Patent thickets, particularly those involving pharmaceutical patents, appear to have caught the ire of many US senators. Within the past few weeks, two separate letters have urged action to find ways to prevent business of overlapping patents covering a single pharmaceutical product. The letters provide insights into the tools they believe are available to address such alleged patent abuse.
On May 25, 2022, US senators Bill Cassidy, MD (R-LA) and Maggie Hassan (D-NH) alleged that “lack of coordination” between the US Food and Drug Administration (FDA) and Patent and Trademark Office (“PTO”) ”) allowed patent thickets to grow in a letter to Kathi Vidal, Director of the PTO, and Dr. Robert M. Califf, Administrator of the FDA. The letter alleged that lack of inter-agency coordination allowed the pharmaceutical industry to obtain patents of questionable validity that block entry of generic drugs and extend monopoly prices. In the letter, the senators expressed concern regarding drug manufacturers’ increasing reliance on patent thickets to evade competition.
Between 2005 and 2015, 78% of drugs associated with new patents were not new drugs, but existing ones, and the number of drugs with three or more patents added to them in one year doubled. These thickets can preserve a drug company’s monopoly and block the launch of generic drugs for years or even decades after the expiration of the drug’s original patent. In the intervening period, patients are deprived of significant savings: drug prices drop by as much as 20% when the first generic enters the market and as much as 85% when multiple generics enter the market.
In the letter, the senators postulated that the lack of coordination between the PTO and FDA may lead to patent thickets, enabling manufacturers to obtain patents that do not satisfy the Patent Act’s requirement. As an example, the letter mentions the drug manufacturer’s disclosure of its manufacturing process of an already marketed product to the FDA more than a year prior to submitting the patent application to the PTO coupled with the drug manufacturer’s contradictory statements made to the FDA and to the PTO. In this regard, the senators noted that existing sections of the Federal Food, Drug, and Cosmetic Act authorize the FDA to share information with the PTO. Thus, in order to improve the inter-agency coordination, the senators requested Director Vidal and Administrator Califf to address the following questions by June 24, 2022:
- How does the PTO determine whether an application is connected to pharmaceutical product(s) (small molecule drugs or biologics)?
- In the past five years, how many patent applications connected to pharmaceutical products did the PTO review?
- Did the PTO request information from the FDA during the patent application review of the cases in question 2? If so,
a. Did the FDA provide the PTO with information?
b. Was the FDA information adequate to guide the PTO’s analysis?
- Do the PTO and the FDA have a process to collaborate when the PTO reviews pharmaceutical-related patent applications?
a. If not, when will the agencies establish a process?
b. If so, what actions are the agencies taking to improve it, and what is the timeline for implementing these improvements?
Relatedly, on June 17, 2022, Senators Dick Durbin (D-IL), Thom Tillis (R-NC), and Chuck Grassley (R-IA) introduced the “Interagency Patent Coordination and Improvement Act,” or P. 4430, a bill to establish a joint task force between the PTO and FDA to “enhance information sharing on each agency’s processes, standards and methods; improve dialogue on new technologies and scientific trends; enable confidential reciprocal access to information, if requested and only as needed; ensure accurate representations by companies between the two agencies; and ensure accuracy of patent listings.” Notably, Senator Tillis commented that, “[h]aving access to accurate prior art is critical to ensure that the USPTO issues high-quality patents. By improving coordination between the USPTO and FDA, Congress can ensure that patent examiners have access to all of the relevant information that they need to help them make a sound determination regarding patentability. This bill is a simple good-government measure that will protect the strength of the patent system, improve patent quality, and cut down on unnecessary bureaucracy between these two agencies.”
On June 8, 2022, US senators Patrick Leahy (D-VT), John Cornyn (R-TX), Richard Blumenthal (D-CT), Susan M. Collins (R-ME), Amy Klobuchar (D-MN), and Mike Braun (R-IN) alleged that continuation and highly similar patents were being issued too frequently and too easily in a letter directed to Director Vidal. The senators complained that drug manufacturers are able to obtain doses or hundreds of patents on a single drug through minor tweaks to delivery mechanism, dosages, and formulations. The senators expressed concerns that the prevalence of continuation and other highly similar patents is contrary to the Patent Act, which envisions a single patent per invention and impedes generic drugs’ production, hurts competition, and extends exclusivity beyond the mandated patent term. Thus, the senators asked the director to change the PTO’s regulations and practices to address the problem during the examination phase and asked that the PTO issue a notice of proposed rule-making or a public request for comments by September 1, 2022 addressing the following questions :
- Terminal disclaimers, allowed under 37 CFR 1.321(d), allow applicants to receive patents that are obvious variations of each other as long as the expiration dates match. How would eliminating terminal disclaimers, thus prohibiting patents that are obvious variations of each other, affect patent prosecution strategies and patent quality overall?
- Currently, patents tied together with a terminal disclaimer after an obviousness-type double patent rejection must be separately challenged on validity grounds. However, if these patents are obvious variations of each other, should the filing of a terminal disclaimer be an admission of obviousness? And if so, would these patents, when their validity is challenged after issuance, stand and fall together?
- 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 USC § 112, and whether the claims do not cover the same invention as a related application?
- Should there be heightened examination requirements for continuation patents, to ensure that minor modifications do not receive second or subsequent patents?
- The Patent Act requires the USPTO Director to set a “time during the pendency of the [original] application” in which continuation status may be filed. Currently there is no time limit relative to the original application. Can the USPTO implement a rule change that requires any continuation application to be filed within a set time frame of the ultimate parent application? What is the appropriate timeframe after the applicant files an application before the applicant should know what types of inventions the patent will actually cover? Would a benchmark (eg, within six months of the first office action on the earliest application in a family) be preferable to a specific deadline (eg, one year after the earliest application in a family)?
- The USPTO has fee-setting authority and has set fees for filing, search, and examination of applications below the actual costs of carrying out these activities while maintenance fees for issued patents are above the actual cost. If the up-front fees reflected the actual cost of obtaining a patent, would this increase patent quality by discouraging filing of patents unlikely to succeed? Similarly, if fees for continuation applications were increased above the initial filing fees, would examination be more thorough and would applicants be less likely to use continuations to cover, for example, inventions that are obvious variations of each other?
One of the more interesting proposals raised by the senators is the elimination of terminal disclaimers. Obviousness-type double patenting is a judicially-created doctrine that is commonly raised during examination of continuation applications and can typically be overcome by filing a terminal disclaimer. In theory, eliminating terminal disclaimer practice would force applicants to only patent inventions that are not obvious variants of each other. However, there are at least two complications. First, obviousness is a highly subjective inquiry and obviousness-type double patenting analysis is often even more confounding given that an examiner must decide what would have been an obvious variant of a given patent’s claim. Second, the scope of obviousness-type double patenting rejections and challenges has expanded in recent years and is routinely applied to applications that are not continuations, are not related to each other, and often are not even owned by the same entity. Given that obviousness-type double patenting rejections are extremely common, and thus terminal disclaimers are widely used, it remains to be seen how the PTO will respond to the complex issues posed by the senators’ questions and whether further legislative action would be required given that obviousness-type double patenting is a judicially-created doctrine with an expanding and amorphous reach. Moreover, it will be interesting to see how the PTO will respond to the proposals that will have difficult to predict impacts on activities that account for a significant portion of the application filing fees, terminal disclaimer fees, and maintenance fees that the PTO collects.
We will continue to monitor for further developments including how Director Vidal and Administrator Califf address the senators’ questions.