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New Developments in AbbVie’s BPCIA Suit Targeting Amgen’s Humira® Biosimilar

November 14, 2016

New Developments in AbbVie’s BPCIA Suit Targeting Amgen’s Humira® Biosimilar

November 14, 2016

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AbbVie’s suit against Amgen, centering on Amgen’s Humira® biosimilar Amjevita®, moved forward as the parties stipulated to the dismissal of AbbVie’s count alleging an anticipated violation of the BPCIA notice provisions and submitted a joint proposed scheduling order.


On August 4, 2016, AbbVie filed a complaint against Amgen alleging that Amgen’s Humira® biosimilar Amjevita® infringes ten AbbVie patents. Humira® received FDA approval in 2002 to treat rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis, plaque psoriasis, juvenile Crohn’s disease, hidradenitis suppurativa, and uveitis. In 2015, Humira® had sales of $8.4 billion in the U.S. and worldwide sales of over $14 billion.

In its complaint, AbbVie sought to enjoin Amgen from the manufacture or sale of any product that infringes ten of AbbVie’s patents, and further sought to enjoin Amgen from the manufacture or sale of any product until 180 days after Amgen gives proper post-licensure Notice of Commercial Marketing under the Biosimilar Price Competition and Innovation Act (“BPCIA”). (Complaint at 48.) AbbVie noted that procedural rules of the patent dance limit this stage of the litigation to ten patents, but alleged that as soon as Amgen serves its 180-day Notice of Commercial Marketing, AbbVie will assert the remaining 51 patents. (Id. at 7.) AbbVie asserted that Amgen likely “will refuse to comply with the notice provisions of the BPCIA.” (Id. at 47.) But Amgen has claimed that “it intends fully to comply with its obligations under 42 U.S.C. § 262(l)(8)(A).” (Counterclaims and Answer at 9, 44.) Amgen’s biosimilar Amjevita® received FDA approval under the BPCIA on September 23, 2016.

The Patent Dance

On January 26, 2016, Amgen tendered its Biologics License Application (“aBLA”), and the parties began the patent dance. (Complaint at 11.) Each party has alleged that the other did not properly comply with the BPCIA procedures. (Id. at 10-16; Answer and Counterclaims at 4-10.)

AbbVie’s Allegations

First, AbbVie alleged that Amgen failed to disclose any “other information that describes the process used to manufacture,” as required by 42 U.S.C. § 262 (l)(2)(A). (Complaint at 11.) Second, AbbVie claimed that “Amgen refused to enter into a confidentiality agreement that would have given AbbVie’s outside expert witness access to Amgen’s aBLA . . . .” (Id.) Third, AbbVie alleged that on April 11, 2016, when AbbVie provided its 3(A) list of patents in dispute, “Amgen provided no additional evidence to support non-infringement of the listed patents.” (Id. at 11.) AbbVie further stated that on June 10, 2016, “Amgen responded by providing AbbVie with a statement contesting Amgen’s infringement of certain patents, and the validity of those patents.” (Id. at 12.) But Amgen “did not provide any additional evidence relating to its non-infringement contentions,” “nor did it provide any copies of the invalidity references it is relying on . . . .” (Id.) Finally, AbbVie claimed that “Amgen refused to engage in good faith negotiations over which patents should be the subject of this litigation,” as required by 42 U.S.C. § 262(l)(4)(A). (Id. at 15 (citing Amgen v. Sandoz, C.A. No. 2:16-cv-01276 (D.N.J. July 22, 2016.)) AbbVie proposed to litigate all of the patents in dispute, but claimed that “Amgen refused to provide any counter-proposal” and “instead wait[ed] until the last day possible to provide AbbVie with the number of patents that it would agree to be sued on.” (Id. at 16.) That number was 6. The parties exchanged their list of 6 patents pursuant to 42 U.S.C. § 262(l)(5), and with two overlapping, the ten patents in suit resulted. (Id.)

Amgen’s Responses and Allegations

In response to AbbVie’s claims, Amgen claimed that it “has fully complied with its obligations under the BPCIA, while AbbVie has repeatedly violated the BPCIA or frustrated the goals of the BPCIA process.” (Counterclaims and Answer at 4.) First, Amgen alleged that the disclosure of its aBLA was timely, and that it “contains extensive information concerning ABP 501 [the biosimilar], including information that describes the processes used to manufacture ABP 501.” (Id.) Second, Amgen asserted that AbbVie did not “identify any information that it believed Amgen was required to disclose pursuant to Section 262(l)(2)(A) that had not been adequately described in Amgen’s BLA.” (Id.) Third, Amgen alleged that on June 10, 2016, “Amgen provided AbbVie with a detailed statement describing the factual and legal basis for Amgen’s view that 65 of the patents on AbbVie’s 3(A) List are invalid and/or would not be infringed by Amgen’s commercial marketing of ABP 501.” (Id. at 5.) Finally, Amgen clarified that this disclosure “totaled over 2,750 pages,” and “provided detailed non-infringement contentions” and also “provided detailed invalidity contentions.” (Id.)

Amgen then asserted that 42 U.S.C. § 262(l)(3)(C) required AbbVie to provide a “detailed statement that describes, with respect to each patent . . . on a claim by claim basis, the factual and legal basis of [its] opinion . . . that such patent[s] will be infringed . . . and a response to the statements[s] concerning validity.” (Id. at 6.) Amgen claimed that AbbVie’s response “did not provide any responses for six of the patents identified on AbbVie’s 3(A) list,” that AbbVie “failed to respond to many of the non-infringement contentions set forth in Amgen’s 3(B) statement,” and “ignored Amgen’s invalidity contentions and failed to respond to Amgen’s invalidity claim charts.” (Id.) Ultimately, Amgen asserted that it tried to negotiate in good faith which patents should be the subject of this suit, but that AbbVie refused to put forth any proposal to “make the litigation manageable for the court and the parties . . . .” (Id. at 8.) “Because AbbVie refused to offer any proposal to limit the scope of the (l)(6) Litigation, Amgen, at the end of the (l)(4) Negotiation period on July 30, 2016, exercised its right under (l)(5)(A) to limit the number of patents to be litigated in this action, by notifying AbbVie that Amgen believed six patents should be the subject of the (l)(6) Litigation . . . .” (Id.) This suit then commenced with the ten patents the parties had agreed upon.

Recent Events

On October 28, 2016, the parties submitted a joint proposed stipulation. (D.I. 20, Stipulation and [Proposed] Order of Dismissal Without Prejudice.) Amgen stipulated that it will comply with the notice requirements of 42 U.S.C. § 262 (l)(8)(A), and further agreed that if the law changes so that it is not required to provide such notice, it will still provide at least 21 days’ notice. (Id.) In exchange, AbbVie stipulated that it will dismiss Count XI of the complaint—alleging that Amgen would violate 42 U.S.C. § 262(l)(8)(A) by not providing the required 180-day notice—without prejudice pursuant to Rule 41(a)(1)(A)(ii) of the Federal Rules of Civil Procedure. (Id.) Essentially, the parties have agreed that they will follow legal precedent set by Amgen v. Apotex Inc., No. 2016-1308, slip op. at 3–4 (Fed. Cir. July 5, 2016) (holding that “the commercial marketing provision is mandatory, with the 180-day period beginning only upon post-licensure notice.”). In light of these stipulations, the Court has dismissed Count XI. (D.I. 21.)

On October 31, 2016, the parties submitted a joint proposed case scheduling order, which proposed trial for the week of November 4, 2019. On November 1, the parties participated in a scheduling conference, after which the Court ordered the parties to submit a final proposed scheduling order.

We will continue to provide updates as the case develops.

Authors: Jenny Shmuel, Tucker Terhufen, Tasha Francis

The opinions expressed are those of the authors on the date noted above and do not necessarily reflect the views of Fish & Richardson P.C., any other of its lawyers, its clients, or any of its or their respective affiliates. This post is for general information purposes only and is not intended to be and should not be taken as legal advice. No attorney-client relationship is formed.

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Jenny Shmuel, Ph.D. | Principal

Jenny Shmuel, Ph.D., represents clients on a range of intellectual property matters, with an emphasis on medical device and pharmaceutical technologies. She has extensive experience in pre-suit diligence, case management, expert and fact discovery, and brief writing, and has examined and cross-examined witnesses at trial. Over the last several...