ASKED & ANSWERED

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Compiled by Amber Lepage-Monette

Many academic institutions and some biotechnology companies develop new research tools during the course of their R&D programs. Research tools are usually biological products (peptides, genes, cell lines, animals) or methods (screening assays) that are used in the research and development of commercial products such as new therapeutic compounds. Previously, it was common for institutions and companies to file patent applications on any new and useful research tool, as such patents could be licensed to others in order to generate revenue. However, over the past number of years there have been many court decisions, notably in the United States, that tend to decrease the value of research tool patents. In light of these decisions, institutions and companies should carefully consider whether or not there is significant value in filing a patent application on a new research tool.
The value of a patent is dependent on many factors. Two important factors are 1) the strength of the claims at issue and 2) the ability to enforce the claims against a third party. This reply will focus on the second factor, enforceability, due to a recent U.S. Supreme Court decision in this regard. However, with respect to scope of claims, it is worth noting that for many research tool patents, the scope of claim is often narrow in the current U.S. examination environment. This is especially true when the invention relates to a novel gene sequence or partial gene sequence. It is highly advisable to consult with a patent agent or lawyer to discuss the likely scope of claim before filing any application, especially in the area of research tools.
The ability to enforce a research tool patent should also be considered before filing. Research tools, by definition, are used in research. Activities conducted in a research context are often kept confidential, especially in large pharmaceutical companies. As such, it is difficult to police patents to research tools. Further, many countries have experimental-use exemptions, which means that using a patented invention for certain limited experimental purposes may not be considered infringement. Some countries, notably Canada and the United States, also have an exemption from infringement for activities that are reasonably related to the development and submission of information for regulatory approval. This safe harbour exemption was at issue in the recent U.S. Supreme Court decision in Merck KGAA, petitioner vs. Integra Lifesciences I, Ltd., 125 S. Ct. 2372. In this case, the U.S. Supreme Court has created a broad exception to patent infringement for research using a patented compound. While the court specifically declined to rule on research tool patents generally, owners of these patents are now concerned about their enforceability.
To briefly summarize, Integra Lifesciences Ltd. (Plainsboro, NJ) owns five U.S. patents relating to a tripeptide sequence known as the RGD peptide. Merck KGaA (Darmstadt, Germany) 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 discover a compound later submitted to the U.S. Food and Drug Administration (FDA) for approval. Integra sued for patent infringement and, in defence, Merck relied on the U.S. safe harbour exception to patent infringement for drugs (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 harbour 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 preclinical 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.
The above decision is based on a specific situation and it is unclear how it will be applied in other situations. The Supreme Court, in a footnote, explicitly did not express a view about whether, or to what extent, the safe harbour exempts the use of research tools from infringement. Legal advice should be sought regarding particular situations.
It would be advisable to carefully consider the merits of filing a patent application on a research tool before investing both time and money obtaining and trying to enforce the patent. Both are extremely valuable resources for academic institutions and biotechnology companies.

Micheline Gravelle heads Bereskin & Parr’s (Toronto, ON) biotechnology and pharmaceutical practice group. She is a registered patent agent whose practice focuses on biotechnology and pharmaceutical patents, including assessing new technologies, preparing and prosecuting patent applications worldwide, and conducting due diligence analysis on patent portfolios.

Noel Courage is a lawyer and registered patent agent with Bereskin & Parr. His practice focuses on the patenting and licensing of chemical, biotechnology and pharmaceutical innovations. He also provides opinions on patent validity and infringement issues, as well as advice on IP portfolio management strategy.