Biosimilar Litigation: Genentech Avastin Suit Tossed; Janssen Remicade Case Uncertain

US court dismisses Genentech suit over Amgen's patent dance moves; Janssen v. Celltrion trial is postponed as parties fight over Janssen's standing to sue; and Amgen wants to bar AbbVie citizen petition filers from seeing its Amjevita information.

While industry eagerly awaits the Supreme Court's review of the biosimilars statute, companies are making various maneuvers in ongoing litigation.

Genentech Inc. was blocked in its move to get Amgen Inc. to turn over manufacturing process information for its biosimilar to Genentech's monoclonal antibody Avastin (bevacizumab), ABP 215. In a March 1 order, a district court judge granted Amgen's motion to dismiss Genentech's complaint but granted Genentech the opportunity to amend it within 45 days. The complaint is one of numerous suits between innovator and biosimilar applicants (see chart below).

Genentech, a unit of Roche, filed suit on Feb. 15 seeking a declaratory judgment that Amgen's failure to provide the information violated requirements of the Biologics Price Competition and Innovation Act. In 2015, the US Court of Appeals for the Federal Circuit ruled that engaging in the patent exchange process is optional. In that case Amgen sued Sandoz Inc. over Sandoz's failure to provide information about Zarxio (filgrastim-sndz), a biosimilar to Neupogen (filgrastim). But Genentech argued that since Amgen had begun the information exchange process, known as the "patent dance," it could not opt out of it (Also see "Amgen Can't Stop Avastin Biosimilar 'Patent Dance' After Opting In, Genentech Says" - Pink Sheet, 17 Feb, 2017.)

In a letter to the court, Amgen argued that the Federal Circuit's decision in Amgen v. Sandoz has no language to support this distinction and that the court's reasoning did not turn on whether Sandoz "opted in" or "opted out" of the exchange, but on its reading of the provision in context with other related provisions of the BPCIA.

In addition, Amgen said Genentech's position cannot be reconciled with the Federal Circuit's reasoning in Amgen v. Apotex that the procedures in the statute are designed to facilitate the "channeling of litigation and provide[ ] incentives for the applicant to proceed in those channels."

That case involved a dispute over the provision requiring a biosimilar applicant to provide 180-day notice of commercial marketing. The Federal Circuit ruled in Amgen v. Sandoz that the applicant could not provide notice until after approval. Apotex unsuccessfully argued that the requirement did not apply in its case since it had engaged in the patent dance. (Also see "Biosimilar Launch Notification Delay Remains In The US, Might Not Matter For Newer Products" - Pink Sheet, 7 Jul, 2016.)

The Supreme Court will hear oral arguments on both issues in the Zarxio case on April 26.

Patent Assignment Agreements Could Derail Remicade Suit

In other litigation, Celltrion Inc. and Pfizer Inc. have raised new arguments against Janssen Biotech Inc.'s suit claiming their Inflectra (infliximab-dyyb), a biosimilar to Remicade (infliximab), infringes Janssen's cell culture media patent, No. 7,598,083. A trial was scheduled to begin on Feb. 13 but was postponed to permit Celltrion and Pfizer to file a motion to dismiss for lack of jurisdiction and, possibly, limited additional discovery.

Celltrion and Pfizer contend that Janssen failed to join all co-owners of the '083 patent in either of its two complaints and therefore lacks standing. If a plaintiff fails to join all co-owners in a patent infringement action the case must be dismissed without prejudice (i.e., another suit can be filed) for lack of jurisdiction. Janssen filed its first complaint against Celltrion in March 2015 claiming Celltrion infringed several patents and failed to provide manufacturing process information. It filed the second complaint in June 2016 alleging infringement of the '083 patent based on new information about Celltrion's cell culture media. The two suits were consolidated.

Celltrion contends that one named inventor of the '083 patent did not assign patent ownership to Janssen until after Janssen filed the 2015 lawsuit and four other named inventors assigned their rights not to Janssen alone, but to the "Company," which means Centocor and Johnson & Johnson and other related entities.

The amount of damages Janssen could receive if Celltrion and Pfizer are found to infringe the '083 patent is also at stake.

In a Feb. 24 amended memorandum and order, Massachusetts District Judge Mark Wolf said Celltrion and Pfizer contend that under the BPCIA, dismissal without prejudice would limit plaintiff's potential damages to a reasonable royalty on the product covered by the '083 patent because any subsequent suit would be filed more than 30 days after the parties agreed to a list of patents that would be subject to an infringement action. But Janssen contends that the 30-day period never began running because defendants did not properly participate in the process prescribed by the BPCIA before the suit was filed.

At a hearing on Feb. 23, the judge ruled that even if Janssen loses on the standing issue it can refile a new suit and would be entitled to seek the recovery of all lost profits on Remicade sales. Pfizer launched Inflectra in November.

The parties are to report to the court by March 13 whether Celltrion and Pfizer seek discovery related to the issue of standing and whether Janssen agrees to provide it.

Biosimilar Suits
Case	Status
Sandoz v. Amgen (Neupogen/Zarxio) Supreme Court 15-1039 Amgen v. Sandoz Supreme Court 15-1195	Supreme Court to hear oral arguments April 26 on Sandoz's challenge of Federal Circuit ruling that 180-day biosimilar launch notification must be given after approval and Amgen's cross-petition for review of ruling that the patent information exchange process laid out in Biologics Price Competition and Innovation Act is optional.
Janssen v. Celltrion (Remicade) District of Massachusetts 15-cv-10698	Janssen claims Celltrion and Pfizer's Inflectra (infliximab-dyyb), a biosimilar to Remicade (infliximab), infringes its cell media culture patent. A trial scheduled to begin on Feb. 13 was postponed as the parties argue over Janssen's standing to sue.
Amgen v. Apotex (Neulasta and Neupogen) Southern District of Florida 15-cv-61631	Court ruled in September 2016 that Apotex's pegfilgrastim biosimilar, Lapelga, and its filgrastim biosimilar, Grastofil, do not infringe Amgen's manufacturing process patent. In a Feb. 15 order the court said Apotex was to receive $92,077.38 in litigation costs from Amgen; Apotex had sought $229,070.
Amgen v. Sandoz (Neulasta) Northern District of California 16-cv-02581 District of New Jersey 16-cv-1276	Amgen suit filed in Northern District of California in May 2016 alleging Sandoz's biosimilar to Neulasta (pegfilgrastim) infringes two patents is ongoing. Complaint filed in New Jersey district court in March 2016 sought declaratory judgment Sandoz failed to comply with "patent dance" requirements of the BPCIA. The court dismissed the complaint in July finding there was no case or controversy since Sandoz had complied with the provisions of the statute.
Amgen v. Hospira (Epogen) District of Delaware 15-cv-00839 Federal Circuit 16-cv-2179	Amgen claims Hospira's biosimilar to Epogen (epoeitin alfa) infringes two patents and has sought discovery to obtain information Hospira had declined to provide. Th district court denied the discovery request and Amgen appealed to the Federal Circuit, which is to hear oral arguments April 3. The infringement suit is ongoing in district court.
Immunex v. Sandoz (Enbrel) District of New Jersey 16-cv-01118	Amgen, its subsidiary Immunex, and Roche claim Sandoz's biosimilar to Enbrel (etanercept) infringes five patents that cover the active ingredient in Enbrel. The court held a Markman hearing on Feb. 15.
AbbVie v. Amgen (Humira) District of Delaware 16-cv-00666	AbbVie suit seeks ruling that Amgen's biosimilar to Humira (adalimumab), Amjevita, infringes one or more patents and an injunction enjoining AbbVie from manufacturing and selling its product.
Genentech v. Amgen (Avastin) District of Delaware 17-cv-00165	On March 1, the court granted Amgen's motion to dismiss the complaint and granted Genentech leave to amend it.

Barring Humira Info From Citizen Petition Filers

Meanwhile, citizen petitions have become an issue in AbbVie Inc.'s patent infringement suit against Amgen over its proposed biosimilar to AbbVie's Humira (adalimumab), Amjevita. Amgen filed suit in August claiming Amjevita infringes 61 of the more than 100 patents that cover Humira but limited the number to be litigated in the first wave of litigation to 10. (Also see "AbbVie v. Amgen Round One: Humira Biosimilar Infringes 10 Patents, Suit Claims" - Pink Sheet, 5 Aug, 2016.) FDA approved Amjevita (adalimumab-atto) in September.

In a Jan. 27 court filing, Amgen's attorney Melanie Sharp, of Young Conaway Stargatt & Taylor, says the company is proposing that persons exposed to Amgen confidential information be prevented from participating in filing a citizen petition with FDA. She notes that AbbVie has already filed three citizen petitions, including one concerning the interchangeability of a biosimilar product (here, Amjevita) with its reference product (here, Humira).

AbbVie filed a citizen petition in December 2015 arguing that biosimilar product sponsors seeking an interchangeability determination should be required to demonstrate interchangeability for all indications on the reference product label regardless of whether they are on the biosimilar label. (Also see "AbbVie Seeks Strict Interchangeability Standards For Biosimilars" - Pink Sheet, 31 Dec, 2015.)

"Consistent with its past behavior, AbbVie could file a CP seeking to direct the FDA to require, or weigh heavily, certain information when assessing interchangeability," Sharp said. "An AbbVie employee, lawyer or expert knowing the confidential information in Amgen's biosimilar submissions cannot simply forget the information when advising AbbVie on such a CP – the same reason prosecution bars are used."