOC) from the Canadian federal government. In Ontario, the next step for generic drugs is to be listed as interchangeable and a benefit on the provincial drug plan formulary. Interchangeability, which controls which drugs may be interchangeably dispensed by a pharmacist when filling a prescription, is not affected by the new tendering program.

A listing as a benefit means that the Ontario government will pay for the product for patients who are covered by the ODB scheme, generally based on age and financial status. A key issue is the amount the Ontario government is willing to pay for a given product, the “list price”, which is negotiated up-front. Generally, as long as a generic product was able to ensure supply and meet Ontario’s cost expectations (generally 50% of the reference “brand” price), it would be listed on the formulary.

A listing as a benefit on the formulary is the key to both the public (covered by the ODB scheme) and private markets in Ontario. Most pharmacies stock only two versions of a drug, the brand name and one generic, to minimize the pharmacy’s operating costs. Generally, a manufacturer’s product that is not listed as a benefit is not likely to be purchased by pharmacies, who instead will purchase a product that can be sold to their ODB customers as well as their non-ODB customers. Once listed as a benefit, generic pharmaceutical manufacturers compete for pharmacy shelf-space by offering the pharmacies professional allowances - after-sale rebates that are limited to 20% for ODB sales and unlimited as a percentage of sales in the private sector market.

There is a two-tier pricing system in Ontario under which private sector payers pay more for generic and brand-name pharmaceuticals than the price listed on the ODB formulary. In the case of brand-name drugs, the ODB Executive Officer may negotiate secret rebates from brand-name drug makers for patented products. The tendering scheme extends this to the generic drug sector.

The New Tendering Scheme

Under the new scheme, companies will bid for listing as a benefit on the ODB formulary. The two best bids will be listed as benefits for a two-year term (with a possible one-year extension), while all other companies will be de-listed from the ODB formulary. Companies will compete not on list price (which will remain at 50% of the brand price for all bidding companies), but primarily on a confidential volume-based discount to be rebated to the Ontario government, along with other objective and subjective factors. The amount of the secret rebates will not be disclosed by the government, and any disclosure by the winning companies will result in the forfeiture of the listing. This is expected to widen the spread between the prices paid by the government and private payers for multi-source products.

As a pilot project, four drugs - gabapentin, enalapril, ranitidine, and metformin - will be put up for tender on August 1.

Effect on Generic Industry

This scheme, if implemented widely, will disrupt the business models for firms in the generic pharmaceutical industry that sell in the Ontario market, which represents 39 percent of the Canadian market. Instead of predictable access to the formulary, companies will be engaged in a feast or famine competition for the market. In addition, it may be anticipated that even for the winning companies, profit margins on products will be small as generic companies are squeezed between rebate demands by both the Ontario government (to get on the formulary) and pharmacies (to be stocked). Some Ontario-focused generic companies (Ontario is home to one of the largest concentrations of generic drug manufacturers) may be driven out of business, or less dramatically the industry may consolidate through mergers or acquisitions into larger companies that can better manage the uncertainty associated with multiple tendering competitions.

Effect on Pharmaceutical Patents and Brand Name Companies

The immediate effect of this change on brand name companies will be small. Brand name companies are unlikely to compete directly in the tendering process, as a win would reduce the reference “brand” price, the maximum price at which the brand name is allowed to sell in Ontario, to the “list” price specified in their bid, a maximum of 50% of the original brand price. Brand-name drug companies are particularly sensitive to list price reductions as they can put pressure on their prices in other markets, such as the large and lucrative U.S. market. However, brand companies may compete via authorized generics, a company licensed by the brand company to produce the product under whatever patent protection the brand company may possess. Brand companies may also compete in situations where they are already openly selling their products for lower prices in other jurisdictions, as may happen in Ontario with ranitidine.

The more important effect of the tendering scheme from the point of view of brand name companies may be to extend and strengthen their effective Canadian patent rights. The primary mechanism in Canada to genericize brand name pharmaceuticals and lower their cost is the federal Patented Medicines (Notice of Compliance) or “PM(NOC)” regulations. These regulations, which are similar to the Hatch-Waxman system in the United States, prevent the federal Ministry of Health from issuing NOCs to generic companies as long as there are relevant patents listed on the Patent Register. Listed patents may include patents that expire many years after the expiry of the initial drug patent. However, the regulations also allow generic companies to challenge the patents listed on the Patent Register as either invalid or non-infringed by the generic’s planned production and sales, and thus obtain an early NOC. As a result, Canada is an active site for pharmaceutical patent litigation.

Ontario is 39% of the total Canadian market. If tendering is widely used in Ontario, including for products that are newly genericized, the incentive for generic companies to invest in costly patent challenges under the PM(NOC) regulations will be correspondingly reduced. If generic challenges to brand name pharmaceutical patents decline, brand-name companies may well realize many extra years of monopoly-level sales and profits.

Challenges for the Generic Industry and Ontario

The government announcement has generated particular opposition from pharmacists and the generic pharmaceutical industry. The generic industry must confront the longer-term policy drivers that underpin the Ontario government’s actions. Faced with rising health-care costs, the Ontario government is turning to tendering as a means to lower its spending on generic drugs through the ODB program – and tendering may well lower government spending in the short run. To be persuasive, the industry must present alternatives that address the need for lower spending on health care and longer-term considerations. One approach is to emphasize the long-term benefits of a healthy generic industry with active pharmaceutical patent litigation to Ontario government spending, through the accelerated genericization of pharmaceutical products and through the competition flowing from a large number of generic competitors. This may be persuasive, given that the ODB spent $2.6 billion in 2007 on brand-name pharmaceuticals versus $785 million on generic products, although generic products represented more than half of the actual claims. However, the Ontario government is likely to have significant political difficulties with the size of rebates flowing to pharmacists.

As a final complication, this policy announcement and implementation is proceeding at an unusual pace, with the tendering policy first announced to the industry on July 4, 2008 with no previous consultation, written comments to be received by July 11, and the first call for bids to have taken place on July 25. The only written description of the program provided to stakeholders is a power point presentation and a question and answer document. Furthermore, it appears that the policy has taken various Ontario cabinet ministers by surprise. After industry submissions and meetings with government officials, the date of the first call for bids was pushed back by a week to August 1, 2008. However, it is unclear whether the previously announced schedule – a closing date of August 22 and a decision to be announced on September 12 - will be likewise delayed.

This is perhaps an inevitable result of the design of the relevant institutions for developing drug policy in Ontario, which grants significant power and discretion to one official (the “Executive Officer”), who perceives their mandate as solely to lower the immediate costs of administering the ODB program to the exclusion of any other considerations, including increased costs because of later generic market entry and with little formal oversight by other bureaucrats or elected officials. A combination of power with an exclusionary focus on only one of many public interest objectives is likely to generate poor public policy.

It is also unclear, if the pilot is successful, how widely the tendering system may be used. It has been suggested that the system may be widely implemented; however, in the wake of complaints from industry it has also been suggested by government sources that tendering may be limited to only about a dozen products. In any case, even a limited tendering scheme in the present may turn into a widespread tendering scheme in the future.

Tendering on the ODB formulary is a critical public policy issue. It directly affects the cost of administering the ODB programs to the Ontario government, Federal patent and pharmaceutical policy, revenue streams for pharmacies, the cost of pharmaceuticals to the public, and the future structure and health of the generic drug industry. The resolution of these questions will have very significant long-term results.

Alexander Stack

Gilbert’s LLP

Wednesday, August 6, 2008

First Appeal from Re-examination Proceedings in Canada

Here's an article I recently submitted to lexology (www.lexology.com). One of the interesting things about Canadian intellectual property law is that, compared with the United States, you get a lot more cases that are the first or one of a few to address an issue. In this case, re-examination.



Canada: First Appeal from Re-examination Procedure

The Federal Court of Canada recently handed down a decision in the first-ever appeal from the re-examination procedure introduced into the Patent Act in 1987. Genencor International, Inc. v. Commissioner of Patents and Attorney General of Canada 2008 FC 608 sets a number of important precedents, including determining the role of the initiator of the re-examination and the standard of review, and highlights difficulties with the present re-examination system. The trial judge also made a surprising ruling that it is not necessary for patent examiners to interpret claims by the same methodology as courts, raising the specter of many future complications. We can refine our views on the strategic use of re-examination proceedings in light of this decision.

The Re-examination Procedure

Re-examination provides a relatively inexpensive, summary procedure to have the Patent Office reconsider the claims of an issued patent. Any person may request re-examination by filing a request with written prior art (patents, patent applications or printed publications). Within three months, a Re-examination Board of at least three persons, two of whom must be Patent Office employees, determines whether the prior art presents a substantially new question of patentability of any of the claims in the issued patent compared to the proceedings during the initial prosecution. If the Board finds that the prior art does not raise a substantially new question of patentability, the process ends with no right of appeal on the part of the initiator of the re-examination. If a new question of patentability is found, the Board then has 12 months in which to cancel, accept or amend the claims in the issued patent. The patentee makes submissions during this period, typically making arguments in support of its issued claims, and if desirable submitting amended claims for consideration. The final decision of the Board may be appealed to the Federal Court, as was done in this case.

No Role for the Initiator of the Re-examination

The Genencor proceedings reinforce the limited role of the initiator of the re-examination beyond the initial request. In this case, the re-examination was initiated by Novozymes A/S, who alleged that the Genencor patent was anticipated by prior art that was not considered in the initial examination. The Re-examination Board agreed, and cancelled all of the claims of the Genencor patent.

When Genencor appealed to the Federal Court, Novozymes sought standing as a party. The Federal Court of Appeal affirmed that the initiator has no role after persuading the Board that a re-examination is warranted. Subsequent written submissions by Novozymes were not considered or even read by the Board, and on appeal Novozymes was refused standing as either a party or intervenor. This decision confirms that re-examination is an ex parte proceeding, and that the initiator of the re-examination has only a minor influence on its outcome.

Canada has a liberal patent impeachment process, with wide standing to commence an action to have a patent declared invalid by the court, with rights to discovery and to give expert oral evidence. The exclusion of the initiator of the re-examination from the subsequent process may be justified by noting that if the initiator is dissatisfied with the results of a re-examination, an impeachment action is always available. Indeed, the judicial reasons in the Genencor hearings reveal a concern that the re-examination proceedings not be turned into a second patent impeachment process.

Standard of Review

Gibson J. found that the appropriate standard of review of the Board’s decision is “reasonableness”, or that the decision of the Board should not be interfered with in the absence of “palpable and overriding error”.

In contrast, in typical infringement or impeachment actions, no deference is given to the decisions of the patent examiner. However, in a typical patent action, the parties have placed evidence before the court which was not before the examiner, making the question of deference moot. This raises unanswered questions regarding the standard of review of patent examiners’ decisions in impeachment and infringement actions if no new evidence or arguments are placed before the court, and plays into the strategic use of re-examination procedures, as discussed below.

It may seem odd that the patentee lost its patent without the opportunity to be heard before a court on a standard of correctness, with expert witnesses and an authoritative judicial construction of the claims. However, it should not be forgotten that the patentee was the beneficiary of ex parte hearings before the Board and Court, with no written or oral evidence or arguments presented by parties adverse in interest. As might be expected, this situation is generally perceived to be favourable to the patentee, and this is the first of 47 re-examination decisions under the post-1987 Patent Act to be appealed by a patentee.

Difficulties with the Re-examination System

As emphasized by Gibson J., the re-examination procedure set up by Parliament presents difficulties. Primarily, there was no party to contest the patentee, Genencor, on the substantive merits of the Board decision. As discussed above, the initiator of the re-examination, Novozymes, was denied party or even intervener status.

The Commissioner of Patents declined to participate, citing non-intellectual property case-law holding that it is inappropriate for federal agencies to defend their decisions during appeal proceedings. This left the Attorney General of Canada to be necessarily added as a party under the Federal Court Act, but the Attorney General declined to address the merits of the Board decision, arguing only that the procedures provided by the Patent Act and the principles of natural justice were followed by the Board.

As a result, the proceedings before the Federal Court were ex parte on the merits, which while consistent with the statutory scheme of the Patent Act, placed the trial judge in an uncomfortable position. To some extent, the trial judge’s discomfort was relieved by his finding that the review was on a reasonableness rather than a correctness standard. However, if on appeal the correct standard for review is found to be correctness, Gibson J. described his position as “untenable” on substantive issues.

The Different Roles of Courts and Examiners?

Surprisingly, Gibson J. analyzed the approach patent examiners may take to claim construction and concluded that certain Supreme Court jurisprudence applied to trial and appellate courts, but not to examiners. He quoted Binnie J. of the Supreme Court of Canada, who wrote in the 2000 Whirlpool case that a simple dictionary approach to construing claims must be rejected in favour of a reading of the specification to put claim terms in context. Gibson J. then specifically rejected the applicability of this ruling to patent examiners during the examination of patents, whether as part of a re-examination or during normal patent prosecution. Gibson J. returned to this point a second time in his decision, writing that “[C]ounsel for Genencor is urging that the Court place on the Board a burden mandated for courts by the forgoing quotation from Whirlpool, which is entirely inappropriate to their experience, to their accustomed role and the role that is contemplated for them by the re-examination provisions of the Patent Act.”

It is unclear from reading the decision why Gibson J. felt it was necessary to address this issue in this manner, as the record from the Re-examination Board reveals resort by the Board to the specification of the Genencor patent in construing the claims.

Fundamentally, this ruling suggests that a patent claim may be office-valid, but court-invalid, and vice-versa. The results are pernicious. For example, in an appeal from re-examination – the situation in the Genencor case - it may be that the claims are invalid under the claim construction allowed in the patent office, but valid under the claim construction required of the courts. However, since the only question on appeal is on whether the Board properly performed its duties, the patentee has no route to re-issue the claims or get them before a court for a judicial consideration: if the patent was properly rejected under the claim construction standards that apply to patent examiners, that is the end of the matter. Assuming the Genencor case is appealed, this specific finding is most likely to be overturned.

Discussion

From a strategic point of view, the re-examination procedure has typically been disfavoured by counsel to potential patent defendants, largely viewed as providing an opportunity for patentees to strengthen their claims in an ex parte process rather than as a simplified procedure to knock out invalid claims. The Genencor hearings reinforce these views, given the rejection of Novozymes’ attempts to influence either the Re-examination Board or the appeal to the Courts. However, it should be noted that if the Genencor decision stands, patentees will find it difficult to overturn unfavourable decisions by the Re-examination Board, suggesting that in limited situations a re-examination reference may be a fruitful move by a potential patent defendant.

For patent holders, this case and recent Canadian jurisprudence on the standard of review of administrative decisions suggests viewing re-examination more favourably. Possibly, where the facts and arguments on claim validity made before a patent examiner are identical to the facts and arguments before the court, the court is legally obliged to review the examiner’s decisions on a reasonableness rather than a correctness standard. If that is the case, it may be advantageous for a patentee anticipating a particular validity attack to submit the argument to a Re-examination Board and argue the matter in an ex parte proceeding rather than risk an impeachment action with full participation by an opponent. However, the application of recent case-law on the standard of review in the patent context is largely unexplored, and this particular advantage of the re-examination process may be illusory.

Finally, one implication of the Genencor position that patent claims may be construed differently by examiners and courts is that the initiator of re-examination may be entitled to two “kicks at the can”. Potential patent defendants can submit an argument to a Re-examination Board, and if it is accepted, under Genencor the patentee is faced with difficulty in overturning the Board’s decision. If the argument is not accepted by the Board, the potential defendant can argue the validity before the courts by noting that the Board’s method of claim construction is not the same as the Court’s. In other words, the initiator of the re-examination gets to attack the patent on the basis of two different claim constructions. However, as noted above, the position that examiners and courts vary in their approaches to claim construction is the aspect of the Genencor decision most vulnerable to appeal.

It is unknown at this time whether the Genencor decision will be appealed to the Federal Court of Appeal. If it is, several interesting issues may well be raised. The adoption of a standard of review of reasonableness rather than correctness depends in part on the identification of patent examiners as being highly skilled in relation to their mandates and as persons skilled in the art, which may be questioned or at least should be further explored. As noted by Gibson J., the very structure of the re-examination process raises questions of whether a review on the standard of correctness is tenable. Finally, the finding that patent examiners can take a different approach to claim interpretation than the courts is of fundamental importance to the patent system, and hopefully will be subject to appellate approval or revision.

Alexander Stack

Gilbert’s LLP