Sandoz International GMBHis trying to bypass the complicated process for resolving biosimilar patent disputes and get a court ruling that its candidate biosimilar to Amgen Inc.’s Enbrel (etanercept) does not infringe patents Amgen licensed from Roche. While the court tossed out Sandoz’s suit the company recently appealed the decision to the U.S. Court of Appeals for the Federal Circuit.

The case is the first sign of the battles that lie ahead in biosimilar patent litigation. Kurt Karst, of Hyman, Phelps & McNamara, noted in an FDA Law Blog post that the dismissal of Sandoz’s suit is the first decision interpreting the patent resolution provisions in the Biologics Price Competition and Innovation Act, which created a pathway for approval of biosimilar versions of brand-name products. The statute, included in the Affordable Care Act, delineates actions that biosimilar applicants and patent holders must carry out to challenge and defend a patent.

Asked if the case was an indication of things to come, Karst said “if the Federal Circuit agrees with the district court, no. If they strike [the decision] down I think you could see folks trying to do this.”

On June 24, Sandoz filed a complaint for a declaratory judgment of patent invalidity and non-infringement of two Roche patents that Amgen licensed. The Patent and Trademark Office issued one of the patents, 8,063,182, in November 2011 and the other, 8,163,522, in April 2012. The complaint says the patents were issued without prior notice to the public based on unpublished patent applications filed in May 1995.

People following the biosimilars field were stunned when Amgen announced the issuance of the ‘182 patent, saying that it could have a potentially devastating impact for those pursuing Enbrel biosimilars. The patent could extend Enbrel patent protection until November 2028 or longer if the patent qualifies for patent-term extension Also see "Amgen’s Stealth Enbrel Patent May Block Biosimilars; Scenario May Apply To Other Biologics" - Pink Sheet, 5 December, 2011..

Enbrel, a blockbuster treatment for rheumatoid arthritis and psoriasis, had total sales of $1.15 billion in the third quarter of 2013.

Sandoz Says Submarine Patents Put Its Investments At Risk

Sandoz said it began developing a biologic drug containing etanercept to compete with Enbrel in 2004 and since then has devoted tens of millions of dollars for its development. The company has a product in a Phase III trial being conducted outside the U.S. In its complaint Sandoz noted when it expects to file an application and obtain FDA approval but those dates were redacted.

“The issuance of the ‘182 and ‘522 patents disrupted nine years of Sandoz’s settled expectations regarding its rights to develop and ultimately commercialize its etanercept product,” the complaint states. “The emergence of these submarine patents has placed Sandoz in a position of either proceeding with its commercialization plans and facing a patent lawsuit, or abandoning its extensive product development activities and millions of dollars in investments.”

But Amgen and Roche argued in a motion to dismiss the suit that it is premature since Sandoz is just beginning a Phase III clinical trial and many uncertainties remain as to whether its alleged biosimilar will ever be approved and ready to market in the U.S.

“It is the FDA-approved product that will define the scope of any eventual patent dispute between the parties, not the clinical candidate,” their motion states. “Depending on the degree to which an FDA-approved product differs from its clinical candidate (e.g., in structure, formulation, methods of manufacture and administration, and indications) a suit now may be an inefficient use of the courts resources and/or involve the parties in needless litigation.”

The filing also cites a “Pink Sheet” article in which the head of biopharmaceuticals at Sandoz said the Roche patents would not change Sandoz’s investment strategy. The Sandoz executive, Ameet Mallik, said the company believes it has a good faith legal basis to challenge the validity of the patents and “wouldn’t do this if we didn’t think we had a good case” Also see "Sandoz Biosimilar Strategy For Etanercept: Start Small, But Test Globally" - Pink Sheet, 22 July, 2013..

Court Cites Biosimilars Litigation Timeline

U.S. District Judge Maxine Chesney, of the Northern District of California, agreed with Amgen and Roche that a district court lacks statutory authority to consider a patent dispute involving a biosimilar product until an application for FDA approval of the product has been filed and that a cognizable case or controversy does not presently exist.

In a Nov. 12 order granting their motion to dismiss, Chesney cited the provisions of the biosimilars statute regarding the timing of litigation arising from the filing of a biosimilars application.

“Specifically, with limited exceptions not applicable here, neither a reference product sponsor, such as Amgen, nor an applicant, such as Sandoz, may file a lawsuit unless and until they have engaged in a series of statutorily-mandated exchanges of information.”

The statute requires a biosimilar applicant to provide the reference product sponsor with a copy of the application and information describing its manufacturing processes within 20 days after the application is accepted for review. The reference product sponsor must then provide the applicant with a list of patents for which it believes it could assert a claim of infringement. The applicant, in turn, must respond stating why the patents are invalid, unenforceable or would not be infringed by its biosimilar or that it does not intend to begin marketing its product before the patents expire.

The parties must then negotiate which patents will be the subject of an infringement action. The reference product sponsor must then bring an infringement complaint on all these patents either 30 days after the agreement or, if no agreement is reached, 30 days after an exchange of lists. And the biosimilars applicant must notify the reference product sponsor of its commercial marketing 180 days before launch ([A#00720180005_01]).

Chesney said Sandoz cannot have provided “a notice of commercial marketing” since its etanercept product is not licensed under the statute. In addition, she said Sandoz has not established that it faces a real and immediate injury or threat of injury from Amgen and Roche.

“Finally, Sandoz’s allegation that it intends in the future to file an application with the FDA is insufficient to create a case or controversy,” she stated.

Sandoz Still Trying To Sneak Past Amgen’s Stealth Enbrel Patents

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