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Discovery Disputes Related to Manufacturing in BPCIA Litigation

February 22, 2019

Discovery Disputes Related to Manufacturing in BPCIA Litigation

February 22, 2019

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Many reference product sponsors (“RPSs”) of biologic products have sought extensive patent protection for their manufacturing processes, and RPSs commonly assert those patents against biosimilar manufacturers in Biologics Price Competition and Innovation (“BPCIA”) litigation. Disputes over the scope of discovery for manufacturing information are therefore common and have included RPSs seeking manufacturing information from biosimilar manufacturers and biosimilar manufacturers seeking discovery from RPSs and even third parties, as discussed below.

Manufacturing patents are frequently at issue in BPCIA litigation. For example, about half of the 68 patents Genentech has asserted in recent BPCIA litigations are directed to manufacturing.[1] About half of the 18 patents that AbbVie has asserted in BPCIA litigation related to Humira® are directed to manufacturing.[2] And of the 6 patents asserted by Janssen in the BPCIA context, 4 patents have been directed to manufacturing.[3]

Litigants have frequently disputed what manufacturing information must be disclosed during discovery when manufacturing patents are asserted. These disputes have often begun at the very outset of a case. For example, RPSs have alleged in their complaints that, even when biosimilar manufacturers have produced their entire abbreviated Biologics License Applications (“aBLAs”), biosimilar manufacturers have withheld other manufacturing information and therefore allegedly failed to meet the requirements of (l)(2)(A). See e.g., Genentech v. Amgen 18-cv-00924 (D. Del.); AbbVie v. Sandoz 3-18-cv-12668 (D.N.J.).

During litigation, RPSs have moved to compel discovery of manufacturing information, both to assess infringement of the patents-in-suit and potential infringement of non-asserted patents in their portfolio. For example, Sandoz’s manufacturing information became the focus of a discovery dispute when Sandoz needed to change its manufacturing processes after receiving a Complete Response Letter from FDA. Amgen v. Sandoz, 3:14-cv-04741-RS (N.D.Cal.), dkt. 266 (Aug. 4, 2017). Amgen requested “documents that describe the existing and any proposed changes to the manufacturing and purification process for Sandoz’s pegfilgrastim product and documents that show when Sandoz expects to resubmit its aBLA.” Id. at 5. Because Amgen had only accused Sandoz’s anion exchange (AEX) chromatography purification step of infringement, Sandoz sought a protective order to “prevent[] Amgen from seeking discovery on Sandoz’s proposed, future response to the [Complete Response Letter]” beyond that AEX step. Id. The court limited Amgen’s discovery to changes in the anion exchange (AEX) step and noted that “Amgen offer[ed] no reason as to why limited discovery as to changes or modifications to the AEX step does not suffice.” Id. at 6 & dkt. 255.

Although Amgen did not appeal that adverse discovery ruling, it did appeal another one related manufacturing information. In late 2017, Sandoz moved for summary judgment of non-infringement with respect to Amgen’s asserted manufacturing patent, despite the fact that Sandoz planned to make changes to its manufacturing process “in 2018 or 2019.” 14-cv-04741 (N.D.Cal.), dkt. 325. Amgen requested that the Court delay its summary judgment ruling until Sandoz submitted its modified manufacturing process to FDA and produced the underlying documents to Amgen. Id. The district court found that the final process parameters that Amgen sought were “not material to the finding of non-infringement,” and went on to grant summary judgment of non-infringement. Id at dkt. 346 (Dec. 19, 2017). Amgen appealed the district court’s refusal to delay ruling on summary judgment until Amgen could obtain further discovery. On appeal, Amgen argues that “without the discovery that Amgen seeks, Amgen cannot determine the details of the modified process as approved by the FDA (when/if it is approved by the FDA) and thus can only give a preliminary infringement analysis.” Reply Brief for Appellant at 21, No. 18-1551 (Fed. Cir. 2018). Oral argument in this appeal is scheduled for March 4, 2019.

In Amgen v. Hospira, Amgen sought discovery of cell culture information even though it was not related to any patent-in-suit, claiming that Amgen needed the discovery to assess potential infringement of other patents. 866 F.3d 1355 (Fed. Cir. 2017). Amgen asserted it was entitled to the discovery because Hospira failed to disclose all manufacturing information during the patent dance and therefore Amgen had been unable to list cell culture patents on its 3(A) list or assert them in the first wave of litigation. Id. The Federal Circuit ultimately affirmed the district court’s denial of Amgen’s motion to compel that discovery. The Federal Circuit also suggested that future litigants should list potentially assertable patents on 3(A) lists during the patent dance even if they do not have all the information needed to be sure of infringement. Id.

Biosimilar manufacturers have also sought manufacturing information from RPSs. In Amgen v. Sandoz, Sandoz sought discovery into “the manner in which [RPS] Amgen has purified Neupogen and how Amgen has used the invention claimed in the [asserted] patent.” 3:14-cv-04741-RS (N.D.Cal.), dkt. 163, at 2 (Mar. 14, 2016). Sandoz argued that the requested information could be evidence of prior art, obviousness, and non-infringing alternatives, and could reflect the value of the invention, impact the reasonable royalty analysis, and bear on infringement. Id. at 2-3. Amgen countered that the requests were overbroad, burdensome, and privileged, and questioned the relevance of Amgen’s confidential alternative means of purifying Neupogen®. Id. at 4-5. The court generally sided with Sandoz, ordering Amgen to “produce documents showing how it purified all Neupogen that had been commercially sold and not just the method it ‘currently uses’”; “produce the Chemistry, Manufacturing & Controls (‘CMC’) sections from its regulatory submissions for each approved or unapproved product for which Amgen has used a process claimed in the [asserted] patent”; and provide “narratives” in response to interrogatories seeking related information. Id., dkt. 165. Other biosimilar manufacturers have been less successful in seeking such discovery from RPSs. See, e.g., Genentech v. Celltrion 1:18-cv-00574 (D.N.J.), dkt. 128 (Sep. 10, 2018) (rejecting a biosimilar manufacturer’s request for RPS manufacturing information as “not related to the product at issue,” “twelve years old,” containing a “proprietary manufacturing process” and “not pertinent to the preliminary injunction motion for which the current discovery is limited.”).

BPCIA litigants have also targeted confidential manufacturing information of third parties. In Janssen v. Celltrion, Celltrion, to support its non-infringing alternatives arguments, sought discovery of the cell-culture medium that third party Biogen used to manufacture its competing infliximab biosimilar. 1:17-cv-11008 (D.Mass.), dkt. 128 (Dec. 29, 2017). Biogen opposed the discovery, noting that the information contained highly confidential competitive information that was of little relevance, if any, to the non-infringing alternatives available to Celltrion. Id., dkt. 141. The court agreed with Biogen, largely rejecting Celltrion’s discovery request, except for a limited deposition. Id. at dkt. 182.

These cases highlight how discovery related to manufacturing has become central to many BPCIA disputes. They also indicate that a biosimilar manufacturer should expect that RPSs will seek manufacturing information early and often, and illustrate how biosimilar manufacturers explore discovery into manufacturing processes, both of the reference biologic at issue and other products. It will be interesting to see if, against this backdrop, biosimilar manufacturers seek and assert their own manufacturing patents as leverage and protection against RPSs’ patents or against fellow biosimilars.

Note that at least one biosimilar manufacturer—Boehringer Ingelheim (“BI”)—has tried to push back against a RPSs’ assertion of manufacturing patents. AbbVie Inc., et al v. Boehringer Ingelheim, 1:17-cv-01065 (D.Del.), dkt. 269 (Nov. 7, 2018). BI claimed that RPS AbbVie created a “vast thicket of dubious, overlapping patents designed to prevent competition in adalimumab, including patents targeting existing manufacturing processes and observations about routine aspects of adalimumab’s manufacture.” Id. BI claimed that AbbVie therefore had “unclean hands,” a defense which BI is still asserting in that case. Id. We will continue to monitor this and other disputes related to biologic manufacturing patents in BPCIA litigation.

[1] Genentech v. Amgen, 1:17-cv-0140 (D. Del.); Genentech v. Amgen, 1:17-cv-01471-CFC (D. Del.); Genentech v. Pfizer, 1:17-cv-01672 (D. Del.); Genentech v. Sandoz, 1:17-cv-13507 (D. N.J.); Genentech v. Celltrion, 1:18-cv-00095 (D. Del.); Genentech v. Celltrion, 1:18-cv-01025 (D. Del.); Genentech v. Celltrion, 1:18-cv-00574 (D. N.J.); Genentech v. Amgen, 1:18-cv-00924 (D. Del.); Genentech v. Celltrion, 1:18-cv-11553 (D. N.J.)

[2] AbbVie v. Amgen, 1:16-cv-00666 (D. Del.); AbbVie v. Sandoz, 3:18-cv-12668 (D. N.J.); AbbVie v. Boehringer, 1:17-cv-01065 (D. Del.)

[3]  Janssen v. Celltrion, 1:15-cv-10698 (D. Mass.); Janssen v. Hyclone, 1:16-cv-00071 (D. Utah); Janssen v. Celltrion, 1:16-cv-11117 (D. Mass.); Janssen v. Samsung, 2:17-cv-03524 (D. N.J.); Janssen v. Celltrion, 1:17-cv-11008 (D. Mass.)


Authors: Bobby Hampton, Jenny Shmuel, 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.

Blog Authors

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...