Defendant

Plaintiff

Details/decisions

Date

Achillion Pharmaceuticals Inc. (New Haven, Conn.)

Wolf Haldenstein Adler, Freeman & Herz LLP

Achillion is facing a class action lawsuit in the U.S. District Court, District of Connecticut, on behalf of common stock purchasers between Aug. 8, 2012, and Sept. 30, 2013; the complaint alleges that Achillion engaged in a fraudulent scheme to artificially inflate its stock price by disseminating materially false and misleading statements concerning clinical trials of the drug sovaprevir for hepatitis C virus

10/28/13

Actavis Inc. (Parsippany, N.J.)

Astrazeneca plc (London)

Reached a settlement resolving outstanding patent litigation related to Actavis’ generic version of rosuvastatin calcium (Crestor tablets), as well as its rosuvastatin zinc alternate salt product; Actavis can launch its generic version 67 days prior to July 8, 2016, the expiration of pediatric exclusivity, at a fee of 39% of net sales to Astrazeneca

3/26/13

Actavis Inc. (Parsippany, N.J.)

Avanir Pharmaceuticals Inc. (Aliso Viejo, Calif.)

Settlement agreement to resolve pending patent litigation in response to Actavis’ abbreviated NDA for generic versions of Avanir’s Nuedexta; the agreement grants Actavis the right to begin selling a generic version on July 30, 2026, or earlier under certain circumstances

9/4/13

Actavis Inc. (Parsippany, N.J.)

Mallinckrodt Inc. (Dublin, Ireland)

Reached a settlement on patent litigation related to Actavis’ generic version of the 32-mg dosage of Mallinckrodt’s Exalgo tablets

2/15/13

Actavis Inc. (Parsippany, N.J.)

Millennium: The Takeda Oncology Co.

Millennium filed a suit against Actavis on Dec. 21, 2012, in the U.S. District Court of Delaware to prevent Actavis from commercializing its bortezomib before expiration of some Velcade patents; the filing includes a provision to stay the FDA’s approval of Actavis’ ANDA for up to 30 months, or until resolution of the case

1/2/13

Actavis Inc. (Parsippany, N.J.)

Pfizer Inc. (New York)

U.S. District Court for the District of Delaware found U.S. Patent No. 5,100,899 valid and infringed by Actavis’ generic version of Pfizer’s Rapamune

2/4/13

Actavis Inc. (Parsippany, N.J.)

Shire plc (Dublin)

Reached a settlement agreement resolving patent litigation related to Actavis’ generic version of Intuniv to treat attention deficit hyperactivity disorder; it can launch its version on Dec. 1, 2014, or earlier, and Shire will receive a 25% royalty during the 180-day exclusivity

4/26/13

Actavis Inc. (Parsippany, N.J.)

Somaxon Pharmaceuticals Inc. (San Diego)

Settlement agreement to resolve pending patent litigation involving Silenor 3-mg and 6-mg tablets; the agreement grants Actavis the right to begin selling a generic version of the insomnia drug on Jan. 1, 2020, or earlier

2/7/13

Adamis Pharmaceuticals Corp. (San Diego)

Cosmo Bioscience Inc. affiliates (San Diego)

Court entered an order of dismissal with prejudice of a complaint filed regarding a dispute over one of its license agreements; Cosmo affiliates had alleged that Maurizio Zanetti wrongfully terminated a license deal with Cosmo and, through Nevagen LLC, improperly licensed the same technology to Adamis in violation of the sublicense agreements with the plaintiffs

3/4/13

Aeterna Zentaris Inc. (Quebec City)

Faruqi & Faruqi LLP (class action)

The class action lawsuit filed in the U.S. District court for the Southern District of New York has been entirely dismissed with prejudice and without leave to amend; the plaintiff has 30 days to appeal

6/10/13

AFH Holding and Advisory LLC and Amir Heshmatpour

Emmaus Life Sciences Inc. (Torrance, Calif.)

The Superior Court of Delaware granted in full a motion for summary judgment, finding that Emmaus had properly canceled all shares of its common stock held by AFH and that AFH and Heshmatpour must return to Emmaus all stock certificates representing the shares

5/17/13

Amarin Corp. plc (Dublin)

Robbins Arroyo LLP

Company is facing a federal securities fraud class action complaint in the U.S. District Court for the District of New Jersey, alleging that Amarin and certain officers violated the Securities and Exchange Act of 1934 between July 9, 2009, and Oct. 15, 2013; the action follows the release of an FDA briefing document showing that the agency expressed doubt in 2008 that reduction of triglycerides alone evidenced an improved risk of cardiac issues; Amarin’s share price dropped last month after an FDA committee recommended against approval of Vascepa, a lipid-lowering candidate

11/8/13

Amerigen Pharmaceuticals Inc. (Lyndhurst, N.J.)

Forest Laboratories Inc. (New York)

Made a settlement agreement regarding the patent-infringement litigation brought by Forest in response to Amerigen’s abbreviated new drug application for generic versions of Forest’s Bystolic tablets; Forest will provide a license to Amerigen that will permit it to launch its generic versions of Bystolic as of the date that is the later of three calendar months prior to the expiration of U.S. Patent No. 6,545,040 or the date Amerigen receives final FDA approval of its ANDA, or earlier in certain circumstances

7/23/13

Amylin Pharmaceutical Inc. (San Diego), Merck & Co. Inc. (Whitehouse Station, N.J.) and Novo Nordisk A/S (Bagsvaerd, Denmark)

Watts Guerra LLP (San Antonio)

Lawsuit over the death by pancreatic cancer of a patient given diabetes medications marketed by the firms; Watts Guerra has filed a motion to consolidate the incretins litigation nationally; Bernstein Liebhard LLP, of New York, said product liability claims involving Type II diabetes drugs in the incretin mimetics class continue to move forward in a multidistrict litigation now under way in U.S. District Court, Southern District of California; in a Dec. 2 order, the court approved the use of a master complaint and short-form complaint for all cases filed in the litigation; all of the lawsuits pending in the proceeding involve similar allegations that Byetta (exenatide, Amylin Pharmaceuticals Inc. and Eli Lilly and Co.), as well as Januvia (sitagliptin, Merck & Co. Inc.), Janumet (sitagliptin/metformin, Merck) and Victoza (liraglutide, Novo Nordisk AS), can increase a patient’s risk of developing pancreatic cancer.

4/12/13; 12/16/13

Banner Pharmacaps Inc. (High Point, N.C.) and Watson Laboratories Inc. (Parsippany, N.J.)

Depomed Inc. (Newark, Calif.)

Depomed filed a patent infringement suit against Banner and Watson related to filings of an abbreviated NDA for a generic version of Zipsor, a nonsteroidal anti-inflammatory drug for acute pain

7/30/13

Bioniche Life Sciences Inc. (Belleville, Ontario)

Shareholders William M. Wells and Greg Gubitz

Bioniche reached a settlement with the shareholders agreeing to divest the company’s animal health business and sell or partner its vaccine manufacturing center; Bioniche also agreed to distribute 90% of net proceeds to shareholders through share buybacks and/or dividends; Gubitz also was named an independent director of the board

9/16/13

Boehringer Ingelheim GmbH (Ingelheim, Germany)

Mcphadden Samac Tuovi LLP (Toronto)

Lawsuit relating to the blood thinner Pradax on behalf of persons in Canada who ingested the drug; the claim is for damages in the amount of $150M; there have been reports that Pradax causes excessive bleeding, and the plaintiff claims that patients should have been warned about the lack of an antidote for the compound

4/12/13

Catalyst Pharmaceutical Partners Inc. (Coral Gables, Fla.)

Investor

Company is facing a federal securities fraud class action complaint in the U.S. District Court for the Southern District of Florida alleging that the company and some of its officers violated the SEC Act of 1934 between Oct. 31, 2012, and Oct. 18, 2013, by failing to disclose the existence of a biological equivalent to Firdapse, which is in development for Lambert-Eaton myasthenic syndrome; the complaint alleges that Jacobus Pharmaceutical Inc. has provided patients with an equivalent free of charge through a compassionate use program, causing Catalyst’s stock to fall 25% upon the news

11/14/13

Dakota Laboratories LLC (St. Louis)

FDA

FDA entered a consent decree of permanent injection enjointing Dakota and its president, Charles L. Voillinger, from manufacturing and distributing drugs until the company corrects ongoing violations of drug manufacturing laws

9/6/13

Dendreon Corp. (Seattle)

Shareholders

Dendreon reached an agreement to settle securities class action litigation pending against it in the U.S. District Court for the Western District of Washington; the lawsuit was over alleged false or misleading statements concerning the market launch of Provenge

3/19/13

Drug Enforcement Administration

Eisai Inc. (Woodcliff Lake, N.J.)

Eisai filed a petition with the U.S. Court of Appeals for the District of Columbia, asking the court to direct the DEA to promptly schedule the company’s epilepsy drug so that it can make it available to patients; Eisai said the DEA has “unreasonably” and “egregiously” delayed the scheduling

8/21/13

Enzymotec Ltd. (Midgal Ha’emeq, Israel) and Enzymotec USA Inc.

Neptune Technologies and Bioressources Inc. (Laval Quebec, and Acasti Pharma Inc. (subsidiary of Neptune)

An administrative law judge presiding over an International Trade Commission investigation granted a joint motion by the parties to stay the proceedings for thirty days; Neptune and Acasti filed with the ITC alleging infringement of Neptune’s krill extract composition patents by Enzymotec and other companies in the industry; the purpose of the stay was to allow a final binding written settlement agreement so that the parties can file a motion to terminate the investigation

12/19/13

European Medicines Agency

Abbvie Inc. (Chicago) and Intermune Inc. (Brisbane, Calif.)

Companies sought court injunctions preventing the disclosure of clinical trial data for Humira and Esbriet in a new data transparency regime that will occur Jan. 1, 2014

3/12/13

Exela Pharma Sciences LLC (Lenoir, N.C.)

Cadence Pharmaceuticals Inc. (San Diego)

U.S. District Court for the District of Delaware ruled in favor of Cadence in the company’s patent infringement lawsuit against Exela regarding Ofirmev

11/18/13

Exela Pharma Sciences LLC (Lenoir, N.C.), Exela Pharmsci Inc. and Exela Holdings Inc.

Cornerstone Therapeutics Inc. (Cary, N.C.)

Cornerstone filed a complaint in the U.S. District Court for the District of Delaware alleging infringement on two U.S. patents related to Cardene that expire in 2027

7/26/13

Genentech Inc. (South San Francisco)

PDL Biopharma Inc. (Incline Village, Nev.)

PDL filed a notice of arbitration against Genentech, alleging, inter alia, that Genentech underpaid royalties going back to at least 2007 and impeded PDL’s attempts to have Genentech’s books and records inspected

6/12/13

Genentech Inc. (South San Francisco; unit of Roche AG; Basel, Switzerland)

Sanofi SA (Paris)

The U.S. Court of Appeals for the Federal Circuit upheld a district court’s decision to deny Genentech’s request for an injunction on foreign arbitration over its terminated licensing contract for DNA enhancers allegedly used in the making of the biologic Rituxan; Genentech had asked for the injunction after the district court ruled that Rituxan and Avastin didn’t infringe Sanofi’s patents, but the federal circuit distinguished between the two actions, saying the infringement suit had to do with U.S. patent law, whereas the foreign case concerns a licensing contract subject to German law and International Chamber of Commerce (ICC) arbitration

5/14/13

Genta Inc. (Berkeley Heights, N.J.)

Rosen Law Firm P.A.

Hearing will be held in September for whether the proposed class action settlement of $785,000 should be approved by the court

7/11/13

Genvec Inc. (Gaithersburg, Md.)

Brower Piven

The putative class-action lawsuit filed against the company and its current and former officers in the U.S. District Court for the District of Maryland has been dismissed with prejudice

9/24/13

Genzyme Corp. (Cambridge, Mass.)

Shareholders

Washington Legal Foundation urged the U.S. Court of Appeals for the First Circuit to uphold a lower court’s dismissal of the case, which claimed Genzyme defrauded investors by not immediately disclosing all observations noted by FDA staff until Feb. 2009 following an October 2008 inspection of a manufacturing facility for Pompe disease treatment Lumizyme; Genzyme disclosed the information following a complete response letter from the FDA

7/10/13

Gilead Sciences Inc. (Foster City, Calif.)

Idenix Pharmaceuticals Inc. (Cambridge, Mass.)

Idenix filed two lawsuits, one in the U.S. District Court in Boston alleging that Gilead infringes two U.S. patents co-owned by Idenix that cover methods of treating the hepatitis C virus using 2’-methyl nucleosides, and the other in the U.S. District Court in Wilmington, Del., alleging that Gilead infringes a separate U.S. patent co-owned by Idenix that covers methods of treating the hepatitis C virus using 2’-methyl-2’-fluoro nucleosides

12/3/13

Glaxosmithkline plc (London), partner of Genmab A/S (Copenhagen, Denmark)

Genentech Inc. (unit of Roche AG; South San Francisco) and Biogen Idec Inc. (Weston, Mass.)

The Court of Appeals for the Federal Circuit upheld the District Court’s judgment in favor of GSK in a patent infringement case involving Arzerra; the lawsuit claimed Arzerra infringed a patent covering methods of treating chronic lymphocytic leukemia with CD20 antibodies; Genentech and Biogen are asking the Court of Appeals to reconsider the case; the U.S. Court of Appeals for the Federal Circuit declined the request to re-hear the case, essentially ending the lawsuit, unless Genentech and Biogen are granted review by the U.S. Supreme Court

4/17/13; 5/20/13

Immunovative Therapies Ltd. (Shoham, Israel)

Immunovative Inc. (New York)

Filed a lawsuit against ITL in district court, alleging ITL’s wrongful termination of a license agreement between ITL, as licensor, and Immunovative, as licensee; Immunovative discovered ITL’s president and CEO Michael Har-Noy was Michael L. Gruenberg, a felon convicted of wire fraud, securities fraud and interstate transportation of checks obtained by fraud in connection with a scheme to inflate the reported instrument sales of a medical devices company

1/25/13

Incyte Corp. (Wilmington, Del.)

Shareholders represented by the law offices of Howard G. Smith

Class action lawsuit was filed on behalf of purchasers of the firm’s common stock between April 26, 2012, and Aug. 1, 2012, alleging that Incyte misled investors with false reports of strong demand for myelofibrosis drug Jakafi

3/15/13

Intas Pharmaceuticals Ltd. (Ahmedabad, India) and subsidiary Accord Healthcare Inc.

Roche AG (Basel, Switzerland)

Settlement and license agreement to resolve pending patent litigation related to cancer drug Xeloda; Roche granted Accord a license to enter the U.S. market with a generic version ahead of its exclusivity period; pursuant to the agreement, pending litigation would be dismissed

6/26/13

Investors

Advanced Cell Technology Inc. (Marlborough, Mass.)

Reached a settlement agreement with CAMOFI and CAMZHN Master LDC resolving a lawsuit filed in the Supreme Court of New York on the conversion price of certain ACT notes and the exercise price of certain warrants; ACT agreed to pay $12.5M, plus legal expenses

1/22/13

Ista Pharmaceuticals Inc. (Irvine, Calif.)

Department of Justice

Ista will be excluded from federal programs for the next 15 years as a result of its felony guilty pleas involving off-label marketing of Xibrom and physician kickbacks; Ista will pay $33.5M, including $18.5M in criminal fines and forfeiture and $15M in civil penalties resulting from the whistleblower allegations

5/29/13

Janssen Pharmaceuticals Inc. (unit of Johnson & Johnson; New Brunswick, N.J.)

State of Arkansas

The Arkansas Supreme Court is being asked to overturn the $1.2B penalty assessed against Janssen; the lawsuit was filed by the state due to the placement of risk information on the FDA-approved label for Risperdal

4/9/13

Johnson & Johnson, unit Janssen Pharmaceuticals Inc. and unit Scios Inc. (New Brunswick, N.J.)

U.S. Department of Justice and 45 states

J&J, Janssen and Scios will pay $2.2B to resolve criminal and civil claims in multiple settlement agreements; the claims pertained to promotional practices of Risperdal from 1999 to 2005, sales and marketing of Invega and Natrecor by Scios, and allegations related to Janssen’s interactions with Omnicare Inc. to drive prescribing of drugs in exchange for payments, which prosecutors said were disguised as grants or educational funding

11/5/13

Keryx Biopharma-ceuticals Inc. (New York)

Bronstein, Gewirtz & Grossman LLC (class action lawsuit)

Class action lawsuit filed in the U.S. District Court for the Southern District of New York; in April 2013, Keryx’s stock plunged 65% on Phase III news that perifosine did not meet the primary endpoint in an advanced colorectal cancer study; shareholders allege the company issued a series of material or false misrepresentations of the market

2/6/13

King County, Wash.

Biotechnology Industry Organization, Consumer Healthcare Products Association, Generic Pharmaceutical Association and Pharmaceutical Research and Manufacturers of America

The associations asked the U.S. District Court for the Western District of Washington to declare a regulation unconstitutional; the regulation requires drugmakers to set up and maintain secure take-back programs for unused prescription and over-the-counter drugs – at no cost to King County residents; the associations claim the rule violates the federal Commerce Clause, shifts local government responsibilities onto interstate businesses and transfers to patients in other states the cost of King County’s drug disposal

12/4/13

Kymab Ltd. (Cambridge, UK)

Regeneron Pharmaceuticals Inc. (Tarrytown, N.Y.)

Kymab notified the English Court that it will defend the UK patent proceedings brought by Regeneron in respect to European patent EP1360287 on the grounds of non-infringement and invalidity of the patent

10/10/13

Mallinckrodt Inc. (Dublin)

Nuvo Research Inc. (Mississauga, Ontario)

Nuvo commenced legal action against Mallinckrodt with a complaint in the U.S. District Court for the Southern District of New York, alleging it breached its contractual obligations to Nuvo as set out in a licensing deal for the rights to market and sell Pennsaid and Pennsaid 2% in the U.S.; Nuvo said Mallinckrodt failed to conduct certain clinical studies required

8/22/13

Medivation Inc.

Aragon Pharmaceuticals Inc. (San Diego)

Superior Court of California, County of San Francisco, granted summary adjudication in Aragon’s favor on its Complaint in Intervention against Medivation; on May 3, 2011, Medivation had filed a breach of contract claim against the Regents of the University of California claiming rights to a series of anti-androgen compounds that were exclusively licensed to Aragon in 2009, including ARN-509

1/7/13

Mylan Inc. (Pittsburgh)

Forest Laboratories Inc. (New York)

Forest Sued Mylan in connection with the filing of an abbreviated new drug application with the FDA for Milnacipran HCL Tablets, the generic version of Savella, indicated to manage fibromyalgia

9/26/13

Mylan Pharmaceuticals Inc. (Pittsburgh)

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

Patent infringement lawsuit against Mylan, which filed an abbreviated new drug application seeking to market a generic version of Azasite; the lawsuit triggers an automatic stay for the FDA’s approval of the ANDA for up to 30 months or until a final court decision of the infringement lawsuit

6/18/13

Mylan Pharmaceuticals Inc. (Pittsburgh)

OSI Pharmaceuticals LLC (unit of Astellas Pharma Inc.), Pfizer Inc. (New York) and Genentech Inc. (unit of Roche AG; Basel, Switzerland)

Mylan’s subsidiary Mylan Pharmaceuticals Inc. entered into a settlement agreement resolving patent litigation related to erlotinib hydrochloride tablets, 25 mg, 100 mg and 150 mg, generic versions of Tarceva; all pending litigation will be dismissed with all other terms and conditions of the settlement remaining confidential; the agreement is subject to review by the U.S. Department of Justice and the Federal Trade Commission

7/25/13

Mylan Pharmaceuticals Inc. (Pittsburgh)

Teva Pharmaceutical Industries Ltd. (Petach Tikva, Israel)

U.S. District Court for the District of New Jersey gave it a favorable ruling in a patent infringement lawsuit against Mylan related to Azilect for Parkinson’s disease

9/24/13

Myriad Genetics Inc. (Salt Lake City)

The Association for Molecular Pathology

Supreme Court ruled that naturally occurring isolated DNA is not patent eligible, but upheld the patent eligibility of complementary DNA, which is synthetically created; the decision strikes down Myriad’s isolated DNA claims to the BRCA1 and BRCA2 genes

6/14/13

National Institutes of Health

Scientists James Sherley and Theresa Deisher

Supreme Court declined to hear a challenge to NIH funding of human embryonic stem cell research, marking the end of the legal road for Sherley v. Sebelius

1/8/13

Novartis Pharmaceuticals Corp. (East Hanover, N.J.; part of Novartis AG)

U.S. Attorney’s Office for the Southern District of New York

Novartis disputes the allegations made pertaining to an investigation into discounts and rebates to specialty pharmacies for Myfortic, and an investigation into speaker programs conducted by Novartis for Lotrel, Starlix and Valturna; Novartis claims the suit is a significant expansion of the anti-kickback statute and disputes allegations that its speaker programs lacked legitimate business purpose

4/30/13

Oxygen Biotherapeutics Inc. (Morrisville, N.C.)

Tenor Opportunity Master Fund Ltd., Aria Opportunity Fund Ltd. and Parsoon Opportunity Fund Ltd.

Reached a tentative oral settlement of all litigation that alleged a right of first offer held by Tenor was breached in connection with the company’s June 2011 financing; the agreement calls for a $600,000 cash payment

2/21/13

Par Pharmaceutical Cos. Inc. (Woodcliff Lake, N.J.)

Acura Pharmaceuticals Inc. (Palatine, Ill.)

Entered a settlement agreement concerning Acura’s patent infringement suit in the U.S. District Court for the District of Delaware, alleging that a generic Oxecta product for which Par and Impax were separately seeking approval infringed a U.S. patent owned by Acura; terms calls for Par to launch its products through the grant of a nonexclusive, royalty-bearing license from Acura that would trigger on Jan. 1, 2022

10/11/13

Par Pharmaceutical Cos. Inc. (Woodcliff Lake, N.J.)

Horizon Pharma Inc. (Deerfield, Ill.)

Entered settlement and license agreements to resolve pending patent litigation involving Duexis tablets; Par gained a nonexclusive right to market a generic ibuprofen and famotidine product in the U.S. under Par’s abbreviated new drug application, beginning Jan. 1, 2023, or earlier under certain circumstances

8/23/13

Pfizer Inc. (New York)

Sanofi-Aventis (Paris)

A Federal Circuit ruled on cDNA claims, affirming that a company “can ‘possess’ a DNA without having the entire nucleotide sequence of the DNA 100% correct”

11/7/13

Proteonomix Inc. (Paramus, N.J.)

Investors

Proteonomix settled investor litigation, with terms and conditions including a payment of $200,000, $50,000 due in cash and the rest in stock

4/2/13

Royalty Pharma Inc. (New York)

Elan Corp. (Dublin, Ireland)

Elan won a court injunction blocking Royalty Pharma from taking it over in a $6.4B hostile bid; a hearing is slated for June 11

6/5/13

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

Napo Pharmaceuticals Inc. (San Francisco)

A trial data of Feb. 10, 2014, was set in New York County State Supreme Court to decide breach of contract claims against Salix, which Napo alleges delayed the development of the licensed drug crofelemer and delayed its commercialization

11/5/13

Sandoz Inc. (Holzkirchen, Germany; a division of Novartis AG)

Avanir Pharmaceuticals Inc. (Aliso Viejo, Calif.)

Settlement agreement to resolve pending patent litigation in response to Sandoz’s abbreviated NDA seeking approval to market generic versions of Avanir’s Nuedexta capsules

8/15/13

Sandoz Inc. (Holzkirchen, Germany; a division of Novartis AG), Teva Pharmaceuticals USA Inc. and Dr. Reddy’s Laboratories

Genzyme (Cambridge, Mass.) and its parent company Sanofi SA

Genzyme and Sanofi filed suit against Sandoz, Teva and Dr. Reddy’s in Delaware federal court, claiming the generic product, Plerixafor Injection 20 mg/mL, infringes Genzyme’s patents for Mozobil

9/6/13

Sandoz Inc. (Holzkirchen, Germany; a division of Novartis AG)

Insite Vision Inc. (Alameda, Calif.)

U.S. district Court for the District of New Jersey upheld all four of the patents protecting Azasite in a patent infringement lawsuit against Sandoz, which filed an abbreviated new drug application in 2011, seeking to market a generic version

10/8/13

Siga Therapeutics Inc. (New York)

Pharmathene Inc. (Annapolis, Md.)

The Delaware Supreme Court upheld a lower court that found Siga breached its contractual obligation to negotiate a licensing agreement in good faith seven years ago; the Supreme Court remanded the case to the Delaware Chancery Court, which ruled in September 2011 that Pharmathene receive half the net profits, after the first $40M, from Siga’s ST-246 in the first 10 years of sales

5/29/13

Takeda Pharmaceuticals U.S.A. Inc. (Deerfield, Ill.)

Jack Cooper

A jury found in favor of the plaintiffs and awarded a total of $6.5M in damages; Takeda has filed motions asking the judge to rule in favor of the company; it could file an appeal if the motions are denied; the suit claimed that Takeda’s Actos caused bladder cancer; a judge granted Takeda’s motion for nonsuit

4/30/13; 5/3/13

Teva Pharmaceuticals Industries Ltd. (Jerusalem)

Gilead Sciences Inc. (Foster City, Calif.)

Reached an agreement settling litigation concerning the patents protecting Viread; it allows Teva to launch a generic version on Dec. 15, 2017

2/21/13

Teva Pharmaceuticals Industries Ltd. (Jerusalem)

Momenta Pharmaceuticals Inc./Sandoz Inc. and Mylan Laboratories Inc./Natco Pharmaceuticals

Federal Circuit declared some patents for Teva Pharmaceutical Industries’ multiple sclerosis drug, Copaxone, to be invalid; the decision could clear the way for generic Copaxone to hit the market as early as May 2014, if approved by the FDA; Teva and Mylan agreed to settle and dismiss pending patent litigation in the UK, the Netherlands and France relating to non-infringement and the validity of a European patent expiring in May 2015

7/30/13

Teva Pharmaceuticals Industries Ltd. (Jerusalem)

Mylan Inc. (Pittsburgh)

The U.S. District Court for the Northern District of West Virginia granted Mylan’s motion for partial summary judgment, finding that the production and marketing of Teva’s generic version of Performist Inhalation solution infringes one of Mylan’s Orange Book-listed patents

7/19/13

Teva Pharmaceuticals Industries Ltd. (Jerusalem) and Sun Pharmaceutical Industries Ltd. (Mumbai, India)

Pfizer Inc. (New York) and Nycomed A/S (part of Takeda Pharmaceutical Co. Ltd.; Osaka, Japan)

Teva and Sun will pay $2.15B in a settlement reached with Pfizer and Nycomed, ending a 10-year patent infringement battle that culminated in Teva’s launch of 20 mg and 40 mg generic Protonix in December 2007, three years ahead of the patent expiry for pantoprazole; Teva will pay $1.6B and Sun will pay $550M; Pfizer and Takeda will divide the proceeds, with Pfizer getting 64%; Pfizer also settled its litigation against Teva Pharmaceuticals USA, a unit of Teva Pharmaceutical Industries Ltd., relating to Pfizer’s patent covering the use of Viagra (sildenafil) to treat erectile dysfunction, which expires in April 2020; Teva will be allowed to launch a generic version of Viagra in the U.S. on Dec. 11, 2017, or earlier under certain circumstances, and will pay Pfizer a royalty for a license to produce the generic version

6/13/13; 12/18/13

Teva Pharmaceuticals USA Inc. (subsidiary of Teva Pharmaceutical Industries Ltd.; Jerusalem)

Pfizer Inc. (New York)

Signed an agreement to settle patent litigation related to sildenafil citrate tablets, a generic equivalent of Viagra; under the agreement, Teva will launch its ANDA products pursuant to a royalty bearing license on Dec. 11, 2017, or earlier; the FDA has given tentative approval to Teva’s sildenafil citrate tablets 25, 50, and 100 mg

12/19/13

Trius Therapeutics Inc. (San Diego) and Optimer Pharmaceuticals Inc. (San Diego)

Shareholders

Shareholders filed lawsuits concerning the proposed takeovers by Cubist Pharmaceuticals Inc. of Trius and Optimer, alleging the sales are happening at unfair prices

8/6/13

Upsher-Smith Laboratories Inc. (San Diego)

Auxilium Pharmaceuticals Inc. (Malvern, Pa.) and Xstelos Holdings Inc. (New York)

Lawsuit filed alleging infringement of 10 patents related to Testim 1% testosterone gel; it was filed in the U.S. District Court for the District of Delaware; the Court granted a motion from Upsher-Smith for a summary judgment; Auxilium is considering its options, including an appeal

1/30/13; 12/6/13

Valeant Pharmaceuticals International Inc. (Laval, Quebec)

Anacor Pharmaceuticals Inc. (Palo Alto, Calif.)

Valeant has been ordered by an arbitrator to make a one-time payment of $100M in damages plus costs and fees to resolve a breach of contract dispute derived from services provided by Dow Pharmaceutical Sciences Inc. before it was acquired by Valeant; on Oct. 27, Valeant agreed to pay Anacor $142.5M to settle all existing and future claims and to resolve all other disputes involving Valeant, Dow and Medicis

10/21/13; 10/29/13

Ven-A-Care (Florida), U.S. government and the state of Texas

Pfizer Inc. (New York) and Endo Pharmaceuticals Inc. (Chadds Ford, Pa.)

Pfizer agreed to pay $25M to settle a lawsuit alleging that it deliberately inflated prices for certain generic drugs; Endo Pharmaceuticals also agreed to pay $25M to settle a lawsuit alleging similar price-inflating behavior

1/8/13

Victory Pharma Inc. (San Diego)

Whistleblower Chad Miller and the Justice Department

Victory will pay $11.42M to resolve liabilities resulting from marketing of Naprelan, Xodol, Fexmid and Dolgie; it paid a criminal forfeiture of $1.4M to resolve federal Anti-Kickback Statute allegations and $9.9M for False Claims allegations; Miller will receive $1.7M of the proceeds

1/2/13

Warner Chilcott Co. LLC (subsidiary of Actavis plc; Dublin)

Zydus Pharmaceuticals USA Inc. and Cadila Healthcare Ltd.

Entered an agreement in principle to settle all outstanding patent litigation related to Zydus’ generic version of Asacol HD (mesalamine) delayed-release tablets; Warner Chilcott will grant Zydus a royalty-bearing license to market its generic Asacol HD beginning on Nov. 15, 2015, or earlier under certain circumstances, following receipt by Zydus of final approval from the FDA; if FDA approval is not granted by July 1, 2016, Zydus can launch a generic version beginning on that date

12/12/13

Watson Laboratories Inc. (Parsippany, N.J.)

Horizon Pharma Inc. (Deerfield, Ill.) and Skyepharma plc (London)

Horizon and Skyepharma filed a patent infringement lawsuit against Watson in the U.S. District Court for the District of New Jersey related to an abbreviated NDA that Watson filed with the FDA to market generic versions of Rayos (low-dose prednisone)

8/29/13

Wockhardt Ltd. and Wockhardt USA LLC

Avanir Pharmaceuticals Inc. (Aliso Viejo, Calif.)

Settlement agreement to resolve pending patent litigation in response to Wockhardt’s abbreviated NDA for generic versions of Avanir’s Nuedexta capsules

9/9/13

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 2013. The date indicated refers to the BioWorld Today issue in which the news item can be found.