Canada: Pharmacapsules @ Gowlings - August 27, 2008

Last Updated: September 15 2008
Article by Adrienne Blanchard

Edited by Adrienne Blanchard and Jane B.H. Steiberg


  • Creation of Disease Specific Stem Cells for Ten Diseases Announced

  • A New Way to Study Cancer

  • 2008 World Patent Report Released by WIPO

  • Recent Cases

Creation Of Disease Specific Stem Cells For Ten Diseases Announced

By: Natalie de Paulsen

On August 7, 2008 the article Disease-Specific Induced Pluripotent Stem Cells which details the creation of stem cells from patients with ten different genetic diseases, was published in the on-line version of Cell. In this article, the authors describe the generation of induced pluripotent stem (iPS) cells from patients with the following diseases:

  • Adenosine deaminase deficiency-related severe combined immunodeficiency (ADA-SCID)

  • Shwachman-Bodian-Diamond syndrome (SBDS)

  • Gaucher disease (GD) type III

  • Duchenne muscular dystrophy (DMD) and

  • Becker muscular dystrophy (BMD)

  • Parkinson disease

  • Huntington disease (HD)

  • Juvenile-onset, type 1 diabetes mellitus (JDM)

  • Down syndrome (DS)/trisomy 21 and

  • Carrier state of Lesch-Nyhan syndrome.

The study's corresponding author, George Daley states: "Researchers have long wanted to find a way to move a patient's disease into the test tube, to develop cells that could be cultured into the many tissues relevant to diseases of the blood, the brain, and the heart, for example. Now, we have a way to do just that --- to derive pluripotent cells from patients with disease, which means the cells can make any tissue and can grow forever."

Being able to work with the cells in test tubes will facilitate investigation of the diseases and allow others around the world to do so as well. The authors have confirmed that the stem cell lines developed will be made available to scientists worldwide.

For more information, please see the link to the abstract and article Disease-Specific Induced Pluripotent Stem Cells by In-Hyun Park et al. at and the summary article Scientists Create Disease-Specific Stem Cell Lines by Catharine Paddock at

A New Way To Study Cancer

By: Natalie Rizkalla-Kamel

A team of researchers in Calgary have developed new research techniques for studying cancer. They have presented a new way to grow an atypical teratoid/rhabdoid tumour (brain cancer found in children), which involves adding brain fluid to the cancer cells in a Petri dish, simulating their natural growing environment. This method is a deviation from traditional methods of growing specimens for cancer research, which includes growing tumours in animals and harvesting them later to be studied or trying to grow them in a culture rich with nutrients. A result of this study is that now researchers have an endless supply of cell lines for this type of cancer. With this information, the research team tested a new drug called AEW-541 specifically designed to inhibit the growth of this type of cell. It is hoped that this new research method can be applied to other forms of cancer, although its too early to predict the lasting effects.

For more information, please see:

Cancer researchers in Calgary develop new way of studying cancer

2008 World Patent Report Released By WIPO

By: Jennifer Wilkie

On July 31, 2008, the World Intellectual Property Office (WIPO) released its report detailing statistics on patent filings around the world, for 2006 (the latest year for which complete statistics are available) and makes comparisons to previous years. The report shows increased a patent activity of 4.9% between 2005 and 2006, due largely to increased filings in China, Korea and the U.S. Further, statistics, among other things, show increased internationalization of patent filings, detail resident vs. non-resident filings, and show details as to the number of filings by subject matter. For example, pharmaceutical filings were up a modest 1.7% and biotechnology filings were down 2.7%.

For more information, please see:

The full report: World Patent Report: A Statistical Review (2008)

Recent Cases

By: Beverley Moore

Canada v. Abbott; appeal of a listing decision; July 25, 2008; lansoprazole

The Court of Appeal overturned the trial judge and upheld the decision of the Minister to remove a patent from the Patent Register. The Court of Appeal held that under the amended Regulations, in order to be listed on the Patent Register, the patent must contain a claim to the changed use in the SNDS. Even though the changed use may come within the claims of the patent, it must specifically claim the changed use, and not the original use of the medicine. The expert evidence went no farther than showing that the patent would have been eligible for listing against the original submission if the date of the submission had not preceded the date of the patent application.

The Court of Appeal concluded stating that to allow the listing of the patent for a changed use which was not the subject of a specific claim would undo the reform which the amended Regulations seek to introduce.

The full text of the decision can be found at:

Abbott v. Apotex; motion to dismiss under Section 6(5)(a); July 29, 2008; lansoprazole

In a decision made with respect to a patent listed under the old Regulations, prior to the amendments, the Court found that the patent only claims a delivery system or a means of enhancing a delivery system. Thus, it does not include a claim for the medicine itself and is not eligible for listing on the Patent Register.

Full text of the decision can be found at:

Apotex v. Executive Officer for the Ontario Public Drugs Programs; judicial review; August 6, 2008; perindopril

The Court dismissed Apotex' judicial review of the Executive Officer of the Ontario Public Drugs Programs (EO) decision refusing to list Apo-perindopril at 85% of the price of the original brand name product.

The Court held that the general rule is that generic drugs are to be listed at 50% or less of the price of the original brand drug. However, the EO has discretion to negotiate an agreement with the generic price for a higher price. In this case, Apotex requested a higher price on the basis that even at 85%, there would be significant savings to the government and furthermore, as it was involved in patent infringement litigation, such a price was necessary to cover the cost of its legal defence.

The Court held that the EO was open to negotiation, but Apotex' rationale was not helpful to that negotiation. The statement that 85% is better than nothing is simply stating the obvious. Furthermore, while litigation is ongoing, there can be no rational basis for the government to back one of the litigants by giving special consideration and pricing to offset litigation costs. In addition, Apotex' suggestion that the government indemnify Apotex if it is ordered to pay damages to Servier is irrational.

Thus, it was not surprising that the EO declined to exercise discretion in favour of a higher price for Apotex' drug. She was provided with no good reason for doing so.

Full text of the 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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