On February 15, 2017, Genentech filed litigation accusing Amgen of violating the Biologics Price Competition and Innovation Act (“BPCIA”), 42 U.S.C. § 262.  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®.

Amgen announced in November 2016, that it submitted a biologics license application to FDA for bevacizumab, an anti-vascular endothelial growth factor (Anti-VEGF) specific monoclonal antibody that inhibits formation of new blood vessels  and is used to slow the growth of tumors related to several types of cancers.  Avastin® is indicated for treatment of conditions related to metastatic colon cancer, lung cancer, glioblastoma, ovarian cancer and cervical cancer.

The litigation concerns the scope of the information, if any, in addition to a copy of the 351(k) application, that an applicant must provide to the reference product sponsor at the beginning of the “patent dance” pursuant to section 262(l)(2)(A) of the BPCIA.  The parties also disagree as to whether Genentech should be permitted to share Amgen’s confidential information with its outside scientific experts at this stage of the proceeding, subject to a confidentiality agreement.

According to the Complaint, Amgen notified Genentech on January 4, 2017 that its abbreviated application for a bevacizumab biosimilar had been accepted for review by FDA.  For those applicants who decide to avail themselves of the benefit of the patent dance, section (l)(2) of the BPCIA provides that “no later than 20 days after the FDA notifies the applicant that the application has been accepted for review,” the section (k) applicant:

(A) 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

(B) may provide to the reference product sponsor additional information requested by or on behalf of the reference product sponsor.

See 42 U.S.C. § 262(l)(2) (emphasis added).  The statue further requires that no later than 60 days “after the receipt of the application and information under paragraph (2),” (cited above), the reference product sponsor shall provide to the subsection (k) applicant, a list of patents for which it believes a claim of patent infringement could reasonably be asserted (“the 3A list”) and identify the patents from the 3A list that the reference product sponsor would be willing to license to the applicant.  Id. at § 262(l)(3)(A).  The exchange of information, including detailed statements on each party’s claims and defenses of patent infringement/non-infringement and validity/invalidity continues thereafter, but it is the exchange of information for the first two steps (under sections (l)(2)(A) and (l)(3)(A)) that gave rise to the Complaint.

The Federal Circuit has held that an applicant using the 351(k) pathway may “opt-out” of the patent dance entirely, in which case it is not required to provide early access to its application prior to the filing of a lawsuit.  See Amgen, Inc. v. Sandoz, Inc., 794 F.3d 1347, 1356–57 (Fed. Cir. 2015).  As discussed in this post, the Supreme Court recently granted certiorari and will consider the appeal of that decision later this term.  The Amgen v. Sandoz, decision, however, does not address the specific issue presented here – namely, what is required to satisfy the disclosure requirement of 262(l)(2)(A).

Genentech alleges in the Complaint that “Amgen has refused to provide Genentech with anything except its aBLA” and that Amgen has “[taken] the position that producing the aBLA alone was sufficient under the statute.”  More specifically, Amgen asserts that “Amgen has purported to opt into the BPCIA’s information exchange procedures, and consequently, it should have given Genentech access to certain specific categories of Amgen manufacturing information” that Genentech says are “highly relevant for Genentech (and its outside expert consultants) to review in order to determine whether the manufacture and/or sale of Amgen’s product would infringe Genentech’s patents.” Genentech characterizes the consequences of not receiving the requested information as “potentially disastrous,” because if Genentech fails to list a patent, it could be barred permanently from asserting that patent against Amgen’s biosimilar Avastin®.”

The Complaint includes a separate count accusing Amgen of violating 42 U.S.C. § 262(l)(1)(C) by “unreasonably withholding consent” for Genentech to share Amgen’s information with Genentech outside scientific experts (subject to confidentiality requirements).   Although Genentech interprets section (l)(1)(c) as imposing an affirmative obligation to “reasonably” allow access by experts, subsection (l)(1)(c) is actually written as a limitation that prohibits the disclosure of confidential information to any person, including the reference product sponsor’s outside scientific consultants,  without the applicant’s written consent.  The full text of that subsection provides that:

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.

Genentech also criticizes Amgen in the Complaint for allegedly taking a position on the scope of the required disclosures here that is contrary to the position Amgen has taken when it has been on the other side of patent dance negotiations (as the reference product sponsor) for other products.  For example, Genentech cites to specific statements Amgen made in prior litigation with Hospira (involving Epogen®) and with Sandoz (involving Neupogen®) and characterizes Amgen’s position here as “an about face” on the scope of the required disclosures.

It is interesting to note, however, that Amgen’s position here in the bevacizumab patent dance appears to be consistent with the positions that it took in the patent dance with AbbVie regarding adalimumab (Amjevita® and Humira®), where Amgen (as an applicant for a proposed biosimilar) only provided access to its BLA and did not provide any other manufacturing information.  See AbbVie v. Amgen, Civ. No. 16-cv-00666, (D. Del.), Doc. No. 1 (Complaint) and Doc. No. 13 (Answer).  During the patent dance for adalimumab, Amgen also declined Abbie’s request to expand the scope of confidential access to include outside experts at this stage of the proceeding.  Id.

Finally, the Complaint seeks declaratory relief that because of Amgen’s failure to provide the information required by section (l)(2)(A), Genentech should not be required to provide its 3A list of patents until after Amgen has satisfied its obligations discussed above.

The issues presented in the Complaint are new issues of statutory interpretation that have not yet been addressed by the Courts.  The plain language of the statue says that the biosimilar applicant “shall provide . . . 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.” The use of the conjunctive term “and” as well as the specific reference to other manufacturing information seems to indicate that, at least in some instances, manufacturing information outside of the application must be provided when an applicant elects to participate in the patent dance. However, the statue does not identify what specific manufacturing information is required to satisfy the requirement for “such other information that describes the process or processes used to manufacture the biological product that is the subject of such application” in the second prong of clause (l)(2)(A).

Elsewhere in the BPCIA, section (l)(1)(B) separately states that:

When a subsection (k) applicant submits an application under subsection (k), such applicant shall provide . . . confidential access to the information required to be produced pursuant to paragraph (2) and any other information that the subsection (k) applicant determines, in its sole discretion, to be appropriate (referred to in this subsection as the ‘‘confidential information’’).

See 42 U.S.C. § 262 (l)(1)(B) (emphasis added).  Thus, section (l)(1)(B) makes it clear that the decision to provide any additional information requested by the reference product sponsor pursuant to section (l)(2)(B) is within the sole discretion of the applicant.  Once again, however, section (l)(1)(B) does not identify or further clarify what information other than the application, if any, must be provided by the applicant to satisfy the second part of clause (l)(2)(A) by an applicant who is participating in the patent dance.

Another threshold question that will have to be addressed by the Court is whether the Complaint contains a claim for which relief can be granted.  The BPCIA expressly provides in section (l)(9)(C) that if an applicant “fails to provide the application and information required under paragraph (2)(A),” then the reference product sponsor (but not the applicant) may bring a declaratory judgment action for infringement, validity, or enforceability of “any patent that claims the biological product or a use of the biological product.”  See 42 U.S.C. § 262(l)(9)(C).  Subsection (l)(9)(b) further provides that the reference products sponsor may file a declaratory judgment action for infringement, validity or enforceability of any patent on the reference product sponsor’s 3A list if the applicant fails to cooperate in subsequent steps of the patent dance (for example, by not providing a 3B detailed statement, failing to identify the number of patents to be listed in accordance with paragraph 5, and the failure to provide  notice of commercial marketing, among others). See 42 U.S.C. § 262 (l)(9)(B).

On the other hand, section (l)(9)(A), expressly provides that if the applicant “provides the application and information required under paragraph (2)(A),” neither the reference product sponsor nor the subsection (k) applicant may bring a declaratory judgement for infringement, validity, or enforceability of any patent that is described in clauses (8)(b)(i) and (ii) prior to the date notice of commercial marketing is received.

Here, the parties disagree whether Amgen has provided “the information required under paragraph (2)(A).” If Amgen has not provided sufficient information to satisfy the disclosure requirement of section (l)(2)(A), then Genentech is permitted to bring a claim for patent infringement, validity or enforceability pursuant to section (l)(9)(C).  If Amgen has satisfied the disclosure requirements of section (l)(2)(A), then Genentech is prohibited from bringing a declaratory judgment claim for patent infringement, validity or enforceability until after the notice of commercial marketing is received.

The Complaint filed by Genentech, however, does not assert a claim for patent infringement or any claim regarding the validity or enforceability of any patent. Rather, the Complaint asserts claims discussed above, and Genentech’s Complaint seeks the following relief:

1. an order directing Amgen to comply with its obligations under 42 U.S.C. § 262(l)(2)(A) by providing manufacturing information;
2.  an order directing Amgen to comply with its obligation under and § 262(l)(1)(C)  by not withholding consent for Genentech to share the information with experts;
3. a resetting of the BPCIA deadlines for resolving patent disputes; and
4. an order prohibiting Amgen from selling its proposed biosimilar to Avastin®, until the statutory process is completed.

 This raises the threshold question of whether Genentech has the right to bring claims for violation of the BPCIA based on an alleged “failure to provide the application and information required under paragraph (2)(A),” other than a declaratory judgment claim for patent infringement, validity or enforceability as permitted by (l)(9)(C) – particularly in view of the Federal Circuit’s statement in Amgen v. Sandoz that section (l)(9)(C) and 35 U.S.C. § 271(e) provided the only remedies available to Amgen and that “the BPCIA has no other provision that grants a procedural right to compel compliance with the disclosure requirement of paragraph (l)(2)(A).”   See Amgen, Inc. v. Sandoz, Inc., 794 F.3d 1347, 1365 (Fed. Cir. 2015), cert. granted, 85 U.S.L.W. 3343 (Jan. 13, 2017) (Nos. 15-1039 and 15-1195).

Amgen has not yet filed an Answer to the Complaint.  Absent entry of an expedited case schedule, Amgen’s answer to the complaint is due on March 8, 2017, and Genentech has identified the 60-day deadline for its 3A list as March 24, 2017.  If this matter is not resolved quickly, it seems unlikely that Genentech would let that date pass without providing at least a partial (if not complete) patent list to Amgen.