Life Sciences

November 30, 2020
Europe Hits Teva With €60M Fine Over Pay-For-Delay Deal

Europe's competition watchdog has slapped Israeli pharmaceutical giant Teva and its subsidiary Cephalon with more than €60 million (about $71 million) in fines for conspiring to keep a generic version of the narcolepsy drug Provigil off the market.
November 30, 2020
AbbVie Gets Humira Kickbacks FCA Suit Limited To Florida

AbbVie Inc. on Monday partially beat a suit over an alleged kickback scheme to boost prescriptions of its blockbuster immunosuppressant drug Humira when an Illinois federal judge limited the case to only Florida-related allegations.
November 30, 2020
11th Circ. OKs Sanctions Against Ex-Stryker Salesperson

The Eleventh Circuit on Monday backed dismissal and sanctions in a retaliation and age discrimination suit against the medical device manufacturer Stryker Sales Corp., saying a former employee's false testimony and "bad faith" action justified the penalties.
November 30, 2020
Coherus Loses Bid To Shift Fees To Amgen In Patent Suit

A U.S. District Court judge in Delaware on Monday shot down Coherus BioSciences Inc.'s bid to shift legal fees to Amgen Inc. in its failed patent infringement suit against Coherus over a blockbuster anti-infection drug.
November 30, 2020
Moderna Seeks FDA Approval For COVID-19 Vaccine

Moderna on Monday said it is filing an emergency approval request with the U.S. Food and Drug Administration, asking the regulator to sign off on its COVID-19 vaccine that the drugmaker claims is 100% effective at preventing severe cases and 94% effective at preventing infection.
November 30, 2020
Greenberg Traurig Taps Ex-HHS Atty For Health Care Practice

Greenberg Traurig LLP has hired an attorney who worked for more than a decade with the federal agency that oversees Medicare and Medicaid to join the firm's health care and U.S. Food and Drug Administration practice.
November 25, 2020
Law360 Names Practice Groups Of The Year

Law360 congratulates the winners of its 2020 Practice Groups of the Year awards, which honor the law firms behind the litigation wins and major deals that resonated throughout the legal industry in the past year.
November 25, 2020
The Firms That Dominated In 2020

The eight law firms topping Law360's Firms of the Year managed to win 54 Practice Group of the Year awards among them, for guiding landmark deals, scoring victories in high-profile disputes and helping companies navigate uncharted legal seas made rough by the coronavirus pandemic.
November 27, 2020
DNA Sequencing Trial Wraps, Illumina Rival Seeks Invalidity

Four subsidiaries of Chinese company BGI Group seeking to invalidate patents behind an American company's system for rapid DNA sequencing maintained in closing arguments at trial on Friday that the techniques at issue were obvious based on earlier lessons.
November 25, 2020
Monsanto, BASF Get $265M Dicamba Verdict Slashed To $75M

A Missouri federal judge on Wednesday cut a punitive damages award that a Missouri farm won against Monsanto and BASF in a bellwether trial over claims the weedkiller dicamba ruined the farm's peach trees from $250 million to $60 million, ruling that the case involved only economic damages as opposed to physical harm.
November 25, 2020
Zydus Insists Mitsubishi Doesn't Deserve Diabetes Patents

Zydus Pharmaceuticals punctuated the six-day trial in its bid to bring generic diabetes drugs to market by filing a 100-page, post-trial brief doubling down on its claim that Mitsubishi Tanabe Pharma Corp. is engaging in "gamesmanship" to extend the life of one of three patents Zydus is accused of infringing.
November 25, 2020
EU Regulatory Plan Targets Big Pharma Competition, Mergers

The European Commission on Wednesday adopted a plan to develop a regulatory framework by 2022 to increase access to cheap generic drugs by cracking down on anti-competitive behaviors by pharmaceutical companies across the European Union.
November 25, 2020
Appeals Court Says NJ Medical Pot Permit Scoring Is Flawed

A New Jersey appellate panel said Wednesday there were serious problems with the way the state scored medical marijuana permit applications, sending the state's Department of Health back to reconsider applications submitted by rejected companies.
November 25, 2020
US, Smith & Nephew Urge Justices To Overturn Arthrex

The Federal Circuit misapplied clear U.S. Supreme Court precedent when finding that administrative patent judges weren't constitutionally appointed, the government and medical tech company Smith & Nephew said Wednesday in their opening salvos for the closely watched Arthrex case.
November 25, 2020
SmileDirect Tries To Save Calif. Dental Board Suit At 9th Circ.

SmileDirectClub has told the Ninth Circuit that a California federal court was wrong to find that what the company calls a harassment campaign by the state's dental board was instead a proper exercise of its regulatory authority.
November 25, 2020
GAO Denies Protest Of Vaccine Research Contract

The U.S. Government Accountability Office denied a bid protest from the global research firm Battelle Memorial Institute on Wednesday, the company's third such protest, because it found that the company's proposal had not been disparately evaluated by the Centers for Disease Control and Prevention.
November 25, 2020
Goodwin Steers Mass Spectrometry Biz Eyeing $75M IPO

Mass spectrometry company 908 Devices on Wednesday filed for an initial public offering guided by Goodwin Procter LLP that is preliminarily estimated to bring in about $75 million.
November 25, 2020
Coronavirus Regulations: A State-By-State Week In Review

Ahead of the long weekend, when Americans are most known for gathering and traveling, Thanksgiving-minded governors laid down more restrictions as COVID-19 cases continued surging over the past week.
November 25, 2020
Sport Supplement Co., Owner Plead Guilty Over Steroids

The U.S. Department of Justice on Wednesday announced that a North Carolina man and his sport supplement company pled guilty to a felony charge for illegally distributing steroids with the intent to defraud consumers and the U.S. Food and Drug Administration and agreed to forfeit $1.2 million.
November 25, 2020
Suit Says 'Infant' Fever Drugs Are Same As 'Children' Drugs

Parents who bought infant fever medication made by Prestige Consumer Healthcare Inc. are suing the company in California federal court, alleging in a proposed class action that the drugs are the same dosage and formula as the medication labeled for children, but at nearly double the price.
November 24, 2020
Telehealth Platform Can't Oust Medical Pot Co., Judge Says

An Illinois federal judge said on Monday that a cannabis telehealth service could not evict a medical marijuana business from its platform even if some of the company's practices were questionable, saying there was no material violation of the pair's agreement.
November 24, 2020
Groups Sue Trump To Block New Drug Import Rule

An organization representing top pharmaceutical research firms and two health care advocacy groups have sued the Trump administration in D.C. federal court to block a new federal policy allowing states, tribes, pharmacists and wholesalers to import certain prescription drugs from Canada without approval from drug manufacturers.
November 24, 2020
Jury Awards $3.5M In Iowa Artificial Hip Trial

An Iowa federal jury has awarded $3.5 million over a hip implant patient's claims that her Biomet M2a Magnum metal hip shedded microscopic particles and caused her to need revision surgery.
November 24, 2020
Chancery Slams Gilead Stonewalling Over Records Demands

Pointing to "overly aggressive" efforts by Gilead Sciences Inc. to shut down demands for records as part of stockholder investigations into potential company malfeasance over its AIDS drug, a Delaware vice chancellor has ordered the company to cooperate and authorized investors to seek shifting their legal fees to the company, saying Gilead's conduct "epitomizes a trend."
November 24, 2020
No Discrimination Ban For Medical Pot Patients, Hospital Says

A Pennsylvania hospital system urged a federal judge to throw out parts of a discrimination lawsuit filed by a former employee who was fired after testing positive for marijuana, saying state courts have rejected the idea that medical pot use is protected.

Editor's Picks

All Work, No Pay: HHS Sues Gilead Over HIV-Prevention IP

The U.S. Department of Health and Human Services accused Gilead Sciences Inc. on Wednesday of infringing four agency patents covering the use of HIV treatment medication to prevent infection, escalating a fight that has been brewing for months.

Expert Analysis

Anticipating The Biden Administration's Health Care Agenda

The Biden administration is unlikely to successfully push sweeping and partisan health care legislation in the next two years, but it will be able to reverse a litany of Trump administration policies pertaining to the Affordable Care Act, reproductive health care and more, say Nick Manetto and Ilisa Halpern Paul at Faegre Drinker.
7 Tips For Predeposition Meetings Under New Federal Rule

Attorneys can use a new predeposition meet-and-confer obligation for federal litigation — taking effect Tuesday — to better understand and narrow the topics of planned testimony, and more clearly outline the scope of any discovery disputes, says James Wagstaffe at Wagstaffe von Loewenfeldt Busch.
How To Prepare For Congressional Investigations In 2021

Congressional investigations in the health care, financial services, fossil fuel and technology sectors are likely to intensify next year amid a highly partisan environment, and companies that may be targets should get ready for testimony and document production well before an inquiry, say attorneys at Hogan Lovells.
Ethics Reminders As Employees Move To Or From Gov't

Many organizations are making plans for executives to go into government jobs, or for government officials to join a private sector team, but they must understand the many ethics rules that can put a damper on just how valuable the former employee or new hire can be, say Scott Thomas and Jennifer Carrier at Blank Rome.
NJ Cannabis Strides Highlight Nearby States' Need To Legalize

As New Jersey's ballot measure approving adult-use cannabis gives the state a strong head start in the race to legalization, neighboring states Pennsylvania, New York and Connecticut need to move quickly to follow suit or risk losing out on significant cannabis tax revenue, say attorneys at Saul Ewing.
Surveying Drug Pricing Reform: The Latest State Activity

Attorneys at Ropes & Gray explore four types of high-impact drug pricing initiatives at the state level — pricing transparency, pharmacy benefit manager controls, drug importation and value-based arrangements — examining how the current wave of reforms may affect drug companies' business operations.
Don't Fear IP-Antitrust 'Turducken' In Reverse-Payment Cases

Although some judges are apprehensive of a "turducken" analysis — a patent case stuffed inside a reverse-payment antitrust action — it is procedurally viable and may be a fair way to adjudicate the antitrust liability of generic companies settling Hatch-Waxman litigation, say attorneys at Katten.
How Joe Biden Will Change The FDA: Part 2

When the Biden administration takes control of the U.S. Food and Drug Administration, companies can expect to see increased attention to the safety of medical devices, the rigor of audits and inspections, and the concerns of consumer advocacy groups, say attorneys at Covington.
A Key To Helping Clients Make Better Decisions During Crisis

As the pandemic brings a variety of legal stresses for businesses, lawyers must understand the emotional dynamic of a crisis and the particular energy it produces to effectively fulfill their role as advisers, say Meredith Parfet and Aaron Solomon at Ravenyard Group.
How Joe Biden Will Change The FDA: Part 1

During the Trump administration, the U.S. Food and Drug Administration has tended to issue warning letters and other regulatory tools to secure voluntary corrective actions, but the Biden administration is likely to pursue more vigorous judicial enforcement, including through consent decrees and criminal referrals, say attorneys at Covington.
A Forgotten But Effective Tool Against Opioid Scams

With the pandemic contributing to rising rates of opioid and substance use disorders, prosecutors should consider the regrettably underused Eliminating Kickbacks in Recovery Act as a tool for targeting and shutting down body brokers and others in the treatment industry that place profits above patients, say Michael Adelberg and Matthew Rubin at Faegre Drinker, and Melissa Garrido at Boston University.
Ethics Considerations For Law Firms Implementing AI

Richard Finkelman and Yihua Astle at Berkeley Research Group discuss the ethical and bias concerns law firms must address when implementing artificial intelligence-powered applications for recruiting, conflict identification and client counseling.
When A Product Liability Case Can't Survive Outside An MDL

Baca v. Johnson & Johnson, a recent pelvic mesh lawsuit brought in Arizona federal court, is a perfect example of how some product liability cases that might be accepted in a multidistrict litigation contain deficiencies that cannot withstand scrutiny when tried individually, says Rachel Weil at Reed Smith.
How Federal Virus Liability Law Will Apply To Vaccine Claims

Three federal court decisions addressing the Public Readiness and Emergency Preparedness Act suggest that the law likely preempts state claims related to a COVID-19 vaccine, but is unlikely to cover the failure to administer the vaccine, says Nathan Adams at Holland & Knight.
Picking The Right Location And Tools For Virtual Courtrooms

Attorneys should consider the pros and cons of participating in virtual court proceedings from home versus their law firm offices, and whether they have the right audio, video and team communication tools for their particular setup, say attorneys at Arnold & Porter.