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Sandoz v. Amgen concerned the interpretation of two procedural provisions of the BPCIA setting the framework for biosimilar patent litigation. Essentially, the BPCIA (codified at 42 USC s. 262(l)(2)(A)) states that once the FDA accepts an application for a biosimilar drug, that the biosimilar applicant “shall provide” the brand/reference drug maker, within 20 days, a copy of the application and information about the biosimilar and its manufacturing. Now, this initial disclosure starts an exchange that essentially boils the patent dispute down to 2 lists. Now, the first list is a shortlist of patents to be litigated immediately, and the patents on the second list aren’t litigated until the biosimilar applicant provides notice of commercial marketing to the reference drugmaker. Now, under BPCIA (as codified at 42 USC 262(l)(8)(A)), the biosimilar applicant “shall provide” notice of commercial marketing not less than 180 days before marketing of an FDA-licensed biosimilar.

So, the Sandoz holding is fairly clear on the issue of the timing of commercial notice. The Supreme Court held that FDA approval is not required before the 180 day notice. So that issue was, for the most part, resolved.

But the other issue of whether the BPCIA’s requirement that a biosimilar applicant “shall provide” their applications and manufacturing information after the FDA accepts their application—introduces a fair bit of uncertainty into how biosimilars will be launched and what biosimilar patent litigation will actually look like.

The Supreme Court agreed with the Federal Circuit that the initial disclosure requirement of the BPCIA isn’t enforceable by injunction under Federal law. So it’s essentially up to the applicant whether they want to proceed with the two-stage patent litigation procedure set out by the BPCIA. But they remanded the question to the Federal Circuit as to whether an injunction may be available under state law, and specifically whether an injunction for failure to provide the initial disclosures was available under California’s unfair competition law. That’s one question that was deliberately left unanswered by the Court in Sandoz.

And so, depending on the outcome of remand, we could see that the initial disclosure provision is unenforceable under state and federal law, or that the provision is enforceable on a state-by-state basis. If the initial disclosures under the BPCIA are essentially optional, biosimilar applicants may decide there isn’t enough of an incentive to participate, and may choose to force brand drugmakers to operate in the dark as they assert basically all patents at once after they receive notice of commercial marketing.

Justice Breyer actually issued a short concurrence in that decision, saying that while the court’s interpretation was reasonable, if the FDA promulgated a different interpretation, the Court may be inclined to defer to the FDA’s position. So, whether and how the FDA responds to this, and how that will impact the process, is also an open question.

Ultimately, there remains uncertainty over the initial disclosures, just as a whole. Will there be a state-by-state availability to enforce compliance? Will the FDA act on this? Will Congress act on this? There’s still plenty to be concerned about.

 

Ha Kung Wong has extensive experience litigating a wide variety of pharmaceutical cases, including those concerning biologics used to treat rheumatoid arthritis and autoimmune disorders. He also has extensive experience consulting, conducting due diligence and licensing pharmaceutical portfolios. Ha Kung has a B.S. in Biochemistry and a B.S. in Chemistry.

Methodology

Information contained in the Venable Fitzpatrick BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website (www.fda.gov). Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable Fitzpatrick BiologicsHQ database.

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