Senate Judiciary Committee Archives

New Rx for High Drug Prices? Senate Judiciary Committee Advances Six Bills With Heavy Dose of Options

The US Senate Judiciary Committee advanced to the full Senate six bills intended to reduce pharmaceutical prices and enhance market competitiveness. The package collectively targets several aspects of the pharmaceutical landscape, including pharmaceutical benefit manager (PBM) pricing practices, next-generation drug releases, patent portfolio assertions, and use of US Food and Drug Administration (FDA) regulatory mechanisms. Many of the bills’ proposals have been proposed before, but it is significant that the six bills were moved to the full Senate with bipartisan support.

The Affordable Prescriptions for Patients Act, if passed, would limit how many patents a reference product sponsor can assert in a Biologics Price Competition and Innovation Act (BPCIA) litigation against a biosimilar applicant, although such limits could be surpassed with court approval. A biologics license holder could assert up to 20 patents in a BPCIA case. Certain patents, such as method of treatment patents, would fall outside the limitation.

Against the backdrop of the Supreme Court’s 2013 holding in FTC v. Watson that certain “pay for delay” agreements are prohibited as anticompetitive, the Preserve Access to Affordable Generics and Biosimilars Act would add precision to the boundaries of permissible settlements in the pharmaceutical industry. The Federal Trade Commission (FTC) would have specific authority to institute a civil action to recover penalties, and certain presumptions would apply. For example, any agreement providing a generic or biosimilar applicant with “anything of value, including an exclusive license,” would be presumptively anticompetitive, with certain exceptions and exclusions. Terms that would remain permissible include a pre-expiration launch date, reasonable litigation expenses, and covenants not to sue for patent infringement.

Targeting the concern that branded small molecule and biologics drug manufacturers release new products with patent protection and withdraw or unfairly disincentivize older products to avoid generic competition, the Drug Competition Enhancement Act would deem the alleged practice of “product hopping” unfair competition subject to enforcement actions. The bill would define a hard switch as when a branded or biologics manufacturer discontinues or withdraws an application and introduces a follow-on product within a certain period relative to generic or biosimilar approval. It would define a soft switch as when the brand manufacturer took actions that “that unfairly disadvantage the listed drug or reference product relative to [a] follow-on product.” The bill would provide specific exclusions and justifications for branded manufacturer actions that would otherwise constitute a hard or soft switch.

Seeking to curb perceived abuses of the FDA citizen petition process, the Stop Significant and Time-Wasting Abuse Limiting Legitimate Innovation of New Generics (Stop STALLING) Act would grant the FTC the authority to bring a civil action against those filing “sham petitions” with the FDA, with penalties up to $50,000 per calendar day of review or the revenue earned by the seller of the branded product, whichever is greater. A petition could be classified as a sham based on its own objective unreasonableness, an intention to delay approval of a generic or biosimilar product, or as part of a series of covered petitions.

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Senate Holds Hearing on Legislative Initiative to Address Patent Eligibility

Seeking to undo the current jurisprudence “mess” on the issue of patent eligibility, the Senate Judiciary Committee’s Subcommittee on Intellectual Property heard testimony on January 23, 2024, on the Patent Eligibility Restoration Act (PERA) (text here). PERA seeks to address the uncertainty and unpredictable outcomes created by the 2014 Supreme Court of the United States decision in Alice Corp. Pty. v. CLS Bank Int’l.

PERA is the latest iteration of 35 USC § 101 patent eligibility reform that Senators Thom Tillis (R-NC) and Chris Coons (D-DE) have been introducing for years. Although the language has been tweaked over time, the bill’s purpose is to eliminate “[a]ll judicial exceptions to patent eligibility” and in their place codify several categories of inventions as unpatentable, such as mathematical formulas; processes that are substantially economic, financial, business, social, cultural or artistic; processes that are mental or purely natural; unmodified human genes; and unmodified natural materials.

The January 23 hearing featured eight witnesses, divided into two panels. The first panel included:

Andrei Iancu, former US Patent & Trademark Office (PTO) director
Richard Blaylock, testifying on behalf of Invitae Corporation
Courtenay Brinckerhoff, partner at Foley & Lardner
Phil Johnson, steering committee chair at the Coalition for 21st Century Patent Reform.

The second panel included:

The Honorable David Kappos, former PTO director
Adam Mossoff, professor at the Antonin Scalia Law School
Mark Deem, operating partner of Lightstone Ventures
David Jones, executive director of the High-Tech Inventors Alliance.

Harkening back to prior panels, the testimony was largely in favor of reform considering what many characterized as inaction by all other stakeholders. Senators and witnesses alike recognized that legislative reform is likely the only way to gain clarity on § 101 considering the Supreme Court’s failure to take up more than 100 certiorari petitions seeking review, many with the Solicitor General’s endorsement.

During the first panel, Blaylock testified that PERA would improperly provide patent eligibility to new uses of natural phenomena, such as genetic material, and therefore “would stifle innovation and harm patient care in the fields of diagnostic genetic testing and precision medicine.” Iancu testified in response that “all human invention is the manipulation of nature towards practical uses by humans on this planet . . . and it should be eligible for a patent.” Brinckerhoff’s testimony also opposed Blaylock’s view; she explained that considerable research and development is needed to develop new uses for isolated natural products and would be disincentivized without patent eligibility. Brinckerhoff highlighted an important theme at the hearing: “PERA would bring eligibility back in line with other countries” by permitting patents on methods of detecting new diagnostic markers, thus maintaining international competitiveness. Lastly, Johnson testified that “[j]ust because something is eligible doesn’t mean it’s patentable” and stressed the importance of using §§ 102, 203 and 112 as additional filters to determine patentability.

During the second panel, venture capitalist Deem testified that “the United States is failing many of our most innovative startups” because [...]

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