Genentech filed suit against Amgen this past February when a dispute arose between the parties during the first step of the “patent dance” for Amgen’s bevacizumab product (ABP 215), a proposed biosimilar to Genentech’s Avastin®.  Genentech accused Amgen of violating sections (l)(2)(A) and (l)(1)(c) of the Biologics Price Competition and Innovation Act (“BPCIA”), 42 U.S.C. § 262, as previously discussed in this post.

The lawsuit came to a swift end when the Court dismissed the Complaint for lack of subject matter jurisdiction, only two weeks after it was filed, in light of the Federal Circuit’s decision in Amgen v. Sandoz, 794 F.3d 1347 (Fed. Cir. 2015).[1] As we previously reported, Judge Sleet dismissed Genentech’s complaint without prejudice and expressly provided Genentech forty-five days, until April 14, 2017, to amend the Complaint to seek declaratory judgment of patent infringement.

Last week Genentech submitted a letter to the Court indicating that it will not be filing an amended Complaint prior to the expiration of the 45-day period provided by the Court’s Order.  In the letter to Judge Sleet, dated April 14, 2017, Genentech states that it believes it would be “more efficient for the Court and the parties to address both the patent merits and Amgen’s continued noncompliance with its statutory production obligations. . . . after the Supreme Court’s expected decision in June in Amgen v. Sandoz.”  Genentech also provided a Proposed Judgment dismissing the case and requested that the Court enter the Judgement.

Before the next business day, Amgen submitted a responsive letter to the Court advising Judge Sleet that “Genentech failed to inform the Court in its April 14 letter that it elected to provide its disclosure under § 262(l)(3)(A) and continue with the “patent dance” instead of amending its Complaint within the 45 day window it requested.” According to Amgen’s April 16, 2017 letter, Genentech provided its section 3A patent list (see 42 U.S.C. § 262(l)(3)(A)) on March 24, 2017, and  “the parties are moving through the ‘patent dance’ as contemplated under the BPCIA.”  Amgen further suggested that in light of the Court’s prior order of dismissal on March 1, 2017, “there is nothing left for the Court to do and it need not entertain Genentech’s request to again dismiss this action.”  Yesterday, on April 19, 2017, Judge Sleet issued an oral order indicating that the court agrees with Amgen’s position set forth in its April 16 letter, and the Court declined to enter the proposed judgment provided with Genentech’s April 14 letter.

In view of Genentech’s decision not to amend its Complaint and the subsequent Court Order, the case is completed.   But, we can expect to see a new patent infringement case after the parties complete the patent dance, if not before.  We will continue to provide updates on any future litigation over bevacizumab.


[1] In Amgen v. Sandoz, the majority of a split panel of the Federal Circuit held that when an applicant fails to comply with the disclosure requirement of section (l)(2)(A), the BPCIA permits the filing of a declaratory judgment suit for patent infringement, and that such suits, pursuant to 42 U.S.C. § 262(l)(9) and 35 U.S.C. § 271(e), are the only remedies available.  The Federal Circuit’s majority decision recognizes that “the BPCIA has no other provision that grants a procedural right to compel compliance with the disclosure requirement of paragraph (l)(2)(A).” However, that decision is currently on appeal to the Supreme Court, and a decision from the high court is expected early this summer as discussed in this post.