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
Although much of the coverage relating to price gouging enforcement has focused on bad actors hoarding pandemic-related goods, businesses that make good faith efforts to comply with the panoply of price gouging restrictions may nevertheless find themselves in the crosshairs. The relevant statutes typically impose a form of strict liability, and do not take motive … Continue Reading
The Supreme Court recently granted three petitions for certiorari challenging the Federal Circuit’s holding in Arthrex v. Smith & Nephew that administrative patent judges of the Patent Trial and Appeal Board (PTAB) are unconstitutionally appointed. Under the Patent Act, PTAB judges are appointed by the Secretary of Commerce in consultation with the Director of the … Continue Reading
In a recent post, we summarized recent developments in litigation and legislative activity concerning whether online marketplaces may be directly liable for the sale of defective and counterfeit products on their platforms. Now the executive branch has weighed in, with President Trump issuing (on Prime Day, no less) a Memorandum on Stopping Counterfeit Trafficking on … Continue Reading
Consumers are doing more and more shopping online. But when a consumer buys a product that is defective or counterfeit, are online marketplaces liable for misconduct by third-party sellers? E-commerce platforms have generally avoided being treated like their brick-and-mortar counterparts by arguing that they do not actually “sell” goods, but rather provide services (e.g., payment … 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
In a recent order from Livingston v. City of Chicago, Magistrate Judge Young Kim of the Northern District of Illinois provided useful guidance to litigants in the use of technology assisted review, or TAR. Importantly, Judge Kim affirmed what is known as “Sedona Principle Six,” the notion that a responding party is in the best … Continue Reading
Common practice dictates that plaintiffs often prefer to be in state court – and will sometimes go to great lengths to avoid federal court jurisdiction. That was the case in Deroy v. Carnival Corporation, a recent Eleventh Circuit decision, wherein the court rejected a plaintiff’s “creative effort” to escape a forum-selection clause requiring her to … Continue Reading
On July 24, 2020, a panel of the Court of Appeals for the Federal Circuit issued splintered precedential opinions surrounding the interplay of state sovereign immunity under the Eleventh Amendment and required joinder of parties under Rule 19 of the Federal Rules of Civil Procedure in a patent-in-suit infringement case in Gensetix, Inc. v. Baylor … Continue Reading
Federal Rule of Evidence 702, which governs the admissibility of expert testimony, was most recently amended in 2000 in response to Daubert and its progeny. In response to concerns about misapplication, the Advisory Committee on the Federal Rules of Evidence has been considering whether Rule 702 is due for an update.… Continue Reading
Businesses may be wondering whether there is increased risk of price gouging liability when they impose higher penalty terms, ask for higher up-front payments, raise rates, or otherwise seek terms that may be more burdensome. Sellers and service provides should consider the risk of being held liable for non-price terms that result in higher customer … Continue Reading
With the federal government’s increasing focus on enforcing price gouging compliance, attention has turned to the Defense Production Act (the “DPA”). Passed in 1950 in response to the Korean War, the DPA is modelled on the War Powers Acts of 1941 and 1942 and gives the President, among other things, sweeping power to control the … Continue Reading
While the majority of price gouging enforcement has occurred at the state level (see Proskauer on Price Gouging — A Coast-to-Coast Reference Guide), the federal government has also been active, and several federal price gouging bills have been introduced, though none have been signed into law. See, e.g., S. 3574 (empowers the FTC and Attorney … Continue Reading
In response to the current pandemic, antitrust enforcers at the Department of Justice have been issuing business review letters at record pace. One of these business review letters addressed an inquiry from the pork industry about reducing supply based on the COVID pandemic disruption. This raises the question as to whether the DOJ letter about antitrust … Continue Reading
President Obama’s Affordable Care Act has survived yet another challenge in the federal courts. In a resounding 8-1 decision this Monday, April 27, 2020, the U.S. Supreme Court ruled that health insurance companies who suffered losses entering the new marketplaces established by the Affordable Care Act (“ACA”) were entitled to compensation for those losses.… Continue Reading
On April 20, 2020, the Supreme Court held in a 6-3 decision that the Sixth Amendment requires a unanimous jury verdict to convict a defendant of a serious offense in state courts. In so holding, the Court not only paved the way for potentially hundreds of defendants convicted by divided juries, like petitioner Evangelisto Ramos, … Continue Reading
Even though states are leading the way on price gouging enforcement, recent action in Congress may lead to overlapping federal government enforcement. Recent Congressional letters, statements, and proposed bills show a strong appetite for action on price gouging. House Democrats tried but failed to add price gouging language to the coronavirus relief package in March. … 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
On January 26, 2018, the Federal Trade Commission announced revisions to HSR Act and Clayton Act Section 8 thresholds, which are indexed annually to account for inflation. We have identified the adjustments that are likely to be the most relevant to our clients, and reiterate several important practice tips. The Hart-Scott-Rodino Antitrust Improvements Act of 1976, commonly … Continue Reading
Should Titanic’s Box Office release or the debut of Harry Potter already be described as events from the ancient past? It would hardly seem so. But, the amendment to the ancient documents exception to the rule against hearsay contained in Fed. R. Evid. 803 (16) suggests otherwise. Fed. R. Evid. 803 (16) provides that statements … Continue Reading
Electronic filing is coming to the U.S. Supreme Court! Effective November 13, 2017, amendments to the Supreme Court’s rules take effect that require represented parties (and their amici) to submit petitions, briefs, and most other filings through the Court’s electronic filing system. The Rules explain that the new e-filing requirements are “[i]n addition to the … Continue Reading
Recently, E.D.N.Y. Magistrate Judge Steven M. Gold ordered that a third-party subpoena may be served upon an internet service provider (“ISP”) to identify information about network users who allegedly infringed copyrighted material.… Continue Reading
On July 10, 2017, the Consumer Financial Protection Bureau (CFPB) issued a new rule that would make it easier for consumers to bring class action lawsuits against financial institutions. The new rule bans financial institutions from using mandatory arbitration clauses in consumer contracts to prevent and avoid class action lawsuits. If the new rule goes … Continue Reading
