Contents
- European Commission Posts Submissions in the Wake of Inquiry
Into the Pharmaceutical Sector
- EU Commission Proposal on Counterfeit Drugs
- Recent Cases
European Commission Posts Submissions in the Wake of
Inquiry Into the Pharmaceutical Sector
By Scott Robertson
Following the European Commission's inquiry into the pharmaceutical industry, a consultation process was launched. In response to the consultation process, the European Commission has received over forty submissions which will be posted on the competition website.
The inquiry was initiated as part of a report by the Commission last year in response to allegations that pharmaceutical companies in Europe were attempting to delay the entry of generic medicines onto the market as well as blocking competitors' efforts to develop new drugs.
The Commission, as part of its investigation, initiated a public consultation process in an effort to encourage debate of the investigation's preliminary results. The results of this process are intended to be published later this year.
Jonathan Todd, the EU executive's internal market spokesperson, confirmed that, as per common practice at the Commission, the comments received as part of the consultation process will be considered when the Commission draws up its definitive report on the pharmaceutical sector inquiry.
For more information, please see:
http://www.euractiv.com/en/health/commission-publish-submissions-pharma-inquiry/article-179070
EU Commission Proposal on Counterfeit
Drugs
By Roger Tam
The EU Commission released its proposal in December 2008 designed to deal with the issue of counterfeit drugs.
One of the proposals raised was a ban on repackaging of drugs in Europe. In its current form, this proposal may effectively prohibit the legal practice of "parallel trading" where exporters repackage drugs for export. This is a break from the earlier EU position which supported free movement of goods, and appears to acknowledge that parallel trading weakens the ability to track goods and facilitates counterfeiting.
Other measures in the proposal include anti-tampering seals on medications, electronic batch tracking, and new controls relating to manufacturing and import/exports. This proposal has been criticized by some for doing little to curb Internet sales, which the Commission considers to be an issue of enforcement of existing legislation.
For more information, please see:
www.stockholm-network.org/downloads/media/Pharmafocus.pdf;
and http://content.usatoday.com/topics/article/European+Commission/08Ik5YR31d27Y/3
Recent Decisions
By: Beverley Moore
Solvay v. Canada (Minister of Health); judicial review of listing decision; 2009 FC 102; testosterone; January 30, 2009
The Court upheld the decision of the Minister refusing to list a patent on the Patent Register. An SNDS was filed to update the product monograph to reflect the safety and efficacy of the use of the drug in longer term therapies. The Court held that the SNDS was not a change in use of the medicinal ingredient. A change in use is measured by the approved use in the product monograph. The indications in clinical use of the product monograph section were not changed.
Further, the patent does not claim a changed use as it does not address the issue of duration of testosterone therapy. The court found that the expert evidence was clear that the patent at issue contains no limitation as to duration of use.
The full text of the decision can be found at:
http://decisions.fct-cf.gc.ca/en/2009/2009fc102/2009fc102.html
Novopharm v. Eli Lilly; leave to intervene in an appeal; 2009 FCA 24; olanzapine; January 29, 2009
The Court dismissed a motion by the Canadian Generic Pharmaceutical Association (CGPA) requesting leave to intervene in Novopharm's appeal of a decision of the Federal Court.
In the underlying motion, Novopharm sought a declaration that sections 2, 3 and 4 of the 2008 amendments to the NOC Regulations are ultra vires and an order dismissing Eli Lilly's prohibition application pursuant to section 6(5)(a) of the NOC Regulations. The motion had been dismissed by the motions judge.
The Court of Appeal held that even if it finds at the appeal that the Court below should have exercised its jurisdiction to declare the impugned section of the 2008 amendments to be invalid, it is unlikely that the Court of Appeal will then proceed to determine the validity of those amendments. The Court is reluctant, in the context of an appeal to decide controversial, difficult and important questions of law at first instance without the benefit of a reasoned decision by a judge. Thus, the only question likely to be at issue on the appeal is whether a decision that the Regulations are invalid is properly made in an interlocutory motion.
Full text of the decision can be found at:
http://decisions.fca-caf.gc.ca/en/2009/2009fca24/2009fca24.html
Apotex v. Pfizer; appeal of a 55.2 decision; 2009 FCA 8; sildenafil; January 16, 2009
The Court of Appeal dismissed the generic company's appeal and upheld the decision of the trial judge prohibiting Apotex entering the market until the expiry of the patent.
Apotex revised the grounds of its appeal two days before the hearing and provided no advance submissions. The argument at hearing was that the Supreme Court in Sanofi fundamentally changed the approach to obviousness in Canada.
The Court of Appeal considered the test developed by the Supreme Court in Sanofi and held that the test was whether something is "obvious to try" where the word "obvious" means very plain. Under this test, an invention is not obvious because the prior art would have alerted the person skilled in the art to the possibility that something might be worth trying. The invention must be more or less self evident.
The Court then went on to consider whether the trial judge had in fact applied this test and found that he had. Thus, the Court dismissed Apotex' appeal. The Court then awarded increased costs by the reason of the late change in the appellant's position on appeal. If proper attention had been given to the matter, the change in the approach would have been communicated earlier and the respondents would have been in a better position to reflect their response.
Full text of the decision can be found at:
http://decisions.fca-caf.gc.ca/en/2009/2009fca8/2009fca8.html
G.D. Searle v. Canada (Minister of Health); appeal of a delisting proceeding; 2009 FCA 35; celecoxib; February 9, 2009
The Minister of Health removed a patent from the Patent Register on the basis that it was ineligible for listing. Pfizer sought judicial review of that decision, which was dismissed. The Court dismissed the appeal, holding that the Minister's decision was consistent with the intended purpose of the NOC Regulations.
An SNDS was filed in 2001. The patent was listed against the SNDS. However, following the October 2006 amendments to the NOC Regulations, the Minister concluded that the patent was not eligible for listing and removed it from the Patent Register.
The patent contained a claim for the use of the medicine to treat pain. The new approved use was for management of pain in conditions such as sprains, post-operative and following dental extraction. The Court held that while this claim would cover the new approved use it would also cover, inter alia, the earlier approved uses. Thus, to interpret section 4(3)(c) as applying in this circumstance would be contrary to the Court's decision in Abbott and to give "a meaning so broad as to defeat the purpose for which [the section] was enacted."
The Court rephrased the test to be applied as: "Does [the patent claim] the very use that was approved by the issuance of the NOC..."
Full text of the decision can be found at:
http://decisions.fca-caf.gc.ca/en/2009/2009fca35/2009fca35.html
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