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Genentech’s BPCIA Complaint Against Amgen Dismissed

Today, Judge Gregory Sleet of the U.S. District Court of Delaware orally dismissed Genentech’s lawsuit against Amgen alleging violations of the BPCIA.  Judge Sleet did not issue a written opinion, but his order states that the case is dismissed without prejudice for lack of subject matter jurisdiction in light of Amgen v. Sandoz, 794 F.3d 1347 (Fed. Cir. 2015).

The case arose from Amgen’s application for a biosimilar of Avastin, Genentech’s best-selling cancer drug and one of the top-selling drugs in the United States, with recorded global sales of almost $7 billion in 2016.  The FDA accepted Amgen’s application for review on January 4, 2017.  Under the BPCIA (specifically, 42 U.S.C. § 262(l)(2)), once a biosimilar application has been accepted for review, an applicant has twenty days to provide the application and  “such other information that describes the process or processes used to manufacture the biological product that is the subject of such application” to certain designated counsel for the reference product sponsor.  The BPCIA also directs the applicant not to “unreasonably” withhold consent to give such information to the reference product sponsor’s employees, other outside counsel, or outside scientific consultants. 

Amgen provided Genentech with a copy of its application pursuant to the statute.  However, Genentech’s suit, filed as a declaratory-judgment action on February 15, 2017, alleged that Amgen failed to provide manufacturing information, and that Amgen unreasonably withheld consent to share its application information with Genentech’s outside scientific consultants. 

First, Genentech alleged that Amgen “ignor[ed] the express statutory language” of the BPCIA by disclosing only its application, and not any information about how the Avastin biosimilar will be manufactured.  Genentech asserted that being deprived of this information could lead to “disastrous” results, as under the BPCIA Genentech only has until March 24, 2017 (sixty days from receipt of the applicant’s information disclosure) to list patents that could reasonably be infringed.  Genentech alleged that if it failed to list a patent, it could be permanently barred from asserting it against the Avastin biosimilar.  Without complete information, Genentech might accidentally leave a patent off the list, and thereby forfeit valuable enforcement rights.  Further, Genentech argued, allowing Amgen to get away with not disclosing the other information would countenance hypocrisy, as Amgen itself sued Hospira over withholding information in litigation over Amgen’s biologic Epogen (that case is currently on appeal to the Federal Circuit).

Second, Genentech alleged that Amgen prevented outside scientific experts from helping Genentech to identify potential patent infringement, specifically by unreasonably withholding its permission for any of Genentech’s expert consultants to review Amgen’s application, in violation of 42 U.S.C. § 262(l)(1)(C).  Amgen, for its part, insisted that Genentech’s “experienced patent counsel should not need any expert help to determine whether Amgen’s proposed biosimilar infringes any Genentech patents.”  Genentech sought an order stating that: (1) Amgen must comply with the BPCIA; (2) the relevant BPCIA deadlines are extended; (3) commercial marketing of the Avastin biosimilar is enjoined until the patent dance is complete; and (4)  FDA review of the Avastin biosimilar is enjoined until Amgen complies.

On February 22, one week after filing the complaint, Genentech moved for a “speedy hearing” pursuant to Federal Rule of Civil Procedure 57, asking for a disposition of its claims before the March 24, 2017 deadline for its BPCIA patent list.   On February 27, 2017, Amgen submitted a letter asking the Court to dismiss Genentech’s complaint as barred by Amgen v. Sandoz, which held that the only remedies for an applicant’s failure to provide information pursuant to the BPCIA are those prescribed by the statute, chiefly the right to sue immediately for patent infringement.  Amgen acknowledged that it was on the losing side of Amgen v. Sandoz and disagreed with the decision, but argued that it “nevertheless remains controlling authority here.”  The next day, Genentech responded by arguing that Amgen v. Sandoz did not control, because that case addressed the available remedies for an undisputed refusal to follow the BPCIA, whereas Genentech was requesting declaratory relief to resolve a dispute as to whether Amgen had followed the statute.

After a hearing held this morning, Judge Sleet issued his order dismissing the case pursuant to Amgen v. Sandoz, but allowing it to be refiled within 45 days.  It remains to be seen what Genentech’s next move will be as the March 24 BPCIA deadline approaches.  In its letter brief, Genentech argued that it should not be “forc[ed] . . .  either to produce a list of potentially infringed patents under [42 U.S.C.] § 262(l)(3)(A), without the full production of materials or expert assistance that should have informed that list, or sue Amgen for infringement and wait and see whether that lawsuit was proper at some later time.”  That appears to be the choice that Genentech now faces.