Apotex Countersues Amgen on Neulasta Biosimilar

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By John Aquino

Oct. 8 — Amgen's “sham” and baseless claims that Apotex's planned biosimilar of Amgen's Neulasta infringes patents violate antitrust laws, Apotex alleged in counterclaims filed Oct. 5 in federal district court (Amgen Inc. v. Apotex Inc., S.D. Fla., No. 0:15-cv-61631, filed 10/5/15).

Amgen sued Apotex Aug. 6 in the U.S. District Court for the Southern District of Florida, alleging that Apotex's biosimilar of Neulasta (pegfilgrastin) would infringe claims of two of its patents. The suit also said Apotex violated the Biologics Price Competition and Innovation Act (BPCIA) for failure to comply with the statute's notice of commercial marketing provision.

Apotex's countersuit denied the infringement and the BPCIA violation and made counterclaims of non-infringement, invalidity of one of the patents and unlawful monopolization in violation of the Sherman Act and the Clayton Act, 15 U.S.C. §2 and 15 U.S.C. §§15 and 26, respectively.

Neulasta is used to treat neutropenia, a lack of certain white blood cells caused by cancer chemotherapy.

Wants to Expedite Biosimilar Release

“Counterclaim Defendants have engaged in an overall predatory scheme to monopolize the relevant market through actions including, but not limited to, initiating objectively baseless and sham judicial proceedings designed to effectuate their monopoly of pegfilgrastin,” Apotex wrote.

By asserting that the BPCIA allows it not to give Amgen notice that it will market its Neulasta biosimilar, which would result in its having to delay release of its biosimilar for 180 days after Food and Drug Administration approval, Apotex is setting the stage for a planned release of the biosimilar on or near the FDA approval date.

The release of Sandoz's biosimilar of Amgen's Neupogen, which was the first approved under the BPCIA, was delayed for 180 days after FDA approval as a result of the U.S. Court of Appeals for the Federal Circuit's interpretation of the BPCIA in Amgen v. Sandoz (9 LSLR 828, 7/24/15).

A few days before Apotex's counterclaim filing over the Neulasta biosimilar, Amgen filed a similar but separate lawsuit in the same court against Apotex, alleging that its planned biosimilar of Amgen's cancer drug Neupogen infringes patents and violates the BPCIA.

A biosimilar is a biologic product that is approved for market by the FDA based on a showing that it is highly similar to an already-approved biologic product known as a reference product.

No Apotex Marketing Notice

In its Aug. 6 complaint, Amgen said Apotex had provided it with a copy of its biologic license application (BLA) for a Neulasta biosimilar and exchanged information on Amgen patents that the biosimilar could infringe in conformance with the BPCIA.

But Amgen also claimed that Apotex violated the statute by refusing to give Amgen an expected date when it would commercially market the biosimilar. The complaint included counts that Apotex's Neulasta biosimilar would infringe Amgen's U.S. Patent Nos. 6,162,427 and 8.952,138.

The Federal Circuit panel held in Sandoz that a biosimilar applicant can decide not to engage in the information exchanges, at which point the biologic reference product sponsor can file for infringement and a preliminary injunction against the release of the biosimilar.

The court also held that the 180-day notice period to the reference product sponsor (RPS) of the commercial marketing of the biosimilar doesn't begin until the FDA approves the biosimilar for market. Both Amgen and Sandoz have petitioned for an en banc (full court) hearing of the case.

Amgen alleged that Apotex told it in a letter that because it had agreed to comply with the information exchanges concerning its Neulasta biosimilar under the BPCIA, it could opt out of providing a notice of commercial marketing. This communication prompted Amgen's lawsuit.

Says Statute Supports Opting-Out

In its answer to Amgen's Aug. 6 complaint, Apotex supported its interpretation of the BPCIA by quoting 42 U.S.C. §262(l)(9)(B), which describes what actions an RPS may take when a biosimilar applicant fails to engage in the information exchanges.

Apotex said this section of the statute allows an applicant that provides the RPS with the required information to opt either to provide a notice of commercial marketing or face an action for a declaration of patent infringement. Any other interpretation would make subsection (l)(9)(B) superfluous, Apotex wrote.

Apotex also submitted affirmative defenses in its answer of non-infringement, invalidity and failure to state a claim upon which any relief can be based.

Patents Invalid, Not Infringed

In its counterclaim, Apotex noted that the '427 patent expires on Oct. 20, that it has notified Amgen that it won't begin commercial marketing of its Neulasta biosimilar until after that date and that therefore it won't infringe the '427 patent.

Apotex wrote that it won't infringe the '138 patent because that patent doesn't claim a method of manufacturing Apotex's Neulasta biosimilar, which requires a protein concentration that doesn't fall within the “2.0 g/L or greater” concentration claimed in the '138 patent.

The BLA provided to Amgen clearly indicated the details of the manufacture of Apotex's Neulasta biosimilar and showed that it isn't covered by the '138 patent, Apotex wrote.

Apotex also asserted that the claims of the '138 patent are invalid for “failure to comply with one or more of the conditions for patentability set forth in Title 35 of the United States Code.”

Sham Claims to Chill Competition

In spite of the proof it provided Amgen of non-infringement of Amgen's patents by its planned Neulasta biosimilar, Apotexwrote, Amgen filed “objectively baseless” infringement claims “for the purpose of significantly delaying Apotex's entry into relevant markets.”

Apotex said the “sham judicial proceedings” instituted by Amgen “are not a genuine effort to obtain an adjudication of a valid patent claim that is infringed; rather, they were instituted to achieve an unlawful objective to the detriment of competition in the relevant market” in violation of the Sherman and Clayton acts.

Apotex asked the court for declaratory judgments of non-infringement of the '138 patent; invalidity of the '138 patent; violation of Section 2 of the Sherman Act with an award to Apotex of its damages, treble damages, costs and reasonable attorneys' fees; a declaration that Apotex may elect not to provide Amgen with a notice of commercial marketing, subject only to the consequences of 42 U.S.C. §262(l)(9)(B); and a declaration that Amgen can't delay Apotex from beginning commercial marketing of its Neulasta biosimilar for the 180-day period after FDA approval.

An Amgen spokeswoman told Bloomberg BNA in an Oct. 8 e-mail that the company wouldn't comment on pending litigation.

The complaint was filed by Cozen O'Connor, West Palm Beach, Fla.

To contact the reporter on this story: John T. Aquino in Washington at jaquino@bna.com

To contact the editor responsible for this story: Randy Kubetin at rkubetin@bna.com

Apotex's answer and counterclaims are athttp://www.bloomberglaw.com/public/document/Amgen_Inc_et_al_v_Apotex_Inc_et_al_Docket_No_015cv61631_SD_Fla_Au/1.