On March 8, 2018, Amgen Inc. (“Amgen”) filed suit against Adello Biologics, LLC (“Adello”) in the District of New Jersey, alleging infringement of seventeen patents:  U.S. Patent Nos. 6,180,391; 7,083,948; 7,118,884; 7,384,765; 7,427,659; 7,662,930; 7,735,525; 7,781,395; 8,191,566; 8,273,707; 8,940,878; 8,952,138; 9,418,416; 9,632,095; 9,643,997; 9,704,239; and 9,856,287.  The case is assigned to Judge Claire C. Cecchi and Magistrate Judge Mark Falk, and is Civil Action No. 18-cv-3347.

According to the complaint, in a letter dated September 11, 2017, Adello “purported to provide notice, pursuant to 42 U.S.C. § 262(l)(8)(A), of its intent to commercially market a proposed biosimilar to NEUPOGEN® ” and “informed Amgen that Adello took advantage of the abbreviated subsection (k) pathway in submitting its aBLA.”  Complaint ¶12.

However, the complaint also asserts that Adello’s September 11, 2017 letter explained that Adello did not intend to participate in the patent dance, stating that “Adello ‘is not required to and does not intend to provide Amgen with [the Adello aBLA] or manufacturing information contemplated by 42 U.S.C. § 262(l)(2)(A).’”  Id. ¶13.  As a result of not having this information, Amgen has stated in each count of infringement that it is “thus unable to provide a more detailed infringement analysis for the Adello Filgrastim Product or the process(es) of its manufacture at this time without discovery, including the Adello aBLA and other information that describes the process or processes used to manufacture the Adello Filgrastim Product.”  Complaint ¶¶95, 106, 117, 128, 139, 150, 161, 172, 183, 194, 205, 216, 227, 238, 249, 260, and 271.  The Complaint alleges infringement under 35 U.S.C. § 271(e)(2)(C)(ii) based on Adello’s aBLA submission to FDA, Id. ¶18, and alleges that “[u]nless enjoined by this Court, upon information and belief, Adello will infringe one or more claims of each of the Asserted Patents under 35 U.S.C. §§ 271(a) and 271(g) by making, using, offering to sell or selling within the United States, or importing into the United States the Adello Filgrastim Product which Adello makes by a process covered by the Asserted Patents, before the expiration of Asserted Patents.”  Id. at ¶20.

Adello recently answered the complaint on May 17, 2018, denying infringement and asserting counterclaims of non-infringement and invalidity for all seventeen patents.  Relying on the Supreme Court’s Sandoz, Inc. v. Amgen, Inc. decision (137 S. Ct. 1664, 1674-75 (2017)), Adello admitted “that it was not required to, and did not, provide Amgen with a copy of its aBLA or manufacturing information prior to Amgen filing this lawsuit.”  Answer ¶13.  In its counterclaims, Adello points out that two of the patents-in-suit, U.S. Patent Nos. 8,940,878 and 8,952,138, were the subject of prior district court litigations where the biosimilar applicants, Sandoz and Apotex, respectively, were found not to infringe.  Counterclaim ¶¶15-16.  Adello also alleges in its counterclaims that “[n]one of the Patents-in-Suit specifically claim G-CSF or methods of treatment using G-CSF. Nor are any of the Patents-in-Suit identified on the label for NEUPOGEN® as covering that product. Upon information and belief, Amgen does not practice any of the Patents-in-Suit in its manufacture of NEUPOGEN®.”  Id. ¶19.

A scheduling conference is set for June 19, 2018.