The answer? Not much, in itself. If one patent is good, 132 is probably fine too. That was Judge Easterbrook’s reasoning in a recent decision addressing indirect purchasers’ antitrust challenge to AbbVie’s so-called “patent thicket” of 132 patents around the blockbuster drug Humira, arguing the sheer number of patents blocked would-be biosimilar competition. But “if … Continue Reading
In the United States, the scale of trade secret theft is estimated to be between $180 billion and $450 billion annually. Among the targets of this theft are pharmaceutical companies, which are some of the most research-intensive institutions in the world. Pharmaceutical research generally requires extensive work and often generates proprietary data that is pivotal … Continue Reading
The Federal Circuit’s recent ruling in MaxPower Semiconductor Inc. et al v. Rohm Semiconductor USA, LLC highlights the interplay between the liberal federal policy favoring arbitration agreements and the Patent Trial and Appeal Board’s (“PTAB”) authority as an agency tribunal having a broad role to protect the public interest in ensuring the quality of patents. Read the … Continue Reading
The situation is familiar: an employee leaves one company to go work for another, or perhaps to found her own start-up. She may be working on the same problems that she faced at her former workplace, and in the same technological space. The employee’s work at her new company results in the issuance of a … Continue Reading
The prosecution of Elizabeth Holmes, founder of the infamous healthcare and life sciences company, Theranos, Inc., has sparked media attention around the country. With just a few months before trial is slated to begin, Holmes recently lost her pretrial battle over whether the attorney-client privilege precludes the introduction of certain emails with counsel. While the … Continue Reading
According to the Federal Circuit, twenty-two communications with a party over the course of three months may be enough to force a defendant to defend itself in the state where the party is located. But three letters sent over that same time period is not enough. In a recently published opinion, Trimble, Inc. v. PerDiemCo … Continue Reading
CRISPR patents continue to face priority challenges in Europe. Following an earlier revocation of CRISPR patent EP2771468 based on a successful priority challenge, another foundational CRISPR patent EP3241902, co-owned by University of California Berkeley (UCB), was revoked in its entirety last month by the European Patent Office (EPO) based on an invalid priority claim. This … Continue Reading
In Apple v. Qualcomm, Federal Circuit Finds No Standing to Challenge Validity of a Few Patents When Many Were Licensed The development timeline for small-molecule drugs and biologics is lengthy, estimated to take between 10 and 15 years. As a result, pharmaceutical companies need to consider freedom to operate issues long before they receive FDA … Continue Reading
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
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
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
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
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
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
The Orphan Drug Act provides two mechanisms by which a drug can receive an orphan drug designation for a “rare” disease: (1) if it affects less than 200,000 persons in the United States, or (2) if it “affects more than 200,000 in the United States and for which there is no reasonable expectation that the … Continue Reading
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
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
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
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
“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 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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