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Canada Assists Third-World AIDS FightCanada intends to permit Canadian generic pharmaceutical companies to produce some patented drugs and export them to developing countries. The initiative is in response to the need for drugs to combat the AIDS and malaria epidemics in developing countries around the world. This announcement came on the heels of the World Trade Organization agreement to permit compulsory licenses to manufacture and export patented drugs to a developing country suffering a national health emergency. The legislation will include safeguards to reduce the risk of gray marketing of generic drugs back into industrialized nations.
The Truth About False Statements by CompetitorsIt is difficult to get an injunction to stop a competitor from spreading false statements. This was confirmed by a recent interlocutory injunction case holding that Amgen's ad agency, Karisma Canada, recklessly or dishonestly made false statements about Janssen-Ortho's drug EPREX to the media and physicians. The court would not issue an injunction because irreparable harm had not been shown. The court stated that to prove irreparable harm, Janssen-Ortho should have provided evidence of doctors unwilling to prescribe EPREX or patients unwilling to take EPREX because of the statements. (Janssen-Ortho v. Amgen et al, Ont. SCJ)
Enforceability of US Patents Against "Equivalents"Two new US Court of Appeal decisions may make it difficult for patentees to resort to the doctrine of equivalents to catch a potential infringer that is not within the literal claim wording. The latest Festo decision stated that a presumption of file wrapper estoppel is raised by i) any narrowing claim amendment made to comply with a patent statute (e.g. s. 112 written description or enablement), ii) any voluntary amendment, or iii) any unexplained narrowing amendment. The Deering case held that rewriting a dependent claim in independent form, while also canceling the broader claims from which the dependent claim depended, is a narrowing amendment raising the presumption of prosecution history estoppel. (Festo v. Shoketsu & Deering v. Vector)
Natural Health Product Licenses and LabelsNew regulations will place restrictions on companies that manufacture, package, label, import and distribute Natural Health Products, which include vitamins, minerals, herbal remedies, homeopathic medicines, traditional medicines, probiotics, amino acids and essential fatty acids. The regulations create a product licensing regime for Natural Health Products, so that the products are reviewed for safety, quality and health claims. The products will require a product identification number for authorized sale in Canada. Site licensing will be implemented to ensure proper handling, storage and delivery of the products and good manufacturing practices. The regulations also include labeling requirements.
Pharmaceutical Patent Register Wrap-UpBelow is a summary of some of the more interesting cases this year. Heart Failure Patent Appears D.O.A.An allegation of invalidity was justified against a patent for the use of carvedilol for prolonging survival in Congestive Heart Failure (CHF) patients. Prior art, including published phase II trial results, showed that some beta-blockers possibly had a beneficial function in reducing mortality in CHF. The phase III results, which formed the basis of the patent, merely confirmed the earlier findings and eliminated any uncertainty – there appeared to be no inventiveness. (GlaxoSmithKline et al. v. The Minister of Health and Pharmascience, Fed. Ct. Trial Div.)
Surprising Results Support PatentThe patent claimed omeprazole "base addition salts". Methods that could be readily used for production of the base addition salt of omeprazole were known in the art as of the patent priority date. While a skilled person could produce base addition salts of omeprazole, that same person would not do so because the therapeutic value of a base addition salt of omeprazole was unexpected. There was sufficient teaching away from the use of base addition salts that the allegation of obviousness was unjustified. (Ab Hassle and AstraZeneca v. Apotex, 2003 Fed. Ct. Trial Div.)
Requirement to File a Notice of Allegation (NOA)A second person that files a new drug submission rather than an abbreviated new drug submission may still have to serve a NOA on the first person. (Biolyse Pharma v. Bristol-Myers Squibb et al., Fed. C.A.)
Patent Register – Eligibility for Inclusion- A sustained release capsule patent is not eligible for inclusion the patent register even if it claims the capsule containing the active ingredient. Patents for devices that administer medicines (rather than for the substance being administered) are not "medicines" for patent register purposes. It is not decisive that the capsules are regulated as drugs. (Eli Lilly Canada Inc. v. Canada, Fed. Ct. Trial Div.) - Patents for patches are generally not eligible for inclusion on the patent register. An eligible patent has claims for a drug, rather than a system for the administration of a drug. The test is whether the patches are administered to the patient or whether they administer substances to the patient. An example of an eligible drug claim would include a dosage formulation combining both active ingredients and inactive ingredients. (Janssen-Ortho Inc. v. Canada, 2003 FCT 286; Novartis Pharmaceuticals Canada Inc. v. Canada, 2003 Fed. C.A. 299)
Patent Register - Timing- A patent application must have a Canadian filing date prior to the filing of a new drug submission (NDS) in order to be eligible for the patent register. It is not enough that a Canadian application filed after the NDS date has a priority date before the NDS date. (Pfizer Canada et al. v. The Attorney General of Canada et al., Fed. C.A.) - If a company misses the date to add a patent to the patent register, the patent cannot be subsequently added by filing a supplemental NDS to change the trade name of the drug. (Apotex v. Ferring et al., Fed. C.A.) - Where a supplemental NDS does create the opportunity to add new patents (e.g. submission for a new disease indication), a 24-month statutory injunction can begin for each new patent. (GlaxoSmithKline Inc. v. The Minister of Health and Apotex, Fed. Ct. Trial Div.) - A patent grant of rights is different than the physical patent issuance. Where there is a delay in issuance, the first person may still be able to add a patent to the register after the 30-day period from grant, as long as it is added within 30 days of issuance. (Procter & Gamble Pharmaceuticals Canada v. Genpharm et al., Fed. Ct. Trial Div.)
Generic Omeprazole Can't Piggyback on Omeprazole MgHealth Canada refused to review a generic company's abbreviated ANDS that compared omeprazole to omeprazole magnesium. The court upheld Health Canada's decision because in an ANDS the compared drugs must contain identical amounts of the identical medical ingredients. (Reddy-Cheminor v. Canada, Fed. Ct. Trial Div.)
Privacy Law AlertCanada is bringing in new privacy laws effective January 1, 2004. Call us for more information if you collect and store other people’s information. Ensure that your company is in compliance.
B&P INSIDERAnnouncements We are pleased to announce that Carol Yip has joined us as a technical consultant in both the Chemical Group and Biotechnology and Pharmaceutical Group. Carol has a B.Sc. Honours in Biological Chemistry from the University of Toronto and a M.Sc. in Chemistry (Organic Synthesis) from the University of Guelph. Carol has research experience in the fields of bio-organic, inorganic and physical chemistry and has several years of prior experience in the patent field. Carol is fluent in Cantonese and Mandarin.
Articles An article summarizing recent developments in biotechnology written by Melanie Szweras, Tina Loucaides and Micheline Gravelle will be published in the 2004 edition of the Canadian Legal Lexpert Directory. Micheline Gravelle is named as leading practitioner in the directory. An article written by Noel Courage entitled "WTO Agreement Improves Access to Life-Saving Drugs" was published by Lawyers Weekly in September 2003.
Speaking Engagements Anita Nador will be chairing a session at the University of Toronto Technology Group conference on regulation of genetic technology on February 6. Micheline Gravelle will be chairing a session at a Canadian Venture Funding conference held by the Canadian Institute on February 19, at the Sutton Place Hotel in Toronto. Anita Nador will be in attendance. Micheline Gravelle will be speaking at the Drug Patents conference hosted by Insight Information on March 30, at the InterContinental Toronto Centre. Andrew McIntosh will be speaking on IP due diligence at a Canadian Institute conference in Toronto, on April 6 and 7. Anita Nador will be attending the LES 2004 Winter Meeting, February 11-13, in San Francisco. Anita is the co-chair of the Toronto Chapter of LES. Anita Nador chaired the Intellectual Property panel at the BioFinance Early Phase 2003 conference on November 26, in Toronto. Bereskin & Parr was a proud sponsor of the BioFinance Early Phase 2003 program, which was an investor forum where emerging life science companies met Venture Capital, Seed and Angel Investors. Edited by Noel Courage. Please send comments or suggestions to Noel at ncourage@bereskinparr.com Disclaimer This newsletter is for informational purposes only. These materials constitute general information relating to intellectual property law and our firm. They do not constitute legal advice or other professional advice and should not be relied on as such. While all materials are believed to be current and accurate at the time of writing, they are not guaranteed.
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