Pharmacapsules @ Gowlings

European Commission Proposes Strategy For Dealing with Rare Diseases
By Scott Robertson

On November 11, 2008, the European Commission adopted a new initiative which will address among other things improving the recognition and visibility of rare diseases, supporting national plans for such conditions in EU member states and strengthening cooperation and coordination for rare diseases at a European level.

Some of the diseases which will be treated through the introduction of this new program include: genetic, rare cancers, autoimmune diseases and congenital malformations.

The expertise on rare diseases is fragmented across the EU which equates to some of these diseases not being fully recognized. This initiative will help bring together resources from across Europe which will link together centres or expertise in different countries and will provide assistance with the aid of new information and communication technologies.

The Commission hopes to build on previous the success of previous health programs on rare diseases and the existing regulatory framework to provide additional incentives for the development of orphan drugs to help alleviate some of these conditions.

For more information and to review European Commission press release, Communication, Proposal and Impact Assessment, please see:

http://ec.europa.eu/health/ph_threats/non_com/rare_10_en.htm

Great Britain's Royal Commission on Environmental Pollution Releases its Report on Nanotechnology
By Natalie de Paulsen

Great Britain's Royal Commission on Environmental Pollution released the Novel Materials in the Environment: The Case of Nanotechnology report on November 12, 2008. The Royal Commission had studied the properties of nanomaterials and the potential pathways by which these materials could present an environmental or health hazard. The Royal Commission's report notes that its enquiries produced no evidence of harm. However, it states "having analysed the potential health and environmental impacts which flow from the properties of nanomaterials, we concluded that there is a plausible case for concern about some (but not all) classes of nanomaterials." One broad concern highlighted in the report is that the pace of innovation often exceeds knowledge of the potential health and environmental effects. Finally, the report suggests that as nanomaterials are hugely variable in their nature, regulation based strictly on size is likely misguided and the basis for regulation should be functionality.

For an electronic copy of the full report, please see:

http://www.rcep.org.uk/novel%20materials/Novel%20Materials%20report.pdf

Recent Cases
By: Chantal Saunders

Bristol-Myers Squibb v. Apotex; appeal of interlocutory motion; October 24, 2008; nefazodone

The Court dismissed Apotex' appeal of an Order of a Prothonotary, denying leave to make amendments to its Statement of Defence and Counterclaim.

Apotex was seeking to amend its pleadings to assert that the Plaintiffs are not entitled to recover damages for lost sales due to infringement and/or Apotex is entitled to set off against such damages the money it invested in developing a generic formulation and stockpiling inventory. The basis put forward by Apotex for the claim was that the Plaintiffs owed a duty to Apotex to ensure that the product was safe for human consumption and Apotex would not have sought approval to market a product were it not for the Plaintiffs' activities of bringing their product to market in Canada.

The Court considered the applicable standard of review and determined that it should conduct a de novo review of the decision on the basis that the proposed amendments were "vital amendments". The Court found that the proposed amendments are scandalous, frivolous and vexatious in that the findings to be made by the Court do not have a sufficient relationship with the real questions and controversy in the action, namely relating to the patent rights themselves or to the question of whether infringement has occurred.

The full text of the decision can be found at:

http://decisions.fct-cf.gc.ca/en/2008/2008fc1196/2008fc1196.html

Biovail v. Apotex; motion seeking reversal of order of evidence and compel production pursuant to s.6(7); October 15, 2008

Biovail brought a motion seeking a reversal of the order of evidence in a proceeding under the NOC Regulations and for production of information relating to Apotex' product. The Court set out that the Court is seeking, in reversing the evidence, to lead to the least expensive and most expeditious determination of the issues on the merits in a manner that remains just. The Court found that, invalidity being the dominant focus of the challenge, the case would benefit from a reversal of the evidence. The Court set out that there is no comprehensive list of factors to consider for ordering a reversal of evidence but factors to consider may be the complexity of the case, the level of detail provided in the grounds in the Notice of Application and whether the allegation of invalidity is the primary allegation. However, the dominant consideration will be whether it will result in the streamlining of the proceeding or result in delay and increased expense by further motions seeking to file reply evidence.

The Court found that Apotex had already provided substantial disclosure and Biovail's request did not meet all the tests required for an Order to be made in this case.

The full text of the decision can be found at:

http://decisions.fct-cf.gc.ca/en/2008/2008fc1162/2008fc1162.html

Eli Lilly Canada v. Novopharm; section 6(5)(a) motion; November 3, 2008; olanzapine

Novopharm brought a motion seeking an order declaring sections of the 2008 Amendments to the NOC Regulations ultra vires and of no force and effect, and dismissing the application proceeding pursuant to paragraph 6(5)(a) of the Regulations.

The patent in issue was added prior to the 2006 Amendments. Novopharm submitted in this motion that there was no link between the subject matter of the submissions and the invention claimed in the patent. The 2008 Amendments prevent the Court from dismissing an application in whole or in part solely on the basis that the patent list submitted before June 17, 2006 is not eligible for inclusion on the Register. The Court declined to make a general and binding judicial declaration that the 2008 Amendments are ultra vires and of no force and effect on the basis that this decision would go well beyond the limited scope of the within application under the NOC Regulations. The Court indicated that a judicial review application may be better suited for this determination.

Considering the Court's limited jurisdiction and powers, the summary nature of the proceeding, the public interest, the complexity of the matters Novopharm raised, the balance of convenience and the availability of another and better suited recourse, the Court found that it was not in the best interests of justice that a final ruling be made with respect to Novopharm's motion to invalidate section 2, 3 and 4 of the 2008 Amendments. As a result, the motion was dismissed.

The full text of the decision can be found at:

http://decisions.fct-cf.gc.ca/en/2008/2008fc1221/2008fc1221.html