he United States Food and Drug Administration recently announced approval for Teva Pharmaceuticals to market generic epinephrine autoinjectors.  According to the press release, Teva’s autoinjectors are the first generic versions of Mylan’s EpiPen® and EpiPen Jr ® to receive FDA approval.

In a recent report, the U.S. Department of Health & Human Services (HHS) Office of the Inspector General (OIG) recommended that the U.S. Food & Drug Administration (FDA) include cybersecurity review as a greater part of the premarket review process for medical devices. In particular, the report suggests including cybersecurity documentation as a criterion in the FDA’s Refuse-To-Accept (RTA) checklist, using presubmission meetings to address cybersecurity questions, and including cybersecurity as an element of the FDA’s Smart template.

Before Wallach, Linn and Hughes.  Appeal from the United States District Court for the Southern District of New York. 

Summary: In determining whether to award sanctions under 28 U.S.C. § 1927, the domain of colorable claims is broader when the law is unsettled.

Before Prost, Bryson, and O’Malley.  Appeal from the United States District Court for the Western District of Wisconsin.

Summary: (1) To uphold a jury verdict of infringement, evidence must support an inference that claim limitations are at least sometimes met by the accused product; and (2) when a patent repeatedly and consistently characterizes a claim term in a particular way, the term should be construed consistent with that characterization.

Before Lourie, Clevenger, and Stoll.  Appeal from the Patent Trial and Appeal Board.

Summary: 35 U.S.C. § 315(b), which prohibits the Board from instituting an IPR based on a petition filed more than one year after the date on which the petitioner is served with a complaint, is fully applicable to complaints that are involuntarily dismissed by the court.

At the recent OCBA Seminar, partner Lauren Katzenellenbogen, “Panel on IP Valuation: How Much is it Worth? How Much Can You Get? How Can You Protect It?” View and download…

On September 7, 2018, Olaplex, LLC and LIQWD, INC. (collectively, “Olaplex”) filed suit in the United States District Court for the Southern District of Florida against Verbena Products, LLC d/b/a BEAUTYVICE and Robert Roque (collectively “Beautyvice”) based on Beautyvice’s sales of Olaplex hair care products.  Olaplex alleges that the products sold by Beautyvice do not bear certain codes that Olaplex includes on its products.

The medical device and related markets have shown some growth recently.  For example, IHI, an iShares U.S. Medical Devices ETF, has a total return of about 24% year-to-date in 2018.   In the same time period, the S&P 500 has a return of about 8%.  The IHI fund has an average annual return in the last ten years of about 14% compared to about 10.7% for the S&P 500.  According to MarketWatch, the IHI fund invests in “medical-products companies that deliver the tubes, pumps and tools that are necessary to make medical facilities function. . . .  While some of the products offered by these companies are indeed high-tech, such as artificial heart valves, many are less glamorous, such as catheters and blood-pressure cuffs. But despite their flash, these items are staples, and medical offices and hospitals nationwide remain big revenue sources for these companies.”

Before Reyna, Wallach, and Hughes. Appeal from the United States District Court for the District of Nevada

Summary:  District Courts have jurisdiction to hear APA challenges to the PTO’s denial of a petition for rulemaking. An Examiner’s ability to reopen prosecution under a new ground does not deprive applicants of their right to maintain an appeal.

            On September 5, 2018, the Food and Drug Administration (FDA) published a press release highlighting recent actions taken to ensure that pharmaceuticals meet high-quality standards[1]. Currently, there are over 5,000 pharmaceutical sites worldwide. Of these sites, over 3000 are based outside of the United States. This large number of ex-U.S. sites requires a regulatory scheme that ensures both Current Good Manufacturing Practice (CGMP) and transparency regarding drug manufacturing.