Life Sciences

  • July 2, 2015

    White House Orders Updated GMO Rules Amid Criticism

    The White House on Thursday ordered three federal agencies to overhaul the government’s regulations on genetically modified organisms, saying current rules are excessively complex and confusing and need updating to boost public confidence in federal oversight of biotech crop products.

  • July 2, 2015

    Georgia AG Wades Into Mesh Implant Appeal In 4th Circ.

    The Georgia Attorney General weighed in on C.R. Bard's appeal in the Fourth Circuit over a $2 million jury verdict for a vaginal mesh plaintiff on Thursday, defending a law that sent three quarters of the punitive damages to the state.

  • July 2, 2015

    Health Cases To Watch In The 2nd Half Of 2015

    The second half of 2015 is shaping up as a potential litigation blockbuster for health care providers, as major developments loom in cases involving the False Claims Act, the future of crucial Affordable Care Act funding and the 340B drug-discount program. Here are six cases that attorneys will be watching closely.

  • July 2, 2015

    VC-Backed Natera Beats Expectations With $180M IPO

    Venture capital-backed Natera Inc. outshot expectations to raise $180 million in its initial public offering, pricing its shares at $18 apiece, the genetic diagnostics company said late Wednesday.

  • July 2, 2015

    J&J Beats Bid For New Trial In Philly Risperdal Case

    A Philadelphia judge declined to rehear a suit by a teenage patient who claimed the antipsychotic drug Risperdal made by Johnson & Johnson subsidiary Janssen Pharmaceuticals Inc. caused him to grow breasts in a ruling issued Tuesday.

  • July 2, 2015

    Girardi Keese Can't Avoid Recovery Sharing In Avandia Suits

    The Third Circuit on Thursday upheld an order forcing The Girardi Keese Law Firm to kick in its purported share to a common benefit fund in centralized suits against GlaxoSmithKline LLC over the diabetes drug Avandia, finding that a district court had the power to decide the cross-country dispute.

  • July 2, 2015

    Daiichi Sankyo Loses Patent Term Adjustment Challenge

    The Federal Circuit on Thursday rejected a pharmaceutical company’s challenge to the way the U.S. Patent and Trademark Office calculated patent term adjustments for two of its patents on treating dead tissue, saying the agency’s decision wasn’t unreasonable.

  • July 2, 2015

    Brand Battles: Bayer, Philips, HBO, Red Bull

    In Law360's latest roundup of new actions at the Trademark Trial and Appeal Board, Bayer's Phillips' Milk of Magnesia and Koninklijke Philips come to blows, HBO takes on Sling Media over a “Slingshot,” and Red Bull is “red” in the face over soft-drink mark.

  • July 2, 2015

    Fla. Jury Clears IP Firm Of Malpractice In Legal Fees Flap

    A Florida federal jury on Thursday found in favor of intellectual property firm Stein Law PC on malpractice charges brought by a medical supply company, but rejected a series of counterclaims the firm brought related to alleged contract breaches.

  • July 2, 2015

    The Biggest Pa. Court Decisions Of 2015: Midyear Report

    While a focus on criminal matters has resulted in few blockbuster civil decisions by the Pennsylvania Supreme Court so far this year, major pharmaceutical trials in Philadelphia and a defense attorney’s ongoing fight over a $1 million sanction have grabbed the attention of business lawyers in the state in 2015. Here, Law360 takes a look at some of the major decisions and the cases to keep on your radar.

  • July 2, 2015

    FTC Asks Court To Review AbbVie Pay-For-Delay Dismissal

    The Federal Trade Commission asked a Pennsylvania federal judge Wednesday to consider taking a second look at a May ruling that gutted the agency’s pay-for-delay suit against AbbVie Inc. over testosterone drug AndroGel, following a recent Third Circuit decision in a similar case.

  • July 2, 2015

    Amarin Ducks Securities Action Over Vascepa Denial

    A New Jersey federal judge has dismissed a securities class action against biopharmaceuticals maker Amarin Corp. PLC that claimed it artificially inflated its stock price before a U.S. Food and Drug Administration panel denied expanding the use of its fish oil drug Vascepa to treat more adults with high triglycerides.

  • July 2, 2015

    Fed. Circ. Wipes Out Medicines Co.'s Angiomax Patents

    The Federal Circuit on Thursday invalidated two of The Medicines Co.'s patents for the blood thinning drug Angiomax, finding that the claimed process was offered for sale before the patent applications were filed, in a victory for Hospira Inc., which is planning a generic version of the drug.

  • July 2, 2015

    Judge Nixes Lupin Pay-For-Delay Suit Against Alaska AG

    Alaska's attorney general on Thursday fought off Lupin Ltd.'s bid to block the state from forcing the generic drug manufacturer to turnover materials about alleged pay-for-delay settlements for Loestrin and Effexor, convincing a Maryland federal judge to toss the case.

  • July 2, 2015

    M&A Boom Soars To Highest First-Half Clip In 8 Years

    Coming off a robust 2014, corporations kicked up their buying spree again in the first half of 2015, led by deal-hungry health care and pharmaceutical companies and buoyed by cheap financing that has fueled the mergers and acquisitions boom to its highest level in eight years.

  • July 2, 2015

    Swiss Pregnancy Tests Deliberately Misleading, Judge Rules

    A Swiss company knowingly deceived U.S. consumers by claiming that its home pregnancy tests reveal how many weeks a woman has been pregnant when the tests deviate from the “universal” measure used by doctors, a New York federal judge ruled Wednesday.

  • July 2, 2015

    Teva Tells DC Circ. Ranbaxy Deserved Drug Revocation

    Teva Pharmaceuticals USA Inc. teamed up with another drugmaker Wednesday to argue in favor of the U.S. Food and Drug Administration pulling exclusivity periods for two Ranbaxy Inc. generics, telling the D.C. Circuit that Ranbaxy committed fraud to obtain the approvals and should be forced to live with the FDA’s decision.

  • July 1, 2015

    FDA Reviewing Codeine Cough Medicine Safety For Children

    The U.S. Food and Drug Administration said Wednesday that it is reviewing the safety of medicines containing the opioid pain killer codeine for children under 18, citing a European regulator's decision earlier this year to restrict the medications for children under 12.

  • July 1, 2015

    1 Firm Tops June IPO Activity As Volume Hits New Heights

    One law firm cashed in on initial public offering activity in June, leading the underwriters on 11 of the month’s 35 floats and championing four new issuers’ debuts — including one that had the largest first-day pop in roughly 18 months — as the month marked the busiest for IPOs since 2000.

  • July 1, 2015

    Magistrate Urges Dismissal Of Merck's Generic Nasonex Suit

    A Delaware magistrate judge on Wednesday recommended the court dismiss Merck Sharp & Dohme Corp.’s suit claiming Teva Pharmaceuticals USA Inc. is infringing its patent by intending to produce and sell a generic version of the popular nasal spray Nasonex.

Expert Analysis

  • Regulators Are Cracking Down On Drug Disposal

    William J. Walsh

    Given several recent environmental developments indicating greater effort by regulators to minimize the release of pharmaceutical waste, the health care industry may need to adopt new tracking and disposal methods, say William Walsh and Greg Narsh at Pepper Hamilton LLP.

  • An 'Exceptional Case' One Year After Octane: Part 2

    Timothy P. Cremen

    One year on, the U.S. Supreme Court’s Octane and Highmark decisions have drastically altered the fee-shifting landscape in patent cases, and courts have repeatedly permitted fee-shifting in cases where there are clear differences between the asserted claims and accused products, or where a patentee has ignored settled law or otherwise proceeded in bad faith, say attorneys with Paul Hastings LLP.

  • How Drug Cos. Can Minimize Risks Of 'Right To Try' Laws

    Vicki G. Norton

    With "right to try" measures that provide seriously ill patients access to experimental treatments being drafted in 40 states, drug and biologic developers have faced increasing pressure from patients and their advocates to make investigational drugs available for compassionate use. Vicki Norton of Duane Morris LLP has some advice for navigating the risks associated with allowing patients compassionate use of experimental drugs.

  • Your Advance Conflict Waiver May Be A Conflict Creator

     Daniel H. Tabak

    A recent Western District of Pennsylvania decision has carved out new ground in the already fertile fields of affiliate conflicts and advance conflict waivers by recommending that Kirkland & Ellis LLP be enjoined from representing the would-be purchaser of a Kirkland pharmaceutical client’s parent company. The court’s interpretation of the words used in the advance waiver is almost certainly not what Kirkland expected, say Daniel T... (continued)

  • An 'Exceptional Case' One Year After Octane: Part 1

    Timothy P. Cremen

    Now that we have reached the one-year anniversary of the U.S. Supreme Court's decisions on fee-shifting in patent cases, it is worth looking back at the history of fee-shifting and how the Federal Circuit and various district courts have applied Octane and Highmark, say attorneys with Paul Hastings LLP.

  • Post-Grant Challenges In Life Sciences: A Midyear Assessment

    Raymond Miller

    Inter partes reviews and post-grant reviews have only begun to affect the life sciences industries. While petitions filed by hedge fund-like entities have grabbed headlines, highlighting the law of unintended consequences of post-grant proceedings and causing uncertainty in the industry, the vast majority of IPRs have been filed by generic and branded competitors, say Raymond Miller and Nicole Stakleff of Pepper Hamilton LLP.

  • The Top 3 New Do’s And Don’ts For Law Firm Websites

    Stephan Roussan

    In legal marketing circles, there are few topics peddled about more than “hot tips” for improving your law firm’s website. Google it. You’ll find more advice than you could ever digest. However, there are larger trends in technology, culture and user behavior that are impacting firms in very significant ways and are not being talked about nearly as much as they should be, says Stephan Roussan, founder of consulting and web developm... (continued)

  • Grooming Lessons For Biotech From Abercrombie & Fitch

    Jennifer A. Kearns

    The recent U.S. Supreme Court decision in U.S. Equal Employment Opportunity Commission v. Abercrombie & Fitch Stores Inc. poses unique questions for many nonretail industries — especially biotech companies — which may require applicants to meet certain clinical or safety standards, says Jennifer Kearns at Duane Morris LLP.

  • 4 Life Science Innovations That Give Life To Patent Growth

    Kevin M. Granahan

    With a rapidly increasing and largely inelastic demand resulting from health-conscious and aging populations throughout the world and the relative availability of capital, the life sciences industry is in an enviable position regarding patent growth — especially when compared with other industries competing for revenues, say Kevin Granahan and David Magagna at Fox Rothschild LLP.

  • Your Future Tech Clients Would Like A Word With You

    Andrew E. Samuels

    Greetings from the future! Ninety-five percent of Earth’s nourishment is supplied by food trucks, the Cincinnati Bengals just won their third consecutive Super Bowl, and the latest social media craze is the “reverse selfie” (taking pictures of other people). Also, my engineering law students from the Spring 2015 semester at Ohio State are now your tech clients. Their answers to two questions back in 2015 should help you serve them ... (continued)