BIO 2014: Public access to medicine at risk in US - report

The American public's access to new and effective medicines could be at risk as a result of the US Supreme Court's decisions in the Prometheus and Myriad cases, and the resulting guidance for examiners from the US Patent and Trademark Office (USPTO), according to a report presented to the 2014 BIO International Convention in San Diego today (Wednesday).

The decisions in Mayo Collaborative Svs v Prometheus Labs and Assn for Molecular Pathology v Myriad Genetics on patent eligibility, and the guidance that followed, have “rewritten the playbook for biotechnology patent applications, placing the industry at a crossroads”, according to the Bloomberg BNA report Stopped at the threshold: the practical impact of the Supreme Court's Mayo and Myriad decisions on biotechnology patent practices.

The decisions and the guidance appear to have shaken the life sciences industry at its roots and could affect therapeutic approaches in the future as well as public access, says the report by Matthew McFarlane and Tara Guffrey Sharp, trial attorneys at Robins, Kaplan, Miller & Ciresi LLP, and John Aquino of Bloomberg BNA.

“If the industry is unable to adapt to the [US]PTO's new patent application examination regime, it could lead to less innovation overall and limit access for patients to new biotech-based therapies and diagnostic methods that are key components in the practice of personalised medicine,” the report adds.

In a survey by Bloomberg BNA, most of the comments by attorneys surveyed suggested that the [US]PTO's guidance was overreaching, misinterpreted the Supreme Court's holdings, and could force inventors and investors to abandon what could be life-saving projects or move to other countries where the laws facilitate innovation.