Big Molecule Watch

(1) Amgen v. Sandoz

No. 3:14-cv-04741-RS (N.D. Cal.): On October 24, 2014, Amgen filed a complaint alleging that Sandoz had violated the BPCIA (1) by not providing its application and manufacturing information within 20 days of FDA acceptance as “required” under the first step of the patent dance set forth in subsection (l)(2)(A) of the BPCIA, and (2) by providing a purported notice of commercial marketing under subsection (l)(2)(A) of BPCIA before FDA had approved the application. Amgen asked the court to order Sandoz to follow the pathway set out in the BPCIA. On March 19, 2015, the District Court issued an order ruling in favor of Sandoz that the patent dance steps are not mandatory, and that biosimilar applicants do not have to wait for FDA approval before they can provide sufficient notice of commercial marketing. Amgen appealed, but ultimately the Supreme Court and Federal Circuit ruled in Sandoz’s favor.

In July 2017, the district court declined to stay discovery on the expected approval, marketing, and sales of Sandoz’s proposed pegfilgrastim product.

The case was coordinated with the Amgen v. Sandoz pegfilgrastim matter.

On December 19, 2017, the district granted Sandoz’s motion for summary judgment of non-infringement of the sole remaining patent-in-suit regarding both Sandoz’s filgrastim and pegfilgrastim biosimilars. Amgen’s appeal is pending.

No. 15-1499: On July 21, 2015, the Federal Circuit, in a split panel decision, ruled: (1) in Sandoz’s favor (affirming the District Court) that the disclosures set forth in subsection (l)(2)(A) of the BPCIA are not mandatory and that the statute allows a biosimilar applicant to choose between either disclosing its subsection (k) application and manufacturing information, or not disclosing such information and instead facing an immediate infringement action from the reference product sponsor; and (b) in Amgen’s favor (reversing the District Court) that a notice of commercial marketing pursuant to subsection (l)(9)(A) of the BPCIA can be given only after FDA approval of the biosimilar product. In light of its interpretation of the “notice of commercial marketing” provision and its ruling in favor of Amgen, the Federal Circuit extended the injunction against Sandoz through September 2, 2015 (180 days after Sandoz received approval and provided an effective post-licensure notice of commercial marketing). Subsequently, however, the Supreme Court reversed in part and remanded.

On December 15, 2017, upon remand from the Supreme Court, the Federal Circuit held that Amgen’s state law claims, based on the failure to follow procedures of the BPCIA patent dance, were preempted by Federal law on both field and conflict grounds.

No. 18-1551: On February 5, 2018, Amgen appealed to the Federal Circuit from the District Court’s judgment of non-infringement. The parties are in the process of completing the appellate briefing.

Nos. 15-1039, -1195: On February 16, 2016, Sandoz filed a petition for certiorari, asking the Supreme Court to review the Federal Circuit’s interpretation of the BPCIA’s “notice of commercial marketing” provision. On March 21, 2016, Amgen opposed Sandoz’s petition and also filed a conditional cross-petition for certiorari, challenging the Federal Circuit’s ruling that a biosimilar applicant is not required by the BPCIA to disclose a copy of its aBLA and related manufacturing information. On January 13, 2017, the Supreme Court granted both cert petitions, and on April 26, 2017, held oral argument. On June 12, 2017, the Supreme Court issued its opinion, holding that notice of commercial marketing may be given prior to FDA approval and that no injunction is available under federal law to force compliance with the patent dance. The Court declined to resolve, and remanded to the Federal Circuit, the question of whether an injunction might be available under state law, but questioned whether such a state-law injunction might be preempted by federal law.

(2) Amgen v. Apotex

No. 15-62081-JIC (S.D. Fla.): BPCIA complaint filed October 2, 2015. In November 2015, the case was consolidated into the Amgen v. Apotex pegfilgrastim litigation, where the district court entered judgment of non-infringement with respect to Apotex’s filgrastim and pegfilgrastim products. Amgen has appealed. See the summary below of the Amgen v. Apotex pegfilgratim litigation for more details.

No. 17-1010: See the summary below of the Amgen v. Apotex pegfilgratim litigation for more details.

(3) Amgen v. Adello

No. 18-3347-JMV-SCM (D.N.J.): BPCIA complaint filed March 8, 2018. On June 15, 2018, the parties submitted a joint proposed discovery plan.

(1) Amgen v. Apotex

No. 15-61631-JIC (S.D. Fla.): BPCIA complaint filed August 6, 2015. In November 2015, the Amgen v. Apotex filgrastim litigation (discussed above) was consolidated into this case. On December 10, 2016, the district court preliminarily enjoined Apotex from launching its pegfilgrastim biosimilar product until 180 days after it provides a post-licensure notice of commercial marketing. After holding a bench trial in July 2016, the district court (1) granted Amgen’s motion for judgment on partial findings with respect to each of Apotex’s invalidity defenses except for non-enablement, (2) entered judgment of non-infringement in Apotex’s favor, and (3) reserved judgment on Apotex’s non-enablement defense by dismissing Apotex’s invalidity counterclaim without prejudice. The patent-in-suit is also the subject of a pending IPR petition.

No. 16-1308: Apotex appealed from the District Court’s grant of a preliminary injunction. On July 5, 2016, the Federal Circuit affirmed the District Court’s ruling, and, on August 11, 2016, issued its mandate. Apotex filed a petition for certiorari, which was denied.

No. 17-1010: On October 3, 2016, Amgen appealed to the Federal Circuit from the District Court’s judgment of non-infringement. The Court heard oral argument on October 3, 2017.  On November 13, 2017, a Federal Circuit panel affirmed the District Court’s judgment in favor of Apotex.

No. 16-332: On September 9, 2016, Apotex filed a petition for certiorari, asking the Supreme Court to review the Federal Circuit’s application of its Amgen v. Sandoz decision to Apotex, as well as its interpretation of the BPCIA’s “notice of commercial marketing” provision. The Biosimilars Council and Mylan filed amicus briefs in support of Apotex. Briefing on the petition concluded on November 21, 2016. On December 12, 2016, the Supreme Court denied Apotex’ petition.

(2) Amgen v. Sandoz

No. 16-1276-SRC-CLW (D.N.J.): On March 4, 2016, Amgen filed a complaint against Sandoz seeking a declaratory judgment that Sandoz violated the BPCIA by attempting to unilaterally waive steps of the patent dance. Sandoz later restarted the patent dance negotiations, and this complaint was dismissed.

No. 3:16-cv-02581-RS (N.D. Cal.): BPCIA complaint filed on May 13, 2016. The case was coordinated for discovery the Amgen v. Sandoz filgrastim matter, discussed above. On December 19, 2017, the district granted summary judgment of non-infringement in favor of Sandoz regarding both its filgrastim and pegfilgrastim biosimilars. Amgen’s appeal is pending.

No. 18-1552: On February 5, 2018, Amgen appealed to the Federal Circuit from the District Court’s judgment of non-infringement. This appeal was consolidated into 18-1551, discussed above (see filgrastim cases).

(3) Amgen v. Coherus

No. 17-546-LPS (D. Del.): BPCIA complaint filed May 10, 2017. Amgen alleged infringement of one patent. On March 27, 2018, consistent with a prior recommendation from the magistrate judge, the district court granted Coherus’s motion to dismiss the complaint for failure to state a plausible claim of infringement. Amgen’s appeal is pending.

(4) Amgen v. Mylan

No. 17-1235-MRH (W.D. Pa.): BPCIA complaint filed September 22, 2017, alleging infringement of two patents. On April 6, 2018, Mylan moved for judgment on the pleadings with respect to one of the patents-in-suit.

(1) Janssen v. Celltrion

Janssen v. Celltrion, No. 15-10698-MLW (D. Mass.): BPCIA complaint filed March 6, 2015. On May 21, 2016, the District Court denied a motion by Janssen to stay the litigation, but granted Janssen’s motion to amend the protective order to permit it to file a new case against HyClone, the third-party cell culture media supplier for Celltrion’s biosimilar product, based on information produced by Celltrion under the protective order. In August 2016, the District Court granted Celltrion’s motion for summary judgment that all claims of the ’471 patent are invalid for obviousness-type double patenting, based on multiple reference patents. On September 26, 2016, the District Court entered partial final judgment of invalidity with respect to the ’471 patent, and Janssen has appealed to the Federal Circuit. The defendants moved for summary judgment of non-infringement of the ’083 patent, the sole remaining patent-in-suit. On December 22, 2016, the district court denied the summary judgment motion as to Celltrion, but requested additional briefing with respect to Hospira. On February 22, 2017, Celltrion moved to dismiss for lack of standing to bring the suit, a motion which the parties recently completed briefing. On March 3, 2017, the court issued a memorandum and order providing guidance regarding the standards for determining damages in the litigation. The original jury trial date of February 13, 2017 has been postponed. This case has been dismissed without prejudice, in favor of the new action, Civil Action No. 17-11008, discussed below.

Janssen v. Celltrion, No. 16-11117-MLW (D. Mass.): Complaint filed June 14, 2016 for infringement of ’083 patent based on cell culture media. This action is consolidated into the 15-10698 action. This case has been dismissed without prejudice, in favor of the newly filed action, Civil Action No. 17-11008, discussed below.

Janssen v. HyClone, No. 16-00071-BCW (D. Utah): Complaint filed June 14, 2016 for infringement of ’083 patent based on cell culture media. On August 5, 2016, HyClone moved to dismiss the complaint and stay the litigation. This case has been stayed pending resolution of the D. Mass. cases.

Janssen v. Celltrion, No. 17-11008-MLW (D. Mass.): Complaint filed May 31, 2017 for infringement of ’083 patent, after Celltrion allegedly attempted to reengage in negotiations under 42 U.S.C. § 262(l)(4). The prior D. Mass. litigations (15-10698 and 16-11117) were dismissed without prejudice in favor of this action. On October 31, 2017, the district court denied Celltrion’s motion to dismiss for lack of standing. On April 6, 2018, Celltrion moved for summary judgment of non-infringement based on the legal doctrine of ensnarement; the Court held a summary judgment hearing on June 12-13, 2018, but did not decide the motion. On May 4, 2018, Janssen and Celltrion filed competing motions for partial summary judgment regarding the issue of non-infringing alternatives, for purposes of determining potential damages. In May 2018, the parties filed approximately two dozen pretrial motions. The Court is still considering the summary judgment motions but reportedly “has indicated it is giving serious consideration to granting the Defendants’ summary judgment motion” regarding ensnarement. The Court has ordered that, in the event that motion is denied, trial will commence on August 27, 2018.

No. 17-1120: On October 24, 2016, Janssen filed a notice of appeal to the Federal Circuit from the District Court’s partial final judgment of invalidity with respect to the ’471 patent, based on double patenting. On January 23, 2018, the Federal Circuit dismissed Janssen’s appeal as moot, upon affirming the decision in a related appeal (No. 17-1257) from an ex parte reexamination ruling by the USPTO that the ’471 patent’s claims are unpatentable for double patenting.

(2) Janssen v. Samsung Bioepis

No. 17-3524-MCA-SCM (D.N.J.): BPCIA complaint filed May 17, 2017. Janssen’s complaint alleged (a) infringement by Samsung Bioepis of three patents, including the ’083 patent, which is also in suit in the Janssen v. Celltrion case, and (b) violations by Samsung Bioepis of the BPCIA (1) by refusing to produce its aBLA or engage in the patent dance, and (2) by providing a purported “notice of commercial marketing” prior to receiving FDA approval.  After withdrawing its BPCIA violation claims as moot in September 2017, Janssen voluntarily dismissed its patent infringement claims on November 10, 2017.   On November 30, 2017, the Court dismissed the suit with prejudice.

(1) Amgen v. Hospira

No. 15-839-RGA (D. Del.): BPCIA complaint filed September 18, 2015. In May 2016, the District Court denied Amgen’s motion to compel Hospira to produce manufacturing information and correspondence with FDA, finding that Amgen had not shown that the information sought was relevant to the charges of infringement of the asserted patents. On August 5, 2016, the District Court denied a motion by Hospira to dismiss count I of Amgen’s complaint regarding Hospira’s alleged failure to comply with the BPCIA’s notice of commercial marketing provision. On October 3, 2016, the District Court issued an order granting-in-part and denying-in-part a motion by Amgen to amend its complaint. On May 26, 2017, Amgen moved for a preliminary injunction to enjoin Hospira from launching its biosimilar “until Hospira has complied with the requirement of 42 U.S.C. § 262(l)(8)(A),” but withdrew the motion on July 12, 2017. Prior to trial, the district court denied Hospira’s motion for summary judgment of non-infringement.  In September 2017, the case was tried to a jury, which (1) found that Hospira’s manufacture of 14 of 21 accused batches of drug substance infringed one of the patents-in-suit, (2) found that the infringed patent was not invalid, and (3) awarded Amgen $70 million in damages.  Hospira has since moved for judgment as a matter of law of, among other things, no infringement, and Amgen has filed its own motion seeking judgment as a matter of law of infringement of the patent the jury found was not infringed.  The parties have completed briefing, but the Court has not yet ruled on the motions.

No. 16-2179: Amgen appealed from the denial of its motion to compel. On August 12, 2016, the Federal Circuit denied a motion by Hospira to dismiss Amgen’s appeal and ordered the parties to address both the merits of the discovery dispute and the issue of jurisdiction in their briefs. The parties completed briefing the appeal in November 2016, and the Federal Circuit held oral argument on April 3, 2017. On August 10, 2017, the Federal Circuit dismissed Amgen’s appeal.

(1) Immunex v. Sandoz

No. 16-01118-CCC-JBC (D.N.J.): BPCIA complaint filed February 26, 2016. On August 11, 2016, the District Court entered a scheduling order and a consent preliminary injunction that enjoins Sandoz from making, using, importing, offering to sell, or selling its product, “except as allowed by 35 U.S.C. § 271(e)(1).” Amgen has moved for summary judgment of infringement.  A trial is scheduled for September 11, 2018.

(1) AbbVie v. Amgen

No. 16-666-MSG (D. Del.): BPCIA complaint filed August 4, 2016. AbbVie asserted 10 patents as part of the first wave litigation but, according to its complaint, had identified 51 other patents that it could assert against Amgen in a second wave litigation. On September 28, 2017, Amgen announced that it had settled this litigation and expected to launch Amjevita™ in the United States on January 31, 2023. The case was dismissed by the Court that same day.

(2) AbbVie v. Boehringer Ingelheim

No. 17-1065-SLR (D. Del.): BPCIA complaint filed August 2, 2017. AbbVie is asserting 8 patents as part of the first wave litigation but, according to its complaint, has identified 66 other patents that it could assert against BI in a second wave litigation. The court has entered a scheduling order under which expert discovery will close on May 29, 2020, and the court will hold an in-person status conference on June 4, 2020, during which a schedule for dispositive motions and trial will be discussed. In June 2018, the court issued several discovery orders addressing disputes raised by the parties.

(1) Genentech v. Amgen

Genentech v. Amgen, No. 17-165-GMS (D. Del.): On February 15, 2017, Genentech filed a complaint for declaratory judgment against Amgen alleging certain violations of the patent dance provisions of the BPCIA following FDA’s acceptance of Amgen’s aBLA. On March 1, 2017, the court dismissed Genentech’s complaint without prejudice.

Amgen v. Genentech, No. 17-7349-GW-AGR (C.D. Cal.): On October 6, 2017, Amgen filed a complaint for declaratory judgment against Genentech of non-infringement, invalidity and/or unenforceability of the 27 patents that Genentech had allegedly listed on its (l)(3)(A) list.  On February 2, 2018, the Court granted Genentech’s motion to dismiss the complaint for lack of subject matter jurisdiction.

Genentech v. Amgen, Nos. 17-1407-GMS & 17-1471-GMS (D. Del.): On October 6, 2017, Genentech filed a complaint for patent infringement under the BPCIA against Amgen, alleging infringement of 24 patents (all of which were included in Amgen’s complaint) (17-1407). On October 18, 2017, Genentech filed a second complaint for patent infringement under the BPCIA against Amgen, alleging infringement of 25 patents (adding one additional patent to the previously asserted 24 patents) (17-1471). The first action (17-1407) includes claims asserting direct infringement, whereas the second action (17-1471) includes claims brought on the basis of Amgen’s technical act of infringement by filing of its aBLA. On January 22, 2018, the court denied Amgen’s motions to transfer these cases to the Central District of California. On May 1, 2018, Amgen answered the complaint and alleged counterclaims. On May 22, 2018, Genentech moved to dismiss certain counterclaims and refiled the motion papers on June 19, 2018, after Amgen amended its answer and counterclaims on June 5, 2018.   A 15-day trial is scheduled for July 13, 2020.

(1) Genentech v. Pfizer

Genentech v. Pfizer, No. 17-1672-GMS (D. Del.): BPCIA complaint filed Nov. 17, 2017, alleging infringement of 40 patents.

(2) Genentech v. Celltrion

Celltrion v. Genentech, No. 18-274-JSW (N.D. Cal.): On January 11, 2018, Celltrion and Teva filed a complaint and on February 8, 2018 filed an amended complaint for declaratory judgment against Genentech of non-infringement, invalidity and/or unenforceability of the 38 patents.  On May 9, 2018, the court dismissed this action.

Genentech v. Celltrion, No. 18-095-GMS (D. Del.): On January 12, 2018, Genentech filed a complaint for patent infringement under the BPCIA against Celltrion and Teva, alleging infringement of 40 patents. On May 29, 2018, Celltrion and Teva answered the complaint and alleged counterclaims (amended on July 3, 2018). On June 19, 2018, Genentech moved to dismiss certain counterclaims.

Genentech v. Celltrion, No. 18-1025 (D. Del.): On July 11, 2018, Genentech filed a new complaint alleging infringement of the same 40 patents.

(3) Genentech v. Amgen

Celltrion v. Amgen, No. 18-924-GMS (D. Del.): On June 21, 2018, Genentech filed a complaint for patent infringement under the BPCIA against Amgen, alleging infringement of 37 patents.

(1) Genentech v. Sandoz

Genentech v. Sandoz, No. 17-13507-RMB-KMW (D.N.J.): BPCIA complaint filed Dec. 21, 2017, alleging infringement of 24 patents. In January and February 2018, the various Sandoz defendants answered the complaint. In March, April and May 2018, the parties and the court were in discussions about a preliminary injunction briefing schedule, but, based on the public docket, those discussions appear to have been put on hold. On July 3, 2018, the parties submitted a proposed case schedule. A trial is scheduled for July 10, 2020.

(2) Genentech v. Celltrion

Celltrion v. Genentech, No. 18-276-JSW (N.D. Cal.): On January 11, 2018, Celltrion and Teva filed a complaint and on February 8, 2018 filed an amended complaint for declaratory judgment against Genentech of non-infringement, invalidity and/or unenforceability of the 37 patents.  On May 9, 2018, the court dismissed this action.

Genentech v. Celltrion, No. 18-574-RMB-KMW (D.N.J.): On January 12, 2018, Genentech filed a complaint for patent infringement under the BPCIA against Celltrion and Teva, alleging infringement of 40 patents. On June 13, 2018, Celltrion and Teva answered the complaint and alleged counterclaims. On July 5, 2018, Genentech amended its complaint to allege infringement of 18 patents. An initial scheduling conference is scheduled for August 2, 2018.

Genentech v. Celltrion, No. 18-11553-RMB-KMW (D.N.J.): On July 11, 2018, Genentech filed a new complaint alleging infringement of the same 18 patents.