Life Sciences Masters panelists say USPTO’s controversial anti-pharma rules unlikely to move forward

During IPWatchdog’s Master’s program in Life Sciencestaking place from Monday to Wednesday this week, panelists on the one hand breathed a sigh of relief that certain regulatory proposals considered most destructive to the sector appear unlikely to move forward, but on the other hand lamented the general negative tenor of the public debate surrounding pharmaceutical patents today.

Control packages

Life Sciences Masters 2024 kicked off yesterday with a panel featuring program sponsors Sherry Knowles of Knowles IP Strategies and Robert Sahr of Wolf Greenfield, joined by Jeffrey Depp of the University of Pittsburgh. Knowles opened the discussion by observing that the pharmaceutical industry has recently been “considered quite close to the devil,” pointing to legislation such as the Inflation Reduction Act (IRA) and other proposals linking patents to drug pricing. Knowles listed a total of ten blows the industry has taken in the past two years, including from the U.S. Patent and Trademark Office (USPTO). proposed rule on terminal disclaimer practice; a design rule rate increases for continuation patents and terminal disclaimers; the National Institute for Standards and Technology (NIST) proposal on expanding marching rights; and that of the Federal Trade Commission crackdown on patents listed in the Orange Bookamong others.

Regarding the rate increases and the terminal disclaimer rule packages, Knowles and fellow panelist Brad Pedersen of EnQuanta said on another panel Tuesday that Vidal has indicated that these controversial proposals are dead in the water. According to Pedersen, Vidal strongly hinted at the recent American Intellectual Property Law Association (AIPLA). Annual meeting that she will close all open rule packages by the end of her term in January, and a deep dive into the Office of Management and Budget (OMB) website shows neither the reimbursement proposal nor the terminal disclaimer NPRMs as pending work products. This likely means they will not be completed by the time Vidal leaves office, Pedersen said. IPWatchdog reached out to the USPTO to confirm the status of the rule packages, but had not received a response at time of publication.

Although this saves the industry the trouble of filing a lawsuit similar to the one Knowles filed in 2007 as Senior Vice President and Chief Patent Counsel at GlaxoSmithKline to prohibit the Bureau from promulgating its Claims and Continuations rule packageKnowles said it is still “quite shocking that such a detailed package with examples of how it should be implemented” would be published by the Bureau if it was not confident it would be completed. The NPRM also received more than 300 detailed comments from the public, and many high-ranking people in the industry spent a lot of time on it, Knowles said. So while Pedersen said he thought the package was more of a “lead trial balloon” from the start, Knowles said she thinks the agency was “hoping it would land.” But with a very large percentage of comments opposing the changes and no evidence of movement toward a final rule, it appears the industry has won this battle for now.

The fee changes affecting the continuation and practice of terminal disclaimers were issued before the Supreme Court’s decision in Runner Bright against Raimondo, Knowles noted. That decision is arguably a game-changer for what some see as substantive rules. Commentators did not have a chance to comment on the SCOTUS decision before the comment deadline.

Drug prices

During the opening panel on Monday, Sahr said there are “fundamental misunderstandings about how drugs are developed” and that many of the narratives that influence policy decisions, such as the NIST framework on March rights, stem from those fundamental misunderstandings, like what the government actually does. pays for. “The basic research does not show the whole picture.” Sahr said. “Several inventions have to happen along the way to get from an idea to an actual physical thing.”

Moreover, the NIST proposal “cannot really do anything effectively that policymakers want,” Sahr said. Even the proposal itself seems to recognize that price is only one factor to consider when deciding whether to pursue patents. But even the possibility of marching in because of the price “has a chilling effect,” Sahr added. “If at any point the government can say we will march in, it will create uncertainty.”

Another troubling trend, according to Knowles, is that some universities, following NIST’s lead, have begun to take drug pricing into their own hands. Knowles said she has seen universities come up with “affordable access plans” as part of their licensing agreements, where the terms require the licensee to provide the university with a pricing plan within a certain number of months of approval to guarantee access to least developed countries. low-income patients. Time will tell whether companies will accept such terms, Knowles said.

Changing the story

Another panel on Monday, moderated by Jon Putnam of Life Sciences Masters sponsor Competition Dynamics, looked at the “drug pricing conundrum” and why there is a perception that patents are responsible for high prices. While the United States undoubtedly has the highest list prices for drugs, Novartis’ Corey Salsberg said the most accurate question is: What value are we getting? “No one talks about the value of a drug before saying the price is too high or too low,” Salsberg said. For example, criticism of the high price for the hepatitis C drug Sovaldi has failed to recognize that the drug replaces lifelong hospital treatment for patients, Salsberg noted. Moreover, the list price is not what people ultimately pay, and net prices are fairly comparable internationally. The other benefit of paying more is that you have faster access to new medications.

Retired Chief Judge of the U.S. Court of Appeals for the Federal Circuit Paul Michel, who also joined the panel Monday, said there is also a political perspective to the drug pricing debate. “There are people in the United States who are having trouble affording the medications they need,” Michel said. “It’s an issue that has enough of an emotional kick to get the attention of politicians. And when that fate is reinforced by ideological groups, it gains enormous power.”

While Michel acknowledged that the problem of the hypothetical person who “can’t afford the medicine she so desperately needs” is very real, the solution is “for society to step in and subsidize that person, not to destroy the patent system ” that laid the foundation for the incentives to make that drug.

But for politicians competing for votes and having to maneuver through a highly complex web of American health care players, the best solution is often to target the easiest scapegoat, Michel said. That, compared to the entire insurance and pharmacy benefit manager (PBM), is mostly the pharmaceutical industry. Whether the solution is likely to work or not doesn’t matter, Michel says. “The fact that (the proposals) might not do much good is somewhat irrelevant because if it’s a PR battle for votes, effectiveness isn’t really that important.” For example, the NIST march-in framework has yet to be implemented, so it cannot be stopped with a lawsuit, but it is already reportedly deterring investment, Michel noted. And fellow panelist Ratib AIi of Competition Dynamics said that fewer than 3% of patents would actually be covered by the march-in proposal, and not all of them are associated with high drug prices. “I don’t think any of these proposals are well thought out or based on facts,” Ali added.

The way forward, therefore, seems to come down to educating lawmakers – and more importantly, their staff – on how the research, innovation and patent processes work, which Michel urged those in attendance to do. “You hold the secret; the ability to train policy makers and their staff,” said Michel. “I hope you will help train the advisors to America’s policymakers.”