Drug Patent Thicket Letter from U.S. Senators to Vidal Seeks Reforms on Continuation Patent Filings

On June 8, a letter signed by a bipartisan group of U.S. senators was sent to U.S. Patent and Trademark Office (USPTO) Director Kathi Vidal voicing concerns over the anti-competitive impacts of so-called “patent thickets,” especially in the drug industry. The senators’ letter urged Director Vidal to address issues of large numbers of patents granted to cover various aspects of a single pharmaceutical treatment, “primarily made up of continuation patents.”

Senators: Patent Thicket Problem is Actually a Continuation Filing Problem

The letter, signed by Senators Patrick Leahy (D-VT), John Cornyn (R-TX), Richard Blumenthal (D-CT), Susan Collins (R-ME), Amy Klobuchar (D-MN) and Mike Braun (R-IL), advances a few claims about continuation filings that don’t come from any clear source. Continuation filings, which are subsequent patent applications disclosing the same invention from an earlier-filed pending patent application but including different claim language, were the focus of a great deal of the ire raised by the senators’ letter. Not only does the senators’ letter to Director Vidal attribute most of the patent thicket issue to such continuation filings, it claims that continuation filings constitute one quarter of all patent filings and are granted at higher rates than original patent applications, claims which aren’t supported by any citations to an original data source.

The failure to properly substantiate these claims is disappointing, especially in light of controversy raised in recent months regarding drug patent data influencing policy debates in Congress. This January, Hudson Institute published a policy memo authored by Adam Mossoff, Professor at George Mason University’s Antonin Scalia Law School, calling out inconsistencies between government data and drug patent reports issued by the Initiative for Medicines, Access & Knowledge (I-MAK), noting that I-MAK has reported much higher numbers of patents covering major pharmaceuticals than are included in the U.S. Food & Drug Administration’s (FDA) Orange Book. Senator Thom Tillis (R-NC), who did not sign the recent letter on drug patent thickets sent to Director Vidal, asked I-MAK to disclose its methodologies and datasets following the release of Mossoff’s memo, which I-MAK’s Co-Founder Tahir Amin refused to do in his response to Tillis, instead contending that the data “has deliberately been kept opaque by the pharmaceutical industry and its well-funded supporters over the years.”

Leaving aside I-MAK’s attempt to deflect blame by prejudicing pharmaceutical industry activities instead of disclosing its own data, concern over the impact of unclear or poorly cited data on the U.S. patent system should have motivated Sen. Leahy and others to at least identify their data sources for their claims regarding continuation patents. This is especially so given that any action taken to rein in continuation filings would impact far more than players in the drug industry. Patent continuations are filed by a wide array of entities, often to correct issues in the claim language from the original patent application. Any changes at the USPTO affecting the entire universe of continuation patent filings could be very harmful to small businesses and independent inventors who need the opportunity to more properly claim their invention and correct issues with the original patent application.

Reforms to Continuation Filings Would Impact Far More Than Drug Industry

The senators’ letter to Director Vidal makes it clear that they have more than the drug industry in mind when considering how to reduce the number of continuation filings. The senators’ letter also cited concerns about continuation filings in tech industries that involve the adoption of technological standards, such as 5G or WiFi networking standards. In the senators’ view, there are major consumer harms posed by the ability of entities to obtain patents through continuation filings to cover technologies being widely implemented thanks to the promulgation of technological standards.

Like the drug patent thicket claims, this apparent problem in continuation patents affecting the implementation of technological standards has little if any support from existing sources of data, and the senators’ letter includes no citation providing further background on the issue. Yet these perceived issues have compelled these lawmakers to ask the USPTO to make major changes to its examination practices surrounding continuation patent filings. In a series of questions to Director Vidal, the senators ask the USPTO to consider whether terminal disclaimers should be eliminated or considered to be admissions of obviousness; whether heightened examination standards of continuation filings are appropriate; whether the USPTO should set a defined timeframe following the filing of an original patent application within which continuations must be filed; and whether increased fees for continuation filings would support more thorough examinations and reduce the number of such filings. The senators asked Director Vidal to issue either a notice of proposed rulemaking or a public request for comments based on their questions in the Federal Register by September 1.

For some of the signatories of the patent thicket letter to Director Vidal, this is only the most recent attempt to address perceived issues with large numbers of patents covering a single product in the pharmaceutical industry. In May 2019, Senators Cornyn and Blumenthal first introduced the Affordable Prescriptions for Patients (APP) Act into Congress. The bill as originally written would have given the Federal Trade Commission (FTC) to define patent thicketing as an unfair method of competition violating Section 5(a) of the FTC Act. The APP Act languished in committee during the 116th Congress, and although Cornyn and Blumenthal reintroduced the act into Congress in April 2021, the new edition of the bill only targets “product hopping,” a term referencing a practice by some drug firms who switch the drug formulation covered by new patents in an existing product in response to abbreviated new drug application (ANDA) filings by generic drugmakers.

Senators Leahy and other signatories to the letter argue that the issuance of continuation patents following an original patent application contravenes the statutory text of 35 U.S.C. § 101, which says that inventors “may obtain a patent” for a new and useful process, and 35 U.S.C. § 112, which states that patents must “distinctly claim the subject matter” of the invention (emphasis added by senators’ letter). But the senators’ concerns regarding patent thickets cannot simply be the result of a large number of continuation filings. Indeed, recent studies on patent thickets show that a large number of patents within those thickets protect manufacturing processes or secondary uses of a treatment. The kind of continuation filings with which Senator Leahy and others seem to be concerned would be limited to original formulations or therapeutic equivalents. In any case, the recent letter from the senators to Director Vidal underscores the deep-felt need within the drug patent policy debate for clarity and transparency in the data supporting the claims that the U.S. patent system needs further reforms.

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