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Allergan successfully obtains two prohibition orders re: bimatoprost
On June 13, 2014, Justice O'Reilly granted Allergan's applications for prohibition orders regarding bimatoprost (Allergan's LUMIGAN RC) against Cobalt and Apotex: 2014 FC 566 and 2014 FC 567.
Apotex and Cobalt both alleged that Allergan's patent is obvious, lacks utility and is anticipated. The patent at issue relates to a formulation for eye drops containing bimatoprost and benzalkonium chloride, both within specified concentration ranges. Allergan had a prior patent which the Judge described as covering "a wide range of concentrations of active ingredients and preservatives" and had previously marketed LUMIGAN — another bimatoprost product containing more bimatoprost and less benzalkonium chloride than LUMIGAN RC — which was covered by the prior patent.
Read more »
Government of Canada news
Plain Language Labelling Initiative. As previously reported in the May 2014 and July 2013 issues of Rx IP Update, the Government of Canada has begun the implementation of its "Plain Language Labelling Initiative" for drugs. On July 2, 2014, the Minister of Health announced the finalization of the plain language labelling regulations (Announcement). The Regulations Amending the Food and Drug Regulations (Labelling, Packaging and Brand Names of Drugs for Human Use) were registered on June 13, 2014 (SOR/2014-158, Canada Gazette Part II). The Regulations come into force one year post-registration for prescription products and those administered or obtained through a health professional, and three years post-registration for non-prescription drugs.
Health Canada has published information for the industry on how it intends to implement the Regulations, with more detailed information on implementation for prescription products and products administered or obtained through health professionals given the earlier coming-into-force date. The consultation is open for comment until September 2, 2014.
Health Canada announcement of consultation. Consultation document.
Amended patient safety legislation "Vanessa's Law" moves to Senate for consideration. The House of Commons Standing Committee on Health adopted amendments to Protecting Canadians from Unsafe Drugs Act (Vanessa's Law) (Bill C-17), which has now passed in the House of Commons and received First Reading in the Senate. The Bill was initially introduced in December 2013, and would enable the Government to:
- Require strong surveillance including mandatory adverse drug reaction reporting;
- Recall unsafe products;
- Impose tough new penalties for unsafe products, including jail time and new fines of up to $5 million per day instead of the current $5,000;
- Provide the courts with discretion to impose even stronger fines if violations were caused intentionally;
- Compel drug companies to do further testing on a product, including when issues are identified with certain at-risk populations such as children.Compel drug companies to revise labels to clearly reflect health risk information, including updates for health warnings for children; and
The amendments to the Bill require that both positive and negative decisions about drug authorizations be disclosed on a public website and that clinical trial information be disclosed on a public registry. The amendments also better define the scope of Confidential Business Information (CBI) and allow the Minister of Health to disclose CBI about a product if the Minister believes the product may pose a serious risk to Canadians.
News release. Status of Bill C-17.
Health Canada news
Guidance documents. Health Canada has published the following final guidance documents:
- Guidance document for the Submission and Information Requirements for Extraordinary Use New Drugs (EUNDs). The objective of the document is to provide guidance to sponsors to enable them to meet the pre-market and post-market information and regulatory requirements under the Food and Drug Act and its Regulations for the authorization of EUNDs in Canada. Guidance document.
- Biopharmaceutics Classification System (BCS) Based Biowaiver. The objective of the document is to provide sponsors of new drug submissions with the information necessary to comply with Division 8 of the Food and Drug Regulations (Regulations) with respect to BCS based biowaivers for comparative bioavailability studies to be used in support of the safety and efficacy of a drug. Guidance document.
Health Canada suspends establishment licence of "CanadaDrugs.com LP": Health Canada expressed significant concerns with the Good Manufacturing Practices of the wholesaler CanadaDrugs.com LP, of Winnipeg, Manitoba and has suspended the company's establishment licence. Health Canada has also notified the College of Pharmacists of Manitoba of the concerns and suspension, as the College separately licences Canadadrugs.com as a pharmacy to sell drugs authorized in Canada to consumers over the internet.
Announcement.
Recent Court decisions
Patented Medicines (Notice of Compliance) Regulations
Federal Court of Appeal grants Pharmascience's appeal regarding esomeprazole magnesium prohibition. On May 22, 2014, the Federal Court of Appeal overturned the order prohibiting the Minister of Health from issuing a Notice of Compliance (NOC) to Pharmascience for its generic version of AstraZeneca's NEXIUM product (esomeprazole magnesium). The patent at issue relates to a formulation of, inter alia, esomeprazole and hydroxypropyl methylcellulose (HPMC) with a certain characteristic (cloudpoint). The Federal Court of Appeal held that the Federal Court erred with respect to the legal standard to be met by a second person in order to put its allegation of invalidity into play, and the legal standard that the first person is required to meet to prove that its invention was useful and overturned the finding below that the allegation of inutility was not justified.
Pharmascience Inc v AstraZeneca Canada Inc, May 22, 2014
Federal Court of Appeal decision — 2014 FCA 133; Federal Court decision — 2012 FC 1189.
Other decisions
Federal Court finds disclosure requirement for sound prediction not required for patents other than use patents. On July 2, 2014, the Federal Court invalidated AstraZeneca's patent claiming a salt of the (–)–enantiomer of omeprazole having an optical purity of 99.8% or greater. Apotex had launched a generic version of AstraZeneca's esomeprazole magnesium, NEXIUM. The Federal Court held that while the patent was novel and inventive, the promised utility had not been demonstrated or soundly predicted. In its discussion of the law of sound prediction, the Federal Court concluded from its review of the law that the requirement for a disclosure of the factual basis and sound line of reasoning for a sound prediction is limited to those patents claiming a new use for an old compound. The same patent had previously been litigated under the Patented Medicines (Notice of Compliance) Regulations, where the Court had held that Apotex's allegations of lack of sound prediction and obviousness were justified, as reported in the July 2010 issue of Rx IP Update.
AstraZeneca Canada Inc v Apotex Inc, July 2, 2014 2014 FC 638.
Federal Court of Appeal declines to stay injunction regarding Janssen's STELARA (ustekinumab). As reported in the June 2014 issue of Rx IP Update, the Federal Court enjoined (with certain exceptions) Janssen from "making, using, selling, offering for sale, or promoting the use" of STELARA in Canada for the treatment of psoriasis until Abbvie's patent expires. Janssen has appealed the injunction, and moved for a stay pending its appeal of the injunction. The Federal Court of Appeal declined to stay the injunction, holding that Janssen had failed to establish that it will suffer irreparable harm if the stay is not granted. The appeals of the injunction and the decision finding Abbvie's patent valid and infringed are scheduled to be heard in October 2014.
Janssen Inc v Abbvie Corporation, June 30, 2014
Federal Court of Appeal decision — 2014 FCA 176; Federal Court decision — 2014 FC 489
BC Supreme Court dismisses proposed class action product liability case against Teva and Sandoz prior to certification. Teva Canada Limited and Sandoz Canada Incorporated, two of five corporate defendants in a proposed class action proceeding relating to transdermal fentanyl patches, succeeded in a summary trial prior to certification of the class. The proposed class action alleges that transdermal fentanyl patches can cause serious injuries, including respiratory depression and death, and that the defendants' designs for their patches are negligent. Notwithstanding the considerable evidence that was before the Court, including some conflicting expert evidence regarding the design of the transdermal fentanyl patches, the Court considered the proceeding to be appropriate for a summary trial. The Court reasoned that while "class actions are a powerful too..., it is not a tool where simply making an allegation against a defendant or group of defendants is sufficient. There must be evidence to warrant the expense of a full trial." The Court discounted the plaintiffs' expert evidence, finding that she had acted as an advocate. Ultimately, the Court held that Teva and Sandoz did not sell a defectively designed product, and thus did not breach any duty of care owed to the plaintiffs either by selling a product that was defectively designed or by failing to provide a reasonable warning.
Player Estate v Janssen-Ortho Inc, 2014 BCSC 1122
New Court proceedings
Patented Medicines (Notice of Compliance) Regulations
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Medicine:
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moxifloxacin hydrochloride (AVELOX IV)
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Applicant:
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Bayer Inc and Bayer Intellectual Property GmbH
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Respondents:
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Pharmaceutical Partners of Canada Ltd, Pharmaceutical Partners of Canada Inc, the Minister of Health
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Date Commenced:
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May 22, 2014
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Court File No.:
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T-1260-14
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Comment:
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Application for Order of prohibition until expiry of Patents Nos. 1,340,114, 2,192,418 and 2,378,424. PPC accepts it will not receive a NOC until expiry of the 114 patent and alleges non-infringement with respect to the 418 and 424 patents.
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Medicine:
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travoprost (TRAVATAN Z)
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Applicants:
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Alcon Canada Inc and Alcon Research, Ltd
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Respondents:
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Pharmascience Inc and the Minister of Health
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Date Commenced:
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May 26, 2014
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Court File No.:
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T-1292-14
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Comment:
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Application for Order of prohibition until expiry of Patents Nos 2,606,370 and 2,129,287. Pharmascience alleges non-infringement and invalidity.
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Medicine:
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bortezomib (VELCADE)
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Applicant:
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Janssen Inc
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Respondents:
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Sandoz Canada Inc and Minister of Health
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Respondent Licensee and Sub-Licensor:
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Millennium Pharmaceuticals, Inc
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Respondent Patentee:
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United States of America represented by the Secretary, Department of Health and Human Services
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Date Commenced:
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June 12, 2014
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Court File No.:
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T-1086-14
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Comment:
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Application for Order of prohibition until expiry of Patent No 2,435,146. Sandoz alleges invalidity.
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Medicine:
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moxifloxacin hydrochloride (AVELOX IV)
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Applicant:
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Bayer Inc and Bayer Intellectual Property GmbH
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Respondent:
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Pharmaceutical Partners of Canada Inc (PPC) and the Minister of Health
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Date Commenced:
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June 18, 2014
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Court File No.:
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T-1440-14
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Comment:
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Application for Order of prohibition until expiry of Patents Nos 1,340,114, 2,192,418 and 2,378,424. PPC accepts it will not receive a NOC until expiry of the 114 patent and alleges non-infringement with respect to the 418 and 424 patents.
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Medicine:
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drospirenone/ethinylestradiol (YAZ,
Mya)
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Applicant:
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Bayer Inc and Bayer Pharma Aktiengesellschaft
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Respondent:
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Apotex Inc
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Date Commenced:
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June 4, 2014
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Court File No.:
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T-1368-14
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Comment:
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Infringement action regarding Patent No. 2,382,426.
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Medicine:
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Eli Lilly Canada Inc.
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Applicant:
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Minister of Health
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Date Commenced:
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June 11, 2014
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Court File No.:
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T-1410-14
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Comment:
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Application for judicial review of the decision of the Minister of Health dated May 23, 2014 to disclose third party information belonging to the applicant, pursuant to a request under the Access to Information Act.
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Medicine:
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pregabalin (LYRICA)
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Applicant:
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Pharmascience Inc
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Respondent:
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Pfizer Canada Inc
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Date Commenced:
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June 17, 2014
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Court File No.:
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T-1434-14
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Comment:
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Action for section 8 damages related to the prohibition proceedings in Court Files Nos. T-556-11 and T-185-13.
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To check the status of Federal Court cases, please click here.
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