Manufacturers in the pharmaceutical and biotechnology sector are driven to rapidly produce and introduce innovative drugs and therapies to the market. While the sector is fueled by scientific advances, it also faces a number of challenges, many of which have legal implications. Among them are product liability, regulation and compliance, and patent and other intellectual property issues.
We counsel clients with a global perspective supported by a deep understanding of the science (organic chemistry, molecular biology, biochemistry, and pharmacology) as well as the venues (U.S. district courts, Patent Trial and Appeal Board, Federal Court of Australia, and the Unified Patent Court).
We have extensive experience with pharmaceutical patent work and a successful track record of representing pharmaceutical companies in more than 40 Hatch-Waxman cases over the past decade, numerous inter partes review proceedings, hundreds of opinions, and thousands of patent applications.
Underpinning our work is a deep understanding of the pharmaceutical industry and technology from first-hand knowledge and experience:
Intellectual property lawyers with doctorates
Lawyers and agents with biotechnology-related degrees
Lawyers and agents with chemistry or chemical degrees
Following earlier announcements as to the efficacy of vaccine trials by pharmaceutical companies Pfizer, Inc. (Pfizer) and Moderna, Inc. on November 20, 2020, Pfizer and BioNTech submitted applications for emergency use authorization to the U.S. Food and Drug Administration (FDA) for their COVID-19 vaccinations.
The Australian Government has announced a number of changes to its migration policies in September in response to the ongoing COVID-19 pandemic. This alert collates some of the recently announced changes that are most relevant to employers in Australia.
On 23 December 2020, Judge Catherine Blake of the U.S. District Court for the District of Maryland granted the Pharmaceutical Research and Manufacturers of America (PhRMA) a 14-day nationwide temporary restraining order, preventing the Centers for Medicare and Medicaid Services (CMS) from implementing and enforcing its Most Favored Nation (MFN) interim final rule (MFN Rule) scheduled to take effect on 1 January 2021.
On 7 January 2021, the U.S. Equal Employment Opportunity Commission (EEOC) proposed two new rules designed to clarify the scope of incentives that employers may offer employees as part of a wellness program without violating the Americans with Disabilities Act (ADA) or Genetic Information Nondiscrimination Act (GINA).
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