Tuesday, November 16, 2010

Amazon case appealed

The Federal Government has appealed the recent Amazon case dealing with patentable subject matter.  HERE is a copy of the Notice of Appeal (from Alan Macek's ippractice.ca).  Unsurprisingly, the government is appealing on a long list of grounds. 

An interesting background point - there may be an underlying clash between the "spirit" of the invention and what the claims actually say.  For example, suppose that a person has invented a "business method" (whatever that is) but the actual claim says "A machine comprising..." - is the court and patent office bound to treat that claim as a claim to a machine (which is definitely patentable subject matter) and then deal with it under the usual rubrics of anticipation, obviousness, utility etc.?  What if the claim is for "A system comprising..."?   Supposedly, the purposive approach to claim construction does away the "spirit" of the invention, but some courts and officials keep on wanting to resurrect it under a different name...

Thursday, November 11, 2010

Dosage regimen invalid as a method of medical treatment

A quick...  OK, long blog post on yesterday's PM(NOC) decision concerning a Janssen patent covering galantamine.   Matt Dugas, who wrote this, Nathaniel Lipkus and Tim Gilbert argued the case. 

On November 10, 2010, the Federal Court released its judgment in Janssen Inc. v. Mylan Pharmaceuticals ULC, 2010 FC 1123.  In this Patented Medicines (Notice of Compliance) decision, Justice Barnes found that the claimed dosage regimens are, as methods of medical treatment, unpatentable subject matter.

The 950 Patent

The subject of the decision is Patent No. 2,310,950 (the “950 Patent”), which relates to galantamine.  Galantamine is drug used to treat Alzheimer’s disease.  The compound galantamine was known well before the 950 Patent, as was its use as a treatment for Alzheimer’s disease. 

The 950 Patent claims an escalating dosage titration schedule.  Specifically, the 950 Patent claims a dosage schedule where a smaller initial dose of galantamine is slowly increased to a final effective dose.

The decision

Mylan Pharmaceuticals ULC (“Mylan”) applied to the Minister of Health to obtain a Notice of Compliance for its generic version of galantamine, alleging that Janssen’s 950 Patent was invalid. 

The present decision concerns the resulting Application brought under the PM(NOC) regulations.  The Federal Court found Mylan’s allegation of invalidity justified on the grounds that the subject matter claimed is unpatentable as a method of medical of medical treatment, and denied Janssen Inc.’s (“Janssen”) Application for an Order prohibiting the Minister of Health from issuing a Notice of Compliance to Mylan.

Method of medical treatment

The doctrine of method of medical treatment was articulated by the Supreme Court of Canada in Tennessee Eastman Co. v. Canada (Commissioner of Patents) [1974 S.C.R. 111, 8 C.P.R. (2d) 202.  There is a general distinction in the case law between vendible products on the one hand, and decisions related to the professional skill and judgment of the medical profession on the other hand.  The former is patentable, the latter is not.[1]

The Federal Court’s rationale is that physicians should not be prevented or restricted by patented monopolies from applying their best skill and judgment in treatment decisions.

As it has done in the past, the Federal Court once again dismissed the argument raised by Janssen that the doctrine should be reformulated or abandoned because of the repeal of a section of the Patent Act which was partially at issue in Tennessee Eastman.  Justice Barnes states: “Notwithstanding the intervening repeal of s.41, Tennessee Eastman, above, remains good law in Canada because the policy concerns it recognized continue to be valid.” 

Stating that the policy concerns apply in both jurisdictions, the Federal Court also references a decision by the United States Court of Appeals for the Federal Circuit[2].  The Federal Court also sees no problem reconciling the method of medical treatment doctrine and the recent Amazon.com Inc. v. Canada and the Commissioner of Patents, 2010 FC 1011 decision on business method patents because of the policy rationale of the method of medical treatment doctrine.

The method of medical treatment doctrine applies to the dosage regimen claimed in the 950 Patent

The claims of the 950 Patent cover the dosing schedule recommended in the Product Monograph for galantamine and other sources.  Janssen originally led evidence that physicians prescribing galantamine more or less rigidly follow the recommended dosing schedule, which does not involve any professional skill and judgment. 

However, all of Janssen’s expert witnesses (except one expert witness who was impeached and had his testimony strongly rejected by the Federal Court) admitted on cross-examination that, while the recommended dosing schedule may be a helpful starting point, there are many examples where a physician must employ an individualized treatment approach. 

The Federal Court stated that “Contrary to the affidavit evidence put forward by Janssen’s witnesses, [consideration of individualized factors] does not begin and end with the manufacturer’s dosing advice”  and that “It is simply not a valid argument that, in the face of a manufacturer’s dosing recommendation, the exercise of all professional judgment by treating physicians goes out the window.”  Physicians used their professional skill and judgment in selecting appropriate dosage schedules for their patients, and this process is therefore covered by the doctrine of method of medical treatment.

Other grounds of invalidity

The Federal Court did not formally address any of the other allegations of invalidity because it found the method of medical treatment analysis sufficient. 

However, the decision briefly suggests that the 950 Patent may also be invalid because of either obviousness or lack of utility.  Justice Barnes notes that one inventive promise of the 950 Patent was well-known prior to the 950 Patent, and that the other inventive promise relies on conclusions not supported by the evidence.

- Matthew Dugas - 

[1] Apotex Inc. v. Wellcome Foundation Ltd., 2002 SCC 77, 21 C.P.R. (4th) 499; Visx v. Nidec Co. (1999) 181 F.T.R. 22 3 C.P.R. (4th) 417, affirmed by Federal Court of Appeal 2001 FCA 215, 16 C.P.R. (4th) 251; Merck & Co. v. Nu-Pharm Inc., 2010 FC 510, 85 C.P.R. (4th) 179; and Axcan Pharma Inc. v. Pharmascience Inc., 2006 FC 527, 50 C.P.R. (4th) 321.
[2] King Pharmaceuticals, Inc. v. Eon Labs, Inc., 09-1437 (Fed. Cir. 2010).

Shoppers moves ahead with private-label generic drugs

From the newspaper today, Shoppers is moving ahead with its plan to market its own private-label generic drugs despite the disapproval of the Ontario government.  They plan to sell in seven other Canadian provinces, as well as export products.  They are also challenging the Ontario government's  regulations forbidding pharmacies from selling their own store-brand products.

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?


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.  



The recruiting season just ended.  Congratulations to Patrick Dyke, Zarya Cyrander and Harman Dhillon who will be Gilbert's LLP summer students!

Pictures from our student party setup here.