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BIO Deputy General Counsel Remarks on Revised Eligibility Guidance

February 4, 2015
Hans Sauer, BIO’s Deputy General Counsel for Intellectual Property recently spoke at the U.S. Patent and Trademark Office’s public forum on patent-eligible subject matter.US PTO

The forum was a chance for the Office to receive public feedback regarding the most recently revised Eligibility Guidance for determining subject matter under 35 U.S.C. 1010. Biotechnology advocates are concerned that PTO examiners have interpreted recent decisions by the U.S. Supreme Court, including those in Alice Corp, Myriad, and Mayo in a way that makes many claims covering breakthrough inventions ineligible for patent protection.

In his remarks, Mr. Sauer noted that many inventions based on naturally occurring substances, such as vaccine antigens, crop protection products, and antibiotic drugs, have become patent ineligible.

“Throughout the summer and fall of last year, BIO’s members reported rejections of applications for antibiotics, medicinal molecules, industrial enzymes, and other preparations that were first discovered or derived from natural starting materials,” he noted.

[caption id="attachment_17877" align="alignleft" width="208"]Taken from BioSpectrum Taken from BioSpectrum[/caption]

While the recent revisions to the Guidance have incorporated public feedback, and are generally an improvement, Mr. Sauer discussed several areas of continued concern, including the continued ineligibility of isolated enzymes, and ambiguity regarding how the PTO will be considering functional characteristics of claimed inventions in their determination of eligibility.

He warned that while the revised Guidance had engendered cautious optimism among BIO members, the Federal Circuit’s December decision in the Ambry case could upend any efforts by the PTO.

“If anything, this decision…is a reminder that the PTO’s efforts to bring stability to this area of the law could easily be undone by the next Federal Circuit decision, or the one after that. We are afraid that we will be prosecuting applications on a shifting slate for some time to come. We need a more stable solution going forward.”

Supreme Court

Mr. Sauer ended his remarks by reminding those present that the inventions under this scrutiny are ones which have the potential to drastically improve human life-ranging from anticancer drugs to antibiotics which will fight the spread of drug resistant infections. Eliminating the patent protection of socially beneficial technologies is not in the interest of public policy. He emphasized that it is the PTO’s responsibility to provide a dialogue on IP outside the purview of the courts, and will hopefully “begin the process of democratically deciding what needs to be done going forward.”