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 The leading web portal for pharmacy resources, news, education and careers October 22, 2014
Pharmacy Choice - Pharmaceutical News - Biotech Lawsuits: Jan. 1 - Dec. 31, 2011 - October 22, 2014

Pharmacy News Article

 1/17/12 - Biotech Lawsuits: Jan. 1 - Dec. 31, 2011

Defendant

Plaintiff

Details/Decisions (Date)#

Abbott (Abbott Park, Ill.)

Centocor Ortho Biotech Inc. (Horsham, Pa.)

Court of Appeals for the Federal Circuit in Washington overturned a 2009 federal court jury verdict that awarded Centocor $1.8 billion after finding Abbott liable for patent infringement; a panel of the court ruled that the patent relating to Centocor antitumor necrosis factor alpha rheumatoid arthritis treatments was invalid (2/24)

Abbott International LLC(Queenborough, UK)

MedImmune LLC(Gaithersburg, Md.)

MedImmune filed a lawsuit in the U.S. District Court for the District of Maryland claiming breach of contract; it stems from a disagreement over how much Abbott must pay for MedImmune's blockbuster drug Synagis for distribution outside the U.S. (8/24)

Abraxis BioScience Inc.(acquired by Celgene Corp., Summit, N.J., in 2010)

Elan Corp. plc (Dublin)

Elan and Celgene entered a settlement and license agreement resolving a patent infringement suit involving breast cancer treatment Abraxane; Celgene will pay Elan a one-time fee of $78M and will acquire an exclusive worldwide license to select Elan U.S. and foreign patents for Abraxane (2/28)

Actelion Ltd. (Allschwil, Switzerland)

Asahi Kasei Pharma Corp.(Tokyo)

A U.S. jury said Actelion should pay out $547M in its license dispute with Asahi; the case arises from a deal between Asahi and CoTherix Inc. for the U.S. development of Asahi's rho kinase inhibitor fusadil for pulmonary arterial hypertension; Actelion terminated the agreement when it acquired CoTherix (5/3); the Superior Court of the State of California granted Actelion's post-trial motion to offset the previous arbitration payment and applied a reduction of $70.35M to the May jury award, but the court denied Actelion's motion for an election between damages for alleged lost profits and alleged development costs based on procedural grounds; the company expects to file an appeal (8/1)

Acura Pharmaceuticals Inc.(Palatine, Ill.)

Kahn Swick & Foti LLC

Company has reached a proposed $1.5M class action settlement for shareholders who purchased, acquired call options or sold options on Acura's common shares between Feb. 21, 2006, and April 22, 2010; the U.S. District Court for the Northern District of Illinois Eastern Division will review the proposal at a hearing Feb. 16 (11/29)

Advanced Cell Technology Inc. (Marlborough, Mass.)

Warrantanddebenture holders

Advanced Cell entered into settlement agreements with 40 holders of certain warrants and debentures; ACT plans to issue approximately 240.5M shares to the group of holders in exchange for a mutual two-way release of current and/or future claims (12/13)

Alnylam Pharmaceuticals Inc.(Cambridge, Mass.)

Max Planck Society, the Whitehead Institute for Biomedical Researchand the University of Massachusetts

Reached a global settlement resolving ongoing litigation regarding the Tuschl patents for RNAi therapeutics; the Massachusetts Institute of Technology also agreed to the terms of the settlement; the litigation began in June 2009 (3/16)

Alnylam Pharmaceuticals Inc.(Cambridge, Mass.)

Tekmira Pharmaceuticals Corp. (Vancouver, British Columbia)

Alnylam believes the complaint filed alleging misappropriation and misuse of information and trade secrets is without merit or foundation; Tekmira's complaint alleges that Alnylam disclosed its LNP formulation manufacturing instructions to at least one third-party collaborator and incorporated Tekmira's confidential information into its own patent filing; Tekmira is seeking future milestones and royalties that could exceed $1B (3/18); Alnylam said the claim is without merit and filed a counterclaim (4/8)

Amphastar Pharmaceuticals Inc.(Rancho Cucamonga, Calif.), Watson Pharmaceuticals Inc.(Parsippany, N.J.) and International Medical Systems Ltd. (Riverside, Calif.)

Momenta Pharmaceuticals Inc.(Cambridge, Mass.)

Momenta sued the three companies in the U.S. District Court for the District of Massachusetts for infringement of two Momenta patents covering its methods to produce the heparin-like product enoxaparin sodium (9/23); a U.S. District Court granted a request by Momenta and Sandoz Inc. for a temporary restraining order through Oct. 21 preventing Watson and Amphastar from marketing or selling enoxaparin sodium injection, a generic equivalent to Sanofi SA's Lovenox (10/11); Momenta and Sandoz obtained a preliminary injunction preventing Amphastar, Watson and International Medical Systems from launching a generic Lovenox until ongoing patent litigation is decided (11/1)

Apotex Corp. and Apotex Inc. (Weston, Ont.)

Acorda Therapeutics Inc.(Hawthorne, N.Y.)

U.S. District Court of New Jersey ruled against Acorda in its patent litigation against Apotex, saying a patent covering the use of multiparticulate tizanidine compositions are invalid and not infirnged by Apotex; the litigation began after Apotex submitted an abbreviated new drug application to the FDA seeking marketing approval for generic versions of Zanaflex (9/8)

Apotex Inc. (Toronto)

Unigene Laboratories Inc.(Boonton, N.J.)

The U.S. Court of Appeals for the Federal Circuit declined to revive Apotex's counterclaims and bid for summary judgment in a 2006 patent infringement suit by Unigene and its U.S. distribution partner over two patents for Fortical; the court decided that a New York federal court was correct in granting Unigene summary judgment (8/31)

Bayer Healthcare(subsidiary of Bayer AG; Leverkusen, Germany)

Onyx Pharmaceuticals Inc. (South San Francisco)

Companies ended their dispute with a new agreement for the late-stage cancer compound that Onyx claimed was an offshoot of the companies' joint development of Nexavar; the new agreement recognizes regorafenib as a Bayer compound, but Bayer will pay Onyx 20% of future worldwide net sales of regorafenib in oncology, Onyx will have no obligation to pay costs for the compound and it has the right to co-promote it in the U.S. (10/13)

BioAlliance Pharma SA (Paris)

SpePharm Holding BV(Amsterdam, the Netherlands)

The Paris Court of Appeals rejected an Appeal by BioAlliance seeking to overturn two tribunal decisions stemming from its termination of a licensing and supply agreement; the companies formed a joint venture, SpeBio BV, in 2007 to commercialize Loramyc in Europe, excluding France; the court ordered BioAlliance to refund nearly $719,000 in legal costs to SpePharm and SpeBio (6/1); BioAlliance filed an appeal to the French Supreme Court on a procedural matter in arbitral proceedings (6/2)

BioDelivery Sciences International Inc.(Raleigh, N.C.),MEDA Pharmaceuticals Inc.(Somerset, N.J.) andAveva Drug Delivery Systems Inc.(Miramar, Fla.)

Monosol RX LLC(Warren, N.J.)

Company amended a patent infringement and false marking lawsuit in U.S. District Court for the District of New Jersey, claiming that they are infringing its patent on the making of films for drug delivery technology through the sale of Onsolis film products (1/19); BioDelivery said it strongly refutes the claims (1/24)

Bioniche Life Sciences Inc.(Belleville, Ont.)

Ferghana Partners Inc.

A New York court dismissed all claims against Bioniche in the lawsuit filed in 2009, seeking 6% of the funds received under Bioniche's strategic partnership related to bladder cancer drug, Urocidin, as a finder's fee; Bioniche said the claim involved an outreach never disclosed to Bioniche and one that was made without its approval (10/24)

Cellectis SA (Paris)

Precision Biosciences Inc.(Research Triangle Park, N.C.)

Patent infringement suit regarding U.S. Patent No. 8,021,867; Cellectis said the patent is too narrow to cover its meganucleases and should not interfere with its ability to make, use and sell the technology; Cellectis filed a countersuit seeking a declaration that Precision's '867 patent is invalid and not infringed by Cellectis (10/4)

Covance Inc. (Princeton, N.J.)

Sucampo Pharmaceuticals Inc.(Bethesda, Md.)

Settled the lawsuit against Covance, which agreed to pay $10M, and to cancel $1.1M in payables; Covance conducted two Phase III trials of lubiprostone in opioid-induced bowel dysfunction (11/2)

Diamyd Medical AB(Stockholm, Sweden)

The University of Florida Research Foundation Inc.

Settled the breach-of-contract litigation filed by UFRF in January relating to an exclusive license agreement between UFRF and Diamyd and a sublicence of the rights under the agreement between Diamyd and Ortho-McNeil-Janssen Pharmaceuticals Inc.; it involved rights to the GAD65-based drug candidate Diamyd (11/18)

Eli Lilly and Co.(Indianapolis)

Amylin Pharmaceuticals Inc. (San Diego)

Amylin filed suit alleging that Lilly engaged in "anticompetitive" behavior by planning to use its existing Byetta sales force to also sell linagliptin (5/17); the U.S. District Court for the Southern District of California issued a temporary restraining order against Lilly stopping it from proceeding with plans to use the same sales force to sell the competing diabetes products (5/27); the court ruled in Lilly's favor and denied Amylin's request for a preliminary injunction; Amylin said it intends to pursue litigation (6/10); a U.S. appeals court upheld a lower court's denial of a preliminary injunction (11/3)

Embryonic stem cell researchers, including Oliver Brustle and Ian Wilmut

Greenpeaceenvironmental group

The European Court of Justice ruled that any invention involving the removal of a stem cell from an embryo cannot be patented; the ruling was made on ethical grounds and includes not only human embryos generated by in vitro fertilzation, but also a human ovum into which the cell nucleus of a mature human cell has been transplanted and an unfertilized human ovum, which has been stimulated to divide by parthogenesis (10/19)

FDA

AIDS Healthcare Foundation

The foundation filed a lawsuit in U.S. District Court, Central District of California, against the FDA because the agency denied Freedom of Information Act requests related to communications with Gilead Sciences Inc. regarding expansion of Truvada for use as a pre-exposure prophylaxis for HIV; the foundation said the FDA has no legal basis for refusing the requests (9/26)

FDA

Par Pharmaceuticals Inc. (Woodcliff Lake, N.J.)

Par filed suit in federal district court, challenging FDA regulations and saying the agency is violating the Federal Food, Drug and Cosmetic Act and the First Amendment by restricting truthful speech about approved uses of Par's Megace ES (10/24)

FDA Commissioner Margaret Hamburg

ViroPharma Inc.(Exton, Pa.)

The Washington Legal Foundation filed a brief in U.S. District Court for the District of Columbia urging the court not to dismiss a challenge to an FDA rule that makes it easier for generic drug manufacturers to demonstrate that their products are bioequivalent to a brand-name drug already on the market (2/7)

GlaxoSmithKline plc (London)

Department of Justice

GSK reached an agreement in principle to resolve investigations into its U.S. sales and marketing practices, the possible inappropriate use of the nominal price exception under the Medicaid rebate program, and the development and marketing of diabetes drug Avandia; GSK plans to fund the $3B settlement through existing cash resources, and has established a framework of compliance (11/4)

GlaxoSmithKline plc (London)

Genentech Inc.(South San Francisco) and Biogen Idec Inc.(Weston, Mass.)

A U.S. District Court entered final judgment in favor of GSK in a case filed by Genentech and Biogen Idec, which claimed Arzerra infringed patents covering methods of treating chronic lymphocytic luekemia with anti-CD20 antibodies (11/18); Genentech and Biogen Idec appealed the judgment (12/7)

Hemispherx Biopharma Inc.(Philadelphia)

Shareholders

The U.S. District Court for the Eastern District of Pennsylvania granted final approval of a settlement of all pending securities class actions; the settlement will be paid from the company's insurance coverage and is not an admission of culpability; the class actions followed a 41% share drop on news that the FDA rejected Ampligen in chronic fatigue syndrome (2/18)

Immunosyn Corp. (La Jolla, Calif.), three shareholder companies and four senior executives

SEC

SEC filed a complaint in federal court in Chicago alleging they fraudulently misled investors about the regulatory status of Immunosyn's only investigational product, SF-1019; SEC filings said a shareholder, Argyll Biotechnologies LLC, planned to begin or had begun the U.S. regulatory approval process for human trials, but they failed to disclose that the FDA had issued two clinical holds on the drug; the SEC also charged Immunosyn CFO Douglas McClain Jr., Argyll's CSO Douglas McClain Sr. and Argyll's CEO James Miceli with insider trading (8/4)

IntelGenx Corp.(Saint Laurent, Quebec)

Biovail Laboratories International SLR(Toronto)

The U.S. District Court of Delaware ruled in favor of the company regarding claim construction for two patent terms in a patent infringement suit regarding the drug candidate CPI-300, a high-dose buproprion (1/5)

Ironwood Pharmaceuticals Inc. (Cambridge, Mass.)

Synergy Pharmaceuticals Inc. (New York)

Synergy filed a lawsuit against Ironwood and Mark G. Currie, its chief scientific officer and senior vice president of research and development, alleging that after European patent 1,379,224 was granted to Synergy, but before it was issued, Ironwood and Currie opposed the patent before the European Patent Office and presented false, contradictory, inaccurate and misleading data and arguments; the complaint accuses them of unfair competition, fraud and unjust enrichment and seeks $500M in actual and punitive damages (12/14)

Janssen Biotech Inc. (subsidiary of Johnson & Johnson; New Brunswick, N.J.)

Affymax Inc. (Palo Alto, Calif.)

Affymax reached a global settlement agreement related to intellectual property emerging from a 1992-1995 research collaboration; Affymax obtains a release of claims, a covenant not to sue and license to the intellectual property in dispute, thereby eliminating claims by Janssen regarding the use, manufacture, import, sale and licensing of peginesatide worldwide; Affymax agreed to pay up-front fees, consisting of an immediate $6M payment and an additional $2M by June 30, 2012, and milestones connected to approval of peginesatide, $2.5M in the U.S. and $2.5M in Europe (11/10)

Johnson & Johnson (New Brunswick, N.J.)

Department of Justice

J&J agreed to pay an $85M fine and plead guilty to charges that its Scios Inc. subsidiary misbranded heart failure drug Natrecor for unapproved uses; Scios also is placed on organizational probation for three years (9/16)

KemPharm Inc. (North Liberty, Iowa)

Shire plc (Dublin)

KemPharm filed an answer and counterclaims against Shire LLC, a subsidiary of Shire, in response to a lawsuit filed in Virginia on Sept. 30, 2010, by Shire against KemPharm and Travis Mickle, its president and CEO, alleging breach of contract and intentional interference with contract in relation to Mickle's prior employment with New River Pharmaceuticals, which Shire acquired in 2007; KemPharm denied the allegations and made claims of unfair competion, antitrust violations and other relief (3/2)

Laboratory Corp. of America(Burlington, N.C.) and Westcliff Medical Laboratories(Santa Ana, Calif.)

Federal Trade Commission

FTC withdrew its appeal to a federal district court's rejection of a preliminary injunction to keep LabCorp from integrating the Westcliff assets because it would harm competition (3/28)

The Lash Group Inc. (CTI's former third-party reimbursement expert for Trisenox)

Cell Therapeutics Inc.(Seattle)

Cell Therapeutics settled litigation and will receive an $11M payment; the settlement relates to the reimbursement of cancer drug Trisenox (arsenic trioxide), which CTI sold to Cephalon Inc. in 2005 (8/12)

Lundbeck Inc. (Copenhagen, Denmark)

Federal Trade Commission

The Eighth Circuit appellate court sided with the district court in the case in which the FTC sued Ovation Pharmaceuticals Inc. (later acquired by Lundbeck) over its acquisition of NeoProfen from Abbott; the FTC argued that the deal gave Ovation control of NeoProfen and Indocin I.V., the only treatments available for a rare cardiovascular disease affecting infants, and that Ovation subsequently hiked the prices of both drugs, but Lundbeck proved that the drugs are not in the same market (9/6)

Lupin Ltd.(Mumbai, India)

Shionogi & Co. Ltd.(Osaka, Japan)

U.S. district court granted Shionogi's request for a preliminary injunction against Lupin preventing it from importing and selling a generic version of Fortamet in the U.S. until ongoing litigation over several patents has been resolved (12/8)

Manhattan Pharmaceuticals Inc.(New York)

Nordic Biotech Fund II K/S(Copenhagen Denmark)

Entered a settlement and release agreement for the development and commercialization of Hedrin, a nonpesticide treatment for head lice; the agreement resolves all previous disagreements and disputes between the companies; the terms include a $575,000 payment to Manhattan, which will no longer have operational responsibilities to the joint venture (1/11)

MannKind Corp. (Valencia, Calif.)

Barroway Topaz Kessler Meltzer & Check LLP(Radnor, Pa.)

The law firm filed a shareholder class action lawsuit in the U.S. District Court for the Central District of California against MannKind, saying it failed to disclose that inhaled insulin candidate Afrezza was riskier than the company had portrayed and that it was unlikely the FDA would approve it in the near future (2/18)

MannKind Corp. (Valencia, Calif.)

John Arditi (former senior director of regulatory affairs)

MannKind reached a final resolution of the arbitration proceedings initiated by Arditi, with Arditi withdrawing claims against MannKind for violations, including wrongful discharge and breach of contract, and MannKind withdrawing claims against Arditi, who played a key role in preparing clinical sites for FDA inspection and was responsible for the company's GCP compliance audit program; no money was exchanged (12/15)

Matrixx Initiatives Inc.(Scottsdale, Ariz.)

Shareholders (Siracusano)

A U.S. Supreme Court ruling upheld a decision by the U.S. Appellate Court for the Ninth Circuit, allowing shareholders to proceed with a securities fraud class action that claimed Matrixx failed to disclose a possible link between its Zicam Cold Remedy and the loss of smell; a federal district court had dismissed the case, agreeing with Matrixx that the undisclosed adverse event reports had no statistical significance as to causation; the case now goes back to the U.S. District Court for the District of Arizona (3/24)

Med Biogene Inc. (Vancouver, British Columbia) and Precision Therapeutics Inc.(Pittsburgh)

Signal Genetics LLC (New York)

Filed an amended complaint in the Supreme Court for the County of New York charging Med Biogene with fraud, and Precision Therapeutics with tortious interference; Signal said it had filed a complaint charging Med Biogene with breach of agreement, violation of a confidentiality agreement and misuse of proprietary information; the complaint involves the licensing of Med Biogene's LungExpress DX technology (2/28)

Medicis Pharmaceutical Corp.(Scottsdale, Ariz.)

Genzyme Corp.(Cambridge, Mass.)

Genzyme agreed to dismiss a patent infringement suit against Medicis that was filed Oct. 15, 2010, in the U.S. District Court for the District of Massachusetts; Genzyme received a lump sum payment from Q-Med, Medicis' partner (2/17)

Merck & Co. Inc. (Whitehouse Station, N.J.)

ConsumersandJustice Department

Merck agreed to plead guilty to a misdemeanor for its illegal promotional activity of painkiller Vioxx, and will pay a $321.6M criminal fine and will pay $638.4M to resolve additional allegations regarding off-label marketing and false statments about the drug's cardiovascular safety; Merck withdrew Vioxx from the market in 2004 due to heart attack and stroke concerns (11/23)

Mylan Technologies Inc. (St. Albans, Vt.)

Noven Pharmaceuticals Inc.(Miami)

Noven filed a lawsuit in the U.S. District Court for the Southern District of New York against Mylan claiming patent infringement, following Mylan's submission of an abbreviated new drug application seeking FDA approval for a generic version of Noven's Vivelle-Do prior to the 2014 patent expiration (2/24)

Mylan Inc.,Mylan Pharmaceutical Inc., Barr Laboratories Inc.,Teva Pharmaceuticals USA Inc. and Teva Pharmaceutical Industries Ltd.

Eurand Inc. (now Aptalis, of Mount-Saint-Hilaire, Quebec), Cephalon Inc. (Frazer, Pa.) and its subsidiary Anesta AG

The U.S. District Court for the District of Delaware ruled against Cephalon in patent litigation concerning Amrix; the court ruled that the two U.S. patents at issue were invalid for being obvious; Cephalon is considering an appeal (5/16); the court granted the motion filed for a temporary restraining order enjoining the companies from manufacturing, using, offering to sell or selling its cyclobenzaprine hydrochloride extended-release capsules (5/23)

Neuralstem Inc.(Rockville, Md.)

ReNeuron Ltd.(Guildford, UK)

Settled their patent infringement lawusit filed in U.S. District Court for the Central District of California; ReNeuron will compensate Neuralstem and make future milestone and royalty payments based on the development of products in dispute (1/31)

Novartis AG (Basel, Switzerland)

PDL BioPharma Inc.(Incline Village, Nev.)

Settlement agreement under which PDL dismisses all claims against Novartis, which also includes Genentech Inc. and parent company Roche AG, in return for Novartis withdrawing its opposition appeal in the European Patent Office challenging the validity of PDL's Queen patent; PDL agreed to pay certain amounts based on net sales of Lucentis during 2011 and beyond (3/1)

Novelos Therapeutics Inc.(Madison, Wis.)

Shareholders

A District Court dismissed the putative federal securities fraud class action lawsuit related to statements made regarding lung cancer drug NOV-002 before it failed a Phase III trial (6/29)

Omeros Corp. (Seattle)

Richard Klein, the company's former chief financial officer

Klein filed suit in 2009 and amended it last year, alleging that Omeros violated the False Claims Act in connection with National Institutes of Health grants totaling about $1.3M and wrongfully discharged Klein; the U.S. District Court for the Western District of Washington ordered the complaint to be unsealed in October 2011; Omeros has filed counterclaims against Klein, alleging breach of contract, misappropriation of trade secrets and breach of fiduciary duty (10/26)

Par Pharmaceuticals Inc.(Woodcliff Lake, N.J.)

Pozen Inc. (Chapel Hill, N.C.)

Pozen filed a motion for a preliminary injunction seeking to prevent Par from launching a generic version of Treximet for acute treatment of migraine attacks; the motion was filed in U.S. District Court for the Eastern District of Texas (3/23); the U.S. District Court granted a preliminary injunction ordering Par not to make, use, sell, offer to sell or import into the U.S. a generic version of Treximet (4/18)

PDL BioPharma Inc.(Incline Village, Nev.)

MedImmune LLC(Gaithersburg, Md.)

PDL will pay $92.5M to MedImmune as part of a settlement to resolve all legal disputes, including those relating to MedImmune's Synagis and PDL's Queen et al. patents (2/17)

Pfizer Inc.(New York)

Whistleblowers

Pfizer agreed to pay $14.5M to settle False Claims Act charges related to the off-label marketing of Detrol, which is approved to treat overactive bladder; whistleblower claims said Pfizer promoted the drug for use in men with benign prostatic hypertrophy and related conditions; the whistleblowers will receive more than $3M from the settlement, with the rest going to the federal government and state Medicaid programs (10/24)

Prometheus Laboratories Inc.(San Diego)

Mayo Collective Services

Supreme Court agreed to hear the case in which Prometheus plans to defend its method patents; the U.S. Court of Appeals for the Federal Circuit maintained that Prometheus' personalized medicine-type claims are patent-eligible (6/21); Supreme Court began hearing arguments in December (12/8)

Repros Therapeutics Inc. (The Woodlands, Texas)

Shareholders

Several pending securities fraud class-action lawsuits filed in federal court for the Southern District of Texas against the company in August and September 2009 have been dismissed; the plaintiffs had alleged the company made misleading statements related to Proellex (3/7)

Salix Pharmaceuticals Ltd.(Raleigh, N.C.)

Napo Pharmaceuticals Inc. (San Francisco)

Napo filed a lawsuit alleging that Salix breached its commitments under the collaboration agreement concerning the development of crofelemer; Salix said that Napo's claims are without merit (5/10)

Sandoz Inc. (unit of Novartis AG; Basel, Switzerland)

Insite Vision Inc.(Alameda, Calif.), Merck & Co. Inc.(Whitehouse Station, N.J.) and Pfizer Inc. (New York)

Filed a patent infringement lawsuit after Sandoz filed an abbreviated new drug application seeking to market a generic version of Azasite before expiration of the patents covering AzaSite and its use; the suit triggers an automatic stay of the ANDA for up to 30 months or until a final court decision (5/31)

Sandoz Inc. (unit of Novartis AG; Basel, Switzerland), Momenta Pharmaceuticals Inc. and Mylan Inc./Natco Inc.

Teva Pharmaceutical Industries Ltd.(Jerusalem)

The U.S. District Court for the Southern District of New York issued favorable claim construction rulings in the company's patent infringement lawsuit regarding multiple sclerosis drug Copaxone (8/30)

Santaris Pharma A/S(Horsholm, Denmark)

Isis Pharmaceuticals Inc.(Carlsbad, Calif.)

Isis filed a patent infringement lawsuit against Santaris in the U.S. District Court, Southern District of California, saying that Santaris' activities providing antisense drug and antisense discovery services are not protected under an exemption for patent infringement for drug development (9/26)

SciClone Pharmaceuticals Inc.(Foster City, Calif.)

Shareholders

SciClone reached a proposed settlement regarding consolidated lawsuits naming certain SciClone officers as defendants and a separate shareholder demand that the firm address alleged breaches of fiduciary duties; actions against the defendants will be dismissed with prejudice, and the firm agreed to adopt certain corporate governance measures and pay $2.5M in attorney's fees to counsel for the plaintiffs (10/13); California Superior Court for the County of San Mateo granted final approval of a settlement reached by the parties (12/16)

SIGA Technologies Inc. (New York)

PharmAthene Inc.(Annapolis, Md.)

PharmAthene completed the closing arguments in its breach of contract action against Siga, under which it alleges it has the exclusive right to license development and marketing rights for Siga's drug candidate, ST-246, pursuant to a terminated merger agreement between the companies (5/3); the Delaware Court of Chancery awarded PharmAthene half of the net profits greater than $40M on ST-246 over the next 10 years, plus one-third of its court expenses (9/23); PharmAthene filed its legal brief in response to SIGA's motion for re-argument; SIGA is arguing that the court erred in its application of the law, while PharmAthene's brief outlines specific examples supporting the use of a constructive trust as an appropriate equitable remedy (10/14); the Delaware Chancery Court denied its motion for reconsideration of certain aspects of the decision that awards PharmAthene 50% of net profits over 10 years from all sales of ST-246 and related products after the first $40M (12/20)

Stanford University

Roche Molecular Systems Inc. (which acquired Cetus) (Basel, Switzerland)

The Supreme Court said federal funding of research does not automatically void an inventor's patent rights in favor of the federal contractor, affirming a 2009 ruling by the U.S. court of Appeals for the Federal Circuit; the suit revolved around polymerase chain reaction technology first developed in 1985 by Cetus, which began collaborating with Stanford scientists in 1988 on research funded in part by the National Institutes of Health (6/8)

Stiefel Laboratories Inc. (Coral Gables, Fla.; subsidiary of GlaxoSmithKline plc; London) and Charles Steifel(former CEO and chairman)

SEC

SEC charged the company and Staifel with defrauding employees and other shareholders by buying back their stock at severely undervalued prices; the SEC alleges that Stifel used low valuations for stock buybacks from November 2006 to April 2009, omitting information that would have alerted employees that their stock was actually worth as much as 300% more; shareholders lost more than $100M (12/14)

Teva Pharmaceutical Industries Ltd. (Jerusalem)

Amgen Inc. (Thousand Oaks, Calif.)

A federal district court granted Amgen a permanent injunction against Teva prohibiting it from infringing Amgen's patents relating to human G-CSF and methods for its use; the injunction affects Teva's Neutroval sales in the U.S. and extends through Nov. 10, 2013 (7/19)

Teva Pharmaceutical Industries Ltd. (Jerusalem)

Cubist Pharmaceuticals Inc. (Lexington, Mass.)

Settled their lawsuit filed by Cubist in 2009; it alleged that Teva had infringed on Cubist's patent for Cubicin by filing for FDA approval of a generic version; the settlement allows Teva to launch its version in 2018 15 months ahead of patent expiration if Cubist receives a six-month extension of pediatric marketing exclusivity from the FDA (4/6)

Teva Pharmaceutical Industries Ltd. (Jerusalem) and Pliva Hrvatska doo (Zagreb, Croatia)

The Medicines Co.(Parsippany, N.J.)

Settled lawsuits relating to the abbreviated new drug applications filed by Teva and Pliva for generic versions of Angiomax; the settlement includes a license to Teva Pharmaceuticals USA Inc. and its affiliates allowing it to launch a generic bivalirudin product under of one its ANDAs in the U.S. on June 30, 2019 (10/4)

UCB SA (Brussels, Belgium)

PDL BioPharma Inc.(Incline Village, Nev.)

Settlement agreement that resolves all legal disputes relating to UCB's pegylated humanized antibody fragment Cimzia and PDL's Queen et al. patents; PDL agreed not to sue UCB for any royalties in return for a lump sum payment of $10M and the mutual resolution of other disputes (2/9)

U.S. Government and Department of Health and Human Services Secretary Kathleen Sebelius

Two scientists working on adult stem cell projects (James Sherley of the Boston Biomedical Research Institute, and Theresa Deisher of AVM Biotechnology Co.)

A federal appelate court (U.S. Circuit Court of Appeals for the District of Columbia) lifted the preliminary injunction that was intended to keep the National Institutes of Health from funding research involving human embryonic stem cells; the lawsuit has to go to trial on the district court level; the injunction was imposed last August after a judge decided the funding violates a 1996 law that prohibits taxpayer funds to be used in any research that involves the destruction of a human embryo, but the court stayed the injunction to avoid terminating research projects midstream (5/2); district court dismissed the case (7/28)

U.S. Patent and Trademark Office (PTO)

The American Civil Liberties Union and a coalition of patients, pathologists, genetic researchers and other scientists

The lawsuit was filed in the U.S. District Court for the Southern District of New York in Manhattan, challenging PTO's decisions to grant patents for the BRCA gene, which is associated with breast and ovarian cancers, to Myriad Genetics and the University of Utah Research Foundation; a U.S. federal judge ruled PTO had improperly granted seven BRCA gene patents to Myriad because they involved a law of nature; Myriad and the university filed a notice of appeal in 2010; the U.S. Court of Appeals for the Federal Circuit ruled that isolated DNA and complementary DNA can be patented, and reversed a district court's decision that "Myriad's composition claims to 'isolated' DNA molecules cover patent-ineligible products of nature . . . since the molecules as claimed do not exist in nature" (8/2)

Viral Genetics Inc. (San Marino, Calif.)

Timothy and Thomas LLCand its principals

Settlement ended an almost-five-year lawsuit and dismissed all claims without admission of liability by any party; Viral terminated the distribution management agreement, reacquiring the rights to develop and market HIV/AIDS products in Africa; Viral will pay T&T $1.9M over the course of three years (2/1)

Watson Pharmaceuticals Inc.(Corona, Calif.)

Cephalon Inc.(Frazer, Pa.)

The U.S. District Court for the District of Delaware found in favor of Watson in a patent litigation suit brought by Cephalon pertaining to two out of three patents for Cephalon's Fentora buccal tablet; the court has not yet ruled on the third (3/15)

Wyeth

Bruesewitz

U.S. Supreme Court ruled that federal law preempts vaccine design defect claims; it said the National Childhood Vaccine Injury Act of 1986 expressly eliminates liability for unavoidable adverse side effects of a vaccine that's manufactured and labeled in accordance with its FDA-approved license; the suit involved a diphtheria, tetanus and pertussis vaccine made by Lederle Laboratories (2/25)

Notes:

This chart contains information on lawsuits involving biotech companies or the industry as a whole., and is based on news items published in BioWorld Today in 2011.

# The date indicated refers to the BioWorld Today issue in which the news item can be found.



(c) 2012 Thomson BioWorld, All Rights Reserved.

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