The new Director of the United States Patent and Trademark Office (USPTO), Katherine Vidal, has issued a stern reminder regarding the duties of disclosure and reasonable inquiry when examining a patent application, including the reexamination, reissue and proceedings before the Patent Trial and Appeal Board. (PTAB) (87 FR 45764 (July 29, 2022)). The rationale was to provide examiners and judges with all the material information needed to decide on the patentability of a claimed invention. According to the USPTO, stronger and more reliable patents should result, which is better for the public. See USPTO issues notice calling on pharmaceutical industryGoodwin Life Sciences Perspective blog, August 1, 2022.
The USPTO has now issued a Request for Comments (RFC) (87 FR 60130 (October 4, 2022)) on USPTO initiatives to ensure the “robustness and reliability” of patent rights, the new words at the fashion for increased patent quality. Here again, the pharmaceutical industry seems to be the main target of the new initiatives. In the substantive section is President Biden’s Executive Order on Competition (EO) which calls for action “to help ensure that the patent system, while encouraging innovation, does not unduly delay the competition from generic drugs or biosimilars beyond what is reasonably contemplated by applicable law”. The RFC also references Food and Drug Administration and USPTO interactions and communications to help promote EO.
In particular, the new “robust and reliable” patent initiatives are primarily aimed at preventing so-called “patent thickets”, which have been defined by Senators Leahy, Blumenthal, Klobuchar, Cornyn, Collins and Braun as a “large number of patents that cover a single product or minor variations on a single product. According to the senators, patent thickets are hampering the generic drug industry to the detriment of the American public.
New USPTO initiatives to perform EO include more time and resources to review patent applications, improved processes for information disclosure statements, and identification of key prior art , the possibility of applying greater scrutiny to continuation patent applications and the use of declaratory evidence during patent prosecutions, reviewing terminal waiver practice and procedures for third party involvement during prosecutions, and an analysis comparison of the prosecution and granting of “pharmaceutical and biological patents” in the United States compared to other countries.
The stated primary purpose of this RFC is to solicit public comment on these initiatives, as these initiatives are specific to the pharmaceutical industry. It should be noted, however, that specific topics and initiatives currently addressed in the RFC are prior art searching, e.g. databases of non-patent literature, support of patent claims in applications continuation patent, including priority dates, demand for continued examination (RCE) practice, and restriction, divisional, and terminal non-liability practices.
The RFC includes a list of eleven questions. The first five, some of which have numerous subsections, address the USPTO topics and initiatives discussed above. The last six questions are taken directly from a letter from the senators to the USPTO. These last questions are quite illuminating as to what is on the minds of the senators and their possible solutions to their perceived problems with the US patent system.
Specifically, the senators question the practice of the terminal disclaimer, suggesting eliminating it to ban patents that are obvious variants. Another question suggests that patents that have been definitively disclaimed from each other should stay or fall together with respect to their validity, as they are all obvious variants of each other. Other issues lean toward greater scrutiny and examination of continuation patent applications, including limiting the time in which such applications can be filed and increasing fees for such filings.
Although the specific questions posed do not distinguish patents from the pharmaceutical industry or include a comparison of these patents with equivalent non-US patents, the RFC incitement, which usually precedes a Notice of Proposed Rulemaking, seems signal an attempt to change the current patent practices of the pharmaceutical industry.
In summary, like the USPTO’s notice on disclosure requirements, although all technologies are included, the RFC seems to be aimed more specifically at brand name pharmaceutical companies. Is the RFC another blow over the bow of brand pharma patent filing and prosecution strategies? Is it more the signal of the beginning of a more meticulous examination of their patent applications and of the “patent maquis” that they create? If so, will such control allow generics to enter the market sooner, in order to achieve the Administration’s objectives? Again, only time will tell.