CETA talks moving along...

An article appeared in the National Post today by John Ivison discussing the Europe/Canada free trade deal talks.  The article specifically brings up the pharmaceutical/IP issue as a stumbling block:

One sleeper issue could yet derail the whole process. Most of the negotiations should be encouraged, since they are likely to reduce the costs to consumers on both sides of the Atlantic.

However, the European Union is pressing for intellectual property changes that would give brand name drugs several years more of patent protection, delaying the entry into the market of cheaper generic drugs.

In the House of Commons, NDP MP Peter Julian asked Mr. Van Loan if the government has done any due diligence on what this would mean for provincial drug plans. The answer was equivocal but it is clear any such agreement would increase costs to provinces already battling soaring health costs.

One drug, Pfizer’s Lipitor had annual sales of $1.3-billion in Canada during its last year of patent protection, which ended in July. Generic versions of the drug are now being sold for 25% of that price, which would mean provinces would be paying an extra $1-billion this year if the EU’s rule was in place. The brand-name companies argue this is short-sighted and that Canada will be by-passed when the latest drugs come out if it doesn’t fall into line with the EU on patents. It remains to be seen whether the provinces buy that argument.

As has been noted before, the depth and breadth of any deal relies on the cooperation of the Canadian provinces.  On the pharmaceutical issue, even though the European draft language addresses areas of Federal jurisdiction (i.e. the Federal government has the authority to legislate the changes Europe wants without provincial cooperation), it is the provinces who will largely be paying for any extra periods of exclusivity for patent- or data- protected pharmaceuticals.  One possible outcome is that pharma/IP issues are sacrificed in a trade - for example, the provinces get a win on pharmaceutical costs in return for the provinces' agreement to open up their procurement processes to European companies.   

Its a bit dated, but Cyndee Todgham Cherniak wrote about a month ago that provincial agreement to the EU/Canada deal might be difficult, pointing out that several provincial premiers are on politically shaky ground and may not want to face a trade-related debate.

Google to solve European patent harmonization deadlock?

An interesting note via IPKat: The European Patent Office and Google have signed an agreement to use Google's machine translators to translate patent documents into the many languages used in Europe. 

This is potentially a bigger deal than may be apparent to readers in the New World.  There has been a movement in Europe since at least the 1970's to have a true European Patent, enforceable in all European states, including the moribund and non-enacted Community Patent Convention.  Since a European patent isn't in the cards, Europe has instead concentrated on harmonizing national systems and growing the European Patent Organisation, via the European Patent Convention (which is in force).  

In both cases, perhaps the biggest obstacle is language.  Its costly for applicants to translate patents into national languages, and European patent law harmonization efforts are largely European patent language harmonization efforts.  Language is highly political in Europe: if European patents are required to be translated into English, French and German, but not Spanish or Italian, what does that say about the state of Spanish and Italian in the world (or at least Europe) today?

Personally, I think that patents aren't just for multinational corporations, but should be able to be read by the guy running the family manufacturing business - which means I think that if you live in Poland, you ought to have Polish patents (or European patents enforceable in Poland) available to you in Polish.  Even if it does mean foreign companies have to pay to translate their patents.

But, having said that Europe has its own reasons for harmonization and reducing national sovereignty (WWI & II, for starters), so if they want to make Europe an English/German/French patent zone, who am I to complain?  Although I note that the European drive for political and economic harmonization can hardly be said to apply to global patent harmonization efforts - or even other regional harmonization efforts.

Anyway, getting back to the main point of this post, automatic translators like google raise the possibility of cutting the gordian knot regarding language and patents.  If the google and similar translators become able to do a "good enough" job - and I don't think that perfect translation is necessary in the case of patents - a very central, expensive and highly political feature of the patent law harmonization landscape may disappear.

Which would be pretty profound.  (Albeit, working universal translators would probably be pretty profound in general...  ) 

Gilbert's is #1 !

At recruiting!  For the second year in a row, the Ultra Vires student newspaper at the University of Toronto Faculty of Law has named us the top boutique firm for recruiting.

Gilbert's has mastered the art of recruiting, earning top spot among boutique firms for the second consecutive year.  Students marveled at the "fantastic OCI team" and described the recruiting process with the "fun, young" firm as "amazing". 

A tip of the hat to Alison Lester, who coordinated recruiting this year.  

CSI Ottawa (Patent Unit)

A should-read if you're interested in high tech patent litigation - the Globe and Mail has an article on Ottawa's latest high-tech industry - tearing apart high tech devices looking for proof of patent or other intellectual property infringement. 

http://www.theglobeandmail.com/news/technology/an-industry-built-on-tearing-things-apart/article1821358/

An interesting quote

Canada’s other competitive advantage is that it’s not the United States, where the global patent wars are largely fought. Mr. Page of UBM TechInsights pointed out that some of its customers feel more comfortable dealing with a Canadian company, convinced their confidential information is better shielded from the prying eyes of patent lawyers and U.S. court orders. “Our clients like that we keep … all the dialogue surrounding their programs on Canadian soil,” he explained.

RIM sues KIK Messenger for patent infringement

As has been widely reported, RIM has sued KIK Messenger for patent infringement, breach of contract etc. etc. in the Federal Court.  KIK Messenger's texting app went viral over the last two months; several people have pointed out that it challenges the market positioning of RIM's own BBM service.  Another twist is that the founder of KIK, Ted Livingston, used to work for RIM, and the suit accuses Livingston of violating his confidentiality agreement with RIM.

NP article HERE

Ted Livingstone's post in response HERE  (titled "A Sad Day in Waterloo")

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...

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 - 

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

[2] King Pharmaceuticals, Inc. v. Eon Labs, Inc., 09-1437 (Fed. Cir. 2010).