MPEP § 2015 — MPEP § 2015
Current through: 2022-07-01

2015-Duties of Disclosure and Reasonable Inquiry Arise in Dealings With Other Government Agencies 
 
 

 
 
 
 
 
 
 
 

 

 
 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 

 
 
 
 
 
 
 
 
 
 
 

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 Chapter 2000 

 Section 2015 
 

 
 
 
 
 
 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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 2000-Duty of Disclosure 
 2000.01-Introduction 

 
 

 2001-Duty of Disclosure, Candor, and Good Faith 
 2001.01-Who Has Duty To Disclose 

 2001.02-[Reserved] 

 2001.03-To Whom Duty of Disclosure Is Owed 

 2001.04-Information Under 37 CFR 1.56(a) 

 2001.05-Materiality Under 37 CFR 1.56(b) 

 2001.06-Sources of Information under 37 CFR 1.56 
 2001.06(a)-Prior Art Cited in Related Foreign Applications 

 2001.06(b)-Information Relating to or From Copending United States Patent Applications 

 2001.06(c)-Information From Related Litigation and/or Trial Proceedings 

 2001.06(d)-Information Relating to Claims Copied From a Patent 

 2001.06(e)-Information Relating to Regulatory Review 

 
 

 
 

 2002-Disclosure — By Whom and How Made 
 2002.01-By Whom Made 

 2002.02-Must be in Writing 

 
 

 2003-Disclosure __ When Made 
 2003.01-Disclosure After Patent Is Granted 

 
 

 2004-Aids to Compliance With Duty of Disclosure 

 2005-Comparison to Requirements for Information 

 2006‑2009-[Reserved] 

 2010-Office Handling of Duty of Disclosure/Inequitable Conduct Issues 

 2011-Correction of Errors in Application 

 2012-Reissue Applications Involving Issues of Fraud, Inequitable Conduct, and/or Violation of Duty of Disclosure 
 2012.01-Collateral Estoppel 

 
 

 2013-Protests Involving Issues of Fraud, Inequitable Conduct, and/or Violation of Duty of Disclosure 

 2014-Duty of Disclosure in Reexamination Proceedings and Supplemental Examination 

 2015-Duties of Disclosure and Reasonable Inquiry Arise in Dealings With Other Government Agencies 

 2016-Fraud, Inequitable Conduct, or Violation of Duty of Disclosure Affects All Claims 

 2017‑2022-[Reserved] 

 

 

 
 

 
 
 

 
 

 

 
 
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 Last Modified: 
 
 03/09/2026 20:49:31