January 2018 — BPCIA Provides Exclusive Remedies for Generics’ Failure to Provide Reference Product Manufacturers with Confidential Access

In Amgen Inc. v. Sandoz, Inc. 2017-12-14, Appeal No. 2015-1499, the Court of Appeals for the Federal Circuit on remand from the Supreme Court of the United States held that Section 262(l)(2)(A) of the Biologics Price Competition and Innovation Act (“BPCIA”) of 2009 is not enforceable by state law injunction.  Previously, the Supreme Court found that Section 262(l)(2)(A) was not enforceable by federal law injunction.    
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June 2017 — The Supreme Court Reins in Lax Patent Venue Rules

On May 22, 2017, the United States Supreme Court in TC Heartland LLC v. Kraft Food Group Brands LLC., 581 U.S. __ (2017) has tightened rules regarding where patent infringement lawsuits can be filed. Reversing a long-standing practice, the Supreme Court held that a domestic corporation can only be sued for patent infringement in: (1) its state of incorporation; or (2) where the domestic corporation has committed acts of infringement and has a regular and established place of business.
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June 2017 — All Sales are Final

In Impression Products, Inc. v. Lexmark International, Inc. 581 U.S. _______ (2017), the Supreme Court of the United States held that the sale of a patented item anywhere in the world exhausts all patent rights the patent holder held in that item regardless of any restrictions the patent holder placed on the sale.
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March 2017 — No Inducement under Section 271(f)(1) for Shipping Abroad a Single Component of a Multicomponent Invention

In its recent decision in Life Technologies Corp. v. Promega Corp., the Supreme Court limited infringement liability under 35 U.S.C. § 271(f)(1). This section of the patent infringement statute imposes liability upon an entity that 1) supplies from the U.S. “a substantial portion of the components of a patented invention” and 2) actively induces the combination of such components, outside of the U.S., in a manner that would infringe a U.S. patent. The Supreme Court held that infringement under Section 271(f)(1) does not cover the export of a single component of a patented invention.
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February 2017 — For Petitioner’s Without Federal Standing IPR Decisions are Final

Phigenix, Inc. petitioned for an Inter Partes Review (“IPR”) of Immunogen, Inc.’s patent
on the ground that the claims of the patent were obvious over the prior art. The Patent Trial
and Appeal Board (“PTAB”) found that the claims were valid as non-obvious. Phigenix then
appealed the PTAB’s decision to the Court of Appeals for the Federal Circuit (“CAFC”). The
CAFC dismissed the case, finding that Phigenix did not have federal “standing” to bring the case before the court. Phigenix, Inc. v. Immunogen, Inc. Appeal No. 2016-1544, 13 (Fed. Cir. Jan. 9, 2017). This decision effectively means that PTAB’s IPR decisions are final for any petitioner who does not have federal standing to sue the patent owner.
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