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2015 Duties of Disclosure and Reasonable Inquiry Arise in Dealings With Other Government Agencies [R-07.2022]

Each individual with a duty to disclose, or party with a duty of reasonable inquiry, should ensure that the statements made to the USPTO and other Government agencies, or any statements made on their behalf to other Government agencies regarding the claimed subject matter, are consistent. See Belcher Pharms., LLC v. Hospira, Inc., 11 F.4th 1345, 2021 USPQ2d 909 (Fed. Cir. 2021) (affirming a district court’s determination of inequitable conduct because the patent owner’s Chief Science Officer failed to provide to the USPTO submissions he made to the FDA about the prior art that were inconsistent with positions taken before the USPTO during the prosecution of a pending patent application). Furthermore, providing material information to other Government agencies, including the FDA, while simultaneously withholding the same information from the USPTO undermines both the intent and spirit of the duty of disclosure and violates those duties. For example, in Bruno Independent Living Aids, Inc. v. Acorn Mobility Services, Ltd., 394 F.3d 1348, 1354, 73 USPQ2d 1593, 1598 (Fed. Cir. 2005), the U.S. Court of Appeals for the Federal Circuit inferred intent to deceive and found inequitable conduct occurred when an official involved in both the FDA and the USPTO submissions chose to disclose material prior art to the FDA but not to the USPTO.

Activities or documents associated with market testing, marketing, or commercialization by the patent applicant can also be material to patentability, and therefore, when material, should be disclosed to the USPTO. See GS Cleantech Corp. v. Adkins Energy LLC, 951 F.3d 1310, 1330-1332, 2020 USPQ2d 10092 (Fed. Cir. 2020) (finding that a district court did not abuse its discretion in reaching its inequitable conduct determination where the district court concluded that the inventors and their lawyers made a deliberate decision to withhold material information from the USPTO regarding an offer for sale and reduction to practice of the claimed invention that would have implicated an on-sale bar to the granting of a patent; the lawyers filed with the USPTO a declaration containing a false statement about the timing of an offer for sale despite having in their possession materials that would call into question the veracity of the statement; and the inventors and lawyers subsequently failed to correct the false declaration). By following this guidance, it is expected that patent applicants can obtain more reliable patent protection and avoid the findings of inequitable conduct and sanctions.

Similarly, each individual with a duty to disclose, or party with a duty of reasonable inquiry, should review documents it receives from other Government agencies to determine whether the information should be submitted to the USPTO. For example, when a company seeks FDA approval to market a generic drug before the expiration of patents related to the drug, the generic drug application (e.g., an Abbreviated New Drug Application (ANDA)) must contain a “paragraph IV certification” that the patents submitted to the FDA by the brand-name drug’s sponsor, listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (the Orange Book), and related to the drug are invalid, are unenforceable, or will not be infringed by the generic product. Except in limited circumstances, notice of a paragraph IV certification must also be communicated to the owner of the patent subject to the certification and to the New Drug Application holder. Such a notice includes a detailed statement providing factual and legal bases for the paragraph IV certification. 21 CFR 314.95(c)(7). Consequently, to assist USPTO staff in evaluating patentability effectively and efficiently, the party receiving a paragraph IV certification should review such documents to determine whether they are material to the patentability of any pending matters before the USPTO, such as pending patent applications, reexamination proceedings, or issues in proceedings pending before the PTAB. If the content of the detailed statement, or other information that is part of the ANDA process, is deemed material to patentability in a pending USPTO matter, then such information must be submitted to the USPTO during the pendency of the matter, to meet the duties of candor and good faith and disclosure under 37 CFR 1.56, 1.555, 42.11(a) or (c), or 11.18(b)(2).

Deliberate schemes or established practices to prevent individuals with a duty to disclose under 37 CFR 1.56(c) from obtaining knowledge of material information is not acting in accordance with candor and good faith under 37 CFR 1.56(a). For example, walling off the patent prosecution practitioners from the attorneys seeking FDA approval, as a way to prevent material information from being exchanged between the practitioners and attorneys, is inappropriate. The U.S. Supreme Court has refused to enforce patents where deliberate steps were taken to suppress material information. See, e.g., Keystone Driller Co. v. Gen. Excavator Co., 290 U.S. 240, 19 USPQ 228 (1933) (patent owner’s suit dismissed where the patent owner paid a third party to keep a prior use secret); Precision Instruments Mfg. Co. v. Auto. Maint. Mach. Co., 324 U.S. 806, 65 USPQ 133 (1945) (suit dismissed where patent owner actively suppressed evidence of perjury to the USPTO).

Though the FDA compiles paragraph IV certifications and publishes a list on its website, submitting this list to the USPTO does not satisfy the duty of disclosure for any material information submitted with the paragraph IV certification. These lists do not include patent numbers, relevant claims, or an explanation of the basis for the certification. Therefore, information and documents submitted with the paragraph IV certification that are material to patentability or to issues in proceedings pending before the USPTO, including the PTAB, must be submitted directly to the USPTO and as described above, the examiner may appropriately require submission of information concerning the certifications in certain situations.



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Last Modified: 02/16/2023 12:58:19