BIO Statement on SCOTUS Biosimilar Products Ruling

On Monday the United States Supreme Court issued a decision in Sandoz, Inc. v. Amgen, Inc., relating to the Biologics Price Competition and Innovation Act of 2009. BIO issued the following statement regarding the outcome:

“BIO is disappointed with the Supreme Court’s decision today regarding Sandoz v. Amgen, which has effectively gutted a statute that had been carefully designed to facilitate timely resolution of patent disputes in order to avoid delaying market entry of biosimilar products. Importantly, it will do nothing to expedite the delivery of biosimilars to market. To the contrary, it is likely to delay patient access to biosimilars.

“As stated in our legal brief, this outcome will only encourage more confusion, more litigation, and more gamesmanship by biosimilar applicants, negatively impacting patients and the innovators who invested billions of dollars to develop innovative medical breakthroughs.

“The Biologics Price Competition and Innovation Act of 2009 (BPCIA) properly reflects the delicate balance of interests between promoting innovation and lower-cost generic entry. Unlike the BPCIA, today’s Sandoz v. Amgen is a disservice to patients awaiting lower-cost medical therapies.”

Coming Down the Pipeline: Patent Cases to Watch in 2017

The Supreme Court returns from recess on February 17, and alongside the likely confirmation of Neil Gorsuch to the bench, a plethora of IP cases are on their agenda.

Let’s take a look at some of the cases that SCOTUS  will hear in the spring that may have significant impact on biotech IP:

The Supreme Court granted certiorari last month to hear arguments for dual petitions involving the Federal Circuit’s 2015 interpretation of the Biologics Price Competition and Innovation Act (BPCIA).

The Federal Circuit had previously ruled in a split panel decision (1) that the disclosures set forth in subsection (l)(2)(A) of the BPCIA are not mandatory and that the statute allows a biosimilar applicant to choose between either disclosing its subsection (k) application and manufacturing information, or not disclosing such information and instead facing an immediate infringement action from the reference product sponsor and (2) that a notice of commercial marketing pursuant to subsection (l)(9)(A) of the BPCIA can be given only after FDA approval of the biosimilar product.

The briefing schedule has been set and can be found on SCOTUS Blog.

The Supreme Court granted certiorari to decide: “Whether 28 U.S.C. § 1400(b) is the sole and exclusive provision governing venue in patent infringement actions and is not to be supplemented by 28 U.S.C. § 1391(c).”

28 U.S.C. § 1400(b) states that “any civil action for patent infringement may be brought in the judicial district where the defendant resides, or where the defendant has committed acts of infringement and has a regular and established place of business.”

28 U.S.C. § 1391(c) states that “For all venue purposes—

  1. A natural person, including an alien lawfully admitted for permanent residence in the United States, shall be deemed to reside in the judicial district in which that person is domiciled;
  2. An entity with the capacity to sue and be sued in its common name under applicable law, whether or not incorporated, shall be deemed to reside, if a defendant, in any judicial district in which such defendant is subject to the court’s personal jurisdiction with respect to the civil action in question and, if a plaintiff, only in the judicial district in which it maintains its principal place of business; and
  3. A defendant not resident in the United States may be sued in any judicial district, and the joinder of such a defendant shall be disregarded in determining where the action may be brought with respect to other defendants.

The Supreme Court’s decision may limit the districts in which patentees can bring infringement lawsuits and return to a narrower venue rule as outlined in 28 U.S.C. § 1400(b).

Oral arguments are set for March 27, 2017.

This case involves the scope of patent exhaustion.

The first question before the Supreme Court is whether a “conditional sale” that transfers title to a patented item, but also restricts the article’s use or resale post-sale, avoids the patent exhaustion doctrine.  The second question is whether a sale of a patented article (i) occurring outside the United States but (ii) with the U.S. patentee’s authorization exhausts the U.S. patent rights in that article.

“The Federal Circuit ruled en banc that the sale of a product abroad by a U.S. patent holder (or others) does not exhaust the patent owner’s U.S. patent rights, such as the right to exclude sale or importation of that product within the United States.  The Federal Circuit also ruled that, when a U.S. patent holder sells a product with expressed restrictions on resale or reuse of that product, the patent exhaustion doctrine does not preclude the patent owner from exercising its rights to exclude resale or reuse of that product.”

Oral arguments are set for March 21, 2017.

Filed under: Patently BIOtech, Public Policy, , , , , , , , , , , , , ,