In the latest dispute surrounding the “patent dance” provisions of the Biologics Price Competition and Innovation Act (BPCIA), Genentech, Inc. has filed a complaint against Amgen, Inc., alleging that after opting into the BPCIA’s information exchange procedures, Amgen withheld relevant confidential information and unreasonably refused expert consultant review of Amgen’s Abbreviated Biologic License Application (aBLA). This case is not the first to highlight the difficulties with a statutory scheme that requires fierce competitors to share highly confidential information, but may lead to the first decision on just how much information a biosimilar applicant has to disclose and to whom.
Will You Join The Biosimilar Patent Dance?
The BPCIA provides a detailed process for addressing patent disputes surrounding biosimilar products, laid out in 42 USC § 262(l). This process is referred to as the “patent dance,” which has been reviewed in detail in this article. As discussed in this article, the Federal Circuit decided in Amgen, Inc. v. Sandoz, Inc. that the entire patent dance is optional. That decision is pending review at the Supreme Court, but this case raises different issues:
Once a biosimilar applicant has chosen to opt into the patent dance, how much information must be provided and to whom?
The information disclosure requirements at issue is set forth in 42 USC § 262(l)(2), which provides that once the FDA has accepted an aBLA for review the Applicant:
- shall provide to the reference product sponsor a copy of the application submitted to the Secretary under subsection (k), and such other information that describes the process or processes used to manufacture the biological product that is the subject of such application; and
- may provide to the reference product sponsor additional information requested by or on behalf of the reference product sponsor.
In accordance with 42 USC § 262(l)(1)(B)(ii), the information is to be provided to “outside counsel” and “inside counsel,” as those terms are defined in the statute. Use of the information is restricted by 42 USC § 262(l)(1)(C), which provides:
(C) Limitation on disclosure
No person that receives confidential information pursuant to subparagraph (B) shall disclose any confidential information to any other person or entity, including the reference product sponsor employees, outside scientific consultants, or other outside counsel retained by the reference product sponsor, without the prior written consent of the subsection (k) applicant, which shall not be unreasonably withheld.
Under the patent dance framework, the reference product sponsor uses this information to determine which if any of its patents may be infringed by the biosimilar product. Indeed, 42 USC § 262(l)(3)(A) gives the reference product sponsor 60 days from receipt of the information to serve a list of patents it “believes a claim of patent infringement could reasonably be asserted.” The completeness of this patent list is important, since the reference product sponsor is precluded from later asserting certain non-listed patent(s) under 35 USC § 271 (e)(6)(C).
Won’t You Join The Biosimilar Patent Dance?
This case arose from Amgen’s November 2016 aBLA for a biosimilar version of Genentech’s Avastin® (bevacizumab) product, which Genentech describes as it “best-selling cancer drug.” In accordance with § 262(l)(2)(A), Amgen provided a copy of its aBLA to Genentech. However, Genentech’s complaint alleges that Amgen failed to follow the BPCIA’s disclosure requirements in at least the following ways:
- not providing information regarding its manufacturing process, as required by § 262(l)(2)
- unreasonably withholding consent to expert participation, which is prohibited by
Genentech asserts that the manufacturing information is necessary for it to determine “whether the manufacture and/or sale of Amgen’s product would infringe Genentech’s patents and to ensure that Genentech has sufficient time to assert those patents and seek orderly court intervention before Amgen launches its product.”
Genentech also asserts that Amgen unreasonably withheld permission for any expert consultants hired by Genentech to review Amgen’s aBLA, instead “insisting that Genentech’s experienced patent counsel should not need any expert help to determine whether Amgen’s proposed biosimilar infringes any Genentech patents.”
Genentech seeks an order from the court that would, among other things:
- direct Amgen to comply with the BPCIA disclosure obligations
- enjoin Amgen from selling its biosimilar product until “Genentech is restored to the position it would have been in had Amgen met its obligations under the BPCIA” and
- “enjoin Amgen from continuing to seek FDA review of the aBLA … and/or compelling Amgen and/or the FDA to suspend FDA review of that aBLA until Amgen has restored Genentech the benefits afforded to reference product sponsors under the BPCIA.”
Who Wants To Join The Biosimilar Patent Dance?
As Genentech points out in its complaint, Amgen has been on the other side of this issue in biosimilar litigation against Hospira (concerning Epogen®) and Sandoz (concerning Neupogen®), where Amgen was the reference product sponsor seeking manufacturing information from biosimilar applicants. Genentech highlights these other cases to argue that Amgen “cannot reasonably dispute” that Genentech is entitled to the information it seeks, but the court might view the variety of unhappy couples on the biosimilar patent dance floor as a sign that the music is too hard to dance to.
A report from The IMS Institute for Healthcare Informatics estimates the global pharmaceutical biologics market at over $200B, with biosimilars representing 2-4% of that market. In view of these high stakes, it is not surprising that companies are reluctant to provide highly confidential information to their closest competitors, especially in a pre-litigation context without the oversight of a court’s protective order.
It will be interesting to see exactly what information this court decides a biosimilar applicant who has opted to join the patent dance must share with the reference product sponsor, and who else is allowed to review the information.