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November 2010 In this issue: Minor amendments made to Patented Medicines (Notice of Compliance) Canadian Intellectual Property Office news » Court of Appeal denies stay of Order denying confidentiality Order for notice of allegation » Order of prohibition denied regarding Apotex and dorzolamide/timolol » Dedication no answer to double-patenting attack in case of monopoly extension » Judge upholds refusal to strike Pfizer's pleading alleging estoppel based on prior NOC proceedings » Board rejects Novartis's opposition to registration of ESTRASORB » |
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Court of Appeal upholds rejection of product claims for obviousness-type double patenting over product-by-process claims On October 20, 2010, the Federal Court of Appeal dismissed Bayer's appeal of a Federal Court decision dismissing its appeal from a decision of the Commissioner of Patents. The Commissioner had refused to grant a patent for a compound because a patent had already been issued for the same compound made by a particular process. |
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Minor amendments made to Patented Medicines (Notice of Compliance) Regulations On October 7, 2010, amendments were made to sections 7(5)(a) and (b) and section 8(3) of the French version of the Patented Medicines (Notice of Compliance) Regulations. The amendments are described in the Regulatory Impact Analysis Statement as minor and not substantive; the stated objective is to add more precision to the language and to ensure consistency between the English and French versions. (Regulations Amending the Patented Medicines (Notice of Compliance) Regulations (Miscellaneous Program), SOR/2010-212.) |
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Canadian Intellectual Property Office news Canadian Intellectual Property Office requests comments concerning remuneration to patentee for compulsory licence under section 19 of the Patent Act. Pursuant to sections 19 to 19.3 of the Patent Act, the Commissioner of Patents, on application by the Government of Canada or the government of a province, may authorize use of a patented invention by that government. Except in cases of national emergency, extreme urgency or public non-commercial use, authorization may not be granted unless the applicant has made, without success within a reasonable time, efforts to obtain from the patentee on reasonable commercial terms and conditions authority to use the patented invention. If the Commissioner grants a government authorization to use a patented invention under these provisions, the patentee shall be notified and: (a) the scope and duration of the use shall be limited to the purpose for which the use is authorized; (b) the use authorized shall be non-exclusive; and (c) any use shall be authorized predominantly to supply the domestic market. Moreover, the authorized user shall pay to the patentee such amount as the Commissioner considers to be adequate remuneration in the circumstances, taking into account the economic value of the authorization. The authorization may be terminated if the circumstances that led to the granting of the authorization have ceased to exist and are unlikely to recur. The Canadian Intellectual Property Office ("CIPO") has opened a consultation seeking public input to assist in developing guidelines for setting adequate remuneration to the patentee. Full details of the consultation, including an email address to which comments may be sent, are provided on the CIPO website at: http://www.cipo.ic.gc.ca/eic/site/cipointernet-internetopic.nsf/eng/wr02806.html Any comments provided will be posted on the CIPO website. The comment period officially closes on November 8, 2010. |
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Health Canada news Health Canada releases final Guidance Document regarding Schedule A/section 3 of the Food and Drugs Act. The Food and Drug Regulations prohibit preventative, treatment and cure claims of diseases listed in Schedule A of the Food and Drug Regulations in labelling and advertising to the general public. As reported in the August 2008 edition of Rx IP Update, amendments were made to exempt:
from the prohibition on preventative claims for the diseases listed in Schedule A (Regulations Amending Schedule A to the Food and Drugs Act and the Medical Devices Regulations (Project 1539); Regulations Amending Certain Regulations Made under the Food and Drugs Act (Project 1539).) The amendments came into force on June 1, 2008. Health Canada released a draft revised Guidance Document relating to Schedule A/section 3 on July 23, 2008, with a four-month comment period. On October 26, 2010, Health Canada released the final version of the Guidance Document. (Draft Guidance Document - Schedule A and Section 3 to the Food and Drugs Act; Final Guidance Document: Schedule A/Section 3 to the Food and Drugs Act.) |
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Recent Court decisions Patented Medicines (Notice of Compliance) Regulations Court of Appeal denies stay of Order denying confidentiality Order for notice of allegation. A Prothonotary denied Novopharm's motion to designate its notice of allegation (NOA) confidential in a proceeding regarding pregabalin (Pfizer's LYRICA). This decision was upheld on appeal. Novopharm appealed to the Federal Court of Appeal and also brought a motion for an interim stay of the Judge's decision or an order restraining the parties and the Court's registry from disclosing its NOA pending the disposition of its appeal. The Court of Appeal denied the motion, finding that in the absence of evidence in support of the motion materially adding to that considered in the Federal Court, Novopharm had not demonstrated that it would suffer irreparable harm if the motion was not granted. Novopharm Limited v. Pfizer Canada Inc., October 5, 2010. Order of prohibition denied regarding Apotex and dorzolamide/timolol. The Federal Court declined to grant an Order of prohibition relating to a patent directed to a combination of a carbonic anhydrase inhibitor (CAI) with a beta blocker to treat glaucoma, which included claims for a co-formulation of a CAI with a beta blocker. Apotex seeks approval for an ophthalmic solution containing a combination of dorzolamide and timolol (Merck's COSOPT). Justice O'Reilly held that the allegation of invalidity based on anticipation was justified with respect to the use claims but not the co-formulation claims and that the obviousness attack was justified. The Court rejected Apotex's material misrepresentation attack based on an assertion that Merck willfully misled the patent examiner regarding the inventor, relying on the author of an alleged anticipatory reference. This attack was rejected as the Court had rejected Apotex's anticipation argument based on the abstract at issue. Merck & Co. v. Canada (Health), October 22, 2010. Dedication no answer to double-patenting attack in case of monopoly extension. The Federal Court has denied Merck an Order of prohibition against Apotex relating to Patent No. 1,329,211 (’211) and dorzolamide (Merck's TRUSOPT). The ’211 patent issued from a divisional of a parent that issued as Patent No. 1,328,262 (’262). Both patents include claims to dorzolamide. Apotex had served Merck with an earlier NOA regarding the ’211 patent in 2007, and Merck subsequently dedicated its rights in the ’262 patent to the public in 2007. Apotex then withdrew the first NOA and served a second one alleging that the ’211 patent was invalid for double-patenting in view of the ’262 patent. Merck responded by submitting that the dedication had cured any double-patenting. The Court found that as the relevant date for assessing Apotex's allegation was the date of the hearing, it must take into account the dedication. The Court concluded that it should not permit a dedication to have the effect that Merck suggested as Merck would obtain an advantage, namely 28 days of extra monopoly. Accordingly, Apotex's allegation of invalidity was found to be justified. Merck & Co. v. Apotex Inc., October 22, 2010. Other decisions Judge upholds denial of contingent finding of infringement in separate action as defence to section 8 claim. On October 8, 2010, Justice Pinard denied Shire's appeal of the order of a Prothonotary that denied in part Shire's motion to amend its defence. Shire sought to add an allegation that Apotex should be precluded from recovering damages pursuant to section 8 of the Patented Medicines (Notice of Compliance) Regulations ("Regulations") in the event that there is a finding of infringement of the relevant patent in another proceeding. The other proceeding was an action brought by Cephalon against Apotex. The Court exercised its discretion de novo and found that this type of collateral contingency predicated on an unrelated proceeding provides for no reasonable cause of action. The Court also found that the proposed amendment failed to plead material facts and may unreasonably delay, embarrass and prejudice the trial of the action. Shire has appealed. Apotex Inc. v. Shire Canada Inc., October 8, 2010. Judge upholds refusal to strike Pfizer's pleading alleging estoppel based on prior NOC proceedings. In an impeachment action by Apotex relating to sildenafil citrate (Pfizer's VIAGRA), Apotex moved to strike a portion of Pfizer's defence pleading that Apotex was estopped from contesting the validity of the patent at issue by reasons of res judicata, issue estoppel, collateral estoppel, comity and abuse of process. Pfizer asserted that the prior notice of compliance (NOC) proceedings between the parties on the same patent entitled it to raise the allegations. Apotex argued that NOC proceedings have no precedential effect and that Pfizer's pleading should therefore be struck. The motion was denied and Apotex appealed. The Federal Court struck the plea of res judicata on consent but otherwise dismissed the appeal. The Court stated that the issues in Pfizer's pleading had not been squarely raised previously and that it was not sufficiently plain and obvious as would warrant that they be struck out. Apotex has appealed. Apotex Inc. v. Pfizer Ireland Pharmaceuticals, September 28, 2010. Trademark Opposition Board decisions Board rejects Novartis's opposition to registration of ESTRASORB. Novavax had filed an application for registration of the trademark ESTRASORB (later assigned to Graceway) for use in association with "pharmaceuticals namely, topical hormone preparations." Novartis alleged a number of grounds of opposition based on its registered trademarks ESTRADERM and ESTRADERM TTS for "estradiol administered by means of a patch or bandage attached to the skin of humans" and ESTRACOMB for "transdermal hormonal preparation for treatment of menopausal disorders administered by means of a patch." The Trademarks Opposition Board found that "ESTRA" would readily be perceived as a shortened form of the chemical "estrogen"; accordingly, there would be a tendency to focus more on the other components. The Board concluded that the marks would not be confusing and therefore rejected the opposition. Novartis Pharmaceuticals Canada Inc. v. Graceway Pharmaceuticals, September 29, 2010. |
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New Court proceedings Patented Medicines (Notice of Compliance) Regulations
Other proceedings
To check the status of Federal Court cases, please click here. |
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Contact information For more information or to request a copy of any decision, pleading or legislation, please contact: 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 |
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