Pharmacapsules @ Gowlings - August 2007.

Edited by Jennifer Wilkie and Chantal Saunders

Contents

Health Canada Reminds Consumers About the Risks of Buying Drugs Online

U.K. Published New Guidelines for Early Stage-Clinical Trials

Apotex AIDS Drug Costlier than Other Generics

Ottawa Reacts to Lead Scare

Recent Cases

Health Canada Reminds Consumers About the Risks of Buying Drugs Online

By: Roger Tam

On August 15, 2007, Health Canada issued a bulletin reminding Canadians about the dangers of buying drugs online. This bulletin follows a British Columbia Coroner's report attributing the death of a woman to prescription drugs purchased online. The bulletin warns Canadians of drugs being shipped from sources outside of Canada, in terms of the financial risks, as well as the health risks posed by counterfeit drugs. The posting also offers tips on how to identify illegitimate internet pharmacies and counterfeit products.

For more information, please see:

http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/2007/2007_100_e.html

U.K. Published New Guidelines for Early Stage-Clinical Trials

By: Scott Robertson 

The Association of the British Pharmaceutical Industry (ABPI) has published new clinical testing guidelines. The new guidelines are intended to provide more suitable advice on dosages and patient selection in the administration of early-stage clinical trials. ABPI Director General Richard Barker stated that the, "Safety of volunteers for Phase 1 clinical trials is paramount, and this is at the heart of the revised guidelines,"

The guidelines have been produced in consultation with stakeholders, clinical experts and industry best practices.

For more information, please see:

http://www.reuters.com/article/health-SP/idUSL1688916820070816

Apotex AIDS Drug Costlier than Other Generics

By: Marc Richard

As noted by a University of Ottawa Professor, Apotex is selling a drug to treat AIDS to Rwanda at a price which is much higher than other available generics from different countries. This brings into question whether Apotex' agreement to provide the drug through Canada's compassionate patent licensing scheme is the best option.

For more information, please see:

http://www.thestar.com/comment/article/244881

Ottawa Reacts to Lead Scare

By: John Norman 

In recent weeks, Chinese manufactured products such as toothpaste, pet food, children's toys and baby bibs have been reported to contain unacceptable levels of diethylene glycol, melamine, lead and other things. In response, the Health Minister Tony Clement has announced that the Federal Government is launching a sweeping review of safety standards, seeking to determine if there are any gaps in the authority of regulators to ensure product safety.

For more information, please see:

http://www.theglobeandmail.com/servlet/story/LAC.20070816.BLOOD16/TPStory/Front

http://www.cbc.ca/health/story/2007/08/21/consumer-clement.html

Recent Cases

By: Beverley Moore

Abbott v. Apotex; 55.2 Proceeding; July 17, 2007 - clarithromycin

The Court dismissed an application for prohibition. In doing so, the Court held that the applicant bears the legal burden of proving on a balance of probabilities that the allegations of invalidity are unjustified and that it had not done so.

The patents at issue related to two polymorphic forms of clarithromycin and processes by which they could be prepared. The Court found that one of the patents was invalid because the form of clarithromycin it claimed was already known. Thus, the innovator could not have a valid patent for that form even if it was produced by a novel process.

The second patent at issue was found invalid for obviousness. The innovator argued that although the form of clarithromycin was known, its use as an antibiotic was not known. The Court did not accept this argument. Instead, the Court found that the patent contained nothing to support the contention that the use of Form II clarithromycin was not known as an antibiotic. The Court found that the generic company had met its evidentiary burden showing that this use was obvious in light of the prior art, and as the innovator had not tendered evidence supporting its position, and as the innovator bears the onus of proof on the issues of validity, the innovator had not proven this allegation was unjustified.

The full text of the decision can be found at:

http://decisions.fct-cf.gc.ca/en/2007/2007fc753/2007fc753.html

Abbott v. Minister of Health; Listing Case; July 31, 2007 - lansoprazole

The Court granted the application for judicial review and concluded that the patent at issue meets the eligibility requirements and should not have been removed by the Minister from the Patent Register.

The Minister had made a decision to remove the patent at issue from the Patent Register in respect of an SNDS under his obligations to maintain the Patent Register. The patent at issue had been allowed on May 12, 2006 but had not actually issued until June 18, 2006. The date for considering the listability of patents in respect of the New Regulations was June 17, 2006.

The Court did not accept the Applicant's submissions with regards to vested rights and delay. Further, the Court did not accept that the Regulations do not allow the Minister to delete patents from the Patent Register.

However, the Court did find that the patent was eligible for listing under the New Regulations as it contains a claim for the new use of the medicine found in the SNDS. The SNDS specifically added the new use for treatment of NSAID ulcers. The patent claimed the use of the compound for the treatment of ulcers generally. The expert evidence indicated that a person skilled in the art would clearly understand that an NSAID ulcer is a type of ulcer and a skilled chemist would interpret the claims as covering any type of stomach ulcer, however caused.

Furthermore, the Court found simply because a patent includes claims for polymorphic forms of the medicine, does not disqualify it for listing. As the patent contains a claim for the changed use, it is eligible in spite of the fact that it also contains claims for polymorphic forms.

The full text of the decision can be found at:

http://decisions.fct-cf.gc.ca/en/2007/2007fc797/2007fc797.html

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.

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