Canada: Pharmacapsules @ Gowlings – July, 2007

Last Updated: July 19 2007

Edited by Jennifer Wilkie and Chantal Saunders

  • Eli Lilly Canada and PMPRB Reach Agreement on the Price of Forteo
  • Guidance Re Scope of and Implementation of the Data Protection Regulations
  • Stem Cell Patents Challenged
  • U.S. FDA Finds Consumers Continue to Buy Potentially Dangerous Drugs Over the Internet
  • Europeans and Americans Will Now Share More Information About Food Safety
  • Recent Cases
Eli Lilly Canada and PMPRB Reach Agreement on the Price of Forteo

By Wayne Critchley

In an announcement released July 6, 2007, the PMPRB reported that it has approved a Voluntary Compliance Undertaking by Eli Lilly Canada with respect to Forteo.

Forteo (teriparatide) was introduced by Lilly Canada in July 2004. It is a recombinant human parathyroid hormone and is the first in a new class of bone formation agents. It is indicated for the treatment of certain cases of severe osteoporosis in patients who have failed or are intolerant to previous osteoporosis therapy.

For price review purposes, the PMPRB did not identify any comparator drugs to Forteo and therefore reviewed the price with reference to international prices. It concluded that, at the time of introduction, the price in Canada exceeded the median of international prices by approximately 12%. As a result, the PMPRB alleges that Eli Lilly received excess revenues from the sale of Forteo during 2004 and 2005, but by 2006, the price was within the PMPRB's guidelines.

For purposes of resolving this matter, Lilly Canada has agreed on the maximum non-excessive (MNE) prices identified by the Board and will take action to offset the remaining excess revenues of approximately $333,000.00. This sum will be offset by maintaining the price of Forteo in 2007 at levels below the MNE price calculated by the Board.

In making the undertaking, Lilly Canada makes no admission that the price of Forteo in Canada is now or was excessive for purposes of the Patent Act .

For more information, please see:
http://www.gowlings.com/resources/enewsletters/DrugPricingReimbursement/Htmfiles/V1N11_20070710.en.html

For a copy of the Voluntary Compliance Undertaking, please see:
http://www.pmprb-cepmb.gc.ca/english/view.asp?x=271&id=96

Guidance Re Scope of and Implementation of the Data Protection Regulations

By: Jennifer Wilkie

On June 25, 2007, TPD released a draft guidance document relating to the Data Protection Regulations which came into force last October. The draft guidance document speaks to, inter alia , the scope of data protection, requirements for marketing, the Register of Innovative Drugs, terms of protection, how the Minister will implement decisions with respect to providing data protection or not, and pediatric data protection.

Comments on the draft guidance are being sought by September 17, 2007.

To review the draft guidance document, please see:
http://www.hc-sc.gc.ca/dhp-mps/alt_formats/hpfb-dgpsa/pdf/prodpharma/data_donnees_protection_e.pdf

 

Stem Cell Patents Challenged

By: John Norman

Earlier this year ,the U.S. Patent and Trademark Office ("USPTO") released a preliminary decision indicating that patents covering human embryonic stem cells are not inventive and that it may throw them out. The owner of the patents fired back indicating that the patents should be upheld because the inventor was the first to successfully isolate embryonic stems when others had failed.

Recently, however, several internationally recognized stem-cell researchers have jumped into the fray and filed documents with the USPTO alleging that the work leading to the patents was not inventive. Instead, the documents allege that the inventor was the first to isolate embryonic stem cells because he had access to high quality embryos and adequate research funding.

For more information, please see:
http://www.cbc.ca/health/story/2007/07/03/tech-stem.html

U.S. FDA Finds Consumers Continue to Buy Potentially Dangerous Drugs Over the Internet

By: Natalie de Paulsen

On July 2, 2007, the FDA again warned consumers about the dangers of buying medications over the Internet. The FDA highlighted the following safety concerns raised by the purchase of drugs from unregulated Internet sites:

  • use may require careful dosing and monitoring;
  • purchased drugs may not have adequate labelling for safe use;
  • purchased drugs may have been withdrawn from the U.S. market for safety or efficacy reasons; and
  • purchased drugs may expose the consumer to significant drug\drug interactions.

The FDA also discussed new data which indicates that for 45% of the drugs imported through foreign mail, and potentially purchased by consumers on unregulated Internet sites, there are low cost generic versions available in the U.S. This finding may suggest that, in addition to attempting to save money on drug purchases, some consumers may also be buying foreign drugs to avoid obtaining a prescription. Some of the products that have been intercepted which are available as generic products in the U.S. include amoxicillin tablets, fluoxetine capsules, paroxetine tablets and warfarin tablets.

For more information, please see:
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01663.html

Europeans and Americans Will Now Share More Information About Food Safety

By: Natalie Rizkalla-Kamel

In an effort to end the conflict between Europeans and Americans over issues concerning cloned and genetically modified food, the U.S. FDA and the European Food Safety Authority signed an agreement to share more information about the safety of food supply. The FDA says this agreement will pave the way for formally sharing confidential scientific information and that it will help protect confidential information under both regions' laws.

For more information, please see:
http://www.reuters.com/article/health-SP/idUSN0238378820070702

Recent Cases

By: Beverley Moore

Canada v. Janssen-Ortho; Appeal of Decision on ATI Request; June 26, 2006 - cisapride

The drug company was required to give thousands of pages of documents to the Minister of Health (the Minister) when one of its products was withdrawn due to safety concerns. An Access to Information (ATI) request was made for these documents, and the Minister wished to disclose many of them. The drug company resisted.

Before the Federal Court, the Minister argued that some of the documents said to be confidential were not because they comprised submissions made based on public documents. The Court held that the submissions were confidential, and the fact that the drug company may have relied upon public information was not public knowledge. The Court also held that release of the identity of employees of the drug company was not proper as there was not consent to the release of their names. The Minister appealed this decision.

The Court of Appeal dismissed the Minister's Appeal with costs. The Trial Judge's decision related to questions of mixed fact and law, and could not be overturned without palpable and overriding error. No such error was found.

The full text of the decision can be found at:
http://decisions.fca-caf.gc.ca/en/2007/2007fca252/2007fca252.html

Ranbaxy v. Pfizer; Appeal of Interlocutory Motion in 55.2; June 20, 2007

At the trial division, the innovator succeeded in a motion to amend its Notice of Application for a second time, as its initial amendments had been based on misleading information from the generic company.

The Court of Appeal affirmed the decision of the Motions Judge. If the generic company had not given the innovator erroneous information, the innovator would not have amended its original application to discontinue proceedings relating to two patents. Thus, the amendments simply place the innovator in the position in which it would have been but for the misleading information.

Furthermore, the Order extending the statutory stay was discretionary and justified on the record before the Court.

The full text of the decision can be found at:
http://decisions.fca-caf.gc.ca/en/2007/2007fca244/2007fca244.html

Apotex v. AB Hassle; Appeal Motion to Dismiss Impeachment Proceeding; June 27, 2007; omeprazole

The two companies litigated this patent in proceedings under the PMNOC Regulations . The Federal Court issued an Order prohibiting the Minister from issuing a NOC until the patent expired. The Court of Appeal upheld the Order and the Supreme Court did not grant leave to appeal.

The generic company then sued to impeach the patent at issue. The patent expired in January 2007. The patentee then brought this motion to dismiss the proceeding as an abuse of process.

The Prothonotary dismissed the motion. The Federal Court dismissed the appeal. One of the remedies sought by the generic company, if it succeeds, is a declaration that it is entitled to s. 8 damages from the prohibition proceedings. The Court held that as it is not plain and obvious that a determination of this proceeding will not have legal consequences on the parties, the proceeding cannot be dismissed.

The full text of the decision can be found at:
http://decisions.fct-cf.gc.ca/en/2007/2007fc683/2007fc683.html

AB Hassle v. Apotex; 55.2 Proceeding; June 28, 2007 – omeprazole

The Federal Court dismissed the application for prohibition on the basis that the patent is invalid on the grounds of anticipation and obviousness. The Court also found that the claims relied upon do not contain any therapeutic aspects and are ineligible for inclusion on the Patent Register.

The generic company, in earlier proceedings, alleged non-infringement of the patents at issue. It did not challenge validity, and succeeded on narrow points of non-infringement. Then, the generic company sent the within NOA, alleging new grounds of non-infringement and invalidity. The Court held that despite the incremental challenges of the generic company, the innovator cannot use its own unmeritorious challenge as the foundation for an abuse of process argument alleging juridical inefficiency. As the generic company was not attempting to split its case, or avoid an earlier unfavourable disposition, subsequent litigation could be permitted.

The full text of the decision can be found at:
http://decisions.fct-cf.gc.ca/en/2007/2007fc688/2007fc688.html

Novopharm v. Abbott; Appeal of 55.2 Proceeding; June 28, 2007; lansoprazole

The Federal Court of Appeal dismissed the generic company's appeal of a decision granting prohibition.

The generic company had alleged non-infringement in its NOA. The trial judge found that the generic company's bottle label and product monograph will induce and encourage physicians to prescribe the medicine for an infringing use. The Court of Appeal refused to disturb those findings without palpable and overriding error.

The Court dismissed Novopharm's argument the recent Supreme Court decision in Astrazeneca was determinative of the issues. Novopharm had not raised the issue of whether it had to address the patents in its NOA. Thus, the judge did not err in not considering the argument.

The full text of the decision can be found at:
http://decisions.fca-caf.gc.ca/en/2007/2007fca251/2007fca251.html

Apotex v. Bayer; Appeal of 55.2 proceeding; June 22, 2007 – ciprofloxacin

The Federal Court of Appeal dismissed the generic company's appeal of a decision granting prohibition. The patent had expired, and subsequently a NOC issued before the appeal was heard, thus the appeal was moot. However, the Court allowed the appeal to continue because its outcome could affect the rights of the generic company under s. 8 of the PMNOC Regulations .

The Court undertook a determination de novo , of a question of obviousness not considered by the trial judge. The Court accepted the evidence of the innovator as persuasive on the issue, and found the patent not to be invalid on the basis of obviousness. The Court did hold that the trial judge gave undue weight to the commercial success and utility of the medicine on the issue of obviousness. However, the issue was not consequential.

The full text of the decision can be found at:
http://decisions.fca-caf.gc.ca/en/2007/2007fca243/2007fca243.html

Pfizer v. Apotex; 55.2 proceeding; June 15, 2007 – quinapril

The Court dismissed an application for prohibition. The generic company alleged non-infringement and included an Undertaking that it would not engage in the infringing use.

The innovator company does not have approval to sell the medicine for the patented use.

The Court found that the undertaking signed by the CEO was binding on the company. The Court further held that any NOC issued shall contain a condition consistent with the Undertaking in the NOA.

The full text of the decision can be found at:
http://decisions.fct-cf.gc.ca/en/2007/2007fc642/2007fc642.html

Pfizer v. Ranbaxy; Appeal of motion to dismiss 55.2 Proceeding, s. 6(5); June 18, 2007 – atorvastatin

The generic company brought a motion to dismiss the proceeding as an abuse of process. The Prothonotary dismissed the motion. The Federal Court upheld the decision.

The generic company has two processes to make its medicine. One process infringes, yet the other process, which is alleged in the NOA and submitted to Health Canada, does not. The generic company argued that the only process to be considered is that submitted to Health Canada. The Court found that the generic company had not met its burden that it is plain and obvious and the application cannot succeed.

The full text of the decision can be found at:
http://decisions.fct-cf.gc.ca/en/2007/2007fc649/2007fc649.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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