Big Molecule Watch
February 24, 2017


As we covered in previous posts, the Supreme Court will hear arguments regarding the Federal Circuit’s interpretation of the BPCIA’s notice of commercial marketing requirement and patent dance provisions in April 2017.  Several amicus briefs in support of Sandoz were filed last week, including by AARP and AHIP.  Mylan, Inc. (“Mylan”), Apotex Holdings, Inc. (“Apotex”), Coherus Biosciences, Inc.  (“Coherus”) and Adello Biologics LLC (“Adello”) have also filed amicus briefs, available here (Mylan), here (Apotex), here (Coherus), and here (Adello).

Mylan Inc., whose subsidiaries have filed and received approval for hundreds of Abbreviated New Drug Applications for generic drugs, analyzed the Federal Circuit’s decision through the lens of timely providing greater access to high-quality, lower-priced medicines.  Mylan argues that the Federal Circuit’s decision regarding the BPCIA effectively extends the reference sponsor’s 12-year exclusivity period by 180 days every time an aBLA applicant gives notice of commercial marketing under 42 U.S.C. §262(l)(8)(A).   The Federal Circuit’s decision, which converts a simple notice provision into a de facto 180-day extension of market exclusivity and preemptively awards an automatic 180-day preliminary injunction against every biosimilar sponsor, “runs afoul of the statutory language and Congressional intent” in passing the BPCIA into law.  Mylan believes that, in addition to hurting aBLA applicants, the Federal Circuit’s decision ultimately hurts consumers and payors who must wait an extra six months before competing products can enter the market and drop prices.

Similarly, Apotex Holdings, Inc.’s subsidiaries are generic drug and specialty pharmaceutical research and technology leaders.  Apotex argues that the Federal Circuit’s decision is a roadblock in the abbreviated pathway that mandates biosimilars provide a notice of commercial marketing “even when doing so cannot advance the orderly resolution of patent disputes.”  This extends the monopolies for biologic products and delays competition and consumer access to less-expensive medicines.  The Federal Circuit’s interpretation is contrary to the statute’s plain text and purpose; specifically Federal Circuit’s interpretation of “shall” as different than “must” is erroneous.   Additionally, the results of the Federal Circuit’s interpretation contravenes the legislative intent of the BPCIA because there are situations where the notice of commercial marketing serves no purpose.  Ultimately, the Federal Circuit’s interpretation upsets Congress’s careful balance between cost-saving competition and life-saving innovation.

Coherus has a pending application with the FDA for a biosimilar of Neulasta® and has other biosimilar products in the pipeline in Phase 3 clinical trials.  According to Coherus, the Federal Circuit correctly determined that the BPCIA does not require a biosimilar applicant to disclose its aBLA to the RPS because the statute allows an RPS to immediately sue for infringement if the applicant chooses not to dance.  “The statute’s express inclusion of these remedies shows that Congress contemplated that a subsection (k) applicant might chose to not disclose  its aBLA.”  Moreover, Coherus states that the statute’s remedy for non-disclosure, an immediate right to sue for infringement, “leaves no room for an implicit private right of action to compel disclosure.”  According to Coherus, the statute “allows flexibility for dealing with patent disputes, while still preserving an important role for the statutory exchanges.”  The statute provides “incentives to disclose in appropriate circumstances,” including where the RPS has patents on multiple uses of a drug and an applicant is seeking approval for only one use, or where the applicant has designed around patents claiming a particular formulation. In those situations, an applicant may want to engage in the patent dance in order to determine which patents the RPS may assert, and thereby “eliminate these patents up front, rather than risking an immediate suit on those patents by refusing to disclose their application.”

Coherus also asserts that the Federal Circuit “erred by holding that the statute required notice of commercial marketing at all in this case,” because “where, as here, the subsection (k) applicant chooses not to disclose its application, “the notice of commercial marketing serves no purpose.  In that situation, other provisions already give the reference product sponsor the ability to seek such relief at any time.” According to Coherus, even if notice of commercial marketing is required where an applicant declines to dance, the statute does not prohibit an applicant from providing notice before FDA approval.  Coherus argues that the “Federal Circuit miscalculated the consequences of its extra exclusivity,” and “will impose significant costs on consumers, insurers, and the federal government” as a result.

Similarly, Adello “has a pipeline of biosimilar products to be submitted for licensure under the BPCIA.”  According to Adello, “the notice provision at issue is designed to provide a 180-day time period during which the RPS can consider whether to assert, and in fact assert, its rights prior to the commercial marketing of the reference product.”  Adello argues that a plain reading of the statute indicates that notice should be given no later than 180 days before the date of first commercial marketing.  Adello also points out that the notice provision authorizes a “subsection (k) applicant to provide notice,” whereas elsewhere the statute refers to applicants who have had their application approved as “holders.”  “If Congress had meant to require approval before the notice is given, it would have used consistent language and called the notifying party in §262(l)(8)(A) ‘the holder of an approved application.’”  According to Adello, the Federal Circuit “apparently conceived that the biosimilar product could, in fact, be licensed long before the 12-year exclusivity period had expired,” but that view “is demonstrably wrong under the statute” because “the approval is not effective and the biosimilar product is not actually licensed until the 12-year period has expired.”  Finally, Adello argues that notice before licensure provides a “well-crystallized” controversy because the BPCIA expressly contemplates litigation before licensure.  Adello argues that the “Federal Circuit’s expressed concern for crystallizing controversies for suit is even more unrealistic when one imagines a situation where there are no relevant patents to be placed at issue. This scenario is entirely possible, as patents may have expired by the time of licensure, or any patent disputes may have already been resolved between the parties. Yet, the 180-day windfall mandated by the Federal Circuit’s reading would apply even in situations like these where the RPS has no infringement claim to ‘justify’ the delay.”

Stay tuned to the Big Molecule Watch for further developments.