Life Sciences

  • March 26, 2015

    FDA Rejects Amgen's Biosimilars Info-Sharing Petition

    The U.S. Food and Drug Administration in a letter released Thursday rejected Amgen Inc.’s request that biosimilars makers be forced to share their applications and manufacturing processes with competitors, exacerbating the company’s recent defeat in litigation with Sandoz Inc.

  • March 25, 2015

    FedEx Tries To Buck Charges Of Drug Shipping Conspiracy

    FedEx Corp. on Wednesday urged a California federal judge to kick an indictment accusing it of helping illegal online pharmacies ship generic versions of Valium, Xanax and other drugs, arguing it was shielded from trafficking and conspiracy charges because it was a common carrier.

  • March 25, 2015

    Walgreen, Others Sue Over Alleged Aggrenox Pay-For-Delay

    Walgreen Co., The Kroger Co., Safeway Inc. and other grocery chains on Wednesday filed a joint complaint against Teva Pharmaceuticals USA Inc. and Boehringer Ingelheim Pharmaceuticals Inc. in Pennsylvania federal court over an alleged $120 million pay-for-delay deal for a generic version of stroke drug Aggrenox.

  • March 25, 2015

    11th Circ. Won't Revive Chinese Pharma Class Action Claims

    The Eleventh Circuit on Wednesday upheld a lower court’s dismissal of claims against the former chief financial officer of Chinese drugmaker Jiangbo Pharmaceuticals Inc. and a former auditing firm for the company from a securities class action, finding the plaintiffs’ theory of fraud was too vague.

  • March 25, 2015

    ZS Pharma Eyes $214M Offering To Commercialize Lead Drug

    ZS Pharma Inc., a biopharmaceutical company developing treatments for renal, cardiovascular and liver metabolic disorders, announced an upsized public offering on Tuesday that could fetch up to $213.6 million, joining the wave of biopharmaceuticals tapping the public markets.

  • March 25, 2015

    Ariad, Execs Beat Fraud Suit Over Failed Leukemia Drug

    Ariad Pharmaceuticals Inc. beat a securities fraud action Wednesday after a Boston federal judge said allegations that the company and four officers hid evidence suggesting a promising leukemia drug would fail were insufficient despite a "cogent argument" from investor-plaintiffs that defendants including CEO Harvey Berger engaged in insider trading.

  • March 25, 2015

    Utah Bill Targeting Contact Lens Pricing Awaits Gov.’s OK

    Utah is close to approving legislation that would prevent contact lens manufacturers from entering into agreements that restrict the price retailers may charge for their products, a controversial issue that has embroiled the industry in a wave of antitrust litigation.

  • March 25, 2015

    Alps Asks Fed. Circ. To Affirm Inequitable-Conduct Ruling

    Alps South LLC has urged the Federal Circuit to affirm a finding that Ohio Willow Wood Co. engaged in inequitable conduct during re-examination of a prosthetic patent and asked it to hold Ohio Willow liable for even more misconduct.

  • March 25, 2015

    Kilpatrick Townsend Faces Leaner Drug Device IP Theft Suit

    A federal judge pared a suit Tuesday alleging Kilpatrick Townsend & Stockton LLP helped a client steal confidential information about a medication-dispensing device and excluded its inventors from the patent application, tossing conspiracy and fraudulent concealment claims but keeping the fraud and negligence claims in play.

  • March 25, 2015

    SEC Nets $18M From Drug Co. Accused Of Duping Investors

    A Massachusetts-based life sciences company was ordered Wednesday to pay $17.9 million to the U.S. Securities and Exchange Commission in a lawsuit accusing the company of selling investors millions of dollars' worth of stock by falsely suggesting that its products would soon secure the necessary regulatory approvals.

  • March 25, 2015

    FaegreBD Nabs 9 Partners To Amp Up Chicago Operations

    Faegre Baker Daniels has recruited nine partners from four firms to bolster its investment management, intellectual property, product liability and employment practices, as part of a broader strategy to expand in Chicago, the firm said Tuesday.

  • March 25, 2015

    Jones Day-Led Cellectis Outshines Expectations In US IPO

    France-listed Cellectis SA beat expectations in its U.S. debut led by Jones Day, raising $228 million in an upsized initial public offering before listing Wednesday on the Nasdaq alongside the growing number of biopharmaceutical companies developing immunotherapy treatments for cancer.

  • March 24, 2015

    FDA Widened Abilify Scope To Admit Generics, Otsuka Says

    Otsuka Pharmaceutical Co. slammed the U.S. Food and Drug Administration Tuesday for expanding the scope of its antipsychotic drug Abilify to treat Tourette's syndrome in patients of all ages rather than only in children, calling it a ploy to admit generic versions when the company's patent expires next month.

  • March 24, 2015

    Class Cert. Denied In Cephalon Painkiller Marketing Suit

    A Pennsylvania federal judge on Monday refused to certify a proposed class action accusing drugmaker Cephalon Inc. of unjustly enriching itself by marketing a painkiller for off-label uses, ruling the plaintiffs failed to show that a class action was the best way to resolve their claims.

  • March 24, 2015

    Supplement Co. Throws Flag On NFL Agent's Double-Dealing

    A dietary supplement company on Tuesday accused an agency for Pittsburgh Steelers wide receiver Antonio Brown of inducing the NFL star to breach an endorsement deal he signed in November by inking a new agreement with a competitor.

  • March 24, 2015

    Cellectis Boosts IPO Target As Immunotherapy Cos. Rally

    Cellectis SA boosted the target for its U.S. initial public offering to nearly $200 million Tuesday, increasing the number of American depositary shares it plans to sell as the France-listed company’s common stock climbs on the Paris Euronext and U.S.-listed cancer immunotherapy treatment developers' shares rally.

  • March 24, 2015

    Goodwin Procter Leads Blueprint Medicines Toward $100M IPO

    Venture capital-backed Blueprint Medicines Corp., led by a Goodwin Procter LLP team, filed Monday to raise $100 million in an initial public offering, making it the latest biopharmaceutical working toward a breakthrough in cancer treatments to plan a Nasdaq listing.

  • March 24, 2015

    Bristol-Myers Picks Up Autoimmune Research Program

    Bristol-Myers Squibb Co. announced on Tuesday that it has acquired an autoimmune disease research program from Denmark-based Novo Nordisk AS for an undisclosed amount.

  • March 24, 2015

    3rd Circ. Won't Rehear Relator's FCA Suit Over Drug Costs

    The Third Circuit declined Monday to rehear en banc a whistleblower's case accusing Express Scripts Inc. and various pharmacies, retailers and drug wholesalers of violating the False Claims Act by overbilling the federal government for prescription drugs.

  • March 24, 2015

    Pharma Patent Rules Give FTC Too Much Clout, DC Circ. Told

    A pharmaceutical industry group on Tuesday told a D.C. Circuit panel to toss a Federal Trade Commission rule requiring disclosure of more exclusive patent licenses for approval under federal merger law, saying the law does not allow the agency to target a particular industry.

Expert Analysis

  • High Court May Take On Corporate 5th Amendment Privilege

    Ramzi Abadou

    A festering but virtually unnoticed circuit split over a legal doctrine the U.S. Supreme Court first recognized early last century may provide the Roberts court with the opportunity to grant corporate persons privilege against self-incrimination for the first time in U.S. history, says Ramzi Abadou of Kahn Swick & Foti LLP.

  • And Now A Word From The Panel: Just Say No (To MDLs)?

    Alan E. Rothman

    What will spring bring for the Judicial Panel on Multidistrict Litigation? Will it continue to close the door on new MDL proceedings? Will it decide to throw the baby out with the bathwater and decline to create a baby wipe MDL? asks Alan Rothman of Kaye Scholer LLP.

  • Biomet’s DPA Proves An Inescapable Device

    Amy Riella

    As just the latest in a series of companies facing additional scrutiny from U.S. regulators following the settlement of an enforcement action involving violations of the Foreign Corrupt Practices Act, Biomet Inc.’s current plight highlights the risks of continuing reporting and disclosure obligations contained in most deferred and nonprosecution agreements, say Amy Riella and Carla Jordan-Detamore of Vinson & Elkins LLP.

  • BPCIA: How Long Is The Party, And Do I Have To Dance?

    Leslie-Anne Maxwell

    A California federal court's recent ruling in Amgen Inc. v. Sandoz Inc. is the first to interpret two key provisions of the Biologics Price Competition and Innovation Act and, if upheld on appeal, will have a tremendous impact on the patent litigation strategies of both reference product sponsors and biosimilar applicants going forward, say attorneys with Cantor Colburn LLP.

  • A Texas Court’s Broad Reading Of FCA Public Disclosure Bar

    Allyson Singel Aldous

    A Texas federal court's recent decision in U.S. v. Solvay SA curtails whistleblowers’ ability to bring successful False Claims Act claims by expanding the scope of the public disclosure bar and the parameters of voluntary disclosure, says Allyson Singel Aldous of Buchanan Ingersoll & Rooney PC.

  • Medical Device Companies Face Increased TAA Scrutiny

    Lawrence Sher

    A spate of recent multimillion-dollar settlements has shown that medical device manufacturers are subject to substantial liability under the False Claims Act if they misstate the country of origin of their products in violation of the Trade Agreements Act, say attorneys with Reed Smith LLP.

  • NJ Supreme Court Clarifies Expert Testimony Rule

    Timothy Freeman

    Practitioners should take note of the New Jersey Supreme Court's recent decision in Townsend v. Pierre when seeking to exclude expert testimony that is based on factual scenarios that have no support in the record, says Timothy Freeman of Sedgwick LLP.

  • Post-Grant Proceedings Are Important For Biosimilars

    Paul Calvo

    In recent litigations, biosimilar applicants who have sought to circumvent the Biologics Price Competition and Innovation Act have been unsuccessful in their efforts to obtain early resolution of their patent disputes in district court. Thus, biosimilar applicants will increasingly look to post-grant patent challenges as a mechanism for obtaining early and fast patent certainty, say Paul Calvo and Eldora Ellison of Sterne Kessler G... (continued)

  • Lack Of Off-Label Causation Analysis Could Be Costly

    Sophie Yang

    From an economic perspective, there are three guiding questions that can be useful for companies facing litigation related to off-label promotion claims, say Dr. Sophie Yang and Dr. Saul Helman of Navigant Consulting Inc.

  • Teva Will Increase Reliance On Experts In Patent Cases

    Mini Kapoor

    The U.S. Supreme Court's recent decision in Teva Pharmaceuticals USA Inc. v. Sandoz Inc. will likely induce patent litigators to raise factual disputes regarding the meaning of patent terms not only to get the benefit of the deferential standard of review, but also to decrease the chances of appeal on a ruling on this issue, says Mini Kapoor of Haynes and Boone LLP.