Senators call on USPTO to address pharma patent thickets before they start
Three Republican and three Democrat senators on Wednesday called on the US Patent and Trademark Office to attack pharma patent thickets before they start.
The letter points to these patent thickets, or “large numbers of patents that cover a single product or minor variations on a single product,” which can stifle competition. An example of such a thicket can be seen with AbbVie’s Humira, which has been protected by a fortress of more than 100 patents, allowing it to be marketed without competition for more than 20 years as the first biosimilar is coming from Amgen in Jan. 2023.
“In the drug industry, with the most minor, even cosmetic, tweaks to delivery mechanisms, dosages, and formulations, companies are able to obtain dozens or hundreds of patents for a single drug. This practice impedes generic drugs’ production, hurts competition, and can even extend exclusivity beyond the congressionally mandated patent term,” the letter from Sens. Patrick Leahy (D-VT), John Cornyn (R-TX), Richard Blumenthal (D-CT), Susan Collins (R-ME), Amy Klobuchar (D-MN) and Mike Braun (R-IN) said.
So what do they want the USPTO to do?
Specifically, the senators ask that Kathi Vidal, PTO director, consider changes to its regulations and practices “to address these problems where they start, during examination,” adding:
While we still need consistent avenues to address poor quality patents after issuance, this is an opportunity to take prompt action at the preissuance stage. We are interested in your views and those of the public. We therefore ask that your office issue a notice of proposed rulemaking or a public request for comments by September 1, 2022 based on the following questions, with responses due within sixty days.
The questions focus on eliminating so-called “terminal disclaimers,” which allow applicants to receive patents that are obvious variations of each other as long as the expiration dates match.
“Should the USPTO require a second look, by a team of patent quality specialists, before issuing a continuation patent on a first office action, with special emphasis on whether the claims satisfy the written description, enablement, and definiteness requirements of 35 U.S.C. § 112, and whether the claims do not cover the same invention as a related application?” they ask. “Should there be heightened examination requirements for continuation patents,2toensure that minor modifications do not receive second or subsequent patents?”
The senators also seek to consider whether the USPTO might implement a rule change that requires any continuation application for a patent to be filed within a set time frame of the ultimate parent application.
“We are concerned about the prevalence of continuation and other highly similar patents,” they added. “The Patent Act envisions a single patent per invention, not a large portfolio based on one creation. But continuations now account for almost a quarter of all patent filings. We are concerned this could mean the USPTO is granting multiple patents for one invention, in contravention of the statutory text.”
Michael Carrier, distinguished professor at Rutgers Law School, told Endpoints News on the senators’ requests, “Some of the legislation Congress has considered addresses conduct far down the line, in the litigation context, and wouldn’t address the fundamental problem. This could have a more direct effect, taking aim at a central aspect of patent practice that some have criticized for leading to too many patents.”