THIS MONTH'S A&A QUESTIONS WERE SUBMITTED BY THE
FOLLOWING STUDENTS FROM QUEEN’S UNIVERSITY’S (KINGSTON,
ON) MBA FOR SCIENCE & TECHNOLOGY PROGRAM:

Complied by Amber Lepage-Monette

BERNARD H. CHANG, PhD AND LANCE HAN

It is true that compulsory licensing of pharmaceuticals by generic companies, as of right, ceased in 1993, and limits have been placed on the circumstances in which such licences can be issued in Canada and internationally. However, in 2004, Canada once again moved toward a system of compulsory licensing. The difference this time is that the system is directed toward permitting licences that allow for medicines to be produced for export to developing and least-developed countries that are experiencing public health problems such as HIV/AIDS, malaria and tuberculosis.
Compulsory licensing was a significant element of Canada’s pharmaceutical policy until 1993, when Canada introduced Bill C-91, in consequence of its adherence to NAFTA and the World Trade Organization Trade-Related Aspects of Intellectual Property Rights (WTO-TRIPS) agreement. That bill removed the ability for generic manufacturers to seek a licence as of right from the Commissioner of Patents for a pharmaceutical patent, at a payment of a four-per-cent royalty to the patentee.
Now that Canada is a signatory to TRIPS and NAFTA, compulsory licensing can only occur under certain circumstances. Both the TRIPS and NAFTA agreements set out criteria that a government must observe in granting any compulsory licence. These rules require that any licence can only be granted for the supply of the domestic market.
However, the WTO Doha Declaration of Aug. 30, 2003 on the TRIPS agreement and public health, effected an agreement by member countries to relax the criteria for allowing issuance of compulsory licences. This was needed to address the fact that, although countries experiencing problems such as HIV/AIDS, malaria and tuberculosis were free to issue compulsory licences to produce patented pharmaceuticals, they did not have the facilities to manufacture the drugs. As such, product would have to be imported from another country (which would still require issuance of a compulsory licence in the importing country in need). Yet it was not possible, under the TRIPS agreement, for those countries to import the products, since member countries could not grant compulsory licences solely for export. Under the Doha Declaration, member countries agreed to waive the requirement that licences must be issued predominantly for the supply of the domestic market. That way, these countries experiencing public health problems would have access to medicines.
Canada was the first country to announce its intention to implement legislation to put the new compulsory licence system into effect. The first piece of legislation to enable the system, Bill C-56, was introduced on Nov. 6, 2003. After Parliament was prorogued on Nov. 12, 2003, the bill was re-introduced on Feb. 12, 2004 as Bill C-9. The innovative industry supported the bill, to enable access for this worthy cause.
For other types of compulsory licence applications, different rules — as prescribed by the WTO-TRIPS agreement and NAFTA — will continue to apply. In particular, before a licence is issued, there will generally be a need to demonstrate that attempts were made to obtain a licence from the patentee on reasonable terms, but that such attempts were unsuccessful. Licences could only be issued predominantly for the supply of the domestic market, and royalties would be determined on a case-by-case basis.

Adrienne M. Blanchard is a partner practising in the Ottawa, Ont. office of Gowling Lafleur Henderson LLP.

Research in genomics, proteomics, pharmacogenomics and other areas is starting to bear fruit, and the day that biopharmaceutical companies can deliver personalized medicine does not appear far away. How do you perceive the protection of intellectual property can be exercised when many similar, yet not identical, formulations may be required to optimize the therapies delivered to individual patients?

Personalized medicine and tailored therapeutics are scientifically achievable using bioinformatics technologies. The regulatory approval process is likely to be the rate-limiting factor in the market appearance of personalized therapeutics having similar, yet not identical, formulations for different individuals. Regulatory issues aside, inventors are already taking steps to protect their intellectual property in the area of personalized medicine.
Patent protection is available for new inventions involving personalized medicine. A patent gives a patentee the right to exclude others from making, using or selling the invention for 20 years. Thus, in order to achieve valuable patent claims for personalized formulations, the claims must be broad enough to cover a generic formulation under which the personalized formulations fall. Preparing broad formulation claims that allow for a variety of optional components is standard in the pharmaceutical patent practice. It may also be possible to achieve patent claims that cover a method or system through which a personalized therapeutic is formulated. This is a relatively new consideration for pharmaceutical patent practitioners. Bear in mind that a patent directed to such a method or system would not necessarily allow a patentee to prevent others from making, using or selling a particular formulation, especially if the components of that formulation are known in the art.
An example of methods or systems for screening drugs that are effective for specific patients or specific types of cancers can be found in U.S. Patent Application 20030165954, naming Third Wave Technologies Inc. (Madison, WI) as assignee. The invention as described would permit personalized treatment customized to an individual’s cancer, based on the individual’s genetic profile. The customized treatment may involve delivery of known pharmaceutical ingredients.
A further example of the type of protection being sought for personalized medicine inventions can be found in U.S. Patent Application 20020115073 entitled: “Genome-Based Personalized Medicine.” This patent application describes a method of identifying a personalized medical intervention for an individual predisposed to a genetic disorder associated with a polymorphic marker.
Bioinformatics can also be applied in the medical realm for personalized risk assessment. In terms of intellectual property protection, method patents may be sought. For example, a method for assessing a patient’s risk of having or developing coronary heart disease based on lipoprotein measurements has been patented by LipoScience Inc. (Raleigh, NC) (see U.S. Patent No. 6,653,140, issued Nov. 25, 2003). This method involves input of a patient’s individual biological parameters into a model based on a large sample size. Personalized preventative strategies are then recommended, based on the outcome of the risk assessment.
An important advance in personalized medicine is the understanding of biological changes associated with particular disease states. One company having just such a focus is Caprion Pharmaceuticals Inc. (Montreal, QC). Caprion uses proteomics methodology to develop profiles of normal and diseased tissues and plasma in order to identify new therapeutic targets and biomarkers that are particular to a disease state. The use of a large patient sample set exposes the great variation between individuals’ proteomic profiles. Such advances may ultimately allow for individualized therapies.

Kathleen E. Marsman, PhD is a patent agent in the Ottawa, Ont. office of Borden Ladner Gervais LLP. Marsman practises in the area of intellectual property, specializing in the drafting and prosecution of patent applications relating to all areas of biotechnology.