BIO 2017: Section 101 raises fundamental policy question, says 3M
The perceived problem with 35 USC section 101 is a “fundamental question of national innovation policy”, claimed Kevin Rhodes, vice president and chief IP counsel at multinational conglomerate 3M.
He was speaking at the 2017 BIO International Convention during a session called “Subject matter eligibility: where do we go now?”
“If we’re going to deny protection for two of the most innovative sectors of our economy—life sciences and computer-implemented inventions—that’s a policy choice,” said Rhodes, adding that this policy choice should be made by Congress."
Legislation is an “unpredictable exercise” and should not be undertaken lightly, explained Rhodes.
This year, the IP law section of the American Bar Association, the American Intellectual Property Law Association and the Intellectual Property Owners Association revealed legislative proposals for amending section 101.
What got Rhodes thinking that legislation was needed to amend section 101 was partly the pace of change in this space, he said, adding that the “innovation economy has never moved faster”.
He was already thinking along those lines when the tipping point came with the US Supreme Court denying certiorari in Ariosa Diagnostics v Sequenom last year.
In Ariosa, US patent number 6,258,540, which resulted from the discovery of foetal DNA in maternal blood samples, had been held as ineligible.
The discovery had led to the development of a non-invasive prenatal test that required only a maternal blood sample.
“This was truly a meritorious invention,” said Rhodes, adding that either the Supreme Court doesn’t think there’s a problem or doesn’t know how to fix it.
And there’s definitely a buzz at Congress surrounding the subject matter eligibility section.
David Kappos, partner at Cravath, Swaine & Moore and a former director of the US Patent and Trademark Office, said: “A year and a half ago, talking to Congressional staff and members and raising 101 then, I was faced with responses such as ‘section 101, what’s that?’ or ‘don’t even touch that’.”
Now though, many are aware of the issue and concerned about it.
“The lead story is the lost jobs, the lost leadership in innovation, and the simple narrative that you can get patents in China and Europe that you can’t in the US, which is shocking to Congress,” he added.
Barbara Fiacco, partner at Foley Hoag, who moderated the panel, added that “we are stuck in the paradigm where we’re assessing new technologies and inventions by looking backward, and that’s somewhat inherent in our system”.
She questioned what the industry could do to get out of this space where it is relying on the courts to help protect innovation.
Karen Deak, commercialisation specialist at the University of Notre Dame, provided the example of a researcher at the university who had dedicated her life to finding antibiotics directly from plants.
According to Deak, the researcher had found the “holy grail of antibiotics”, but the university was unsure of what to do with the technology because it occurs in nature (making it ineligible under section 101).
Deak plans to “roll the dice” and file a patent application, but she warned that it’s not even clear whether a drug will get to market.
Melissa Grant, BIO’s director of IP policy, added that cases such as Enfish v Microsoft provide more certainty in the software space, but that such findings are not coming out in the biotech area.
“The general consensus is that without any guidance coming from the court, legislation and educating members of Congress is the route to go,” said Grant.
The 2017 BIO International Convention is taking place in San Diego from June 19 to 22.
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