Gene Patents: Common Sense from Down Under

Patently BIOtech

Oh, crikey! The U.S. Supreme Court is currently reviewing briefs to consider whether preparations of DNA molecules are patentable. Possibly unnoticed to the Justices is a recent decision from the Federal Court of Australia confirming the patentability of ‘isolated’ DNA. The Supreme Court may not take any notice of this Australian case, but those following so-called gene patents can learn a lot from the no-nonsense approach of Aussie patent law.

The Australian case focuses its analysis on legal precedent analyzing patent-eligibility by looking for an “artificially created state of affairs which has economic significance.” The Australian Justice applies this judicial precedent and concludes that the ‘isolated’ DNA claimed is scientifically separate and distinct from that which is in the body and confirms this by reviewing the significant human intervention and effort required to create this artificial state. Because it was crystal-clear that the patent claims do NOT claim something that exists in nature, arguments about “products of nature” were dismissed as irrelevant and not helpful analytically. While the case may be appealed, Australia is left with a clear discernable rule to help the scientific community move forward with discovering and inventing new solutions to human problems.

Us Yanks could take a lesson from such straightforward logic. Any biotechnological invention is going to involve nature and so to argue that there is such a thing as a “product of nature” doctrine only confuses the question of what was legitimately invented. The study and manipulation of biology necessarily leads to identifying and reengineering things already present in nature. Trying to decipher patentability based on how close something looks to the real thing you find in the jungle does not, in any meaningful way, measure the inventiveness and entrepreneurial spirit that drives the biotech industry. The ‘product of nature’ doctrine simply cannot apply to the biotechnological arts without knocking out an entire field of scientific inventions.

Second, the approach of the Australian Justice presents a reasonable and rational analytical tool to evaluate biological inventions. The ‘artificial state of affairs’ principle recognizes the human intervention and effort necessary to take a molecule out of nature and make it useful beyond its original design. At the same time, the principle makes clear that patents are only available for things that are, well, artificial. Imagine, for example, a scientist who discovers that a scorpion venom, besides being venomous, has certain medicinal properties. The scientist could not patent the scorpion venom, because there is nothing artificial about it. It is also not particularly useful, because the “natural” scorpion venom is a toxic, painful cocktail of hundreds of different components that few people would want to be injected with. But what if the scientist isolates the many different components of the venom (some scorpion venoms have more than 300 active ingredients) and identifies the one component that has powerful analgesic or immunosuppressive or antihypertensive effects and redeploys that ingredient in pure form for medicinal purposes? Doing so would seem to be quite an inventive feat. Evaluating the artificial state of the purified molecule and the scientific effort to create that state recognizes that the scientist did not merely discover a property of the venom but took that knowledge to a point where it could be used in a new way. That is the definition of invention.

The ‘economic significance’ portion of the argument only further supports the patentability of such inventions.  At the time of the patent application, the economic impact or value is difficult to assess and should be left to the market place. As a result, many patents exist on inventions the marketplace has rejected. However, in the biological arts the opposite is often true and that is no more apparent than in the Myriad case. Cloning the BRCA gene has created a valuable diagnostic tool and may also serve to create targeted treatments and cures in the future. While our society should not become the arbiters of the value of the invention during the patent application process, once that patent reaches litigation the judiciary should take into account the real-life practical value of an invention as a positive sign of its patent-worthiness. Good on Ya, Mates!

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