Edited by Adrienne Blanchard and Jennifer Wilkie
Contents
- Patent Case Injunction Upheld On Appeal
- Innovator Granted Broad Discovery In Damages Proceeding Under The Noc Regulations
- Healthcare Agreement Reached
- Rx&D President Urges Pan-Canadian Pharmaceutical Strategy
- Plea Of Guilty In Internet Drug Sale Scheme In U.S.
- U.S. House Seeks To Ban Future Trade Agreements That Restrict Drug Reimportation
Patent Case Injunction Upheld On Appeal
In a recent decision, the Federal Court of Appeal upheld a trial judge's decision to award an injunction to the patent holder in a patent infringement proceeding.
Both parties claimed that they would suffer irreparable harm. The defendant testified that it would go out of business if the injunction was granted, as this was their only product. The patent holder testified that it would have no remedy for the infringement if successful, at the end of the trial, as the defendant would not be able to pay any damage award.
Because the defendant had entered the market towards the expiry of the patent the Court held that the defendant knew the risk it was taking and that it was springboarding in order to gain an advantage over other competitors. Furthermore, the Court held that unless the injunction was granted, it would be condoning the defendant's action.
For more information, please see the full decision at:
http://decisions.fca-caf.gc.ca/fca/2004/2004fca283.shtml
Innovator Granted Broad Discovery In Damages Proceeding Under The Noc Regulations
The Federal Court recently upheld a prothonotary's decision to allow an innovator to ask broad questions during discovery of a generic company for a damages claim the generic manufacturer brought against the innovator under the Patented Medicines (Notice of Compliance) Regulations. It was held that the following questions were proper: questions relating to the generic's submissions to provincial formularies; questions relating to the innovator's product to which the generic compared its product for approval; questions relating to the generic's conduct in another related proceeding; and questions relating to whether the generic product will, in fact, infringe the innovator's patent.
Specifically, the Court held that all of these matters were relevant, as they were plead in the generic company's statement of claim. They were questions regarding facts that were in dispute.
For more information, please see the full decision at:
http://decisions.fct-cf.gc.ca/fct/2004/2004fc1220.shtml
Healthcare Agreement Reached
An $18-billion deal over six years was agreed to by the Prime Minister and premiers and territorial leaders. Both the federal government and the provinces made a number of commitments under the deal. Areas of commitment include waiting times, a national home care program, and $18-billion to go into provincial health systems over six years, with a total of $41-billion over ten years to be injected. Details of the framework addressing equalization payments remain to be negotiated at a later date.
For more information, please see:
http://www.theglobeandmail.com/servlet/story/RTGAM.20040916.wxministers0916/BNStory/National/
RX&D President Urges Pan-Canadian Pharmaceutical Strategy
In an Op-Ed published in The Calgary Herald, Rx&D President Russell Williams says a pan-Canadian pharmaceutical strategy is necessary for the sustainability of the Canadian health care system.
Mr. Williams described the First Ministers Meeting as "a golden opportunity for the premiers and prime minister to put forward a new vision — a pan-Canadian pharmaceutical strategy — that can be a "win-win" for patients and decision makers alike."
Rx&D proposes a strategy based on the following principles: patient access to new innovative medicines; physician choice in prescribing appropriate medicines; the optimal use of medicines; and safeguarding Canada's ability to attract and retain new research jobs and investment in pharmaceutical research and development.
For more information , please see:
http://www.canadapharma.org/Media_Centre/Op_ed_FMM_EN_Sept_12_04.pdf
Plea Of Guilty In Internet Drug Sale Scheme In U.S.
The leader of a group that sold controlled substances over the Internet plead guilty to a federal conspiracy charge before the U.S. District Court in Alexandria. This is the seventh person that has pleaded guilty to the scheme that federal officials say illegally distributed millions of pills to Virginia, Maryland, the District of Columbia and four other states.
Eleven people from five states, along with three corporations, have been charged in the complex investigation that lasted nearly three years. The case highlights the growing problem of the use of the Internet in the spread of controlled substances and other potentially dangerous drugs to customers across the United States by rogue online pharmacies. The Alexandria investigation is one of the largest multi-state efforts in the recent U.S. federal crackdown.
For more information, please see:
http://www.washingtonpost.com/wp-dyn/articles/A51115-2004Aug31.html?referrer=emailarticle
U.S. House Seeks To Ban Future Trade Agreements That Restrict Drug Reimportation
On September 8, 2004, a resolution was submitted to Congress opposing the inclusion in future free trade agreements of provisions that would restrict or undermine the adoption of drug re-importation legislation.
The Resolution notes that the House of Representatives has passed legislation that would give Americans access to prescription drugs imported from Canada and other countries, and that the Senate is considering such legislation.
The Resolution further states that: "...provisions of the free trade agreements with Singapore, Australia and Morocco would subject the United States Government to international trade suits by the drug industry if prescription drug importation legislation were implemented" and notes that: "'investor-to state'" suits have been brought against governmental authorities in the United States under earlier free trade agreements, effectively undermining the ability of those authorities to protect the health and safety of their citizens".
Article 17.9(4) of the U.S.-Australia Free Trade Agreement drew heavy criticism from supporters of reimportation of lower-cost prescription drugs from other countries. It states as follows:
Each Party shall provide that the exclusive right of the patent owner to prevent importation of a patented product, or a product that results from a patented process, without the consent of the patent owner shall not be limited by the sale or distribution of that product outside its territory, at least where the patentee has placed restrictions on reimportation by contract or other means.
The U.S.T.R. is of the position that the U.S.-Australia FTA imposes no new barriers to imports but rather reflects current U.S. law, which gives any patent holder the right to control sales of its product in the United States.
For more information, please see:
HRES. 758 IH, 108th Congress, 2nd Session
For more information on this and other trade issues, contact Rick Dearden, or Wendy Wagner at Gowlings.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
