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Proskauer’s perspective on developments and trends in commercial litigation.

Category Archives: Life Sciences

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Generic Competition for Withdrawn Drug Products

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 A generic cannot be approved if, in the FDA’s view, the product was withdrawn for “safety and effectiveness” reasons. But how does the FDA reach that conclusion? … Continue Reading

CAFC Tightens Enablement Standard for Functional Claiming of Antibodies

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 … Continue Reading

I’ve Been Sued for Patent Infringement… Is an IPR Worthwhile?

Recent Precedential Decisions Applying Fintiv When a company is sued for patent infringement, often one early strategic consideration is whether to counterattack the patent’s validity at the Patent Trial and Appeal Board (PTAB) in a parallel post-grant proceeding such as inter partes review (IPR) or post-grant review (PGR). Although the PTAB has recently conformed certain … Continue Reading

Are Long-Term Pricing Controls Here to Stay? Three Reasons the Optimists Might Be Right

The gravity of the pandemic is palpable, and seemingly constant news about it is hard to escape, with recent reports including updates on the availability of vaccines, the changing scope of various stay-at-home orders, and the perceived risks of new COVID-19 variants.  But there will come a time—perhaps sooner than the pessimists predict—when this will … Continue Reading

Are Long-Term Pricing Controls Here to Stay? Three Reasons the Pessimists Might Be Right

In some ways, it feels like the country is moving into another phase of how we experience the COVID-19 pandemic. With two vaccines in distribution, and more vaccine approvals possible, the pandemic could very well be effectively managed much sooner than experts initially feared. Given the light the end of the tunnel, it is worth … Continue Reading

Costs of COVID-19 Vaccines: What We Do and Don’t Yet Know

The roll-out of vaccine approvals has led to some confusion over what charges consumers might be asked to cover. This echoes the confusion previously discussed with respect to COVID-19 diagnostic and antibody test pricing. But consumers, providers, and others that will have any involvement with vaccine production, distribution, or administration should be aware that the Coronavirus … Continue Reading

Pre-Election Drug Pricing Regulation Efforts: Where Does Congress Stand?

The regulation of drug prices has received significant recent bipartisan support in Congress. Democrats and Republicans in both houses have proposed approximately eighty bills relating to drug pricing over the past two years. The charts below summarize the key provisions of representative bills.[i] Although the proposed price-regulating mechanisms differ from bill to bill, the bills … Continue Reading

Orphan Drug Exclusivity for CRISPR/Cas-Based Therapeutics

The prospect of genetic engineering using CRISPR (clustered regularly interspaced short palindromic repeats) and CRISPR-associated nucleases (Cas) has long been hailed as a “revolutionary” development in medicine. This technology is rapidly advancing, and several CRISPR/Cas-based drugs have entered clinical trials over the past several years. One kind of product in clinical trials is CRISPR-modified cells, … Continue Reading

HHS Can’t Force Disclosure of Drug Prices in Ads with “Blunderbuss” Rule

Among its various attempts to regulate drug prices, the Trump administration recently sought to force pharmaceutical advertisements to disclose the wholesale acquisition cost (WAC) of certain drugs. This effort was dealt a setback in June, when the D.C. Circuit found that the Department of Health and Human Services (HHS) overstepped its regulatory authority by compelling … Continue Reading

Beyond the Pandemic: Pharmaceutical Industry Compliance Considerations

Since the ongoing states of emergency were put in place in response to a health crisis, pricing in the pharmaceutical industry is under more of a microscope than usual.  While the immediate focus may be on products that are used to diagnose, treat, or prevent COVID-19, price gouging laws cover a wide variety of pharmaceutical … Continue Reading

Bipartisan Congress Intensifies Efforts to Restrict Orphan Drug Exclusivity

“Orphan” drug exclusivity, which is intended to reward drug companies’ investment in the development of certain drugs, might soon be harder to get—and keep. Over the past several months, Congress introduced two similar bills to amend a “loophole” in the Orphan Drug Act (ODA).  On October 17, 2019, a bipartisan group of House members introduced … Continue Reading

Chambers and Partners Releases Pharmaceutical Advertising 2018 Guide

Chambers and Partners released its first ever Pharmaceutical Advertising 2018 guide, authored by Proskauer partners Lawrence Weinstein and Alexander Kaplan with assistance from several litigation associates. The guide provides a comprehensive look at the laws and regulations governing pharmaceutical advertising in various markets, and provides important developments in the most significant jurisdictions and legal commentary on … Continue Reading
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