IPWatchdog LIVE 2024 Day One Highlights Need for IP Community to Stand Up to Recent Attacks

Left to right: Gene Quinn, Joseph Allen, Renee Quinn and Judge Paul Michel.

On day one of IPWatchdog’s 2024 LIVE program, Joseph Allen of the Bayh-Dole Coalition became the fourth recipient of the annual Paul Michel award and was dubbed “a hero to American innovation” by Judge Michel himself.

The Paul Michel Award, created with the blessing of Chief Judge Paul Michel (U.S. Court of Appeals for the Federal Circuiy, ret.), is awarded annually to a respected industry leader and advocate for fairness. The recipient is an individual who has served the best interests of the community and the intellectual property system itself. The Paul Michel Award recognizes advocacy, leadership, mentorship, sacrifice and selfless service, all characteristics commonly associated with the award’s namesake, Judge Michel.

Allen is the Executive Director of the Bayh-Dole Coalition, a nonprofit organization composed of universities, companies, venture capitalists, entrepreneurs, and others who are committed to celebrating and protecting the landmark law.

Introducing Allen, Judge Michel noted that he spearheaded the passage of the Bayh-Dole Act— which in 2002 was dubbed “Innovation’s golden goose” by The Economist—during his time on Senator Birch Bayh’s staff. Not only did he write the statute and guide it to passage, but once it was passed, he was in charge of implementation, said Michel. “Tens of thousands of new products are out there because of Bayh-Dole,” Michel added. “It’s led to several thousand new companies and millions of new jobs and trillions added to the U.S. GDP.”

In his comments upon accepting the award, Allen said “we have to stand up” because the Bayh-Dole system is now under attack.

In December 2023, the National Institute of Standards & Technology (NIST) and the Department of Commerce published a draft version of a Federal Register Notice seeking comments on a proposed framework for deciding whether and when to exercise march-in rights under the Bayh-Dole Act that would significantly broaden the criteria for compulsory licensing of patented technology developed with federal funding.

While Bayh-Dole contemplates march-in rights, the law strictly limits the situations in which they can be exercised and does not make any reference to pricing as a criterion for marching in. But under the proposed framework, an agency may consider “[a]t what price and on what terms has the product utilizing the subject invention been sold or offered for sale in the U.S.” and whether “the contractor or licensee [has] made the product available only to a narrow set of consumers or customers because of high pricing or other extenuating factors”.

“If this goes away it’s going to be catastrophic,” Allen said. “Don’t stop fighting. We have one advantage over the other side—what we’re saying is actually true.”

More Assaults on Patents

Allen’s sentiment echoed that of other panelists throughout day one, many of whom characterized the patent system as being under a full-on attack. In the final session of the day, Henry Hadad of Bristol-Myers Squibb, Sherry Knowles of Knowles Intellectual Property Strategies, and John Miller of Pfizer discussed recent attempts to crack down on perceived gaming of the patent system by pharmaceutical companies.

In May of this year, for instance, the U.S. Patent and Trademark Office (USPTO) published a Notice of Proposed Rulemaking (NPRM) that would change terminal disclaimer practice related to “non-statutory double patenting.”

The judicially-created doctrine of “obviousness-type double patenting”(ODP) has become codified by the USPTO such that the Office will reject claims to more than one patent that vary in only minor ways from one another unless there is a promise by the patentee “not to extend the patent exclusivity term or allow multiple parties to harass an alleged infringer.” This is done via a “terminal disclaimer.”

According to the NPRM: “Even with the protections currently provided by a terminal disclaimer, multiple patents tied by terminal dis

From Left: Gene Quinn, Henry Hadad, Sherry Knowles, John Miller.

claimers that are directed to obvious variants of an invention could deter competition due to the prohibitive cost of challenging each patent separately in litigation or administrative proceedings.”

For this reason, the USPTO proposes to require that a terminal disclaimer must include an “additional agreement that the patent with the terminal disclaimer will not be enforced if any claim of the second patent is invalidated by prior art.”

The Office also published an NPRM in April titled “Setting and Adjusting Patent Fees During Fiscal Year 2025” that proposed fee adjustments that could increase the cost of requests for continued examination by more than 700% in some cases.

Such agency attempts to limit continuation practice have been successfully challenged in the past.

The U.S. Chamber of Commerce’s Global Innovation Policy Center (GIPC), the Pharmaceutical Research and Manufacturers of America (PhRMA) and the Council for Innovation Promotion (C4IP) are among a number of organizations that recently submitted comments on the NPRM to express their concern about the substantial fee increases.

But Miller of Pfizer, speaking on the panel Sunday, said the patent community is in need of a PR campaign. “When [the anti-patent] narrative is mentioned to staffers, it’s easy, whereas our narrative is not easily digestible; it’s more technical and data driven,” Miller said.

Even after a report was published by the USPTO earlier this year debunking the approach to the data on which the Office and others have traditionally relied to justify crackdowns on continuations and other pharmaceutical practices, the narrative has persisted.

“What I think needs to be done more is showing the value of innovation,” Miller added. “We need to show how each individual improvement brings benefit and access to patients so we’re not just seen as bad actors.”

Hadad agreed and said “we do a really bad job not teasing apart some of these terms, like ‘evergreening,’” for instance. “We need to do a better job of walking people through these innovations.”

Knowles, who has been vocal in her opposition to the USPTO’s recent actions, added that the patent community must step up to push back instead of blindly following what many see as unconstitutional policy.

“We need to be bold, we need to write, we need to get out there,” Knowles said. “Each one of us needs to be a spokesperson.”

Day one of IPWatchdog LIVE also featured an opening session on the state of U.S. Intellectual Property, which will be covered in more depth tomorrow; an update on legislation, rulemaking and the Supreme Court; and Cracking the PTAB Code.