 |
|||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|
May 2011 In this issue: Canadian Patent Office grants claims to monoclonal antibodies without a working example » Patented Medicine Prices Review Board news » Shire cannot amend defence to section 8 claim to add patent infringement as a defence/counterclaim » |
||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Canadian Patent Office grants claims to monoclonal antibodies without a working example In Re Immunex Corporation Patent Application No. 583,988 (Commissioner's Decision No. 1302; "Immunex"), for the first time, the Commissioner of Patents ("the Commissioner") has allowed claims directed to monoclonal antibodies in the absence of a working example in the patent specification demonstrating the preparation of at least one monoclonal antibody within the scope of the claims. |
|||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Health Canada news Food and Drug Regulations amended to govern approval of Extraordinary Use New Drugs. Amendments to the Food and Drug Regulations that apply to the authorization for sale of a small number of emergency use drugs (referred to as Extraordinary Use New Drugs ("EUND")), such as anthrax and pandemic influenza vaccines, came into force on March 25, 2011: Regulations Amending the Food and Drug Regulations (1319 – New Drugs for Extraordinary Use). In view of ethical and/or logistical challenges in designing and conducting clinical trials for such drugs, the existing standards for clinical safety and effectiveness for new drugs could not be met for EUNDs. The amendments therefore create a new type of drug submission for EUNDs, which does not require detailed reports of the tests made to establish the safety of the new drug for the purpose and under the conditions of use recommended, or substantial evidence of the clinical effectiveness of the new drug for the purpose and under the conditions of use recommended that are required for other new drugs. The amendments detail the inclusion criteria for EUNDs and outline the requirements for EUND submissions, labeling, plans for post-market safety and efficacy studies, and annual reporting. Existing regulations that apply to other drugs, such as data and patent protection, also apply to EUNDs. Because of the nature and intended purpose of these drugs, manufacturers are only able to sell EUNDs to different levels of government (i.e. federal, provincial, territorial, municipal). A draft of the amendments was published for comment on April 3, 2010: Regulations Amending the Food and Drug Regulations (1319 – New Drugs for Extraordinary Use). (HTML/PDF). Minor changes have also been made to the definitions under the Patented Medicines (Notice of Compliance) Regulations (Regulations Amending the NOC Regulations) and the data protection provision of the Food and Drug Regulations in order to confirm that they apply to EUND submissions. Health Canada fees revised. On April 1, 2011, the Fees in Respect of Drugs and Medical Devices Regulations came into force (Canada Gazette). The Regulations set out the updated fees for Health Canada's human drugs and medical devices programs, fee mitigation measures and provisions for the annual adjustment of fees. Fees have been updated to better reflect the costs to Health Canada in delivering its regulatory activities. The government released the Regulatory Impact Analysis Statement last November, including a detailed cost-benefit statement (RIAS). Further, Health Canada has updated the Guidance Document titled "Management of Drug Submissions" to include changes as a consequence of the Regulations (Notice and Amended Guidance Document). |
|||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Patented Medicine Prices Review Board news DIP Methodology technical working group releases final report. The Board's guidelines include the DIP Methodology to address the situation where benefits to customers are reduced or end. In January 2011, the Board established a DIP Methodology technical working group to identify challenges associated with and develop solutions for the methodology. The final report of the group was presented to the Board on March 4, 2011. The report states that the method in which the current DIP Methodology is applied is not workable, and suggests that it be broken down into two processes: a Simplified DIP Methodology and a Regular DIP Methodology. (Notice. Final Report.) Voluntary Compliance Undertakings for ABILIFY and SUPRANE. The Board recently approved Voluntary Compliance Undertakings for Bristol-Myers Squibb's ABILIFY (aripiprazole) (Notice) and Baxter's SUPRANE (desflurane) (Notice). |
|||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Recent Court decisions Shire cannot amend defence to section 8 claim to add patent infringement as a defence/ counterclaim. Shire was denied an Order of prohibition against Apotex regarding modafinil (Shire's ALERTEC), and Apotex subsequently commenced an action pursuant to section 8 of the Patented Medicines (Notice of Compliance) Regulations. In the motion leading to the present decision, Shire sought leave to amend its pleadings to add a new defence of infringement and to counterclaim for damages for patent infringement and an injunction. As reported in the September and November 2010 editions of Rx IP Update, Shire was denied leave to amend its defence to plead that Apotex should be precluded from recovering damages pursuant to section 8 in the event that there is a finding of infringement of the relevant patent in another proceeding, brought by the patentee (Cephalon) against Apotex. In the present decision, the Prothonotary held that the proposed amendments would introduce an entirely new and complex litigation into the proceeding, and that Shire had not provided a satisfactory explanation as to why it failed to propose these amendments earlier in the proceeding. The Court considered that while the defence of infringement would constitute a triable issue, to allow the amendments would cause non-compensable prejudice to Apotex because "the radical change in the pleadings" would necessarily result in the adjournment of the trial set down for April 2012. The Court concluded that allowing the amendments would not be in the interests of justice. Shire has appealed the decision. Apotex Inc. v. Shire Canada Inc., April 7, 2011. Court of Appeal declines to strike Allergan's patent infringement claim against Apotex regarding gatifloxacin. Allergan sued Apotex Inc. and Apotex Pharmachem Inc. (together "Apotex") for infringement of a patent related to gatifloxacin (Allergan's ZYMAR), and Apotex brought a motion to strike the claim. In an unreported decision, the Federal Court Judge dismissed Apotex's motion, and the Court of Appeal dismissed Apotex's appeal. The Court of Appeal held that it was reasonable for the Federal Court Judge to conclude that the pleadings contained sufficient material facts by which Apotex is alleged to have infringed the relevant patent, in part because of additional particulars that were volunteered by Allergan. The Court of Appeal considered Apotex's argument that the conduct complained of is protected by the common law "experimental use" and the Patent Act regulatory use exceptions to infringement, and held that the Statement of Claim, when read with the additional particulars, alleges facts that are beyond the scope of the experimental or regulatory activity. The particulars included allegations of stockpiling bulk gatifloxacin for commercial and regulatory purposes, and selling and offering to sell formulated gatifloxacin for two months in 2010. On this basis, the Court of Appeal distinguished the present case from Eli Lilly Canada Inc. v. Nu-Pharm, which was reported in the April 2011 edition of Rx IP Update. Furthermore, the Court of Appeal did not agree with Apotex that this was a quia timet action, as the "claims of past and continuing infringement support the claim for future continuing infringement." Apotex Inc. v. Allergan Inc, April 14, 2011. Court of Appeal upholds finding that dosage form patent is ineligible for listing against NDS for combination product, TARGIN. The Federal Court had dismissed an application by Purdue that sought to set aside a decision by the Minister that a patent claiming a controlled-release oxycodone formulation is not eligible for listing on the Patent Register against a new drug submission ("NDS") for TARGIN (a controlled-release product containing two medicinal ingredients, oxycodone and naloxone). The Court of Appeal affirmed. The Court assessed eligibility by considering the following framework: What dosage form does the patent claim? What is the form approved by the existing NOC? Is the dosage form claimed by the patent that which is approved by the existing NOC? On the third question, the Court held that the matching requirement had not been met. While the Court accepted that "at best", the claim did not exclude naloxone, that was not the same as the dosage form of the NOC, which explicitly includes both oxycodone and naloxone. The Court held that the claimed dosage form and the approved dosage form must be "the very same." Purdue Pharma v. Canada (Attorney General)., April 14, 2011. Trademark Opposition Board decisions Board rejects Johnson & Johnson's opposition to registration of ACCUWAVE, allows opposition to ACCUVISION. Johnson & Johnson opposed applications for the trademarks ACCUWAVE and ACCUVISION for use in association with wares and services associated with eye care, including contact lenses and vision correction, on the basis that the trademarks are confusing with ACUVUE and related trademarks owned by Johnson & Johnson. Regarding ACCUWAVE, the Board found that confusion between the marks is not likely, and rejected the opposition, finding that the differences between the final components of each mark are sufficient that confusion between the marks as a whole is not likely. Conversely, the Board rejected the application for ACCUVISION, finding that there was a likelihood of confusion between the two trademarks in view of their resemblance, combined with the overlap between the wares and services associated with each. Johnson & Johnson v. Mahrukh Panthakey, April 12, 2011. |
New Court proceedings Patented Medicines (Notice of Compliance) Regulations
To check the status of Federal Court cases, please click here. |
||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Contact information For more information or to request a copy of any decision, pleading or legislation, please contact:
Case-law briefs prepared by:
Litigation contacts
Prosecution contacts
Regulatory contacts
Our pharmaceutical practice group Smart & Biggar/Fetherstonhaugh's pharmaceutical practice group calls upon decades of extensive and in-depth experience to keep your pharmaceutical IP rights where they belong — in your hands. For more information on our group and a full list of its members, please click here. Disclaimer The preceding is intended as a timely update on Canadian intellectual property and regulatory law of interest to the pharmaceutical industry. The contents of this newsletter are informational only and do not constitute legal or professional advice. To obtain such advice, please communicate with our offices directly. To join the Rx IP Update mailing list, be removed from the mailing list or make changes to contact information, please send an e-mail to rxip.update@smart-biggar.ca. smart-biggar.ca | Ottawa | Toronto | Montreal | Vancouver |
|||||||||||||||||||||||||||||||||||||||||||||||||||||||
