Canada: Pharmacapsules @ Gowlings – May 2006

Last Updated: May 4 2006

Edited by Jane Steinberg and Ken Clark

  • U.S. FTC To Study Authorized Generics
  • Convention on Biological Diversity: Update
  • Natural Health Products - NPN Pending
  • EU Approves First Biogeneric
  • U.S. FDA To Develop Guidelines on Follow on Protein Biologics
  • Recent Cases

U.S. FTC To Study Authorized Generics

The U.S. Federal Trade Commission announced its intention to study the use and competitive effects of "authorized generics" - a drug that is chemically identical to the brand name drug and authorized by the brand name manufacturer to be marketed as a generic product version.

The Commission will examine wholesale prices, business reasons to support authorized generics, factors relevant to the decisions of generic firms to engage in such an arrangement, and licensing agreements between brand name companies and authorized generics.

Comments are being accepted until June 5, 2006.

For more information, please see:

Convention on Biological Diversity: Update

Last month, some 4,000 delegates from around the world gathered in Curitiba, Brazil to review progress in international efforts aimed at the conservation and sustainable use of biological diversity. Representatives of the 188 States Parties to the Convention on Biological Diversity and other interested groups met from March 20-31. The meeting covered a broad agenda and resulted in the adoption of some 30 major decisions, including an agreement to finalize by 2010 the negotiation of an international regime for access to and benefit-sharing of genetic resources.

The Convention on Biological Diversity was adopted at the Earth Summit in Rio de Janeiro in 1992 and came into force in 1993. It sets out commitments for maintaining the world's ecological variability in order to meet the need for food security, medicines, fresh air and water, and a healthy environment. The principal objectives of the Convention are the conservation and sustainable use of biological diversity and the fair and equitable sharing of benefits arising from its utilization. Canada was one of the first countries to ratify the Convention.

Ministers, business leaders and the largest-ever representation of civil society at a biodiversity-related meeting (over 1000), as well as representatives of the indigenous and local communities, participated in the meeting. Various themes were covered, including the increasing demand for food and associated land degradation and pesticide pollution, the pressure on biodiversity resulting from increased trade and the contribution of subsidies to overproduction, access to genetic resources subject to prior informed consent of the country providing such resources, and sharing upon mutually agreed terms with the country providing genetic resources the results of research and development arising from the commercial utilization of such resources .

The Director-General of the World Trade Organization, Pascal Lamy, addressed the meeting and spoke of rewarding innovative pharmaceutical companies that contribute to the maintenance of genetic diversity. Mr Lamy referred to the "medicinal stockpile" that is the rainforests and reminded the international gathering of the importance of using intellectual property rights judiciously. He said "it is incumbent on all countries to use intellectual property rights in a manner that fosters biodiversity."

Participants also agreed to seek to engage the private sector in efforts to curb biodiversity loss through the development of guidelines, certification and best practices.

The next meeting of the States Parties to the Convention will be in Germany in 2008.

Natural Health Products - NPN Pending

If you examine product labels on the shelf of your local health food store in Canada, you will note that there are a variety of natural health products that do not have product licences. When a company applies for a product licence, and is approved by the Natural Health Products Directorate (NHPD), the NHPD issues a natural product number, usually referred to as an NPN. The NPN is then included on the product label. The companies selling products without an NPN are either making no attempt to comply with Canadian law or are selling their products pursuant to the enforcement policies of the NHPD.

Selling products pursuant to the enforcement policies of the NHPD does not make the products "legal"; however, the enforcement policies offer insight into when Health Canada will restrain the marketing of such products. Under the enforcement policies, if a company applies for a NPN, receives a submission tracking number, is otherwise compliant with the Natural Health Product Regulations, and there are no risks or deemed risks to the health and safety of Canadians, then Health Canada will not focus its enforcement on those products. The fact that an NPN is pending not only does not make the sale of a product legal, but it does not provide a legal basis for challenging an enforcement action. It merely provides a company with the ability predict the likelihood of enforcement.

Some companies have included the words "NPN Pending" on product labels while the products are sold based on the enforcement policies. The NHPD takes the position that including the words "NPN Pending" on a product label is misleading, false, or deceptive to consumers and thus in direct violation of the Food and Drugs Act. On April 10, 2006, the NHPD reiterated its position regarding the use of "NPN Pending" product labels in a NHPD bulletin, asking companies to immediately cease this activity.

The NHPD considers the use of "NPN Pending" to be misleading because the mere application for a NPN is not determinative of whether the NHPD will actually issue a NPN. Depending on the type of product, there are a variety of issues that the NHPD will consider, the most obvious consideration being whether the evidence submitted demonstrates that the product works for its intended purpose. The NHPD takes the position that including the words "NPN Pending" implies that the application has been accepted and it is just a matter of time until the NPN will be issued, when in fact the NPN may never be issued for the product as submitted.

EU Approves First Biogeneric

The EU has approved the first biosimilar product, Sandoz's OMNITROPE. The new regulatory framework under which the product was approved allows the regulatory authority to approve copies of biologic drugs without a full dossier of clinical data.

The approval puts pressure on the U.S. Food and Drug Administration (FDA) that has been sued for delaying an application to market the Sandoz product in the U.S. Recently, a federal judge ordered the FDA to decide on the dossier that was filed in July 2003. The judge required the FDA to set out a clear regulatory framework for this type of product in the U.S.

For more information, please see:

U.S. FDA To Develop Guidelines on Follow on Protein Biologics

In a letter recently made public, the U.S. Food and Drug Administration (FDA) has indicated that it will focus on general guidelines about follow on protein products rather than issuing guidelines on specific biologic drugs. The generic industry has been waiting for the agency's advice on how to best test alternative versions of insulin and human growth hormone, and was expecting to learn from anticipated guidelines the FDA's requirements to assist them in seeking product approval. The letter indicated "After reassessing these product-specific documents, FDA has decided that it would be more appropriate to publish guidances which are more broadly applicable to (follow-on protein products) in general". Apparently, several generic biologics have been approved even without guidelines in place.

For more information, please see:

Recent Cases

Abbott v. Pharmascience; March 16, 2006, 55.2 Proceeding

- the Court granted prohibition on the basis of resjudicata

- the generic manufacturer had alleged the invalidity of the patent at issue in a prior proceeding. Those allegations dealt with the issue of over breadth. In the current NOA, the allegations related to obviousness and anticipation.

- the Court held that the generic manufacturer was required to use reasonable diligence to bring forth, in the first instance, all points that relate to the invalidity of the patent.

The text of the decision can be found at:

Biovail v. Canada (Minister of National Health and Welfare, March 13, 2006, Court of Appeal, Listing Issue

- the Court dismissed an appeal of a judicial review of a Minister's decision not to list a patent on the Patent Register.

- the patent at issue claimed a controlled release formulation.

- the Court construed the claims for the use of the formulation to achieve the slow release of the active ingredient; thus, the claimed invention was not for the medicine itself.

The full text of this decision can be found at:

Procter & Gamble v. Canada; March 30, 2006, Listing Issue

- the Court dismissed a judicial review of the Minister's decision not to list patents on the Patent Register.

- one patent at issue claimed a film coated formulation and the other claimed an enteric coated formulation.

- the Court held that when determining whether the patent at issue covered a formulation or a device, the Court should consider whether the patent claims a "delivery system" versus a "payload". Claims to a delivery system are not claims to the medicine itself.

The full text of this decision can be found at:

Purdue v. Novopharm, March 29, 2006, 55.2 Proceeding, Interlocutory Motion

- the Applicants appealed the Prothonotary's order refusing to strike portions of affidavit evidence and refusing reply evidence; the Court dismissed the appeal.

- the Court held that a motion to ignore evidence and a motion to Strike are practically indistinguishable.

- the Court also held that, in order to file reply evidence, it must be demonstrated that the further evidence will serve the interests of justice.

The full text of this decision can be found at:

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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