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

“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.”

https://depositphotos.com/7322225/stock-photo-incoming-letter.htmlOn 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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Join the Discussion

5 comments so far.

  • [Avatar for C. Whewell]
    C. Whewell
    June 17, 2022 08:40 am

    If there were no 19th amendment, most of these so-called senators wouldn’t have an office. Today’s senators don’t represent the States; instead, the People. But, the people are already represented by the House. Even though there are “state senators”, they don’t represent the States. So, the States have no voice in this, and have no opportunity to be heard.

  • [Avatar for William Beaumont]
    William Beaumont
    June 16, 2022 11:51 am

    Continuation applications play a vital role in securing important
    patent rights for claimed inventions deemed patentable. This
    feature of the US patent system is critical for allowing companies
    and individuals to claim every patentable aspect of their inventions.
    In my view, the real nemesis here is the rapid increase of prescription
    drug prices. It is not that continuations applications are anti-
    competitive; it is rather that rapid annual increases is many drug
    prices are unsustainable.

    Town crier

  • [Avatar for Pro Say]
    Pro Say
    June 15, 2022 05:57 pm

    It only took reading this article’s headline to know instantly that the virulent anti-patent Leahy would be a signatory to this unsupported pig slop.

    And the first signatory at that.

    How much longer before this horse’s a.r.s.e. is out to pasture?

    Furthermore, it’s telling indeed that the good Senators Tillis, Coons, Hirono, Cotton, and other Judiciary Committee members would have nothing to do with these innovation-crippling ideas.

    America thanks you, good Senators.

    While the greatest threat to the world China continues to strength their patent system, folks like these signatories want to weaken America’s even further.


    Just sickening.

  • [Avatar for mike]
    June 15, 2022 05:45 pm

    Apparently these Senators have a different definition of what it means to have a “high quality patent”. Their letter says that they “still need consistent avenues to address poor quality patents after issuance”; however, their letter fails to recognize that continuations are indeed how inventors address poor quality patents after issuance.

    I think by “address a poor quality patent”, they mean, “destroy an invention and prevent it from being patented” rather than “enable the inventor to secure a patent with higher quality”. Their tell is so obvious. They don’t like patents.

    In a continuation, an inventor can refine her claims and make them have higher quality. She can even claim a different invention from the same disclosure/specification. But not with these Senators. Let’s be clear—these Senators want to prevent inventors from getting high quality patents. Period.

  • [Avatar for Anon]
    June 15, 2022 04:41 pm

    As to “contravenes the statutory text of 35 U.S.C. § 101, which says that inventors “may obtain a patent” for a new and useful process” – a recent thread on this blog explained that “a” is not the same as “one and only one.”

    Further, Continuations cannot be the bane of evergreening or thicketing, as terminal disclaimers that are routine, as well as effective terms dating back to any starting point of a parent of a chain of continuations negates such “assertions.”

    Leahy should not be confused as any “friend” of innovation or innovation protection. And neither should any other signatory to the letter.

    And this comes from one that is not especially fond of Big Pharma!