When a pharmaceutical company withdraws a product from the market, the basis for the withdrawal can affect whether a competitor can commercialize a generic version of that product. A generic cannot be approved if, in the FDA’s view, the product was withdrawn for “safety and effectiveness” reasons.
State legislatures are still continuing to enact new changes to their states’ price gouging statutes. Some are expanding the scope of their laws, while others are tailoring the law or emergency orders in response to new issues that have arisen during the course of the COVID-19 pandemic. Idaho took a third tack and limited limit overbroad enforcement so that its law applied only to price increase, and not to price decreases that are deemed to be insufficient. Continue Reading
A major technology innovator finds itself on the defensive this week after a start-up company filed an antitrust lawsuit for alleged deceptive business practices. A tech-based online broker named Rex alleged that the National Association of Realtors (“NAR”) and Multiple Listing Services (“MLS”) operate as a cartel to control access to real estate markets, and that Zillow joined their efforts and cut Rex out of the market. Continue Reading
The majority of price gouging laws have been activated throughout the country for over a year now, but reports of price gouging continue, along with enforcement and lawsuits. While many are aware that price gouging restrictions apply to essential goods such as medical and emergency supplies, some covered goods are often mistakenly thought not to be covered. As a result, companies should remain vigilant and familiarize themselves with the scope of covered products and services in the states in which they conduct business. Continue Reading
In the recent case of Amgen Inc. v. Sanofi, Aventisub LLC, the Federal Circuit affirmed the district court’s invalidation of certain of Amgen’s antibody patent claims, concluding that the claims were not “enable[d]” under 35 U.S.C. § 112. This decision establishes that it is more difficult to satisfy the enablement requirement for antibody claims that use functional language to describe the antibody. (The court granted Amgen’s motion to extend the deadline for filing a petition for panel rehearing and/or rehearing en banc until April 14, 2021. See id., Order (March 8, 2021).) Continue Reading
One year after declaring a state of emergency in California due to COVID-19, the California Governor issued a new Executive Order lifting pricing restrictions on most categories of products previously subject to California’s price gouging statute. Governor Gavin Newsom’s 2021 Order comes as states across the nation slowly reopen. This 2021 Executive Order marks a change for businesses in California. Continue Reading
Across the globe, an increasing number of international regulators have opened inquiries or adopted new rules and regulations to address competition law concerns about digital platforms and digital markets. Whilst the spotlight is likely to initially fall on the conduct and business practices of large online platforms – the so-called gatekeepers – we expect international regulators to cast their net more broadly. Businesses looking to expand to new jurisdictions need to navigate these regulations and assess the risk of enforcement actions. Whether the expansion comes through acquisitions or otherwise, regulators are increasingly looking at multinational businesses and platforms. Below is an overview of key international developments. Continue Reading