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BIO Submits Comments on “Myriad” PTO Patent Guidance

August 6, 2014
On July 31st, BIO, alongside a group of international bioindustry trade associations submitted comments to the United States Patent and Trademark Office regarding their March 4, 2014 Guidance on patent subject matter eligibility.

Representing associations from Japan, Australia, Canada, the UK, Germany, Spain, Portugal Belgium, the Netherlands and others, the comments reflect a deep concern among the international community regarding how the PTO is interpreting the Supreme Court’s recent decisions in Mayo v. Prometheus and Myriad v. AMP.

The comments emphasize that regulatory and legal frameworks surrounding biotech patents and products should ensure large scale innovation and global competitiveness-best produced when international standards for patentability are consistent.

Under the established Guidance, biotechnology companies are facing patent rejections left and right. Going outside the purview of the Supreme Court’s decisions, the PTO is rejecting patents for pharmaceutical substances, agricultural and industrial preparations, methods of treatment, and diagnostic laboratory procedures not considered nor discussed by the court. A growing fear in the biotech community is that such rejections will provide a strong disincentive to invest in research and development for new biotechnology that could have a profound impact on society.

Patent protection is essential in the biotech industry, and by singling out biotech for a heightened patentability analysis, not only is the Guidance moving away from what has been the established U.S. patent process for decades; it is departing significantly from internationally accepted standards of patent eligibility. Facing patent obstacles in the United States, whole categories of socially beneficial inventions may find more hospitable patent environments abroad, seriously hampering U.S. economic prosperity and innovation.

Creating such a strong disparity between U.S. and international standards for patent eligibility would additionally hinder current international negotiations to adopt uniform and consistent intellectual property regulations.

BIO and the collection of international bioindustry associations strongly urge the USPTO to convene further meetings with the biotechnology community. These ongoing dialogues can provide substantial contributions to the policy discussion, and there can be real progress on the best (re)interpretation of the subject matter eligibility that has developed in the United States