Potential Combined USPTO and FDA Regulatory Pitfalls
Disclosure is an important part of both the USPTO patent application process and the FDA regulatory review process. The specific disclosures that are required by the USPTO and the FDA can sometimes be potentially problematic for those who are involved in both the patent application process and the regulatory review processes. Generally speaking, disclosures that are made to the USPTO need to also be made to the FDA, and vice versa. Failing to make a disclosure when disclosure is required can lead to a finding of inequitable conduct during prosecution of the patent, which can result in the patent being invalidated, and/or can prompt the FDA to initiate an investigation as to whether significant questions regarding data integrity and reliability with respect to a regulated product have been raised for a medical device product that is under review. Being aware of disclosure requirements, and the consequences for failing to comply with those requirements, can help avoid serious pitfalls during the patent prosecution and regulatory processes.
- 1.Purdue Pharma L.P. v. Endo Pharms., Inc., 438 F.3d 1123 (Fed. Cir. 2005).Google Scholar
- 2.37 C.F.R. § 1.56(a).Google Scholar
- 3.United States Water Servs. v. Novozymes A/S, 843 F.3d 1345 (Fed. Cir. 2016).Google Scholar
- 4.Bruno Indep. Living Aids, Inc. v. Acorn Mobility Servs., 394 F.3d 1348 (Fed. Cir. 2005).Google Scholar
- 5.M. Eagles Tool Warehouse, Inc. v. Fisher Tooling Co., 439 F.3d 1335 (Fed. Cir. 2006).Google Scholar
- 6.FDA Application Integrity Policy, Section 1-1-3(1), available online at https://www.fda.gov/downloads/ICECI/EnforcementActions/ApplicationIntegrityPolicy/ucm072631.pdf (accessed Aug. 21, 2018).
- 7.FDA Compliance Policy Guidance Manual, Section 120.100, available online at https://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm073837.htm (accessed Aug. 21, 2018).
- 8.21 U.S.C. § 360c(i)(1)(A).Google Scholar
- 9.21 C.F.R. § 807.100.Google Scholar
- 10.35 U.S.C. §102(a).Google Scholar
- 11.35 U.S.C. §103.Google Scholar
- 12.Johns Hopkins Univ. v. Datascope Corp., 543 F.3d 1342 (Fed. Cir. 2008).Google Scholar
- 13.Abbott Labs. v. Sandoz, Inc., 566 F.3d 1282 (Fed. Cir. 2009).Google Scholar
- 14.Innovative Therapies, Inc. v. Kinetic Concepts, Inc., 599 F.3d 1377 (Fed. Cir. 2010).Google Scholar
- 15.Abbott Point of Care, Inc. v. Epocal, Inc., No. 5:2008cv00543, Doc. No. 358, (N.D. Ala. Nov. 5, 2012).Google Scholar
- 16.Am. Med. Sys. v. Laser Peripherals, LLC, 712 F. Supp. 2d 885 (D. Minn. 2010).Google Scholar
- 17.Bard Peripheral Vascular, Inc. v. W.L. Gore & Assocs., 586 F. Supp. 2d 1083 (D. Ariz. 2008).Google Scholar