Last November, the U.S. Patent and Trademark Office issued Guidance to the Examiner Corps that was disclosed to the public at the March 19, 2024 Biotechnology, Chemical, and Pharmaceutical Partnership Meeting, on resources to be used by examiners to comply with the dictates of Executive Order 14036 from the Biden Administration related to drug patents and the purported abuse thereof that results in inflated drug prices.
To recap, in one of its first acts, the Administration promulgated Executive Order 14036 (July 9, 2021), which contained the assertion that "Americans are paying too much for prescription drugs and healthcare services — far more than the prices paid in other countries" and the allegation that "too often, patent and other laws have been misused to inhibit or delay — for years and even decades — competition from generic drugs and biosimilars, denying Americans access to lower-cost drugs" (this despite 40 years of generic drugs being available under the Hatch-Waxman Act (1984) and biosimilar copies of biologic drugs for over a decade under the BPCIA, enacted as part of "Obamacare" in 2010). The purported remedy was that "it is the policy of my Administration to enforce the antitrust laws to combat the excessive concentration of industry, the abuses of market power, and the harmful effects of monopoly and monopsony — especially as these issues arise in . . . prescription drug markets" and "to support aggressive legislative reforms that would lower prescription drug prices, including by allowing Medicare to negotiate drug prices, by imposing inflation caps, and through other related reforms."
One aspect of this policy, under Sec. 5(p)(vi), intended "to help ensure that the patent system, while incentivizing innovation, does not also unjustifiably delay generic drug and biosimilar competition beyond that reasonably contemplated by applicable law," was to have, "not later than 45 days after the date of this order, . . . the Commissioner of Food and Drugs write a letter to the Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office enumerating and describing any relevant concerns of the FDA." There followed a series of letters between these officials that were directed to:
• Enhancing collaboration with other agencies on key technology areas, including pharmaceuticals and biologics
• Improving procedures for obtaining a patent to ensure that the USPTO issues robust and reliable patents
• Improving the process for challenging issued patents before the Patent Trial and Appeal Board (America Invents Act proceedings)and improving public participation in the patent system
• Considering new proposals for incentivizing and protecting innovation while minimizing unnecessary delays in getting more affordable drugs to market
These aspirations were further voiced in a joint blog post almost a year later, on July 7, 2022, from Director of the USPTO Kathi Vidal and FDA commissioner Robert M. Califf that, while crediting the pharmaceutical industry for creating, testing, and bringing to market lifesaving drugs, and that 13 of the top 20 "most innovative and inventive pharmaceutical companies" in the U.S., and recognizing the "delicate balance" with generic companies in providing competition and "driving down prices," insisted that "while the issuance of robust and reliable patents to incentivize pharmaceutical innovations is critical, our patent system must not be used to unjustifiably delay generic drugs and biosimilar competition beyond that reasonably contemplated by law." These efforts were directed to "striking [an] appropriate balance" by "encouraging meaningful innovation in drug development while not unduly delaying competition that provides relief from the high cost of medicines," a truly Goldilocks objective.
These officials further enunciated their goal to "protect against the patenting of incremental, obvious changes to existing drugs that do not qualify for patents" so that "companies will not be able to unjustifiably delay generic competition based on trivial changes to a drug product." This was to be done, inter alia, by the PTO giving examiners "time and resources" needed to thoroughly review applications for pharmaceutical inventions (raising the questions, of course of whether examiners had not been given the T&R for the job now and whether so doing would come at the expense of proper T&R for all other areas of technology, and not specifying the resources that would be provided). The FDA information to be made available to examiners under this policy was to be only from unspecified "publicly available sources" (with updated information on these efforts being available on the USPTO-FDA Collaboration Initiatives webpage).
The latest Guidance is specific to Technology Center 1600 for drugs, formulations, and methods of treatment/use, and concerns methods for searching NIH and FDA databases identifying which databases should be searched. The Guidance also directs the Examiners to the searching requirements in M.P.E.P. § 904 (§ 904.02) as well as the importance of compliance for examiner review in performance and quality appraisals (i.e., involving their bonuses, raises, and opportunities for advancement). The Guidance identifies the following "search resources," their properties and characteristics and what information can be gleaned from them:
• FDALabel: this database contains drug labeling information for 140,000 human drugs (including biologics and over-the-counter drugs) and a small number of animal drugs, disclosing prescribing information, patient labeling, and carton/container labeling for the drugs and biologics, as well as label documents for homeopathic remedies, medical devices, dietary supplements, cosmetics, and medical foods. The Guidance directs that this database can be used to find information on indications, dosage and administration, contraindications (including warnings, adverse reactions, drug interactions, or information about use in particular populations of patients). The Guidance also includes information on how to use the database and search capabilities, down to level of the interface and ways to use it including navigating the search results obtained (e.g., identifying the approval date for establishing prior art status).
• DailyMed & DailyMedArchive (NIH): provides labels for FDA-approved products including prescription drug and biological products for human use; nonprescription (e.g., over-the-counter) drug and biological products for human use; certain medical devices for human use; medical gases for human and animal use; and prescription and nonprescription drugs for animal use. These are labels submitted by drugmakers to FDA (not limited to labels for approved drugs) and the Guidance notes that there are almost 146,000 entries in the database. The Guidance sets forth detailed search protocols and further cautions Examiners that prior art-relevant info might be in archives and not on the main page.
• Drugs@FDA: this database contains more information that the DailyMed database according to the Guidance, including regulatory history, FDA reviews, and previously approved labeling. Information regarding drug approval dates can be parsed by month, and the database includes most approved drug products since 1939, with more robust information on drugs approved since 1998, and is updated daily. Further this database includes information about approval year and any revisions as well as therapeutic equivalents thereof.
The Guidance includes comparisons between what is available in these databases to further aid Examiners in searches:
The Guidance also recommends using Google to search FDA.gov domain(s), as a way to use the power of the Google search engine to search specific sites that can be used to "group drugs with like regulatory pathways or omit outliers." The Guidance provides a tabular synopsis of how a combination of these resources can be used to identify specific information related to prior art searching for patents related to drug products:
The Guidance concludes with the Office's intention to "provide additional examiner training and guidance this year to biotech and pharmaceutical patent examiners on examination of declaratory evidence of unexpected results."
At the same time the Office announced that, as part of or ancillary to the duty of candor under 37 C.F.R. § 1.56 there would be applied a "duty of reasonable inquiry . . . to perform an inquiry that is reasonable under the circumstances, including reviewing documents to identify information that is material to the patentability of a claimed invention," falling within scope of 37 C.F.R. § 11.18(b) (part of the ethical duties regarding standards for submitting papers to the Office as part of patent prosecution. The scope of parties having this duty imposed was the same as Rule 56 as well as individuals involved in re-examination and PGR/IPR proceedings, and included a duty to disclose Para IV positions from generic competitors in pending proceedings before PTO and PTAB. Further, this policy expressly prohibited "ethical walls" that would prevent patent practitioners from being aware of inconsistencies in representations taken before the Office and the FDA or other agencies. The impetus for the new duty came, at least in part, in response to a letter from Sens. Leahy (D-VT) and Tillis (R-NC) that USPTO should "take steps to reduce patent applicants' making inappropriate conflicting statements in submissions to the [USPTO] and other federal agencies," specifically in cases where "inconsistent statements submitted to the Food and Drug Administration (FDA) to secure approval of a product—asserting that the product is the same as a prior product that is already on the market— can then be directly contradicted by statements made to the [USPTO] to secure a patent on the product." The scope of enforcement of this duty has not been further defined.
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