As we have been reporting this week, the Federal Circuit handed down its decision in Amgen Inc. v. Sandoz Inc. -- a case of first impression relating to the Biologics Price Competition and Innovation Act ("BPCIA") for approval of biosimilar drug products. Unfortunately, the decision was, much like the BPCIA itself, anything but clear. Judge Newman joined Judge Lourie with regard to whether the Notice of Commercial Marketing had to occur after the FDA approved, or licensed, the biosimilar drug product -- it does. But, Judge Chen joined Judge Lourie with regard to whether the aBLA (abbreviated biologics license application) disclosure and patent exchange provisions were mandatory -- they are not. Therefore, on its face, it appeared as though Judge Newman and Judge Chen were in complete disagreement with regard to the interpretation of the BPCIA statute. However, that is not entirely accurate. Judge Newman and Judge Chen did agree on at least one thing -- that the Notice of Commercial Marketing provision makes no sense if the "shall" in the aBLA disclosure and patent exchange provisions does not mean "must," thereby making the provision optional.
42 U.S.C. § 262(l)(8)(A) provides that:
The subsection (k) applicant shall provide notice to the reference product sponsor not later than 180 days before the date of the first commercial marketing of the biological product licensed under subsection (k).
Once Notice is given, § 262(l)(8)(B) provides the reference product sponsor (the original BLA holder) with the ability to seek a preliminary injunction:
After receiving the notice under subparagraph (A) and before such date of the first commercial marketing of such biological product, the reference product sponsor may seek a preliminary injunction prohibiting the subsection (k) applicant from engaging in the commercial manufacture or sale of such biological product until the court decides the issue of patent validity, enforcement, and infringement with respect to any patent that is—
(i) included in the list provided by the reference product sponsor under paragraph (3)(A) or in the list provided by the subsection (k) applicant under paragraph (3)(B); and
(ii) not included, as applicable, on—
(I) the list of patents described in paragraph (4); or
(II) the lists of patents described in paragraph (5)(B).
As can be seen, the Reference Product Sponsor cannot seek a preliminary injunction on any patent. Rather, the universe of patents available to the original BLA holder is limited by the patent exchange provisions of the BPCIA (the so-called "patent dance"). However, if the patent dance is not mandatory, as the Court so determined, then it is impossible to determine which patents are available to the Reference Product Sponsor. This was one of Judge Chen strongest arguments against the mandatory nature of this provision.
Of course, as Judge Newman pointed out, this section's nonsensical nature is due to the optional nature of the patent dance as determined by the majority. It is precisely because the Court determined that "shall" does not mean "must" with regard to the aBLA exchange provision that this section becomes a non-sequitur, according to Judge Newman. Instead, for her, the statute and the intent of Congress in creating the new biosimilar pathway require that both parties participate in the patent resolution provisions of the statute. If a biosimilar applicant is unhappy with any part of this procedure, she noted, they do not need to take advantage of the abbreviated approval process in the first place.
Tellingly, Judge Newman was the only panel member to quote and cite extensively to the legislative history of the BPCIA. If the statute was indeed "a riddle wrapped in a mystery inside an enigma," it stands to reason that consulting the Congressional record might be useful. And what did she find? "The balance established in the BPCIA requires the statutorily identified disclosures at the threshold, in order both to avert and to expedite litigation. This purpose pervades the legislative record, as interested persons debated which provisions would be mandatory, and which permissive." The "purpose" behind the BPCIA was to establish a scheme for biologics similar to Hatch Waxman for small molecule pharmaceuticals. And, in so creating this act, Congress created two schemes -- one for expedited approval of biosimilar application, and one for the efficient resolution of the patent issues. Unfortunately, these schemes are separate and distinct.
Unlike the Hatch-Waxman statute, there is nothing tying drug approval to patent-issue resolution in the BPCIA. Therefore, the FDA is free to approve or license the biosimilar application regardless of the stage of the "patent dance." This was a point stressed by Judge Chen, both at the oral hearing and in his dissent-in-part. And, unfortunately, without providing for a mechanism to prevent or delay FDA approval if a biosimilar applicant refuses to provides its aBLA, there is a question as to what remedy a BLA holder would be entitled if the section were mandatory. Of course, the Court could fashion some injunctive relief directed either at the FDA or the biosimilar applicant. But barring a consideration of this case en banc, or potential a grant of cert by the Supreme Court, the best that can be hoped for is a modification of the statute by Congress (which would appear unlikely at best).
[*]With all due respect to Bryan Ferry and Roxy Music, even we are tiring of the "dance" puns associated with the BPCIA.
