Court challenge “likely” if USPTO doesn’t change post-Myriad guidance

The USPTO issued a press release on April 16 saying that it will hold a roundtable on May 9 at its headquarters in Alexandra, Virginia to solicit feedback on the guidance, which it published in March.

The announcement follows a storm of criticism about the guidance, which concerns laws of nature and natural products.

In an exclusive interview with Managing IP, Andrew Hirshfeld, the USPTO’s deputy commissioner for paztent examination policy, responded by saying that the agency has to abide by Supreme Court decisions. He said that the Myriad decision “completely changed examination practice.” In a guest article for Managing IP, Sherry Knowles of Knowles Intellectual Property Strategies retorted that “it is not surprising to see the USPTO fall in line over-eagerly this time”.

In June 2013, the Supreme Court ruled in Association for Molecular Pathology v Myriad Genetics that isolated and purified DNA is a product of nature under Section 101 and can therefore not be patented. But it said that complementary DNA (cDNA) can be patented because human skill is required to create it.

Hirshfeld also told Managing IP that the USPTO has to consider the Myriad decision in the context of other cases because the justices based parts of their conclusion on the Chakrabarty and Mayo rulings. He said examiners may have to assess claims that may fall under more than one judicial exception and need guidance on how to proceed in such situations.

Unlike the guidance that followed the Mayo and Bilski decisions, which were first released as proposals, the post-Myriad guidance was initially released as final guidance. Final versions of the post-Mayo and Bilski guidance were issued after the agency solicited feedback from companies and individuals.

But it is still possible that the post-Myriad guidance could change. The USPTO may modify it based on the feedback it receives, or it may be challenged in court.

Courtenay Brinckerhoff, a partner of Foley & Lardner who has written about the issue on her PharmaPatents blog, told Managing IP that the guidance is likely to be challenged in court if the USPTO does not change it.

But that process could take years and the challenge would have to be initiated by someone who has the standing to do so. Someone who has had their application rejected under the guidance would have the strongest standing.

" I hope to see more balanced guidance that takes a more reasonable approach to what can and can’t be patented. I don’t think that the Supreme Court intended to go as broadly as to hold that vaccines can’t be patented" - Courtenay Brinckerhoff, Foley & Lardner

“I have a lot of smaller clients who would not be able to wait it out,” said Brinckerhoff. “People are going to face a decision on abandoning their inventions as they will have difficulty getting funding.”

She said that at present most of the concern is coming from patent lawyers and others who are “in the thick of things” but she expects to see a stronger reaction from businesspeople when they realise how it will affect them.

Brinckerhoff said the guidance extrapolates beyond the limited scope of the Myriad ruling to exclude a “broad range of subject matter” from being patented, including vaccines, antibody compositions and drugs with active ingredients from plants.

“I hope to see more balanced guidance that takes a more reasonable approach to what can and can’t be patented,” she said. “I don’t think that the Supreme Court intended to go as broadly as to hold that vaccines can’t be patented.

“The Supreme Court in Myriad was dealing with isolated DNA. One point where the guidelines take it much further was extrapolating from that to compositions. The USPTO did so by citing a 1948 Supreme Court decision, Funk Brothers. That has not been used in this context but it set up its guidelines around that.”

Mark Summerfield, an Australian registered patent attorney for Watermark International Asset Management, suggested on his Patentology blog that the new guidance may put the US in violation of some international trade agreements, such as Chapter 17 of the Australia-US Free Trade Agreement (AUSFTA).

“The US is generally very quick to criticise trading partners for any perceived weakening of IP protections!” wrote Summerfield.

Chapter 17 states that signatories to the agreement will allow any invention to be patented, provided that it “is new, involves an inventive step, and is capable of industrial application.”

There are exceptions for public policy and morality and diagnostic and surgical methods. Summerfield argues that while excluding genomic DNA may be covered under the public policy and morality exemption, and Mayo “clearly falls” within the category of diagnostic and surgical methods.

“But if new and useful combinations, uses and methods of using natural products are generally excluded under 35 USC 101, as the USPTO has concluded, it is difficult to see how this is consistent with the obligations of the US under Article 17.9(1) of the AUSFTA,” he wrote.