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BIO 2014

Comment sought on Myriad-Mayo patent guidance

Recent U.S. Supreme Court cases Myriad and Mayo shook up the patent world by ruling that naturally occurring products and laws of nature are not patent-eligible.

What that means in practical terms — at what point human mutations to DNA or naturally occurring products make it significantly different than what’s found in nature to qualify — doesn’t have an easy answer.

The Association for Molecular Pathology v. Myriad Genetics case found that a naturally occurring DNA segment is a product of nature and not patent-eligible simply through isolation. To be eligible, there must be a product with a distinctive name, character and use other than that found in nature.

In Mayo Collaborative Services v. Prometheus Laboratories, Inc. the court ruled that laws of nature are not patent-eligible in and of themselves; they must be significantly more than what is found in nature.

Two U.S. Patent and Trademark Office attorneys working on crafting iterations to contested portions of the new patent examiner guidance for subject-matter eligibility of natural products spoke Wednesday at the BIO 2014 International Convention in San Diego.

Their purpose was to soothe fears surrounding current guidance, provide examples of patent-eligible changes, and encourage comment from IP and patent stakeholders before the July 31 deadline.

“We are very serious and dedicated to a transparent, iterative process for creating these guidelines,” said Andrew Hirshfeld, deputy commissioner for patent examination policy, about guidelines released in March after eight months of internal discussions that didn’t seek outside comment.

“We recognize this is complex subject matter and we want to hear from everybody. We are committed to coming out with iterations where necessary, and training our staff members on appropriately and properly applying the guidelines.”

The official deadline for comments has been extended to July 31, but Hirshfeld and June Cohan, patent office legal adviser, said comments received so far concern the breadth of the guidance, the “significantly different” phrase, and the role of functional differences.

Hirshfeld said the office received comments suggesting that the guidance for examiners should have been limited to the Myriad case alone, and is too broad when including Mayo.

Hirshfeld said the patent office considered this, but ultimately decided that examiners see a variety of claims that would contain aspects of both cases, and as such needed comprehensive guidance reflecting the body of case law, not just one case.

A specific concern is the phrase “significantly different,” which is the principle examiners must use to determine if a product is eligible for a patent, or simply something found in nature. Hirshfeld said the phrase was used as a teaching tool to refer to the “markedly different” standard in the Chakrabarty case or the “significantly more” standard set out in Mayo, and was not meant to be interpreted as a separate standard.

Another specific concern is the role of functional differences and structural differences between the way the DNA or product appears in nature and the way it has been manipulated.

Cohan provided some examples the office is inclined to consider eligible based on initial thoughts, although though she and Hirshfeld made clear this was not final. In the first example, if an antibody only found in coyotes is changed by just one base pair or one amino acid, that is considered a structural difference, as it’s not found in nature.

“We see a small structural difference here,” Cohan said. “What we want to know from you is how does function play into this? There are issues that come up, for instance claim one could have a silent modification — you change the DNA sequence but no change to the protein that’s included — is that a functional difference? That’s what we’d like to hear from you ... Or in this case is it enough to say here is a structure that doesn’t appear in nature, so it’s eligible?”

These are complicated questions indeed. In a reverse example, Cohan outlined a situation where one amino acid in a polypeptide was changed, so that the function remains the same but the structure is different.

“We think it can still be eligible, but some people have said ‘No the emphasis shouldn’t be on function, the emphasis should be on information. What if we take that into account?’” Cohan asked. “If the function remains the same but the structure is changed, how do we weigh those things together?”

Cohan said creating a chimeric antibody from parts of the coyote antibody and parts of a human antibody would likely be eligible, along with attaching a fluorescent label to the DNA molecule, which would fall under the structural difference and possibly functional difference clause as well.

There were other questions raised that still need answering, and Cohan and Hirshfeld repeatedly called on industry stakeholders to weigh in during the comment period so the first iteration to the guidance is clearer.

When asked why the patent office waited until releasing the initial guidelines to seek public comment — a point that garnered much audience applause — Hirshfeld said the alternative of introducing proposed regulations would simply be too problematic.

“I can tell you from the deepest part of our heart that there was never any intent to not get comments, but there certainly was a delay there and I understand the impression that that makes,” he said. “We will not proceed that way in the future. You can be assured that when we come out with anything, there certainly will be comments taken right away.”

He said the message that proposed regulations up for discussion but not viable for deeming patents eligible would send, reflects a problem with current law, but you’re not supposed to follow the new guidance.

“That’s a troubling situation that creates chaos for everyone. ... An alternative approach is what we feel is the best way. We think the right way to go forward is to come out with our best interpretation of the law and be getting comments at the same time as that, and have everyone recognize that this is an iterative process with updates.”

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