Publications

Supreme Court Tells Farmer to Keep Hands Off Monsanto's Genes

In a good-news decision for patent owners, the Court decided that claims to genes and genetically engineered cells provide patent protection against use of plants carrying those genes and cells. Specifically, the Court held that "[i]nfringement through use is thus possible even where the patented invention is part of, or composes, a broader unpatented structure or process." This is significant because patents with claims directed to plants or other higher life forms are not allowed in Canada so patent owners rely on claims to isolated genes and genetically engineered cells to protect their inventions.

Schmeiser, the defendant accused of patent infringement, selected those plants that carried the patented genes/cells and therefore, infringed Monsanto's Canola patent. The Court also stated that if Schmeiser had been "a mere 'innocent bystander', he could have refuted the presumption of use arising from his possession of the patented gene and cell."

Competition Bureau Declines to Take Axe to Alleged Patent Evergreening

A number of special-interest groups and unions complained to the Competition Bureau about alleged evergreening by adding additional patents to the Health Canada patent register. Generic drugs relying on brand name companies' clinical data have to state that they would not infringe any valid patent claims on the register prior to receiving Health Canada drug approval (similar to the US Orange Book). The Bureau made a number of general findings but declined to take any action because the Competition Act was not the appropriate vehicle to investigate a non-company specific complaint. Inquiries under the Competition Act relate to specific behavior.

B&P considers complaints about evergreening to be largely unfounded. The patent office is required to issue patents only for new and inventive technology. Patent owners are entitled to use the Health Canada patent register in order to protect their patent rights.

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Patented Medicine (NOC) Cases

Notice of Allegation

• The assertion that Apotex's NOA was deficient because Apotex refused production of their tablets (to allow Astra to test the tablets to determine infringement of Astra's patent) was not accepted by the court. The facts of an NOA are presumed to be true.
  Astrazeneca v. Apotex, 2004 FC 44

• The Supreme Court of Canada has granted leave to appeal to Biolyse in a case involving Bristol-Myers forcing Biolyse to serve a Notice of Allegation for a NOC Proceeding even though Biolyse filed a NDS, not an ANDS. Biolyse filed its NDS without using BMS' paclitaxel as a reference product; however, Biolyse's NDS included many citations to BMS data.
  Biolyse v. Bristol-Myers Squibb, 2003 FCA 180, leave to appeal to S.C.C granted 20/11/03

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Eligibility of Patents for Health Canada Patent List

• Osteoporosis treatment "kit" claims were found not to be a "medicine" eligible to be used to support a NOC Proceeding. The kit is not administered to patients, neither is it a system for administering substances to patients.
  Proctor & Gamble v Genpharm, 2004 FC 204

• A patent for a delayed release verapamil tablet was found ineligible for listing on the Health Canada patent register as not being for the medicine or its use. The tablet wall expands in the gut to allow the drug to be forced out slowly through an opening in the wall.
  Pfizer v Canada, 2004 FC 370

• The Federal Court of Appeal has decided that a supplemental new drug submission provides an adequate basis to add a patent to the Health Canada patent register. The court differentiated its decision from some earlier cases where companies undertook strategies to add patents to the register outside the deadlines such as a Supplemental New Drug Submission for a minor brand name change.
  Abbott v Canada, 2004 FCA 154

• For the purposes of filing a Supplemental New Drug Submission and adding a patent to the Health Canada patent register, the indication applied for in the SNDS does not have to be new, in the sense that this term is used in patent law. The fact that a different manufacturer has obtained approval for the indication is immaterial.
  Abbott v. Pharmascience, 2004 FC 154

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Remedies Available to Generic Company under Section 8 of NOC Regs

• The Federal Courts are deferring ruling on many important s.8 damage issues until after trial. Under s.8, a relatively new rule, a generic company can sue a brand name company for losses during the time period that an NOC Proceeding kept the generic company off the market. Motions for summary judgment and to determine complex questions of law about the types and scope of available remedies have been dismissed in several cases. It will likely take at least a couple of years to receive a trial decision.
  See e.g.: Apotex v. Merck, 2004 FC 314
  

• A six-year limitation period applies to s.8 damage claims.
  Apotex v Pfizer, 2004 FC 190
  

• s. 8 damages may only be sought against the company listing the patent on the patent register (a.k.a. a "first person"). The patent owner may not also be sued where its Canadian subsidiary was the first person.
  Apotex v Eli Lilly, 2004 FC 502
  

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U of Rochester Patent Claims Held Invalid on Appeal

An appeal court affirmed a lower court's decision that invalidated University of Rochester's mechanism of action patent claims. The University invented a screening method to identify drugs and then attempted to reach beyond the screening method to claim unidentified compounds for treating a disease. The claims included "[a] method for selectively inhibiting PGHS-2 activity in a human comprising administering a non-steroidal compound that selectively inhibits activity of the PGHS-2 gene." No examples of inhibitors were identified in the patent, and there was no suggestion of how an inhibitor could be made other than by trial and error. The court agreed that the patent disclosed "nothing more than a hoped-for function for an as-yet-to-be-discovered compound, and a research plan for trying to find it."
University of Rochester v. G.D. Searle. 69 USPQ 2d. 1886 (CAFC 2004)

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USPTO Patent Oppositions on the Horizon

The USPTO is considering a post-patent grant review system. Currently, the USPTO is consulting with interested groups about the scope and structure of the system. Some patent offices already have a post-grant review system, such as the EPO opposition proceedings. The general view is that the review system should include:

• submissions on patentability;
• inter partes proceedings - both the applicant and opponent participate (unlike patent examination); and
• limited discoveries with cross-examination of evidence.

The scope of review would likely include novelty, obviousness, enablement and written description (USC 102, 103 and 112 issues). It would not likely include best mode issues or novelty issues based on patents and printed publications. A challenger would have to show a sufficient basis (for example, a prima facie case of obviousness) before the proceeding would be initiated. The case would be heard by the USPTO, and there would be a right of appeal.

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Lawyers: 1, Book Publishers: 0

The Supreme Court of Canada held that the Ontario's Law Society did not infringe copyright in publishers' works by providing single copies of publishers' works to library patrons through a custom photocopy service. The law society used an access policy to limit copying to fair dealing purposes.

CCH et al v Law Society of Upper Canada, SCC, March 4, 2004

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EPO Revokes Myriad Cancer Diagnostic Patent

The European Patent Office cancelled Myriad's European patent for genetic tests for detecting predisposition to cancer following a successful opposition in which the patent claims were found to lack novelty. The patented methods in EP0699754 involved determining whether a person has mutations in the BRCA1 gene in order to diagnose whether the person is predisposed to developing cancer. Claim 1 stated:

A method for diagnosing a predisposition for breast and ovarian cancer in a human subject which comprises determining whether there is a germline alteration in the sequence of the BRCA1 gene or a BRCA1 gene regulatory sequence in a tissue sample of said subject, said alteration being indicative of a predisposition to said cancer.

The patent had 8 priority applications, each one filed as Myriad obtained more information about the BRCA1 gene and diagnostic methods. As a result of DNA sequence errors, Myriad was not able to fully rely on its earlier priority dates. The loss of priority rendered Myriad’s claims unpatentable in light of prior art.

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Human Antibody Claims Bounced: Noelle v. Lederman US Interference

Noelle claimed mouse and human antibodies to the CD40CR antigen on T-cells as well as a broad genus of antibodies. In an Appeal Court decision arising from a patent interference, Noelle was not permitted to claim the genus and human antibodies because of lack of sufficient written description. Noelle provided adequate description for the mouse antibody and antigen but the human and genus forms of CD40 were not made and characterized. They were not sufficiently described by methods describing how to isolate them and demonstration of successful, similar techniques used to obtain the mouse antibodies to CD40CR. The court found that it would be difficult to obtain the human antigen and antibody and a skilled person would not rely on the mouse antibody to isolate the human antibody.

Noelle v. Lederman et al. 69 USPQ 2d. 1508 (CAFC 2004)

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Speaking of IP...

We are speaking and participating in a number of upcoming conferences and seminars. We hope to see you this summer!

Tina Loucaides will be attending the CHLA Meeting in Gravenhurst on June 9-11.

Intellectual Property Management Group

The next meeting of the group will be Wednesday, June 16th from 8:30 to 10:00a.m. at the National Club in Toronto.

A roundtable of IP experts including, Noel Courage, will attend the meeting to answer your questions on all aspects of intellectual property from IP portfolio management to packaging and labeling requirements.

For more information or to register on-line go to www.ipmg.ca

The ABA IPL Summer Conference is coming to Toronto! Bereskin & Parr is a proud sponsor of the breakfast on June 17th and of the conference Golf Challenge on June 19th. We hope to see you there. For more information go to www.abanet.org

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B & P Insider

Noel Courage is now a partner in Bereskin & Parr, and Melanie Szweras will join the firm as an associate following her articling internship. We are also pleased to welcome Carmela DeLuca and Laurence McPhie as summer students. Carmela has a Ph.D in Experimental Medicine from McGill University and has completed two years of law school at the University of Toronto. Laurence has a Ph.D in Human Genetics from Oxford and has completed his first year of law school at the University of Toronto.

Anita Nador was re-appointed as Vice-president of the Toronto Biotechnology Initiative.

Disclaimer

This newsletter is for informational purposes only. These materials constitute general information relating to intellectual property law and our firm. They do not constitute legal advice or other professional advice and should not be relied on as such. While all materials are believed to be current and accurate at the time of writing, they are not guaranteed.

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