Contents
- New Study Argues for Economic Efficacy of National "Pharmacare" Program
- Generic Drug Companies Complain About Lower Prices
- European Generics Pressing for Global Agreement On Biosimilars
- Recent Cases
- Upcoming Trials and Appeals of Interest
New Study Argues for Economic Efficacy of National
"Pharmacare" Program
By Michel O'Hara
A study released on September 13, 2010 by the Canadian Centre for Policy Alternatives claims that billions of dollars could be saved if the provincial governments could agree on a joint, national plan for purchasing both brand-name and generic pharmaceuticals. The report claims that the provinces deliberately pay between 16 and 40 per cent more than other industrialized countries in order to attract pharmaceutical investment and suggests that if Canada were to buy pharmaceuticals in bulk at a reduced rate, over $10 billion could potentially be saved.
Additionally, the report claims that Canada's industrial policy of paying higher amounts for brand name drugs has been completely ineffective, since only Ontario, Quebec, and BC benefit from the pharmaceutical industry. More significantly, the report claims that Canada is spending "$1,530 million more than the average prices of brand-name drugs in OECD countries in order to generate $537 million in R&D spending." However, no mention is made in the report of other significant factors that might be negatively affecting R&D spending in Canada.
For more information, please see the following link:
http://www.policyalternatives.ca/
Generic Drug Companies Complain About Lower
Prices
By Isabel Raasch
As reported on September 13, 2010 in the National Post, representatives of Canadian generic companies, including Apotex, Teva and the Canadian Generic Pharmaceutical Association are warning that lower prices for generic medicines could backfire. In particular, they claim that without changes to the patent system and pricing regimes, generic firms may be forced to stop making products in Canada and move their manufacturing overseas. In addition, as profit margins fall, generic companies say that they will be less likely to launch the costly court actions required to get generics on the market early. In response to these arguments, Russell Williams, president of Canada's Research-based Pharmaceutical Companies (Rx&D) points out that Canadian generic process have long been among the steepest anywhere and that, if anything, the brand-name industry needs more protection from the patent system, especially given that it is increasingly making drugs that target smaller patient populations and therefore have lower sales. Asked to comment, Mark Rovere, of the Fraser Institute, a conservative think-tank, noted that generics are still doing better under the lower prices recently mandated by Ontario than they would be in a free market.
For more information, please see the following link:
http://www.nationalpost.com/news/Push+lower+prices+generic+medicines+could+backfire+drug+companies/3514068/story.html
European Generics Pressing for Global Agreement On
Biosimilars
By Adrian Howard
The European Generic Medicines Association (EGA) is pressing governments to draft a global agreement regarding the approval process for biosimilar medicines ("follow-on biologics"). Addressing the 8th EGA International Symposium on Biosimilar Medicines in London, EGA Director General Greg Perry advocated that now is the time to seek an international guideline.
Countries around the world, including Canada, U.S.A., Australia, Japan, Turkey and others already have a regulatory framework for biosimilar medicines. It is expected that the WHO will finalize their guidelines for evaluating similar biotherapeutic products (SBPs) this year. As a result, "there is a need to reach a global agreement on criteria and guidelines for biosimilar medicines in the interest of patients and the better availability of high quality medicines," he said. It is essential to demonstrate the biosimilar matches the innovator product in terms of quality, safety and efficacy, and also to reassure patients and healthcare professionals. This will be addressed with a thorough comparability exercise with the reference product.
With the first major group of originator's biosimilar products coming off of patent and/or data protection, it is expected the market for biosimilars to greatly increase in the coming years.
For more information, please see the following links:
http://www.egagenerics.com/pr-2010-09-02.htm
http://www.pharmatimes.com/Article/10-09-10/%e2%80%9cConsistent_global_approach%e2%80%9d_to_biosimilars_urged.aspx
http://www.who.int/biologicals/areas/biological_therapeutics/BIOTHERAPEUTICS_FOR_WEB_22APRIL2010.pdf
Recent Cases
By Scott Foster
Apotex v Shire, motion to amend statement of defence, modafinil, August 19, 2010
In an action brought by Apotex for damages pursuant to Section 8 of the PMNOC Regulations against Shire after an unsuccessful PMNOC proceeding brought by Shire, Shire moved to amend the statement of defence. The first of the two new pleadings sought to be introduced by Shire was denied by the Prothonotary. The pleading in question related to a defence that in the event Apotex is held to have infringed the '967 patent in the patent infringement proceeding commenced by the patentee of the '967 patent, then Apotex should be precluded from recovering damages in the present proceeding for loss of sales ultimately found to be infringing in another action. In dismissing the amendment, the Prothonotary held that the outcome in the parallel proceeding was an uncertain event; the extent of which could not be determined in the present case. Moreover, any success or failure in the parallel proceedings was contingent upon the actions of a third party and therefore the proposed pleading was no more than speculative and hypothetical. The Prothonotary also referred to (and was clearly influenced by) the potential delay that would be caused should she allow this particular amendment to the pleadings.
The second ground sought to be introduced by Shire related to an undertaking alleged to have been given by Apotex in 2005 in respect of a patent related to the '967 patent. That patent (the '824 patent) was directed to a particular use of modafinil and Shire alleged that Apotex had undertaken not to make, use or sell its tablets for that patented use. Shire submitted that Apotex's Monograph declares that its Apo-modafinil product is indicated for the use covered by the '824 patent and, furthermore, states that Apotex had already sold its product for that use in Canada and therefore was in breach of the undertaking. In response, Apotex argued that any such misrepresentation or breach of undertaking (if established) occurred in respect of another patent (i.e. the '824 patent) and not the patent at issue in these proceedings (i.e. the '967 patent) and therefore cannot be a proper defence to the present proceedings. The Prothonotary allowed the amendment. She said that this is a difficult decision on a point of law and it should not be determined upon a motion. She said that Apotex's alleged breach of an undertaking in relation to another patent, if established, may influence the starting point for determining the period in which damages should be paid in the present proceeding. Therefore it was a proper defence, or at least an arguable defence, in the present proceedings.
The full text of the decision can be found at:
http://decisions.fct-cf.gc.ca/en/2010/2010fc828/2010fc828.html
Apotex v. Janssen-Ortho, motion to vary order of Federal Court of Appeal, levofloxacin, August 20, 2010
For a detailed history of this particular proceeding see the July edition of this newsletter. Apotex filed a Notice of Allegation alleging that a particular patent licensed by Janssen-Ortho was invalid and not infringed. Janssen-Ortho sought an order prohibiting the Minister from issuing a Notice of Compliance. At trial, Justice Shore granted the Order of Prohibition and on appeal the Federal Court of Appeal ("FCA") allowed the appeal and remitted the decision back to Justice Shore for redetermination. In doing so, the FCA ordered Justice Shore to assess the evidence before him independently of Justice Hughes' decision in some related proceedings. On being remitted back to the Federal Court, Justice Shore recused himself from sitting on any redetermination because he would be unable to reach a different conclusion to that which he had already reached.
Janssen-Ortho brought a motion in the FCA asking the FCA to vary its judgment remitting the decision to Justice Shore for redetermination. Janssen-Ortho said that on reading the decision of Justice Shore to recuse himself it is apparent that Justice Shore was not influenced by the decision of Justice Hughes and the FCA erred in remitting the decision for redetermination. The FCA denied the motion and held that contrary to Janssen-Ortho's submissions, Justice Shore's findings had not been made independently of Justice Hughes' decision. Furthermore, procedurally speaking, the FCA noted that Janssen-Ortho did not appeal the FCA judgment to the Supreme Court of Canada and it was therefore a final decision.
The full text of the decision can be found at:
http://decisions.fca-caf.gc.ca/en/2010/2010fca213/2010fca213.html
Eli Lilly v Novopharm, motion for reconsideration of judgment of Federal Court of Appeal ("FCA"), olanzapine, September 7, 2010
Novopharm moved for reconsideration of the FCA's judgment allowing Lilly's appeal of a Federal Court decision that impeached Lilly's patent. For a summary of the FCA judgment, see the July 28, 2010, release of this newsletter. By it judgment, the FCA set aside the order of Justice O'Reilly invalidating Lilly's patent and entitling Novopharm to seek damages pursuant to Section 8 of the PMNOC Regulations. Novopharm brought the motion because it was concerned that the FCA judgment might preclude it from seeking damages pursuant to section 8 of the Regulations. The FCA dismissed the motion. The FCA held that there was no need for it to reconsider its judgment (or amend it) because its judgment did not (if the Lilly patent was ultimately held to be invalid) preclude Novopharm from seeking damages pursuant to section 8 of the Regulations.
The full text of the decision can be found at:
http://decisions.fca-caf.gc.ca/en/2010/2010fca219/2010fca219.html
Apotex v Lundbeck, motion to strike pleadings and for security for costs, escitalopram, August 5, 2010
In earlier PMNOC proceedings, Lundbeck successfully obtained an order prohibiting the Minister from issuing a Notice of Compliance to Apotex in respect of its escitalopram product. Although Apotex appealed the decision (appeal hearing commenced on September 14, 2010), Apotex also commenced the present action to invalidate the Lundbeck patent and at the same time sought a declaration of non-infringement. Lundbeck counterclaimed in the action but had to accept that in doing so it had knowledge of no material facts that demonstrated that Apotex had actually commenced any infringing activities. Lundbeck had to accept that it was trite law that speculative pleadings could be struck for being an abuse of process but argued that because its counterclaim for infringement was in response to Apotex's declaration for non-infringement, the usual principles didn't apply. This was because Apotex itself had put before the court the question of whether Apotex's product infringes the Lundbeck patent and Lundbeck was simply responding in pleadings to that allegation. The Prothonotary dismissed the motion to strike and held that it would not be improper or abusive for Lundbeck to seek from the court – even without having any evidence at this stage – a remedy that was opposite to what Apotex was seeking and which Apotex had itself put in issue between the parties. If, however, Apotex had not sought a declaration of non-infringement, Lundbeck's infringement allegation would have been struck.
In the motion for security for costs, even though the particular Lundbeck entity in the proceeding is not ordinarily resident in Canada, it did provide evidence that it had some assets in Canada and did demonstrate a capability to pay an award of costs from assets outside of Canada. Given this, the Prothonotary exempted Lundbeck from the requirement to post security for costs.
The full text of the decision can be found at:
http://decisions.fct-cf.gc.ca/en/2010/2010fc807/2010fc807.html
Upcoming Trials and Appeals of Interest
September 22-23, 2010, Court of Appeals, Ottawa:
Eli Lilly & Company (Eli Lilly Canada Inc.) v. Apotex
Inc. et al (A-451-09)
Appeal from Patent Infringement Trial Decision - Cefaclor
November 1, 2010, 30 days, Federal Court, Toronto:
Apotex Inc. v. Glaxo Group Ltd And Glaxosmithkline Inc.
(T-428-01)
Patent Infringement Trial - Cefuroxime Axetil
November 10, 2010, Supreme Court, Ottawa:
Celgene Corporation v. Attorney General of Canada
(33579)
Health law – Drugs – Patent Act, s. 80(1)(b)
– Patented Medicine Prices Review Board's decision
holding that Board had jurisdiction to require Celgene Corporation
to provide information about the pricing of the drug Thalomid
– Board decision set aside on appeal – Federal
Court of Appeal upheld Board's decision – Whether the
majority decision of the Federal Court of Appeal conflicts with
jurisprudence of this Court, the Federal Court of Appeal and
Exchequer Court – Whether the Federal Court of Appeal
ignored the international comity-based presumption against the
extraterritorial application of domestic law – Whether
the decision of the Federal Court of Appeal wrongly extends the
jurisdiction of an important Canadian regulator to sales made in
the US, contrary to its enabling legislation – Whether
the Federal Court of Appeal erred by ignoring Parliament's
wording of the Patent Act, and inserting its own and whether the
majority changed "in any market in Canada" to "into
any market in Canada" – Whether the appeal court
erred in obiter and extended the Board's jurisdiction by also
ruling on jurisdiction over price regulation when this case
involved jurisdiction over disclosure of data – Whether
this case has wide implications for other foreign suppliers of
medicines.
November 12, 2010, Supreme Court, Ottawa:
Merck Frosst Canada Ltd. v. Minister of Health (33290
and 33320)
Access to information - Exemptions - Third party information - Food
and drugs - Confidentiality of scientific information concerning
new drugs - Interpretation of statutes and regulations -
Information provided to Health Canada protected for five years -
Competitor requesting access to departmental information within
that time - Whether access exemption for department's third
party information applies to scientific information provided by
manufacturer of new drug - Whether third party innovator
manufacturer bears burden of proving that access exemption must
apply - Whether department may disclose certain third party
information without notice - Food and Drug Regulations, C.R.C., c.
870, ss. C.08.002(1), (2), (3) and C.08.004.1(2), (3), (4) - Access
to Information Act, R.S.C. 1985, c. A-1, ss. 20, 25, 27.
November 15, 2010, 15 days, Federal Court, Toronto:
Mycogen Plant Science, Inc. v. Bayer Bioscience N.V. et al
(T-1524-08)
Monsanto Technology Llc v. Bayer Bioscience N.V. et al
(T-1569-08)
Patent Infringement Trial
December 6, 2010, 8 days, Federal Court, Toronto:
Apotex Inc. v. Servier Canada Inc. (T-1783-08)
Patent Conflict, Section 8 Patented Medicines (Notice of
Compliance) Regulations - Gliclazide
December 6, 2010, 4 days, Federal Court, Ottawa:
Hoffmann-LaRoche Limited v. Apotex Inc.
(T-1165-09)
Patented Medicines (Notice of Compliance) Regulations,
mycophenolate mofetil<
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