Monday, June 12, 2017

U.S. Supreme Court Issues Opinion in Sandoz v. Amgen: A Big Win for Sandoz and Other Biosimilar Applicants.

The U.S. Supreme Court released its much-anticipated ruling today in the battle between Sandoz and Amgen over Amgen’s biosimilar version of Sandoz’s Neupogen (filgrastim).  Justice Thomas’s opinion for a unanimous Court was an almost total victory for Amgen. Justice Breyer issued a very brief one-page opinion concurring in the decision but expressing his view that in future cases deference should be given to the FDA’s reasonable interpretation of the Biologics Price Competition and Innovation Act of 2009 (the Act).

There were two major issues decided by the Court today. The first was whether or not Sandoz fulfilled the 180-day notice requirement of the Act when it delivered its original 180-day notice of its intent to market a biosimilar filgrastim at the time of filing its application with the FDA. The second major issue decided was whether the Act’s elaborate provisions providing for exchanges of information (the “patent dance”) is mandatory. In the patent dance the specifying the biosimilar applicant can provide its manufacturing information to the reference drug sponsor followed the reference drug sponsor’s provision of  lists of patents it claims are infringed by the biosimilar applicant

The answer to both these questions favored Sandoz. The original 180-day notice of intent to market that Sandoz provided at the time of filing its original application with the FDA was sufficient.  No subsequent, second such notice was required. The relevant language of the opinion on that clause is:

The Federal Circuit held that an applicant’s biosimilar must already be “licensed” at the time the applicant gives notice. 794 F. 3d, at 1358.
We disagree. The applicant must give “notice” at least 180 days “before the date of the first commercial marketing.”

The provision of manufacturing information by the biosimilar applicant and patent lists by the reference drug sponsor is not mandatory. The remedy for the biosimilar applicant’s failure to provide the information  that the Act provides is that the filing of the biosimilar application is an act of infringement enabling the reference drug sponsor to file suit. Here is the relevant language of that portion of the opinion.

Clause (ii) of §271(e)(2)(C), in contrast, defines artificial infringement in the situation where an applicant fails to disclose its application and manufacturing information altogether and the parties never prepare the §262(l)(3) lists. That clause provides that the submission of the application represents an act of artificial infringement with respect to any patent that could have been included on the lists.

The Court did, however, leave a very small opening for Amgen to snatch victory from the jaws of defeat. While Amgen was not entitled to an automatic injunction under the biosimilar Act, on remand the U.S. District Court must determine (again, from Justice Thomas’s opinion):

whether California law would treat noncompliance with §262(l)(2)(A) as “unlawful.” If the answer is yes, then the court should proceed to determine whether the BPCIA pre-empts any additional remedy available under state law for an applicant’s failure to comply with §262(l)(2)(A) (and whether Sandoz has forfeited any pre-emption defense, see 794 F. 3d, at 1360, n. 5). The court is also of course free to address the pre-emption question first by assuming that a remedy under state law exists.

I would predict the District Court will not issue an injunction based on California law and Amgen’s only recourse is to continue with its infringement suit.

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