BPCIA Litigation Updates: Bevacizumab, Trastuzumab, Filgrastim

More than a dozen BPCIA patent litigations are currently pending in various U.S. district courts.  Below are some highlights of activity in some of those cases from this month.

Genentech v. Amgen (D. Del.): bevacizumab

On August 2, 2018, Judge Sleet issued a memorandum in response to the parties’ ongoing dispute regarding the mechanism by which they plan to narrow the number of patents in dispute in the case.  To narrow the case, the parties had agreed to “an initial phase of discovery” whereby the parties would take depositions of each other’s corporate designees under Federal Rule of Civil Procedure 30(b)(6).  Genentech’s original 30(b)(6) deposition notice contained 236 deposition topics, but Genentech reduced it down to 49 topics after Amgen objected and Judge Sleet counseled Genentech to be “practical” about the number of deposition topics while making clear that the Court did not view the issue “as a numbers game.”  Amgen, however, complained that Genentech’s shorter, revised topics list was “actually broader than their original notice” and failed to comply with Judge Sleet’s directive.

In the Court’s memorandum, Judge Sleet disagreed with Amgen’s characterization of Genentech’s revised 30(b)(6) deposition notice and found that Genentech complied with the Court’s instructions. Judge Sleet further noted the Court’s memorandum was intended “to guide the parties’ continuing efforts to resolve the Rule 30(b )(6) deposition dispute between them as well as other discovery issues that may arise” and instructed that “[i]f Amgen has other objections to the Revised Notice that the parties cannot resolve through a meet and confer, Amgen may raise those objections with the court.”  Judge Sleet, however, cautioned the parties: “The court is a limited resource. Every set of litigants is entitled to use its fair share of this resource – but only its fair share. The litigants in this action are coming perilously close to exceeding that limit.”

Genentech v. Pfizer (D. Del.): trastuzumab

On August 7, 2018, Genentech and Pfizer filed a Joint Status Report regarding their patent litigation concerning Pfizer’s proposed biosimilar of Herceptin® (trastuzumab). The key issue raised in the Joint Status Report is the case schedule.  According to the Joint Status Report, the parties had initially agreed on a trial on December 2019, but had disagreed about some interim dates in the proposed schedule and Genentech was unwilling to commit to a December 2019 trial date in the event Pfizer were to launch its biosimilar before trial.  Subsequently, Genentech’s stance has changed.  Genentech will no longer agree to a December 2019 trial regardless of whether Pfizer launches and now proposes a schedule with a trial in April 2020 in order to coordinate the schedule with that in its two other trastuzumab litigations (one against Celltrion and Teva, and the other against Amgen) as well as a fourth trastuzumab litigation that Genentech expects to file against Samsung Bioepis in September 2018.  Pfizer, on the other hand, will not agree to Genentech’s protracted case schedule because, Pfizer argues, “it would be highly prejudiced by the four-month delay” and “any gain in efficiency from consolidation does not outweigh the prejudice caused by the delay.”

Genentech v. Amgen (D. Del.): trastuzumab

As we previously report, in June, Genentech sued Amgen for infringement of 38 patents under the BPCIA based on Amgen’s aBLA for a biosimilar of Herceptin® (trastuzumab).  Last month, Genentech filed an amended complaint, reducing the number of asserted patents down to 17.  On August 9, 2018, Amgen filed a public version of its answer and counterclaim to the amended complaint, which was originally filed under seal on August 2.  Amgen alleges affirmative defenses and counterclaims of, among other things, non-infringement, invalidity and, with respect to one patent, unenforceability due to unclean hands and inequitable conduct.

Amgen v. Hospira (D. Del.): filgrastim

Last month, Amgen sued Hospira and its parent company Pfizer for infringement of one patent under the BPCIA based on Hospira’s aBLA for a Neupogen® biosimilar, which has since been approved by the FDA as Nivestym™ (filgrastim-aafi). On August 9, 2018, Hospira and Pfizer answered the complaint, asserting affirmative defenses and counterclaims of, among other things, non-infringement and invalidity of the patent-in-suit.

Stay tuned to Big Molecule Watch for further developments in these and other BPCIA litigations