Since mid-2020, many pharmaceutical manufacturers have introduced policies that scope their offering of 340B pricing, including limiting contract pharmacy arrangements and requiring covered entities to submit claims data. These policies have generated a good deal of attention generally, and a significant number of covered entities have made attendant complaints to the Health Resources and Services Administration (HRSA).
On April 27, 2021, the United States Tax Court held that legal fees incurred by generic drug manufacturers in connection with “Section 271(e)(2)” patent infringement suits are deductible as ordinary business expenses and need not be capitalized. The opinion contradicts longstanding IRS field advice, and has potential applicability to generic drug manufacturers and others who have capitalized legal fees in recent years.
Recent trends in the U.S. Food and Drug Administration’s (“FDA’s”) utilization of Complete Response Letters (“CRLs”) would indicate there may be a disconnect between the intended use of CRLs and the reality of how they are actually being used by the FDA. Pharmaceutical companies seeking to acquire FDA regulatory approval for their New Drug Applications (“NDAs”) or Abbreviated New Drug Applications (“ANDAs”) will often receive a CRL from the FDA instead of an approval.
The U.S. Food and Drug Administration (“FDA”) panel’s unanimous recommendation to approve Sandoz’ application for a filgrastim biosimilar of Amgen’s Neupogen® on Jan. 7, 2015, brings into sharp focus the provisions of the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”) for resolving patent issues. The imminent approval by the FDA of Sandoz’ application now leaves resolution of patent issues for Sandoz to contend with as it prepares to launch its biosimilar filgrastim product. The lawsuit to resolve these issues, however, has just begun.
The Patent Trial and Appeal Board (PTAB) issued its first final written decisions June 20, 2014, in four inter partes reviews (IPR) of pharmaceutical-related patents. The four decisions effectively invalidated all 58 of the challenged patent claims spread across four patents owned by Merck & Cie and South Alabama Medical Science Foundation (SAMSF) who previously accused Husch Blackwell client Gnosis SpA of infringement.
Several parts of the America Invents Act (the “AIA”) became law on Sept. 16, 2012, sparking some of the most meaningful changes to patent law seen in decades. One hot provision in the new law is the ability for one to challenge a patent’s validity in a new inter partes review (“IPR”) process. This legal tool could prove to be very valuable in solving some of the biggest business challenges facing generic pharma. This post addresses the business case for generic pharma using the IPR process.
When inter partes review actions first became available in 2012, no generic pharma companies availed themselves to this litigation tool. Not until 2013 did a generic pharma company first seek inter partes review (“IPR”) of a brand drug patent in Apotex Inc. v. Alcon Pharmaceuticals, Ltd., IPR2013-00012 and -00015. In response to Apotex’s petition for inter partes review, the Patent Trial and Appeal Board (“PTAB”) ruled there was a reasonable likelihood that the two challenged patents were invalid for obviousness. Interestingly, a U.S. District Court previously determined that one of the patents was not invalid based upon the same prior art references. Id. at Paper 43; March 19, 2013.
Law360 recently quoted Husch Blackwell attorney Don Mizerk in an article about the FDA’s new request for comments. In the announcement, the FDA established a public docket to receive suggestions for ways to improve the quality of abbreviated new drug applications (ANDAs) and for the FDA to learn about difficulties sponsors are having with