BPCIA: Patent Dance Steps Becoming a Bit Clearer

PatentDanceAmgen v. Hospira (Fed. Cir. 2017)

The dispute here falls under the Biologics Price Competition and Innovation Act of 2009 (BPCIA), which can be loosely described the Hatch-Waxman equivalent for large-molecule biologics.

Particularly, BPCIA creates an abbreviated approval pathway for products that are “biosimilar” to an already FDA-approved biological drug product.  Unfortunately, the actual statute is a complete mess – being both unduly complex and unduly vague.  That said, the Supreme Court used nice words in its recent decision: “The BPCIA sets forth a carefully calibrated scheme for preparing to adjudicate, and then adjudicating, claims of infringement.” Sandoz, Inc. v. Amgen, Inc., 137 S. Ct. 1664 (2017).

The setup in this particular mandamus action is that the patentee Amgen was seeking discovery on exactly how Hospira’s biosimilar was going to be produced – information included within its aBLA applicant to the FDA.  However, the district court refused discovery since the requested information was “irrelevant to the asserted patents” in the case.  Amgen argued that the discovery was necessary to see if they might need to assert further patents.

Ordinarily there is no direct appeal of discovery orders since they are mere interlocutory orders rather than final judgments. Here, Amgen petitioned for a writ of mandamus. However the Federal Circuit has rejected that petition – finding that it lacked jurisdiction in the case.  The court went on to note that the BPCIA permits Amgen to disclose any patent it believes “could be reasonable asserted” and thus perhaps should have included a longer list, which then would have opened discovery further.

In PatentDocs, Andrew Williams explains the potential impact here:

More importantly . . . the Court suggested that if a patent was not included in its paragraph (l)(3)(A) list, even if there was no reason to suspect that it might be relevant to the present case, the BLA holder could be precluded under 35 U.S.C. § 271(e)(6)(C) from ever asserting that patent (depending on what “under this section” turns out to mean).  Of course, this could lead to the unintended (or maybe intended) consequence of overly long patent lists containing every conceivable patent that could be related to the manufacture of biologics in situations when inadequate information has been provided.




5 thoughts on “BPCIA: Patent Dance Steps Becoming a Bit Clearer

  1. 2

    Dennis: However, the district court refused discovery since the requested information was not “irrelevant to the asserted patents” in the case.

    Is there a mistake in this sentence?

  2. 1

    You left out what I consider to be the most important part of the opinion. The court explicitly affirmed that a reference sponsor will not be subject to Rule 11 sanctions for asserting a patent that (because of the refusals of the biosimilar applicant to disclose) the reference product sponsor has no good faith basis to suppose might be infringed.

    If I had been Amgen here, I would not have asserted some of the cell culture patents either, because I would have figured that without a good faith basis to assert them (and how could I have such a good faith basis, given that Hospira had refused to disclose cell culture details), I might be opening myself to Rule 11 sanctions. Now that we have the CAFC’s assurance, however, that assertion of a patent in this circumstance is not a basis for Rule 11, I think that we can expect to see a much wider array of patents asserted in BPCIA litigation.

    Of course, precisely because the biosimilar applicants now know that the reference product sponsor is not facing Rule 11 obstacles, I suppose that biosimilar applicants like Hospira will not be so stingy in their disclosures. That is a long way of saying, maybe we will not see longer lists of patents being asserted. Rather, maybe we will start to see more forthcoming biosimilar disclosures, so as to prevent certain patents from being asserted in biosimilar litigation.

    One way or another, the fact that the CAFC just took Rule 11 off the table is going to have a big impact in the patent dance.

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