Intellectual Property

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.

Case law regarding written description is in a state of flux so it is beneficial for the patent practitioner to understand some key Federal Circuit decisions involving the written description requirement.

One might ask why a separate written description of the invention is needed in the specification when the claims are there to define the subject matter of the invention. The reason is historical.

Dietary supplements represent a huge sector of the consumer market and changes in both intellectual property law and the regulations governing the market entry and advertising of these products is changing.

The new America Invents Act allows anyone to challenge the validity of patents under the inter partes review (IPR) process. In a Sept. 9 webinar, Husch Blackwell Partner Joseph Cwik, who recently won the first pharmaceutical IPR case, will provide an overview of this new process and explain how it is more cost-effective, efficient and successful than the traditional litigation.

Recently, the Federal Circuit provided some insight about the “error” upon which a reissue patent application can be based under 35 U.S.C. § 251. See In re Dinsmore, No. 2013-1637, 2004 WL 2337372 (Fed. Cir. June 10, 2014).

The current section 251 states:

Whenever any patent is, through error, deemed wholly or partly inoperative or invalid, by reason of a defective specification or drawing, or by reason of the patentee claiming more of less than he had a right to claim in the patent, the Director shall, on the surrender of such patent and the payment of the fee required by law, reissue the patent for the invention disclosed in the original patent, and in accordance with a new and amended application, for the unexpired part of the term of the original patent. 35 U.S.C. § 251 (2012).  (The previous version of this statute, which was in effect at the relevant time for the case, included the phrase: “without any deceptive intention.”  This change was made Sept. 16, 2012.)

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.

A deluge of patent applications were filed at the United Stated Patent and Trademark Office on the day before central provisions of the new America Invents Act (AIA) went into effect on March 16, 2013.  This rush to file indicates many inventors wish to preserve their patent status under the pre-AIA provisions.

The first-to-file provisions apply to any patent application that contains OR CONTAINED AT ANY TIME a claim having an effective filing date on or after March 16, 2013, and also apply to any patent application claiming priority of another application/patent that contains OR CONTAINED AT ANY TIME such a claim. America Invents Act § 3(n)(1) (emphasis added).

If you are forming a new venture or starting a new research project, consider these important IP issues before taking the plunge…

1)  Evaluate the “Patent Landscape” before you invest significant resources. A patent attorney can help you with a “Freedom to Operate” opinion. This FTO opinion will contain a “prior art” search, which provides information regarding comparable patents, their inventors/assignees, whether the patents are in good standing, and the remaining patent term. This information will give you a greater understanding of the patentability of your new idea, will help you avoid infringing someone else’s patents, and will help you identify potential licensing issues. The FTO opinion can also help to avoid “willful” infringement should you later be sued.