In March of this year, the United States Patent and Trademark Office (USPTO) had set new rules for biotech patents. The rules categorically forbid new patents on a vast range of naturally occurring products, natural phenomena, and principles. The USPTO had announced that it will be taking public comments on the issue till July 31st, and the deadline is fast approaching. With only fifteen more days to go the biotech industry in the United States is worried about the future and what the lack of future patents can mean to their business.

The USPTO has recently disappointed biotech companies.

The USPTO has recently disappointed biotech companies.

USPTO’s New Rules Based on SC Rulings

In the last two years the United States Supreme Court has rejected several high profile patents from biotech companies. In March of 2012 the court had denied a patent ruling to Promethus Laboratories based in San Diego, California. The company’s patent lawyers were trying to get patent protection for a method of using metabolite levels to guide drug dosing in patients. This claim was denied by the SC. Then in July 2013 the court rejected a claim from the patent lawyers representing Myriad Genetics from Salt Lake City, Utah.

Not Enough Ingenuity

The genetics company was patenting a procedure for using DNA sequences linked to breast cancer disease. The patent would have opened the floodgates for genetic testing firms which could have utilized the technology to create genetic tests to detect breast cancer. In both these rulings the SC cited the section of the patent code that states that no patent shall be given to “laws of nature, natural phenomena, and abstract ideas”.

Decision Made

This section of the patent code was hitherto used as a guidance but the Supreme Court rulings made sure that the industry woke up to the nuances of patenting technology based on natural phenomena. According to the United States Supreme Court, such patents should be forbidden and it seems the SPTO too has taken the recent rulings to heart and decided to base its new set of patent laws dealing with biotech products in the same vein.

A New Outlook on Patent Authorization

The USPTO has decided that the Supreme Court rulings on these cases was built up on previous rulings forbidding patents on natural phenomena and products and hence should be the new benchmark for all future biotechnology patents that recite or involve laws of nature. According to these new rules more than half of the drug patents awarded to pharma companies in the US between 1981 and 2010 should have been in the rejected list as they all were natural, or derived from naturally occurring products.

Even drugs that carried antibodies–which are naturally occurring molecules–and vaccines carrying live proteins or pieces of genes for transmitting resistance would have never been patented had this new rule been in place.

You cannot patent “laws of nature, natural phenomena, and abstract ideas”.

You cannot patent “laws of nature, natural phenomena, and abstract ideas”.

Drug Companies Protest against New Rule

Sherry Knowles, a legal consultant from Georgia and the chief patent lawyer at the drug company GlaxoSmithKline, is among the many protesting the new patent rule from coming into effect. The protestors are arguing the USPTO’s ruling is an overreach of the patent policy. The SC struck down the Myriad patent only on the DNA isolated from nature and the USPTO is using this example to curb any patents on any product with a natural base and not ‘significantly modified’.

The pharma and biotech industry is reeling from an onslaught of rejected patients. Even before the USPTO announced its rule change the SC ruling in the Promethus patent case had saw over 40% of the 1,000 applications filed after April 2011 being rejected. This new trend is worrying patent lawyers and organizations such as the Biotechnology Industry Organization to no end. While it is clear that the Supreme Court ruled rightly in the Promethus and the Myriad cases, using that as a benchmark to create severely restrictive patent rules is not going to help either the USPTO or the biotech industry.