Tuesday, February 22, 2011


One risk of blogging is that I often think of something just after pressing "Publish Post" ;)

Following up on my last post regarding Michael Geist's comments on CETA and copyright - an interesting question is whether there is a difference in the historic linkage between trade and IP between patents and copyright - i.e. is the linkage between trade and patents different from that between trade and copyright?

It might well be different. I've read a lot about the history of international agreements in patents - but a lot less wrt copyright. Historically, "industrial property" (patents and trademarks, mainly) and "intellectual property" (copyrights etc.) were regarded as separate categories by many people - with industrial property being, well, more important to industry, who are also tied heavily into international trade relations. That distinction has blurred a lot, but the international strategies of the copyright-industries were distinct from those of the patent-industries until some time approximately late 70's/early 80's. (apparently, the patent-industries had to persuade the copyright-industries to buy into a multilateral approach that culminated in TRIPs - and at some point the copyright-industries had to get on board or get left behind ;) ).

Meanwhile, over in copyright land...

I have been focused on the effect CETA would have on patents and pharmaceuticals. Of course, there's lots of other stuff in CETA, including copyright. Michael Geist has posted a copy of his comments to the Standing Committee on International Trade HERE.

If I may nitpick, Geist writes:
1. The inclusion of intellectual property policy marks a dramatic shift for Canadian trade negotiations, which conventionally addressed market entry, investment, and tariff issues. As Dan Ciuriak, a former deputy chief economist at the International Trade department, has noted with respect to the CETA intellectual property provisions: "the process is not a sound one. In a hotly contested area, to have fundamental business regulation made in this fashion is not sound."

I think that the shift to including intellectual property policy in trade negotiations happened a while ago, with the FTA, NAFTA and TRIPs. And arguably much earlier - I think trade and IP have been intertwined for a long long time. I guess it depends on your framework or POV.

Whether this is a "sound" way to do IP regulation is a different question. But, it "is" how it is done today.

Some updates on CETA

1)  Rumblings from Ottawa

There have been stories coming out of Ottawa saying the CETA trade deal is in trouble. 

First, there is this from Paul Wells:

which basically says the following:

-          there has been a lot of bad press for the deal (#1 – adding $2.8 billion to drug costs)
-          there is no federal government champion for the deal
-          the provinces seem to be uninterested (and Europe wants concessions from them)
-          pro-business lobby groups seem to be uninterested
-          Europe has said publicly that it would rather scrap the deal than sign a narrow, watered-down deal (as it would set a bad precedent)
-          An influential lobby group – the automotive sector – has recently come out in favour of scrapping the CETA negotiations

Further to this last point, here’s a CTV News report:

A high-powered group of auto executives is pushing Ottawa to halt free-trade talks with South Korea and the European Union and to offer incentives for an industry threatened by the rising dollar and growing competition from lower-cost markets.

The auto executives, including Magna International Inc. chief executive officer Don Walker and the CEOs of the five auto makers with assembly plants in Canada, will meet Friday with Industry Minister Tony Clement to make their case for further government support for upgrades to plants as new automotive investment floods into low-cost Mexico and such emerging markets as China, Brazil and India.

Their concerns form the basis of a 35-page report by a working group of the Canadian Automotive Partnership Council (CAPC), which includes the CEOs of the five vehicle companies that have assembly plants in Canada, Canadian Auto Workers president Ken Lewenza; Sandra Pupatello, Ontario’s Economic Development Minister and her counterpart from Quebec, ClĂ©ment Gignac. A copy of the report, which will be presented to Mr. Clement, was obtained by The Globe and Mail.”
See also http://www.theglobeandmail.com/report-on-business/clement-to-weigh-auto-sectors-concerns-about-free-trade-deals/article1913673/

Also, there is this article in the Globe and Mail:

which says:

“Canada has threatened to scrap a trade deal with the European Union if the EU persists with plans that would block imports of Canada’s highly polluting tar sands, according to EU documents and sources.”

The Oil Sands are a big issue in Alberta, which is the heartland for the Conservative government.

2)  Status of India/EU negotiations.

Apparently, the EU has resumed putting pressure on India in respect of patents, pharmaceuticals and generics, mostly over data protection.    Medecins Sans Frontieres seems to be leading the charge in opposition.  

Also, a UN rapporteur on the right to health also has concerns about the EU/India deal

Wednesday, February 16, 2011

patent applications: Canada pales compared to Switzerland,

An article by Neil Reynolds in the Globe and Mail discussing Canada's relative performance in terms of patent applications filed.  The article questions Canada's performance on a per capita basis:

With a 7.8 million population, Switzerland led the world with 120 patents per million people. Japan finished close behind with 118. Other top-inventor countries: Sweden (80), Germany (68), Netherlands, Finland and Denmark (all 60) – and the United States (40) and Canada (20). Thus the United States beats Canada 10-to-1 in absolute numbers and 2-to-1 in relative (population) numbers.

 and ties it to R&D investment. 

One thing the article doesn't get into: some industries simply are more prone to patenting than others.  Switzerland has a concentration in those industries that Canada doesn't, which accounts for part of the difference.  Of course, maybe that's also an identification of the "problem."  Why this exists probably gets into the realm of historical/economic path dependence - but also leaves open the question of what Canada can do about it (or even if it should want to try to do something about it - something which these sorts of newspaper columns often leave out ;)  ).

Monday, February 14, 2011

Something unamusing: Joseph Weiler on trial

Joseph Weiler - who, long time ago, was one of my favourite professors at NYU - has stood trial in France for criminal libel "because, as editor-in-chief of the European Jouranl of International Law (EJIL), he refused to remove a book review from an EJIL-affiliated website that the book's author claimed is defamatory."

The offensive (to the author) book review is HERE.

More on this HERE, HERE and HERE.  

Frankly, while the book review is certainly negative in tone, I am shaking my head at the publisher of the Journal being sued for criminal libel.  I suppose Joseph Weiler did commission the review, but there doesn't seem to be any reason to believe it is anything other than an honestly negative review. 

This case is cast as a challenge to academic freedom, but I'm not sure that's exactly right.   This seems to be more of an attack on public criticism, period.  I'm not sure what the "academic" aspect adds: what if this was a movie review?  A review of the last Maple Leafs game?  Something is wrong when public criticism is chilled.

In any case, Professor Weiler's editorial in his own defence, linked to above,  goes through his thinking in erudite detail. 

One interesting - or distasteful, depending upon your point of view - aspect is the shadow of forum-shopping and the Internet.  The review is available on-line (my impression is that it is only available online, and wasn't in the printed journal).   As Professor Weiler writes: "The author of the book was an Israeli academic. The book was in English. The publisher was Dutch. The reviewer was a distinguished German professor. The review was published on a New York website."  So why is he in France? 

One answer is that the author of the book is a French national. living in Israel. 

My guess is that its because under the French system, the criminal complaint having been made, it goes to trial - period.  Apparently the first chance to get it dismissed is at the trial itself - and there is no compensation in fees for the defendants' legal expenses.  (there is also the question of whether it is a plaintiff-friendly forum in terms of substantive law, but I really can't comment on that).  

Interestingly, Weiler asked the Court to rule on the substantive issues, even if it finds that it does not have jurisdiction - he'd like a ruling in favour of negative book reviews and their hapless publishers in any case ;) 

Anyway, the verdict is scheduled to be released on March 3.  Hopefully the Court will punt this into the Seine. 

Something amusing: Aidan Butler

Hot off the presses - Aidan Butler of Gilbert's, "a raffish man of mystery" is named one off Canada's 30 most eligible bachelors!



Wednesday, February 9, 2011

CIPO calls for comments on draft MOPOP revisions on Unity of Invention

The Canadian Intellectual Property Office has released a draft of proposed revisions to Chapter 14 of the Manual of Patent Office Practice (or MOPOP), which deals with Unity of Invention.   See


The goals of the revision are to ensure that Canadian standards for unity of invention are equivalent to those under the PCT, clarifying the dispute resolution mechanism in the case of an impasse regarding unity of invention, and providing guidance to ensure a more predictable and consistent application of the standards.

Why the same as the PCT standards?  Well, too be honest that sounds fine to me.  But I hope that some thought has gone into whether the PCT standards are actually good for Canada as opposed to an  assumption that we just "should" adopt PCT standards.    (There also might be a legislative basis for saying they should be the same, but that's a different issue)

CIPO is accepting comments on the draft chapter until April 7.

Monday, February 7, 2011

Norman Siebrasse Canadian patent blog: "Sufficient Description"

Norman Siebrasse of UNB law, whom I've written papers with in the past and I think has all sorts of good things to say about patents, now has his own blog:


I admit to some jealousy as I read it - I wish that I had written that! 

I urge everyone to go read it!  Hopefully, it will be a great source of Canadian patent caselaw and other information for years to come!

Nathaniel Lipkus named partner at Gilbert's LLP

I am happy to relay the news that Nathaniel Lipkus has been named a partner of Gilbert's LLP!  I cannot put it any better than Tim Gilbert in this email:

It is with great pleasure that the partners of Gilbert’s LLP (G2) wish to advise you that Nathaniel has been asked to join the partnership.  We are also delighted to advise you that he has accepted!

I hope that you will have a moment to congratulate Nathaniel.  He is an exceptional lawyer who represents the highest standards in the profession.

Hollis and Grootendorst report on cost of proposed CETA patent provisions

Here's an article from the Globe and Mail about a report by Aidan Hollis (U Calgary) and Paul Grootendorst (U Toronto) released today.  The lead of the Globe article:

Provisions in a new trade deal being negotiated between Canada and the European Union could add about $2.8-billion a year in costs to Canadian drug plans if implemented, a new report warns.

The estimate includes $1.3-billion more for public drug plans and $1.5-billion for private drug plans.

The report itself is in pdf HERE.

latest on CETA progress

Last week, Steve Verheul, Canada's chief negotiator for CETA, held a teleconference to update civil society on the progress of the CETA talks.  The sixth negotiating round was held in Brussels, and some good progress was made on market access, regulatory barriers, government procurement, and some progress was made on dispute settlement and geographic indications (!). 

However, less progress was made in the auto trade, agriculture, rules of origin and dealing with commodities ...

and, pharmaceuticals/patents.  Apparently, the EU is pushing hard on these issues, propelled by fierce lobbying in Europe by patent-powerful pharma companies.  Which, actually, means nothing much has changed.  ;) 

The EU/India negotiations, where the EU has backed off its demands for increased pharmaceutical patent protection, doesn't really seem to be getting much play in negotiations.

The exchange of offers has been pushed off till March (although that's not definitive).  The next round of negotiations is scheduled for April in Ottawa. 

Friday, February 4, 2011

Shoppers court decision, can sell private-label generics in Ontario

According to this article in the Globe and Mail

"Shoppers Drug Mart Corp. (SC-T38.771.624.36%) is hailing an Ontario court ruling that will allow it to substitute its own discount brand of prescription drugs for those made by big pharmaceutical companies.

An Ontario court ruled in a decision released Thursday against a provincial regulation that bars the sale of private-label generic drugs on the same basis as other generics."
In other words, Shoppers can make "Shoppers brand drug X" and sell it in Shoppers stores.  (similarly, I presume Loblaws can have Presidents' Choice minocycline, etc. )

Thursday, February 3, 2011

Gilbert's helps Mylan be first to market with generic galantamine

Gilbert's LLP represented Mylan Pharmaceutical ULC in overcoming a dosage regimen patent to become first to market with a generic galantamine ER product (used in the treatment of Alzheimers).  On November 10, 2010, the Federal Court found Canadian Patent No. 2,310,950 to be invalid as a method of medical treatment and also made findings of obvoiusness and a lack of a sound prediction.  The Federal Court of Appeal dismissed Janssen Inc.'s appeal for mootness on January 17, 2011.  Click to access the Federal Court trial decision and the Federal Court of Appeal dismissal.

(by Nathaniel Lipkus)

Wednesday, February 2, 2011

Gilbert's ranked as a leading Canadian "patent contentious" law firm

The 2011 Managing Intellectual Property survey results are out, and Gilbert's LLP has again been listed among the leading Canadian law firms in the "patent contentious" category.  Link HERE (but it requires a subscription). 

International Harmonization of drug approvals - is Health Canada too slow?

Here’s an opinion piece from the National Post
“Speed and Drugs”, by Brett Skinner and Mark Rovere of the Fraser Institute.

An interesting article – which basically says that Health Canada is slower than its European and United States counterparts in approving new drugs, but has no better safety record.  So, Health Canada is imposing a cost (delays in approving new drugs) on Canadians for no compensating benefit.  And, they suggest greater harmonization with Europe and/or the US to fix the problem – basically by establishing mutual recognition for drug approvals (or steps in the drug approval process) with European or US authorities.

Here are some comments, but first I should acknowledge that this is a newspaper article, limited in length, not a full report or academic article.  My quibbles and concerns might well be considered and discussed in the authors’ work.

Health Canada’s regulation in this area rests upon a three-way trade-off: the speed of approvals, the quality of approvals (i.e. addressing safety concerns), and the cost of approvals.  For a given cost, Health Canada can be fast, or it can be careful, but there is a trade-off involved.  And presumably Health Canada can’t just conjure up additional funding to improve either metric by imposing greater fees on drug company applicants or getting more funding from the government purse.  It is difficult to comment on whether Health Canada, considered as an isolated agency, is doing a good job or a comparable job to its global peers without information on its funding compared to the European and US agencies.

Putting that to one side, however, it is still perfectly fine to talk about the results of the system as a whole – which is what Skinner and Rovere are doing – without identifying where the differences in results between Europe, the US and Canada arise.

One question I would have is about the nature of “safety” issues being addressed by Health Canada and its counterpart agencies.  Does the danger – the drawbacks – of lesser quality decisions follow a normal distribution, or is it skewed?  In other words, does the effect of increases and decreases of decision-quality on safety over a large number of drugs converge on some sort of well-behaved curve, or is it the case that one bad decision can be catastrophic (i.e. a skewed distribution)?  Does this follow the law of large numbers to converge on an average, or not?  (I’m probably not expressing this very well L  )       

Skinner and Rovere go on to suggest that mutual recognition is a “solution” to the problem.  Which generally sounds right to me – especially if we are considering mutual recognition of specific steps in the drug approval process rather than mutual recognition of final approvals, period. 

But, if safety dangers are skewed, then I think the mutual recognition argument is weakened. 

Generally, regulatory harmonization is justified if the benefits outweigh the losses of individual preferences for the harmonizing states.  Here, the benefits seem straightforward: if Canada and the EU have mutual recognition, Canada and the EU can reduce their spending (private or public) on drug approvals. 

What about the benefit of faster approvals for Canadians?  (assuming the European process continues unchanged by mutual recognition)  Well, that’s where we get to questions of the trade-off between safety, cost and speed and whether the dangers of poor decisions are skewed. 

If the dangers follow a normal well-behaved distribution, then is there a reason to think that Canada’s preferences for drug safety are different from Europe’s?  Well, maybe- there’s no doubt Europe has a large pharmaceutical industry that wants its drugs approved! 

But, if that doesn’t matter, differences in preferences for drug safety between Canada and Europe are likely to be small.  As Skinner and Rovere write “In economic terms, any incremental improvement in drug safety from more rigorous or frequent testing is subject to diminishing returns.”  And the field might well be ripe for harmonization and mutual recognition.

But what if it is skewed?  Well, then Canada and Europe’s preferences on the level of testing for drug safety might not converge.  Canada might prefer a higher level of safety testing, and it might be a choice with real impact on risk – not subject to the same kind of diminishing returns.  And the scope for harmonization/mutual recognition is lessened.

Another question (while I’m on a roll, posing unfair questions about a newspaper opinion piece ;) )  - is this harmonization/mutual recognition going to have any effect on improvements to the approval system over time?  One positive effect of parallel systems running is a greater scope for experimentation in procedures, testing etc. – experimentation which can lead to improvements that can be implemented widely to everyone’s benefit.  Harmonization necessarily reduces the likelihood of such experience-based learning. 

But, analyzing whether this is a big concern in the drug approval process would require some careful consideration of the international system(s) as a whole.  It may not be a big deal in the drug approval context. 

Bottom line – mutual recognition sounds good to me, especially if we’re talking about mutual recognition of specific steps in the approval process.  But, I’d need more information and analysis before I’m truly convinced.

Pfizer cuts, anticipating Lipitor patent cliff

Pfizer is one of several drug companies facing a "patent cliff" as their blockbuster drugs lose exclusivity.

"Pfizer faces an unprecedented challenge in November, when Lipitor loses U.S. marketing exclusivity. Pfizer bought Wyeth last year for US$67-billion to replace vanishing Lipitor revenue, but has failed to sufficiently bolster its drug portfolio.

More than a half dozen other Pfizer drugs also lose U.S. patent protection in the next few years, including Viagra and Xalatan for glaucoma."
In response, Pfizer is slashing its 2012 R&D budget by $2 billion. 

This is particularly bad news for the UK

"Among the cuts, Pfizer will close its huge research and development centre in Sandwich, southern England, which employs 2,400 people, dealing a major blow to Britain's scientific jobs base."
As part of its strategy, its expected that Pfizer will make greater use of Contract Research Organizations (CROs) rather than doing their research in-house.  Here's two located in Toronto.