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MBHB snippets Alert - June 20, 2016

In its first pronouncement regarding the post-grant reviewing proceedings established by the America Invents Act (“AIA”), the Supreme Court ruled that the Patent and Trademark Office’s positions on two of the law’s provisions regarding inter partes review (“IPR”) were correct. First, the Court held unanimously that the PTO properly applied the “broadest reasonable interpretation” standard for claim construction for IPRs. Second, six members of the Court also agreed that the statute mandated that the decision to institute an IPR was not subject to judicial review.
MBHB snippets Alert - June 14, 2016

On June 13, 2016, the Supreme Court ruled unanimously, in an opinion by Chief Justice Roberts, that an award of enhanced damages pursuant to 35 U.S.C. § 284 should be within the sound discretion of a district court, albeit wherein this discretion is limited to “egregious cases of misconduct beyond typical infringement.” The decision in the combined Halo Electronics, Inc. v. Pulse Electronics, Inc. and Stryker Corp. v. Zimmer, Inc. cases reverses the Federal Circuit test established in In re Seagate Tech., LLC, which had required a patentee to satisfy a two-part test (having subjective and objective components) to establish willful infringement.
In March 2015, the FDA approved the first biosimilar application, which was for a follow-on biologic drug of Amgen’s reference product NEUPOGEN® (filgrastim). Yet, before the applicant, Sandoz, could launch its biosimilar under the brand name ZARXIO®, it had to wait for the Federal Circuit to interpret the controlling statute, the Biologics Price Competition and Innovation Act (“BPCIA”). This year, a different applicant with an approved biosimilar drug is in a very similar situation.
On March 23, 2016, new rules came into effect substantially amending the Community trademark system in the European Union (the “amended Regulations”).  In this article, we discuss a number of points potentially relevant to U.S. brand owners, including (1) changes in terminology, (2) changes in fees, and, perhaps most important, (3) potential changes to the scope of protection of existing trademark registrations in the European Union.
The “on-sale” bar to patentability refers to a sale or offer for sale of an invention that can invalidate the patent for that invention. The America-Invents-Act (AIA), which altered the language in the statutes that apply to the on-sale bar, has made it difficult to determine what actions might constitute a “sale” or an “offer for sale” under current law. Nevertheless, a clear understanding of the on-sale bar is necessary to enable entities of all sizes—from single inventors to large corporations—to effectively monitor activities surrounding their inventions, and to enable attorneys to provide such entities with accurate and useful advice.
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