From the Hatch-Waxman Act's inception in 1984, which revolutionized drug patenting and approvals, to landmark Supreme Court decisions and regulatory evolutions, this timeline chronicles the critical junctures and legal precedents that have defined and redefined the contours of Hatch-Waxman litigation.
Passage of the Hatch-Waxman Act (1984)
Officially known as the Drug Price Competition and Patent Term Restoration Act, this legislation was enacted to balance the need for innovator pharmaceutical companies to be rewarded for their investment in new drugs and the necessity to provide affordable generic drugs to the public.
1980s-1990s Roche Products, Inc. v. Bolar Pharmaceuticals Co. Inc. (1984)
Eli Lilly v. Medtronic (1990)
The decision meant that generic manufacturers would potentially have to wait until the expiration of a patent to even begin the process of seeking FDA approval, which could significantly delay the entry of generic drugs into the market.
The Supreme Court allowed for broader use of the “safe harbor” provision under 35 U.S.C. § 271(e)(1).
2000s Mylan Pharmaceuticals Inc. v. Thompson (2001)
Medicare Modernization Act (2003)
KSR v. Teleflex (2007)
Changed the standard of obviousness, impacting how patents are challenged and defended.
Introduced changes to the Hatch-Waxman Act, particularly affecting the 180-day exclusivity period for the first generic applicant and addressing some of the issues related to “parking” of exclusivity.
Merck KGaA v. Integra Lifesciences I, Ltd. (2005)
Expanded the scope of the “safe harbor” provision to include preclinical research.
ACI’s
HatchWaxman SERIES
Addressed issues related to the 180-day exclusivity forfeiture provisions.
American Conference Institute launches the first ever Maximizing Patent Life Cycles (Now known as PIV Disputes) (2002)
2010s Caraco Pharmaceutical Laboratories v. Novo Nordisk (2012)
Sandoz v. Amgen (2015)
Addressed the ability of generic companies to challenge the accuracy of brand-name labels.
The America Invents Act (AIA) (2011)
Clarified aspects of the Biologics Price Competition and Innovation Act (BPCIA), impacting biosimilars.
FTC v. Actavis, Inc. (2013)
Introduced Inter Partes Review (IPR), providing a new avenue for challenging patents outside of traditional litigation.
The Supreme Court ruled on the legality of “pay-for-delay” settlements.
Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA Inc. (2019) The Supreme Court clarified the “on sale” bar under the AIA.
2020s
Amgen Inc. v. Sanofi (2023)
SCOTUS held that Amgen’s patents failed the enablement requirement of the Patent Act due to their overly broad claims compared to the actual invention described, could have significant implications for Hatch-Waxman litigation by potentially raising the bar for the specificity required in biopharmaceutical patents.
Vidal v. Hirshfeld
Ongoing case as of 2023, with potential implications for the discretion of the USPTO in reviewing patents post-grant.
COVID-19 Pandemic (2020) Accelerated discussions about patent rights versus public health needs.
United States v. Arthrex, Inc. (2021)
Supreme Court case affecting the authority of Patent Trial and Appeal Board (PTAB) judges.