Blog Big Molecule Watch October 25, 2022

Request for Comments on USPTO Initiatives To Promote Generic Drug and Biosimilar Competition

The U.S. Patent and Trademark Office (USPTO) recently published a request for comments addressing a variety of topics related to generic drug and biosimilar competition.  In July 2021, President Biden issued an Executive Order on “Promoting Competition in the American Economy,” which directed the Secretary of Health & Human Services (HHS) to “help ensure that the patent system, while incentivizing innovation, does not also unjustifiably delay generic drug and biosimilar competition beyond that reasonably contemplated under the law.”  In response to President Biden’s Executive Order, the FDA sent a letter to the USPTO outlining ideas for engagement with the PTO, and in response, on July 6, 2022, the USPTO sent a letter with specific initiatives for considerations.  Relatedly, on June 8, 2022, six U.S. Senators sent a letter to the USPTO to consider changes to its regulations and practices to address “patent thickets.”

The USPTO now seeks public comment on the following questions with regards to the initiatives proposed by the USPTO.

  1. Identify any specific sources of prior art not currently available through the Patents End-to-End Search system that you believe examiners should be searching. How should the USPTO facilitate an applicant’s submission of prior art that is not accessible in the Patents End-to-End Search system (e.g., “on sale” or prior public use)?
  2. How, if at all, should the USPTO change claim support and/or continuation practice to achieve the aims of fostering innovation, competition, and access to information through robust and reliable patents?
  3. How, if at all, should the USPTO change RCE practice to achieve the aims of fostering innovation, competition, and access to information through robust and reliable patents? Specifically, should the USPTO implement internal process changes once the number of RCEs filed in an application reaches a certain threshold, such as transferring the application to a new examiner or increasing the scrutiny given in the examination of the application?
  4. How, if at all, should the USPTO limit or change restriction, divisional, rejoinder, and/or non-statutory double patenting practice to achieve the aims of fostering innovation, competition, and access to information through robust and reliable patents?

The USPTO also seeks public comment on the following questions related to the issues raised by the six U.S. Senators:

  1. 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?
  2. 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?
  3. 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?
  4. Should there be heightened examination requirements for continuation patents, to ensure that minor modifications do not receive second or subsequent patents?
  5. 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 timeframe 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 (e.g., within six months of the first office action on the earliest application in a family) be preferable to a specific deadline (e.g., one year after the earliest application in a family)?
  6. 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?

Written comments must be received by the USPTO on or before January 3, 2023 to ensure consideration.

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