In 2013, the US Supreme Court decided to ban human genetics from applying for patents.
One year after the US Supreme Court published a landmark decision (human genes could not be patented), biotech companies are trying to adapt to a situation where natural-derived inventions are increasingly difficult to apply for patents. They are also countering the follow-up policy proposed by the United States. The Patent and Trademark Office (USPTO) can direct prosecutors to decide whether an invention is too close to natural products and should not be protected by patents. However, the representative of the biotechnology industry pointed out that the scope of these policies goes far beyond the intention of the High Court.
“What we took for granted a few years ago is changing, and it creates a lot of confusion,†said Michigan State patent attorney Damian Kotsis.
At the recent Biotechnology Industry Organization (BIO) International Convention meeting, lawyers and corporate executives are concerned about the fate of recent patent applications involving natural products, including compounds, antibodies, seeds and vaccines, and recent trade conditions. These accidents were refuted by the USPTO. Industry leaders warn that uncertainty will make universities and businesses' commercialization sciences cold. Some people plan to appeal to the federal court.
At the same time, USPTO officials urged participants to provide advice on how to clarify and improve the new natural product patent policy, and announced that it would extend the public comment period. “Everyone in this room has a moral responsibility to provide written advice to the USPTO,†said Teresa Stanek Rea, a patent attorney and former USPTO deputy director, to a participant.
Two resolutions of the Supreme Court
At the center of the storm are two Supreme Court resolutions: the ruling of the Molecular Pathology Society and the biotechnology company Myriad Genetics, the human gene is a natural product that cannot be patented, and the 2012 ruling on the Mayo v. Prometheus case, the court A patent ruling that involves determining the dose of a drug by measuring blood metabolism is ineffective because it relies primarily on "natural laws."
A recent study published that these patent rulings have had a noticeable impact on Myriad and Mayo. The researchers surveyed about 1,000 patent applications reviewed by the USPTO between April 2011 and March 2014, some of which were related to natural products or natural laws. The researchers said that overall, the reviewer rejected nearly 40% of the applications; 23% rejected Myriad, and Mayo had about 35%, with some overlap.
Hans Sauer, BIO's intellectual property attorney, announced at a news conference that five years ago, the rejection rate for such patent applications was only a single digit. (There is no historical data that can be used for comparison.) The study was jointly directed by Bloomberg News and Robins, Kaplan and Miller & Ciseri Legal Affairs.
According to lawyers, the figures show that the USPTO extends its decision-making beyond the diagnostic and DNA categories. For example, Kotsis pointed out that one of his clients recently tried to patent a plant extract with medical properties, and because the inventor changed the relative concentration of the main compound to enhance its effect, it is different from any natural thing. . However, the USPTO believes that it is too close to natural products.
USPTO issues draft guidance
In March, the USPTO issued a draft guide to help reviewers determine such issues and list 12 factors for consideration. For example, if a reviewer believes that a product “structure is significantly different from other natural products,†then it is included in the factors that support the patent application. But if the product is "very high", it may be rejected.
However, the draft has been widely criticized. "I don't think I've seen anything so complicated," said Kevin Bastian, patent attorney at Kilpatrick Townsend & Stockton in California. "I don't believe this will be the standard."
USPTO executives also seem eager to fine-tune these guidelines, but patent experts worry that the Supreme Court's decision has made it difficult to draw a clear line. "The decision in the Myriad case is a hopeless contradiction and completely illogical," said Dan Burk, a professor of law at the University of California, Irvine. He added: "We know that you can't apply for a patent for a genetic sequence, but we don't really know why."
Kostis said that so far, applicants need to use creativity to reduce the chances of patent applications being rejected. For example, the inventors should apply for a patent for the step of treating a patient using the drug as compared to claiming the plant extract itself. Other biotech lawyers may try to narrow the scope of patents.
But this strategy has the downside. They noticed that narrowed patents are difficult to protect applicants from infringement, making it difficult for such patents to attract investors. Others plan to wait until the storm is over, and they believe that the USPTO will eventually reflect on its guidelines and relax the new patent application restrictions.
The USPTO has extended the public comment collection deadline to July 31, but the release date of the final guidelines has not yet been determined. Regardless of the outcome, Stanek Rea warned the angry lawyer that in the field of bio patents, "comfortable days have passed."
Source: Chinese Journal of Science
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