Biotechnology & Pharmaceutical Practice Group Newsletter
Winter 2005-2006
Limited Window to Correct Small Entity Status
Prior to the decision of the Federal Court of Appeal in the Dutch Industries v. Canada case, the Patent Office allowed patentees and patent applicants to make corrective payments to "top-up" insufficient maintenance fee payments, where the small entity fee had been paid in error, instead of the large entity fee. However, the Federal Court of Appeal held that maintenance fees could not be corrected through the use of "top-up" payments. Therefore, the effect of the Dutch Industries decision was to abandon patents and patent applications for which fees had been paid incorrectly at the small entity rate.
A new law, which is designed to partly address the effects of the Dutch Industries decision, is expected to come into force February 1, 2006. It will allow a patentee or applicant a one-year grace period from the coming into force of the section to submit the difference in fees if they paid a fee at the small entity rate when not eligible for small entity status. The amendments are designed to aid only those who had paid the incorrect fee prior to the coming into force of the amendments, and they will not be of any assistance to those who pay the incorrect fees at any time subsequent to the date on which the amendments come into force.
Do U.S. Research Tool Patents Still Have Legal Value?
The U.S. Supreme Court has created a broad exception to patent infringement for research using a competitor's patented compound. While the Court specifically declined to rule on research tool patents generally, some owners of these patents are now concerned about their enforceability. Integra owns five patents relating to a tripeptide sequence, known as the RGD peptide. The RGD peptide promotes cell adhesion by attaching to integrins on the surface of endothelial cells. Merck utilized the RGD peptide in its research to develop a new drug. The RGD peptide provided a benchmark for Merck to measure activity of its own compounds, which helped Merck to discover a compound later submitted for FDA approval. Integra sued for patent infringement and, in defence, Merck relied on the U.S. "safe harbor" exception to patent infringement (35 USC §271(e)(1)) which states:
It shall not be an act of infringement to make, use, offer to sell, or sell … a patented invention … solely for uses reasonably related to the development and submission of information under a Federal law ….
The Supreme Court found that Merck's use of the patented RGD peptide was non-infringing. The safe harbor may extend quite far upstream in the drug discovery process, encompassing research in animals and in vitro testing provided there is a reasonable basis for believing that such research will yield results relevant to the FDA approval process. In other words, as long as there is a reasonable basis to believe that the compound tested could be the subject of a FDA submission and that the experiments will produce the types of information relevant to an application for drug approval, there will be no infringement. The Court held that since the FDA is interested in pharmacological, toxicological and pharmacokinetic data when considering an investigational new drug application, even pre-clinical testing of a patented compound would fall within the safe harbour provision.
This decision will allow companies to screen for medicines using a competitor's patented product with less risk of infringement. However, biotech companies that specialize in research tools and kits and compounds such as enzymes and antibodies are now concerned that this decision may lead to weakening of their patent protection if the reasoning in the context of a patented compound is applied to other inventions used in research.
Since Integra did not argue that that the RGD peptides were being used as research tools, the Supreme Court, in a footnote, explicitly did not express a view about whether, or to what extent, the safe harbor exempts the use of research tools from infringement. Therefore, it could be argued that this case does not apply to research tools, and the safe harbour provision may have to be revisited to determine the fate of research tool patents generally.
Merck KGAA, Petitioner v. Integra Lifesciences I, Ltd. 125 S. Ct. 2372.
Sound Prediction Date is … Unpredictable
Two Federal Court cases have disagreed on whether the soundness of predictions of utility should be addressed as of the priority date or the filing date.
Apotex alleged in an NOC Proceeding that the ramipril drug patent was invalid for lack of a sound basis to predict that the claimed compounds would be useful as ACE inhibitors for treatment of hypertension.
Sound prediction is assessed based on the principles set out by the Supreme Court of Canada in Apotex Inc. v. Wellcome Foundation Ltd. (2002). However, the parties disagreed on the proper date to assess sound prediction. Apotex argued that sound prediction should be determined as of the earliest of the priority dates claimed in the Canadian patent application (October 23, 1980) when the application contained less experimental support. Aventis argued that sound prediction should be assessed as of the Canadian filing date (October 20, 1981) when the application included additional experimental support.
The Court held that the Canadian filing date should be used when assessing sound prediction. However, Apotex's allegation that there was no basis for soundly predicting utility using either date was reasonably justified. Aventis Pharma Inc. v. Apotex Inc. 2005 FC 1283 (Federal Court of Canada).
In another NOC Proceeding, Apotex alleged that the quinapril compound patent was invalid for lack of sound prediction. The parties agreed that the Wellcome test was the appropriate test to assess sound prediction but disagreed on the date to apply the test. In this case, the Court assessed sound prediction as of the priority date and held that the utility of the compounds could be soundly predicted.
Pfizer Canada Inc. v. Apotex Inc. 2005 FC 1205 (Federal Court of Canada).
Patent Application Without Data Laid to REST
The U.S. Court of Appeals considered whether a patent application for ESTs that are purported to be useful as research tools, but are not supported by data, satisfy the utility and enablement requirements. The Court decision more or less followed the current U.S. Patent Office practice of rejecting these types of patent applications. Fisher applied to patent five EST sequences of unknown function obtained from a cDNA library. Seven uses were disclosed: a molecular marker for mapping the maize genome, a probe, a source of primers, identifying polymorphisms, isolating promoters, controlling protein expression and locating genetic molecules in other plants. There was no supporting experimental data for any of these uses.
The U.S. Patent Office requires a patent application to disclose a specific, substantial and credible utility. Enablement requires an application to show others how to make and use an invention without undue experimentation.
The Examiner rejected the application as unpatentable on the basis that the claimed ESTs lacked enablement and were not supported by a specific and substantial utility. The U.S. Court of Appeals found that the application did not meet the utility requirement, in part because the function of the underlying protein-encoding gene was not identified. The Court held that an asserted use must show that the claimed invention has a significant and presently available benefit. Further, an asserted use must not be so vague as to be meaningless. The uses disclosed in the application were generally applicable to any EST and were of hypothetical benefit. Since the utility requirement was not met, the application also lacked enablement.
Interestingly, several "biotech" entities that are downstream users of EST sequences supported the government's position on lack of utility and enablement.
In re: Dane K. Fisher & Raghunath v. Lalgudi No. 04-1465 (U.S. Court of Appeals for the Federal Circuit)
September 7th 2005.
Proposed Amendments to the NOC Regulations Have Not Gone into Hibernation
We previously reported on amendments proposed in December 2004 that would drastically change the NOC Regulations and would increase brand name company data protection from five to eight years. The amendments would generally reduce the types of patents eligible for listing on the Health Canada Patent Register. They would also reduce the use of supplemental new drug submissions to list patents. An overhaul of the draft amendments is expected in response to public comments received in February 2005. We will keep your posted on developments. Please contact us or visit www.bereskinparr.com if you would like a copy of our original article on the proposed amendments.
Nicotine Patch Price Reviewable Based on Patents but not Pending Patent Applications
The Federal Court found that the Nicoderm patch is a patented "medicine" so the Patented Medicine Prices Review Board ("PMPRB") has jurisdiction to review its price. The nexus between the patent and the medicine need only be of the merest slender thread. It is irrelevant whether the patent is actually being used in connection with the medicine Nicoderm. As well, licensing in a patent from another company was sufficient to make the licensee a "patentee" subject to PMPRB jurisdiction.
The Court also found that the PMPRB could not assert jurisdiction over laid-open patent applications. A patent application gives rise only to the potential for the grant of a patent.
Hoechst Marion Roussel Canada Inc. v. Canada 2005 FC 1552 (Federal Court of Canada).
NOC Proceedings and Use Patents
Ramipril is approved by Health Canada for treatment of heart failure and hypertension. Two recent NOC Proceedings involving the drug ramipril have had different outcomes based on courts' consideration of use claims and infringement evidence.
Aventis received an order prohibiting Apotex from obtaining its NOC for generic ramipril until after expiry of a patent for use of ramipril to treat heart failure. Although Apotex was seeking an NOC for treatment of hypertension, the judge found that ramipril would inevitably be dispensed for heart failure. Pharmacists would be obliged by law to substitute lower cost generic ramipril unless directed otherwise by the doctor or patient. Apotex's product monograph also suggested that its generic ramipril could be used to treat heart failure.
In the second case, a different judge refused a prohibition order against the generic company after considering a patent for use of ramipril for treatment of hypertrophy and hyperplasia. Ramipril is prescribed off-label for hypertrophy since it is not a use approved by Health Canada. The Judge found that mere infringement by patients is inadequate and there must be inducement, procurement or marketing of the patented use by Apotex. Apotex's recognition of "off label" prescription and use did not justify a prohibition order. The content of the Apotex product monograph also did not establish a nexus to hypertrophy that would justify a prohibition order. The court relied on an earlier appeal court case stating that there is always the possibility that someone will use the drug for the patented purpose. If prohibition were granted, the patent holder would, therefore, effectively control not just the new uses for the old compound, but the compound itself.
Aventis Pharma Inc. v. Apotex Inc. 2005 FC 1381(Federal Court of Canada)
Aventis Pharma Inc. v. Apotex Inc. 2005 FC 1461 (Federal Court of Canada)
Fewer Formulation Patents Eligible for Health Canada Patent Register Listing
Mechanical device patents such as inhalers and patches are not listable on the Health Canada Patent Register. The Patent Register is the central list of patents that can trigger an NOC Proceeding to determine whether a generic drug company may receive marketing approval. Patents for delayed release capsules that resembled mechanical devices have also been found ineligible for listing in recent years. One example of an ineligible capsule had walls dividing the capsule into compartments. Health Canada then began refusing to list patents that it said were not for a medicine because they were for formulations that could be used to deliver many different kinds of medicines. These patents were refused even though they resembled conventional formulations with all the ingredients thoroughly mixed together. Health Canada's interpretation has recently been upheld by the Federal Court which found a patent for a mixture of a drug with two controlled release polymers to be ineligible for listing. This decision will further narrow the scope of listable patents.
Biovail v. Minister of Health 2005 FC 1135 (Federal Court of Canada).
Announcement
We are very pleased to announce the newest associates in
the Biotechnology & Pharmaceutical Practice Group.
David E. Blais B.Sc. (Biochem.), LL.B.
David is a lawyer with a B.Sc. in biochemistry. Prior to obtaining his LL.B. from Osgoode Hall Law School, David completed two years of graduate research at the Northeastern Ontario Regional Cancer Centre in Sudbury. David's practice will focus on pharmaceutical litigation.
Michael Fenwick B.Sc., M.Sc. (Org. Chem.), LL.B.
Mike is a lawyer with a B.Sc. in biology and an M.Sc. in organic chemistry. Mike spent his articling term at Bereskin & Parr. His practice will focus on patents, licensing and litigation for biotechnology, pharmaceutical and chemical matters.
Louisa Pontrelli B.Sc., M.Sc. (Clinical Biochem.), LL.B.
Louisa is a lawyer with a B.Sc. and an M.Sc. in biochemistry, with a focus on molecular and cellular biology. Louisa spent her articling term at Bereskin & Parr. Her practice will concentrate on biotechnology and pharmaceutical matters, including patents, licensing and litigation.
David St-Martin B.Sc., M.Sc. (Org. Chem.)
David is a patent agent with a B.Sc. in chemistry and an M.Sc. in organic chemistry. Prior to joining Bereskin & Parr, David gained several years of IP experience at a national law firm in Montréal. His practice focuses on patents in the areas of pharmaceuticals, organic chemistry, inorganic chemistry, polymers, materials chemistry, electrochemistry, environmental technology, nanotechnology and cosmetics. David practices out of the firm's Montreal office.
Leah Rodin B.Sc., M.Sc. (Chem.)
Leah is a patent agent with a B.Sc. and an M.Sc. in chemistry. Prior to joining Bereskin & Parr, Leah worked with a North American pharmaceutical development company as a chemist and later as a patent associate in the legal department where she drafted, prosecuted and managed foreign and domestic filings for the company's chemistry patent portfolio. Her practice focuses on patents in the areas of pharmaceuticals, organic chemistry, environmental technology, polymer chemistry and nanotechnology.
The addition of our new associates brings additional strength and technical depth to the firm and solidifies Bereskin & Parr's biotechnology and pharmaceutical practice as one of Canada's strongest groups in the life sciences field.
We are pleased to congratulate the following professionals
on becoming Registered Patent Agents.
Christopher G. Tortorice B.Sc., M.Sc. (Biology), LL.B.
Chris is a lawyer, patent agent and trade mark agent with both a B.Sc. and an M.Sc. in biology. Chris' practice focuses on biotechnology, pharmaceutical and chemical matters, including patents, licensing and litigation.
Carol Yip B.Sc., M.Sc. (Chem.)
Carol is a patent agent with a B.Sc. Honours in biological chemistry and an M.Sc. in chemistry (organic synthesis). Carol has held Research Assistant positions at the University of Toronto and the University of Hong Kong where she gained considerable research experience in the fields of bio-organic, inorganic and physical chemistry. Carol's patent practice focuses on the preparation and prosecution of applications in the areas of chemistry, materials science, food science, pharmaceuticals and biotechnology.
Congratulations also go to David St-Martin and Leah Rodin on this accomplishment.
