Canada: Pharmacapsules @ Gowlings: February 12, 2010

Last Updated: February 16 2010

Edited by Jennifer Wilkie and Chantal Saunders


  • Supreme Court Denies Leave to Appeal in Section 8 Damage Case
  • New U.K. Life Sciences Super Cluster
  • Generic Manufacturers in Europe Seek Regulatory Changes
  • The European Commission Continues to Examine Settlement Agreements and Generic Entry in the Pharmaceutical Sector
  • Recent Cases

Supreme Court Denies Leave to Appeal in Section 8 Damage Case
By: Jennifer Wilkie

Recently, the Supreme Court denied Apotex' leave application for leave to appeal to the Supreme Court of Canada in respect of Apotex' case seeking damages for alleged delays due to a proceeding brought by Merck under the Patented Medicines (Notice of Compliance Regulations) ("NOC Regulations"). At trial Merck was successful in arguing that Apotex was limited to its damages, but the trial judge found that Apotex could claim for losses of future market share. Both parties appealed.

The Court of Appeal dismissed Apotex' appeal and affirmed that Apotex cannot claim Merck's profits. Profits, in the context of the section and the NOC Regulations deals with the second person's damages or lost profits. The scheme does not contemplate disgorgement of the first person's profits but rather is for compensation.

Merck's appeal insofar as the ability to claim future market share was granted. Only damages during the s. 8 period may be claimed. The governor in council chose to limit losses to those during the period. They could have extended this period but did not. Merck had also argued that s. 8 was ultra vires however the Court dismissed this aspect. We have previously reported on the Merck Court of Appeal decision at the following link. ( ).

New U.K. Life Sciences Super Cluster
By: Natalie Rizkalla-Kamel

The U.K. government has recently announced their plans for a new U.K. Life Sciences Super Cluster - a scheme where industry, academia and the National Health Service work together to deliver new treatments for chronic disease. The pilot project is being supported by a £1 Million investment from the government and the first Super Cluster will launch later this year in the area of immunology and inflammation, focusing on diseases such as asthma and rheumatoid arthritis.

The U.K. Life Sciences industry employs over 120,000 people and invests approximately £4.6 billion into R&D. The unveiling of this new scheme comes in addition to recent measures to help the U.K. maintain a competitive edge in translational medicine, including the Patent box and Innovation Pass initiatives, to better compete on a global stage and attract inward investment.

More detailed information can be accessed at the following website and the blueprint documents which may be found there: (

Generic Manufacturers in Europe Seek Regulatory Changes
By: Marc Richard

The European Generic Medicines Association (EGA) is advocating for changes to regulatory framework of the European Union with respect to the marketing of generics and biosimilars in the European Union. The EGA is seeking to enhance tax and R&D incentives for generic and biosimilar research and clinical trials. The generic manufacturers are also seeking to expedite market authorizations by eliminating patent linkage and applying a harmonized single market approach to approvals.

More detailed information can be accessed at the following website: (

The European Commission Continues to Examine Settlement Agreements and Generic Entry in the Pharmaceutical Sector
By: Melissa Binns

The European Commission continues to scrutinize the pharmaceutical sector and patent settlement agreements between innovator and generic pharmaceutical companies. This follows the European Commission's July 2009 Pharmaceutical Sector Inquiry Report which was focused on the behaviour and practices of the "originator industry" which were alleged to have cause undue delays in generic market entry and innovation.

The Report appears to have prompted legal proceedings against pharmaceutical companies such as Servier and Lundbeck and the European Commission has recently sent "requests for information" to a number of other pharmaceutical companies seeking copies of patent settlement agreements conducted between innovator and generic companies executed in the last 18 months. Further, a number of unannounced inspections targeting the legal departments of many large pharmaceutical companies of were conducted in late 2009.

In addition to patent settlement agreements, the Commission's Report notes concerns relating to 'defensive' patents and regulatory complaint strategies. In light of this recent scrutiny and uncertainty, pharmaceutical companies are being encouraged to conduct appropriate due diligence on all patent settlement agreements between generic and innovator companies.

More detailed information can be accessed at the following website: (

Recent Cases
By: Beverley Moore

AstraZeneca v. Apotex; interlocutory motion for reply evidence; esomeprazole; January 20, 2010

The Court dismissed AstraZeneca's appeal from the order of a prothonotary refusing to strike parts of Apotex' evidence and refusing to permit the applicants to file reply.

In the Notice of Allegation (NOA) Apotex stated it would be obtaining the essential ingredient for its medicine from either supplier A or supplier B, each of which used a different process. However, when Apotex filed its evidence, it stated that it would only be seeking to obtain the ingredient from one supplier.

It was argued that the applicants might not have launched the proceedings if they had known only the one supplier was the source of the ingredient and that the applicant may be exposed to a section 8 claim if they persist in respect of the remaining supplier. However, the Court found that this was mere speculation without any evidence to support it. The Court further held that Apotex had not changed its NOA, it merely removed one of the grounds for the allegations as to non-infringement. Thus, it is not a different matter, just less. Furthermore, the applicants did not meet the test for reply evidence. Thus, the motion was dismissed.

The full text of the decision can be found at: (

Biovail v. Apotex; merits of 55.2 proceeding; metformin; January 20, 2010

The Court dismissed the application for prohibition. The Court held that the allegations as to anticipation was not justified. The Court also found that double patenting law did not apply to the situation and furthermore, since the allegation as to anticipation was not justified, the Gillette defence must also fail.

However, the allegation as to invalidity due to obviousness was found to be justified. In this regard, the Court held that the evidence was evenly balanced, thus, the applicant did not satisfy its burden to prove on a balance of probabilities that the allegation was not justified.

The full text of the decision can be found at: (

Apotex v. Sanofi; Interlocutory Motion re: affidavits of documents; clopidogrel;

January 22, 2010

Both parties brought motions for further and better affidavits of documents. Sanofi's motion was granted in part and Apotex's motion was denied. The Court stressed that the rules of procedure and in particular, those relating to affidavits of documents must be adhered to when the parties commit to a shortened schedule leading to trial.

The Court focused on the specificity of the pleadings and the lack of proof to show the existence of other relevant documents. Furthermore, the Court explicitly stated in several instances. that despite the failure of one party to prove that the other party had documents, by not producing those documents at this stage, the party in possession of them had made a decision not to use them at trial.

The full text of the decision can be found at: (

Janssen-Ortho v. Apotex; Interlocutory Motion for Reply Evidence; methylphenidate;

January 25, 2010

In two NOC proceedings, the order of evidence was reversed. Thus, Apotex filed evidence first in respect of validity, while Janssen filed evidence first in respect of infringement. By this motion, Janssen sought to strike much of the infringement evidence filed by Apotex as it was argued that it related more to validity.

The Court struck some of the evidence and allowed reply in a limited circumstance dealing with an additional study attached by Apotex. However, the Court concluded that much of the proposed reply evidence dealt with matters best left for cross-examination.

The full text of the decision can be found at the following 2 links: ( (

Janssen-Ortho v. Novopharm; merits of 55.2 proceeding; methylphenidate ; January 29, 2010

The only issue in this proceeding was an allegation of non-infringement and the application for prohibition was dismissed.

The Court saw the dispute between the parties as the dispute between two legal maxims regarding patent interpretation. On one hand, a patent must be read with a mind willing to understand and not a mind desirous of misunderstanding; however, on the other hand, a patent claim can not be interpreted differently in light of the specification so as to make it into something more or different from what its words express.

The Court held that if the language of the claims is plain and unambiguous and capable of only one interpretation by a person skilled in the art, recourse to the disclosure is unnecessary. When one looks beyond the language of the claims one ought to first look at dependent claims as an aid to interpreting the independent claims before resorting to the disclosure. As a result of the construction, Novopharm's allegation of non-infringement was found to be justified.

The full text of the decision can be found at: (

Mycogen v. Bayer and Monsanto; motion for summary judgment; February 5, 2010

Bayer brought a motion for summary judgment on the basis that Monsanto had missed the time set out by the Commissioner under section 43 of the Patent Act to respond to the conflict proceeding. The Court dismissed Bayer's motion.

The facts were not in dispute. Monsanto had asked for and was granted an extension of time during the conflict proceeding. Bayer argued that the Commissioner did not have the power to grant an extension of time and thus the extension was a nullity making Monsanto out of time to reply. Thus, Monsanto could no longer be a party to the conflict. The Court found that Bayer was precluded from raising the extension issue now because it did not do so when the matter was before the Patent Office. The Court held that it would bring the administration of justice into disrepute if Bayer was permitted to raise the issue now. The Court further found that the Commissioner made no error in granting the extension of time to Monsanto.

The full text of the decision can be found at: (

Epicept v. Minister of Health; Interlocutory Motion for Confidentiality; histamine;

February 10, 2010

Epicept has filed for a judicial review of the Minister's decision that its histamine dihydrochloride product is not an innovative drug and is thus not eligible for listing on the register of innovative drugs. Epicept sought confidentiality for its identity, the identity of any employee of it, the brand name, the medicinal ingredient or its variations, other drug products containing the medicinal ingredient, or its variations, the disease at issue and the entire contents of the new drug submission (NDS). The motion was denied with the exception of protection for the NDS filed with the Minister.

The Court found that while the fact of the filing of the NDS would normally be confidential, Epicept issued a Press Release announcing its filing in Canada. The information in the Press Release was published after Epicet had been informed of the decision that its product was not eligible for data protection. Thus, by issuing this Press Release, Epicet put its competitors on notice regarding its histamine product. Thus, the Court could not see the concerns and risks Epicet identified with respect to any potential headstart by its competitors as a reasonable basis to order the breadth of confidentiality sought.

The full text of the decision can be found at: (

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