The US Patent and Trademark Office or USPTO recently revised its guidelines for its examiners in a bid to ease the process for drug companies and bio-tech firms to obtain patents for their exclusive inventions. The USPTO’s move is reportedly in response to two rulings by the US Supreme Court that limited the extent to which life sciences companies can patent natural products and processes. The USPTO says the guidelines are part of an integrated approach for its examiners to address different types of claims and determine what a court might identify is not eligible for a patent.

The US Supreme Court Rulings

The two rulings by the US Supreme Court came from one case that involved Myriad Genetics and breast cancer tests, and another case involving Prometheus Laboratories. According to patent attorneys, in the Myriad Genetics case, the court ruled that patents on isolated DNA were not possible. In the case of Prometheus Laboratories, the court rejected the company’s argument that tests that rely on connections between drug doses and treatment were eligible for patents. Some patent attorneys are of the opinion that the guidance went beyond the Supreme Court decisions in those cases.

Varied Viewpoints

The guidelines by the USPTO were designed to help examiners in the evaluation of patents related to natural products. However, the industry has viewed the agency’s stance as being too restrictive, which they say has prompted examiners to analyze whether inventions were eligible for a patent. This led to various industry trade groups expressing concerns about the number of applications filed by drug companies and bio-tech firms that were likely to be rejected.

One of the major opponents is the Pharmaceutical Research and Manufacturers of America who was of the opinion that the guidelines would lead to uncertainty, additional costs and increase their burden when seeking patent protection for new and improved therapies.

Percentage of worldwide biotechnology patents. America is on top.

Percentage of worldwide biotechnology patents. America is on top.

Guidelines – a Reason for Rejection

The International Biotechnology Association also complained that the guidelines may deter investments in R&D of entire categories of biotechnology. They say many member companies have already had their applications rejected, which include those for recombinant industrial enzymes, for diagnostic laboratory procedures, and for pharmaceutical formulations with naturally-occurring substances as active ingredients.

The impact of the guidelines issued last March is demonstrated in analysis conducted by a law firm, which indicates an increase of around 8 percent to 13 percent in the number of rejections. Around 5 percent of 266 cited the guidelines as a reason for rejection.

The USPTO in a blog post said the agency was carefully considering the opinion of the public and its patent examiners in its bid to address revisions based on the Myriad and Mayo cases. According to some patent attorneys, the goal of the guidelines is to provide clarity and patent protections for naturally-occurring products. For life science companies, the new guidelines will serve as a pathway to determine if their inventions may get the approval of the agency.