Wednesday, April 08, 2015

Bass goes after third drug company

The Wall Street Journal reports:

His latest challenge seeks to employ a relatively new and inexpensive petition process to invalidate a Jazz Pharmaceuticals PLC patent for Xyrem, a narcolepsy drug with sales of $779 million last year, two-thirds of Jazz’s 2014 revenues.


Inter partes review, created in 2011 under the Leahy-Smith America Invents Act ("AIA"), allows a party other than the patentee to bring a proceeding before the Patent Trial and Appeal Board to challenge the validity of a patent. 35 U.S.C. § 311. The current system of inter partes review replaces the old system of inter partes reexamination. Unlike the inter partes reexamination process, inter partes review is more akin to an adjudicative proceeding. H.R. Rep. No. 112-98, 46 (2011), reprinted in 2011 U.S.C.C.A.N. 67, 77 (the AIA "converts inter partes reexamination from an examinational to an adjudicative proceeding.").

35 U.S.C. § 315(a) provides for the filing of inter partes review in relation to other proceedings. Section 315(a)(1) states:

An inter partes review may not be instituted if, before the date on which the petition for such a review is filed, the petitioner or real party in interest filed a civil action challenging the validity of a claim of the patent.

UPDATE from docketreport.blogspot on 30 Nov. 2015:

DNJ granted plaintiff's motion to compel defendants to produce communications with the FDA regarding defendants' negotiation of a joint Risk Evaluation and Mitigation Strategy program. "This dispute centers on whether the documents in question 'pertain' to Defendants' ANDAs pursuant to L. Pat. R. 3.6(j) . . . The plain language of L. Pat. R. 3.6(j) requires an ANDA applicant to produce 'a copy of all correspondence between itself and the FDA pertaining to the ANDA application to each party asserting infringement, or set forth the basis of any claim of privilege for such correspondence. . . .' The parties have not submitted any case law interpreting that clause and the Court has not located any through its independent research. . . . All parties agree that the product at the center of this case . . . will be not be sold to the public without a REMS, which is required by the FDA. . . . While those communications do not appear to be directly relevant to the questions of infringement or validity, they certainly pertain to and concern the central issue in these cases: Defendants' ANDAs."

Jazz Pharmaceuticals, Inc. v. Amneal Pharmaceuticals, LLC, 2-13-cv-00391 (NJD November 23, 2015, Order) (Dickson, M.J.)


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