Patient Advocates Want Access, Patent Advocates Want Evidence

The United States Patent and Trademark Office (USPTO) and the Food and Drug Administration (FDA) today co-hosted a full-day listening session featuring speakers from patient advocacy groups, industry groups, academia, branded and generic drug companies. Between patents and affordable access to drugs.

The session was announced through a Federal Register notice issued November 7, 2022 and request for comment on the subject. This stems from a joint announcement in July 2022 that the two agencies will carry out a number of initiatives aimed at reducing drug prices as directed. In July 2021, President Joe Biden’s Executive Order on Promoting Competition in the American Economy,

The July 2022 blog post, co-authored by USPTO Commissioner Kathy Vidal and Food and Drug Administration (FDA) Commissioner Robert M. Calif, stated that the agencies “outlined many initiatives on the President’s agenda. We have completed the exchange of letters explaining These initiatives will strengthen our relationship and expand the resources available to assess patentability and address cases where patents are being used inappropriately to slow competition. ”

collaboration and criticism

Collaboration efforts have so far been met with skepticism and concern from industry about the ability of companies to comply with some of the obligations proposed by the USPTO. For example, in late July 2022, the USPTO issued a Federal Register notice stating that “providing material information to other government agencies, including FDA, while withholding that same information from the USPTO is not the intent and obligation of FDA.” Disclosing and violating those obligations.”

FRN clarifies that “activities or documents related to market testing, marketing, or commercialization by a patent applicant may also be material to patentability and, if material, should be disclosed to the USPTO.” I made it FRN also quoted Belcher Pharmaceuticals v. Hospira When Bruno’s Independent Living v. Acorn Mobility As an example where the applicant did not make consistent statements to both institutions.

But Hans Sauer of the Biotechnology Innovation Organization (BIO) told a panel of USPTO and FDA representatives in today’s hearing session that these two examples are decades apart and represent epidemics. He said there were very few[T]The PTO points to only two cases, a 30-year-old case of a 510(k) medical device applicant and a more recent case of a 505(b)(2) new drug applicant,” Sauer wrote. The comments explain. “In each case, applicants relied on FDA approval of prior art predicate devices or reference drugs that had been withheld from the PTO. These are not typical scenarios in the biopharmaceutical industry of innovators, It’s a thin reed to introduce systemic policy change.”

Imposing requirements that lead to a “witch hunt of seemingly inconsistent statements” could place a heavy burden on applicants and examiners, Sauer said. “Caliling all the materials submitted to the FDA places a significant burden on agency staff and applicants, and while unlikely to provide new or additional information relevant to patentability, significant cause delays.”

In addition, the data supporting some of the claims made regarding issues such as, for example, “patent thickets” and continuity practices, have been pointed out as flawed.

I-MAK Calls Out IND Gaming

Some of that data was provided by one organization in particular, the Initiative for Medicines, Access & Knowledge (I-MAK). I-MAK co-founder and co-executive his director, Tahir Amin, spoke at today’s event.

Amin’s testimony focused on FDA’s guidance on polymorphs. I-MAK’s position is that companies are using the FDA’s Investigational New Drug (IND) mechanism to expand patent protection. “Essentially, companies protect the polymorphic data they provide to FDA as trade secrets until they decide to file relevant polymorphic patents for the purpose of meeting U.S. FDA Orange Book listing requirements, if necessary. to block competitors from finding alternative polymorphs that can circumvent the patented forms under Hatch Waxman or simply for the purpose of defensive litigation,” Amin said. increase.

I-MAK made three recommendations in its filings to avoid this practice. Most of which Amin acknowledged in his Q&A from the panel, require legislative or regulatory change to implement.

Mossoff addresses I-MAK discrepancies

Adam Mozoff, professor at George Mason University’s Antonin Scalia School of Law, speaking on the same panel as Amine, urged the USPTO and FDA to focus on the evidence before making drastic changes. Mossoff has been vocally critical of his I-MAK, last year drafting a policy memo questioning the organization’s data, after which Sen. – urged MAK, USPTO, and FDA to submit letters requesting more information. About how the data is extracted and how it is used.

Mossoff reiterated in his hearing statement that the I-MAK relies on pending and abandoned applications in counting patents covering individual drugs, greatly skewing the data. He wants USPTO and FDA panelists to impose the burden of evidence on those proposing systemic changes to prove systemic problems, and that the data driving the debate is not the answer. He said he hoped they would remember that it was riddled with serious questions about its veracity.

Point of view issue?

IPWatchdog sources also expressed concerns about the USPTO panelist line-up. At first glance, each panel’s roster appears to be generally balanced, but during the course of the day at least six speakers were Texas billionaires who have been active in sponsorship. It is worth noting that he represented an organization funded by husband and wife John and Laura Arnold. Regarding the drug pricing law. T1 International, I-MAK, Generation Patient, Patients for Affordable Drugs are all backed by Arnold Ventures, with a total of 6 speaking spots throughout the session, with T1I being featured in his 3 separate panels . This raises the question of whether the event really represents a diverse set of patient perspectives, or whether the same perspectives and issues are just repeated by six different people.

patient testimony

The listening session began with comments from patients dealing with chronic conditions such as multiple sclerosis and ulcerative colitis. They asked the patient to seek more direct access and communication with her USPTO.

Generation Patient founder Sneha Dave, 24, has severe ulcerative colitis and urged the USPTO to involve patient stakeholders. She advocated the creation of a Patient Advisory Committee in the USPTO, which was proposed by several other patient panelists, and that members of such committees should also be remunerated for their time. she said. She also opposed granting patents for minor modifications of inventions, and said young patients in particular were affected by long-term patents. ,” says Dave. “We have a lifetime ahead of us.”

Today’s event also featured opening remarks by USPTO Kathi Vidal, closing remarks by Deputy Commissioner Derrick Brent, and panels on “Patent Practice in the Pharmaceutical Sector” and “Patent Term Extensions and Patent Use Codes.” Vidal said the Secretariat will incorporate the comments received today to “positively impact accessibility to life-saving and modifying medicines.”

You can read the full testimony of today’s speakers here.