|
Federal Court of Appeal upholds Minister's decision denying data protection for the enantiomer DEXILANT
In a split decision, the majority of the Federal Court of Appeal dismissed Takeda's appeal and affirmed the Minister of Health's refusal to list DEXILANT (dexlansoprazole) on the Register of Innovative Drugs.
Read more »
Supreme Court of Canada news
Apotex seeks leave to appeal decision upholding prohibition Order. As reported in the December 2012 issue of Rx IP Update, the Federal Court of Appeal dismissed Apotex's appeal of the Federal Court decision granting an Order prohibiting the Minister from issuing a notice of compliance (NOC) to Apotex for its ophthalmic drug combining brimonidine and timolol (Allergan's COMBIGAN). The Federal Court had found that Apotex's allegation of obviousness was justified (2012 FC 767) yet, despite this finding, issued a prohibition Order specifically to allow the Court of Appeal to address apparent "serious issues raised as to comity," which arose because of a prior decision of the Federal Court relating to the same patent. In dismissing the appeal, the Court of Appeal stated that "although the prohibition order was issued by the Federal Court for the wrong reason, it was nevertheless properly issued." The Court of Appeal held that Apotex's allegation of obviousness was not justified.
Apotex Inc v Allergan Inc et al, January 22, 2013 (SCC Case No. 35184).
Federal Court of Appeal decision — 2012 FCA 308.
Federal Court decision — 2012 FC 767.
Patented Medicine Prices Review Board news
New NEWSletter released. The PMPRB has released its January 2013 NEWSletter.
NEWSletter.
Health Canada news
Government of Canada announces a new streamlined approach to natural health products. The Natural Health Products Regulations ("NHP Regulations"), which came into effect in 2004, are intended to give Canadians access to safe, effective and high-quality natural health products. Under the NHP Regulations, natural health products sold in Canada require a licence, and Canadian sites that manufacture, package, label and import these products require a site licence. Products already on the market when the NHP Regulations came into effect also required licences, resulting in unprocessed applications. The Government therefore introduced the Natural Health Products (Unprocessed Product Licence Applications) Regulations ("NHP-UPLAR") in August 2010. The NHP-UPLAR, which allowed products to be legally sold in cases where Health Canada had not completed its licensing decision in 180 days, ended February 4, 2013.
On February 2, 2013, the Parliamentary Secretary of Health announced a new approach to natural health products that includes new policies, process improvements and newly revised guidance for licensing NHPs. A new approach to site licensing is also being developed. Features of the new approach are product licensing in 180 days or less and a continued recognition of safety as the top priority. The new approach maintains previous policies to protect consumer safety, including the level of evidence required to demonstrate safety, labelling requirements, and submission of serious adverse reaction reports.
News release. Regulating natural health products in Canada.
Recent Court decisions
Patented Medicines (Notice of Compliance) Regulations
Application moot following withdrawal of NOA. Eli Lilly ("Lilly") brought a prohibition application regarding two patents relating to Eli Lilly's injectable pemetrexed disodium (ALIMTA) that were initially at issue. Lilly later accepted that one of the patents would not be infringed by Teva's product and that no Order of prohibition could therefore be issued, rendering the application with respect to that patent moot. Regarding the second patent, Teva failed to file evidence and eventually withdrew its notice of allegation ("NOA"). Lilly asserted it was entitled to an Order of prohibition until expiry of the patent, whereas Teva argued the application was moot. Justice Barnes agreed with Teva, and he also rejected Lilly's argument that, in light of withdrawal of its NOA, Teva must either cancel its submission to the Minister for an NOC or amend its submission to advise the Minister it will await expiry of the patent.
Regarding whether the application was moot, Lilly cited three issues. First, it would be unjust to allow a second person to withdraw its NOA solely to overcome a failure to file evidence. While Justice Barnes agreed that this could be an abuse of process, as there was no clear evidence that this was the case in this proceeding it would be speculative to infer any improper or ulterior motive to Teva or to assume Teva would file a second NOA. Second, Lilly was concerned it could be exposed to section 8 damages. Justice Barnes again found this "remote and speculative." Finally, Lilly raised the possibility of the Minister issuing an NOC to Teva despite withdrawal of its NOA. Justice Barnes characterized this as "unfounded" as it would not be permitted under the Patented Medicines (Notice of Compliance) Regulations ("PMNOC Regulations") and Health Canada had also informed Teva that an NOC would not be issued until the requirements of the PMNOC Regulations were met.
Eli Lilly Canada Inc v Teva Canada Limited, January 14, 2013.
Federal Court decision — 2013 FC 28.
Application for Order of prohibition denied for Pfizer's pregabalin (LYRICA). On February 4, 2013, Justice Hughes denied Pfizer's application for an Order of prohibition against Pharmascience (PMS) regarding pregabalin (Pfizer's LYRICA). The Court considered PMS's allegations of claims broader than the invention made or disclosed, sound prediction, actual inutility and obviousness.
Claim 3, the only claim at issue, was construed by Justice Hughes as claiming:
For use in treating pain, in a mammal, a therapeutically effective amount of pregabalin or its racemate.
Pregabalin was a known compound used for treating central nervous system disorders, including as an anti-convulsant. The patent contained data regarding testing of pregabalin, an enantiomer, in rats.
In construing the term "pain," Justice Hughes considered the use of "pain" throughout the patent, including specific pains listed in other claims and the variety of pains set out in the description. He held that the meaning of "pain" in claim 3 is broad and encompasses all of the specific pains claimed and listed in the description, and that when the pains listed in the description are broadened by the words "but not limited to," pains known at the date the patent was laid open that are "reasonably related to the named pains."
Justice Hughes held that PMS's allegation that claim 3 is broader than the invention made or disclosed was justified. He considered two features of the claim — the enantiomer and the racemate — and the term "pain." Regarding claiming both the enantiomer and the racemate, Justice Hughes found that there was no reference to the racemate in the description, the inventor did not test or contemplate testing the racemate, and the skilled person would not infer that the racemate would be effective based on the disclosure of the patent. Regarding the term "pain," he found that although when properly construed claim 3 included both chronic and acute pain, the inventor stated in evidence that pregabalin is useful only for the treatment of chronic or persistent pain and not acute pain.
Justice Hughes provided a history of the evolution of the test for sound prediction in Canada and concluded:
[159] In taking all of the foregoing into consideration, in circumstances where a patent claims a pharmaceutical that is useful for a particular treatment or therapy:
- the Patent Act and the jurisprudence require that the particular utility be stated in the specification;
- the particular utility needs to be stated in the claim only where the compound is a previously known compound for which a new use is the invention;
- there is a requirement in the jurisprudence that the specification disclose information from which the utility can be confirmed or be said to be soundly predicted;
- where a challenge has been raised as to whether the compound claimed in fact has utility, or whether the utility could have been soundly predicted as of the filing date, the Court may enter into a factual determination as to whether the utility had been established or soundly predicted as of that date.
Based on similar reasoning to the claim breadth analysis, Justice Hughes held that the allegation of a lack of sound prediction was justified. First, he again relied on the broad construction of "pain," stating that "Claim 3 is invalid in that it embraces pain which cannot be treated, as well as pain which ... could not have been predicted as treatable by pregabalin." Second, he found that there was no disclosure in the patent of a factual basis or a sound line of reasoning that the racemate would be useful in treating the pain encompassed by claim 3.
Pfizer was successful on the issue of obviousness. Justice Hughes held that although at least some researchers considered anti-convulsants to be a "fruitful field" of candidates for pain drugs, one would not have known whether a particular drug would work and be without any harmful effects until it was tested.
Pfizer Canada Inc v Pharmascience Inc, February 4, 2013.
Federal Court decision — 2013 FC 120.
Ontario Superior Court refuses to strike Allergan's infringement claim. Allergan is pursuing a claim in the Ontario Superior Court seeking a declaration that certain claims of two patents related to LATISSE (bimatoprost) are valid and infringed by Apotex. Allergan is also seeking an injunction and damages or an accounting of Apotex's profits. Justice Chiappetta refused to strike the claim, finding that the claim for infringement alleges sufficient material facts by which Apotex is alleged to have infringed the relevant patents. Justice Chiappetta accepted that the "mere fact that a defendant pharmaceutical company has sought regulatory approval to market a medicine does not by itself support an action for patent infringement." However, she found that "the claim deemed true alleges that particular actions were taken for reasons not solely related to meeting the requirements of the regulatory scheme." The Statement of Claim alleges that Apotex has:
- continued to purchase and import raw bimatoprost into Canada;
- continued to stockpile raw bimatoprost and manufacture the Apotex product;
- continued to formulate sterile solutions containing the imported bimatoprost, manufacture dispensers for external application of the topical solution to the skin and stockpile the infringing kits;
- exported from Canada to the United States topical solutions containing bimatoprost;
- created marketing plans, a launch plan and sales projections for the Unites States and Canadian markets;
- prepared packaging, labelling, package inserts, monographs and consumer information; and
- made agreements with retailers and pharmacies to stock and distribute the Apotex product in Canada and the United States.
Justice Chiappetta rejected the characterization that the pleadings were quia timet, instead finding that "the claims of past and continuing infringement support the claim of future continuing infringement." The Court also rejected the argument that the claims were "scandalous, frivolous or an abuse of process." Accordingly, Justice Chiappetta declined to strike the claim in whole or in part. Apotex's request for further particulars was also refused.
Allergan Inc v Apotex Inc, January 16, 2013.
Ontario Superior Court of Justice decision — 2013 ONSC 98.
New Court proceedings
Patented Medicines (Notice of Compliance) Regulations
|
Medicine:
|
norgestimate, ethinyl estradiol (TRI-CYCLEN)
|
|
Applicants:
|
Janssen Inc and Janssen Pharmaceuticals Inc
|
|
Respondents:
|
The Minister of Health and Teva Canada Limited
|
|
Date Commenced:
|
January 3, 2013
|
|
Court File No.:
|
T-8-13
|
|
Comment:
|
Application for Order of prohibition until expiry of Patent No. 2,356,747. Teva alleges invalidity.
|
|
Medicine:
|
moxifloxacin hydrochloride (AVELOX)
|
|
Applicants:
|
Bayer Inc and Bayer Intellectual Property GmbH
|
|
Respondents:
|
Mylan Pharmaceuticals ULC and The Minister of Health
|
|
Date Commenced:
|
January 3, 2013
|
|
Court File No.:
|
T-11-13
|
|
Comment:
|
Application for Order of prohibition until expiry of Patents Nos. 1,340,114 and 2,192,418. Mylan alleges invalidity and non-infringement.
|
|
Medicine:
|
bimatoprost (LUMIGAN RC)
|
|
Applicants:
|
Allergan Inc and Allergan, Inc
|
|
Respondents:
|
The Minister of Health and Mylan Pharmaceuticals ULC
|
|
Respondent/Patentee:
|
Millennium Pharmaceuticals Inc
|
|
Date Commenced:
|
January 4, 2013
|
|
Court File No.:
|
T-18-13
|
|
Comment:
|
Application for Order of prohibition until expiry of Patent No. 2,585,691. Mylan alleges invalidity and non-infringement.
|
|
Medicine:
|
drospirenone ethinyl estradiol (YASMIN)
|
|
Applicants:
|
Bayer Inc and Bayer Pharma Aktiengesellschaft
|
|
Respondents:
|
Famy Care Limited and The Minister of Health
|
|
Date Commenced:
|
January 4, 2013
|
|
Court File No.:
|
T-19-13
|
|
Comment:
|
Application for an Order of prohibition until after the expiry of Patent No. 2,261,137. Famy alleges invalidity and non-infringement.
|
|
Medicine:
|
rasagiline mesylate (AZILECT)
|
|
Applicants:
|
Teva Canada Innovation and Teva Pharmaceutical Industries Ltd
|
|
Respondents:
|
Apotex Inc and The Minister of Health
|
|
Date Commenced:
|
January 4, 2013
|
|
Court File No.:
|
T-22-13
|
|
Comment:
|
Application for Order of prohibition until expiry of Patent No. 2,232,310. Apotex alleges invalidity and non-infringement.
|
To check the status of Federal Court cases, please click here.
|
