Life Sciences

  • March 28, 2017

    UC, Medivation Argue Old Fights Decide Drug Royalty Row

    The University of California and pharmaceutical maker Medivation both asked a San Francisco judge Tuesday for an early win in the university’s drug patent licensing suit, with each side arguing that the other was legally hemmed in by how prior lawsuits had defined “royalties.”

  • March 28, 2017

    Novartis Gets Partial Win In Transplant-Drug Patent Dispute

    Swiss pharmaceutical giant Novartis scored a partial victory Tuesday when a Delaware federal judge said three drugmakers induced infringement of its patents when they filed abbreviated new drug applications for a generic version of Zortress, a medication used to treat organ transplant recipients.

  • March 28, 2017

    3rd Circ. Won't Send Birth Control Mass Tort To State Court

    A Third Circuit panel told a group of 113 birth control users Tuesday that their product liability suit against Endo Pharmaceuticals and other manufacturers over faulty packaging belongs in federal court, finding in a precedential ruling they failed to explicitly say they did not want to try their claims jointly under the Class Action Fairness Act.

  • March 28, 2017

    Clovis Investor Sues In Chancery Over Cancer Drug Trials

    An investor in Clovis Oncology Inc. has launched a derivative lawsuit in the Delaware Chancery Court accusing the company board of breaches connected to the clinical trials of the firm's showcase cancer drug and of misleading investors about the medication. 

  • March 28, 2017

    Judge Frustrated At Sluggish Pace Of Atty Suicide Trial

    Three weeks into a trial to determine if GlaxoSmithKline PLC can be held liable for a Reed Smith LLP partner’s death, the federal judge overseeing the case appeared irritated with the trial's slow progression, telling the attorneys Tuesday he was worried the jury might tune them out.

  • March 28, 2017

    Trial Date Set For 2nd Meningitis Defendant

    A Massachusetts federal judge on Tuesday set a date for the second trial over a 2012 fungal meningitis outbreak, locking down the agenda just days after the first trial resulted in a conviction on racketeering charges but an acquittal on murder charges.

  • March 28, 2017

    FDA Warning Wire: Stem Cell Deaths, Bad OTC Promos

    A prominent physician at Northwestern University failed to promptly report deaths in a stem cell study, a seller of popular over-the-counter treatments made dubious health claims, and a manufacturer of contact lens solution sold leaking and unreliable products, according to U.S. Food and Drug Administration warning letters published Tuesday.

  • March 28, 2017

    Bayer Sues Apotex Over Cancer Treatment Patent

    Bayer Healthcare LLC hit generics manufacturer Apotex Corp. with a patent suit in Delaware federal court Tuesday for seeking U.S. Food and Drug Administration permission to make a generic version of the pharmaceutical giant’s Stivarga cancer treatment.

  • March 28, 2017

    Vitamin Maker Must Face 'Made In USA' Class Action

    A consumer’s proposed class action against vitamin manufacturer Nature’s Way alleging it misrepresented its products as “made in the USA” can proceed, an Illinois federal judge ruled Tuesday, saying the consumer provided enough proof she was damaged to avoid having the case tossed.

  • March 28, 2017

    Ex-Katten Atty Says Indictment In Shkreli Case Is 'Careless'

    A former Katten Muchin Rosenman LLP attorney pushed a New York federal court Monday to strike a portion of the securities fraud indictment against him and onetime client ex-pharmaceutical head Martin Shkreli, saying prosecutors used careless language that ropes him into alleged schemes solely charged against Shkreli.

  • March 28, 2017

    Pfizer, Ex-Employee Reach Agreement In Trade Secrets Row

    A Pennsylvania federal judge Monday dismissed a case in which Pfizer Inc. accused a former global marketing director of misappropriating its trade secrets, after Pfizer and the former employee reached an agreement to halt all use of the company’s confidential information.

  • March 28, 2017

    Rite Aid Wants Out Of FCA Suit Claiming Decadelong Scheme

    Rite Aid Corp. on Monday told a Michigan federal court to toss a False Claims Act suit claiming the pharmacy chain ran a decadelong scheme to defraud Medicare and state Medicaid programs, saying that he hasn’t provided enough information to back up his allegations.

  • March 28, 2017

    Goodwin Nabs Ex-Lando & Anastasi IP Atty For Boston Office

    Goodwin Procter LLP announced Monday that it has bolstered its life sciences practice in its Boston office with the addition of a former Lando & Anastasi LLP partner who specializes in intellectual property relating to pharmaceuticals and general chemistry matters.

  • March 28, 2017

    Fosamax Ruling Aids Wellbutrin Case, 3rd Circ. Told

    Wellbutrin buyers continued to urge the Third Circuit Monday to overturn a decision nixing their pay-for-delay suit against GlaxoSmithKline PLC over its popular antidepressant drugs, saying the appeals court’s recent precedential ruling in a product liability case over the drug Fosamax further supports their arguments.

  • March 27, 2017

    Ex-Valeant CEO Sues Drugmaker Over Alleged Unpaid Shares

    The former chief executive of embattled drugmaker Valeant Pharmaceuticals International Inc. sued the company Monday in New Jersey federal court, saying he’s owed more than 3 million company shares under the terms of his separation agreement last May.

  • March 27, 2017

    Atty's Doc Says He Didn't Know Of Paxil's Suicide Risk

    The doctor who prescribed generic Paxil to Stewart Dolin days before he took his own life said Monday he didn’t know the Reed Smith LLP partner to be depressed and wouldn’t have prescribed the drug if GlaxoSmithKline informed him that it could induce suicidal behavior, a characterization the drug company disputes.

  • March 27, 2017

    Berkeley Team Gets European CRISPR Win After PTAB Loss

    The European Patent Office has announced its intention to grant a research team partially based at the University of California, Berkeley a patent on CRISPR gene-editing technology, giving them the latest victory in a multijurisdictional IP battle with a team from the Massachusetts Institute of Technology and the Broad Institute.

  • March 27, 2017

    ClearCorrect Gets PTAB To Nix Claims Of Invisalign Patent

    The Patent Trial and Appeal Board decided Friday that several claims of an Align Technology Inc. patent on teeth-straightening technology are invalid, handing a win to ClearCorrect Operating LLC in the rivals' high-profile patent dispute.

  • March 27, 2017

    Ionis Subsidiary Akcea Files $100M IPO Led By Cooley

    Akcea Therapeutics Inc., a late-stage biotech being spun out of Ionis Pharmaceuticals Inc., on Monday filed a $100 million initial public offering under guidance from Cooley LLP, seeking to raise money to support its pipeline of therapies treating lipid disorders.

  • March 27, 2017

    Spurned Implant Inventor Again Beats PTAB At Fed. Circ.

    For the second time this year, the Federal Circuit has rescued a patent application by inventor Steven Chudik from rejection at the Patent Trial and Appeal Board, finding Monday that Chudik’s design for a shoulder implant legitimately improved upon earlier inventions.

Expert Analysis

  • What New Bulk Substance Rules Mean For The Drug Industry

    Keith S. Hasson

    The U.S. Food and Drug Administration has recently included six bulk drug substances on the 503A bulks list, which allows drug compounders to bypass certain regulations for some drugs. Though progress is welcome, some pharmacists are expressing frustration over how long it is taking the FDA to finalize its guidance, says Keith Hasson of Hasson Law Group.

  • Judge Gorsuch's Dubious Commitment To Legal Textualism

    Max Kennerly

    In practice, being an “originalist” or a “textualist” is a lot like being “gluten-free” except when it comes to pasta and bagels. Most “textualists” are happy to apply these concepts rigorously when it will produce the result they want — but they’ll relax or ignore them if it produces a politically inconvenient outcome. Judge Neil Gorsuch seems to fit this profile, says Max Kennerly of Kennerly Loutey LLC.

  • SEC Scrutiny Of Non-GAAP Disclosures Likely To Continue

    Bret A. Campbell

    It is important that practitioners have a basic understanding of non-GAAP disclosures — including how they are used appropriately to relay important information to investors — because the U.S. Securities and Exchange Commission’s recent actions indicate that it is poring over filings and collecting evidence to shift from issuing comment letters to undertaking enforcement actions, say attorneys with Cadwalader Wickersham & Taft LLP.

  • Are Your In-House Lawyers Happy?

    Aric Press

    What is the mood of the nation’s in-house lawyers? Aric Press — a partner at Bernero & Press LLC and former editor-in-chief of The American Lawyer — shares the findings of a recent survey of more than 800 in-house counsel.

  • Trump's Proposed 2018 Budget Will Double FDA User Fees

    David L. Rosen

    This month, the Trump administration announced its budget blueprint for fiscal year 2018, which proposes to cut funding from the U.S. Department of Health and Human Services and offset the shortfall in funding by increasing user fees. The stated justification for this strategy is seemingly based on the popular but distorted view that there's "a big logjam of wonder drugs that's having to work its way slowly through a thin hallway f... (continued)

  • Proposed Rules Pose Challenges For Pharma Reps In Chicago

    Erik Snapp

    Pharmaceutical companies and their representatives must prepare to navigate new licensing regulations in Chicago in order to market or promote their products to health care providers. Attorneys with Dechert LLP explain the proposed rules and analyze what the changes will mean for pharmaceutical companies and their representatives.

  • Post-Escobar Courts Reaching Consensus On FCA Materiality

    Courtney Saleski

    Following the U.S. Supreme Court's Escobar decision last year, some litigators were skeptical that district courts would actually dismiss qui tam False Claims Act cases on materiality grounds. However, four circuit courts have cited Escobar’s demanding materiality standard when granting the defendants’ pretrial motions, say attorneys with DLA Piper.

  • Understanding Defense Strategies For 505(b)(2) Drugs

    Terry M. Henry

    Manufacturers of new drugs submitted for approval to the U.S. Food and Drug Administration under 505(b)(2) face different challenges than innovators or generic manufacturers. These manufacturers also have access to unique fact-based defenses, so they should closely review allegations setting out the type and dates information that plaintiffs argue should have led to a stronger warning, say Terry Henry and Ann Querns of Blank Rome LLP.

  • TC Heartland May Cause Protective Suits In ANDA Cases

    Colleen Tracy James

    On Monday, the U.S. Supreme Court will hear oral arguments in TC Heartland, a case that could affect where innovator pharmaceutical companies file patent infringement actions brought pursuant to the Hatch-Waxman Act. We recommend some best practices for branded pharmaceutical companies to employ both before and after the decision is issued, say Colleen Tracy James and Manuel Velez of Mayer Brown LLP.

  • Google, NASA, Planes And A Stronger Legal Team

    Nicholas Cheolas

    Why did minor mechanical issues bring down two airplanes, while a catastrophic engine explosion did not bring down a third? The answers lie, in part, in research conducted by NASA in the wake of those crashes and, more recently, by Google. And those answers can help organizations build better teams to meet today’s legal industry challenges, says Nicholas Cheolas of Zelle LLP.