Court Rules That Watson Does Not Infringe Patent Related to Generic Version of Concerta(R) and Declares Patent Invalid

Watson Pharmaceuticals, Inc. (NYSE: WPI), a leading specialty pharmaceutical company, announced today that the United States District Court for the District of Delaware has ruled that Watson’s generic version of Concerta (methylphenidate hydrochloride extended-release tablets) does not infringe United States Patent No. 6,919,373 (the ’373 Patent) and that the ’373 Patent is invalid.  The opinion, dated March 30, 2009, was issued by Judge Joseph Farnan, Jr., and applies to Watson’s generic versions of Concerta(R) in the 18 mg, 27 mg, 36 mg and 54 mg strengths.
Prior to the commencement of the trial, the plaintiffs offered Watson a covenant not to sue on United States Patent No. 6,930,129 (the ’129 Patent). Watson declined to accept the covenant and asked the court to declare that the ’129 Patent is invalid and not infringed.  A decision on Watson’s Declaratory Judgment claim on the ’129 Patent is subject to further proceedings by the parties.  However, Watson believes that the ’129 Patent is invalid  for the same reasons that the court held the ’373 Patent is invalid.

In 2005, ALZA Corporation and McNeil-PPC, Inc. sued Andrx Corporation for patent infringement related to the generic version of Concerta(R). Watson acquired Andrx Corporation in 2006.

New Senate Bill Takes Shortcuts on Path to Biosimilars

March 26, 2009, WASHINGTON–(BUSINESS WIRE)–The following statement was issued by Biotechnology Industry Organization President and CEO Jim Greenwood regarding legislation introduced today by Senators Charles Schumer (D-NY), Sherrod Brown (D-OH), Susan Collins (R-ME) and Mel Martinez (R-FL) to establish a pathway for the approval of biosimilars:

“While well-intentioned, the bill introduced today by Senators Schumer, Brown, Collins and Martinez follows its companion bill in the House (H.R. 1427, The Promoting Innovation and Access to Life-Saving Medicine Act) through the looking glass to a world of biosimilars that would jeopardize patient safety and undermine future medical breakthroughs.

“The legislation short cuts scientific requirements needed to ensure patient safety and creates an imbalanced system that could chill investment in research focused on discovering new treatments and cures for devastating diseases, such as cancer, Alzheimer’s, Parkinson’s and multiple sclerosis.

“As the U.S. Food and Drug Administration (FDA) has noted, biotech drugs are so molecularly complex that they are almost impossible to replicate accurately with existing science. Even minor differences in the purity of a biotech drug can change its efficacy and safety. With this in mind, any biosimilars legislation should mandate that FDA approval of a biosimilar include clinical trial data demonstrating its safety, purity and potency. Yet this bill includes language that would discourage the FDA from conducting certain clinical trials.

“More, the bill unfairly tilts the playing field toward biosimilars manufacturers. This legislation provides for less data exclusivity than traditional pharmaceutical drugs currently receive under the Hatch-Waxman regime even though every credible study on this issue has found that biologics will need greater data exclusivity than traditional drugs to ensure future medical breakthroughs. Additionally, innovators would be required under the bill introduced today to share detailed information about every applicable patent to biosimilar manufacturers, making it easier for the biosimilar company to bypass valid patents. Innovators, on the other hand, would have no ability to receive relevant information from the biosimilar manufacturer about the molecules, ingredients, and processes they use to create the biosimilar.

“A successful pathway to biosimilars must strike the right balance in ensuring patient safety and providing fair, responsible incentives for continued biotech research into cures for diseases such as cancer, multiple sclerosis, Alzheimer’s and HIV/AIDS and unmet medical needs. The bill introduced today fails to meet this reasonable metric.

“We urge Congress to ensure that any pathway for approving biosimilars is grounded in sound science, safeguards patient safety, and preserves incentives to develop future breakthrough therapies and cures.”

Senators announced bipartisan legislation for generic versions of biologic drugs

March 26, 2009, Washington DC: U.S. Senators Charles E. Schumer (D-NY), Susan Collins (R-ME), Sherrod Brown (D-OH), Mel Martinez (R-FL), Debbie Stabenow (D-MI) and David Vitter (R-LA) announcedThursday thatthey have reached agreement on bipartisan legislation to create an approval pathway for generic versions of biologic drugs. The measure, which was endorsed in President Obama’s budget proposal, would save federal programs like Medicare and Medicaid at least $10 billion dollars by bringing needed competition to the marketplace.

Biologics, which are also known as biotech drugs or biopharmaceuticals, are made from living cell cultures, rather than synthesized chemically. They are among the most expensive varieties of pharmaceuticals on the market, but generic versions of these drugs are rare because the Food and Drug Administration (FDA) currently lacks a formalized process, or “pathway,” for approving them. The senators’ legislation would solve this problem by establishing just such a pathway. Consistent with the standard established by the landmark Hatch-Waxman Act of 1984, brand-name biologics would be entitled to five years of exclusive marketing under the bill introduced today. This five-year window would not begin at the time of the bill’s enactment, but rather from the time when the brand-name drug was first approved. So, in the case of some biologic drugs that have been on the market for 20 years with no competition, generic companies can seek approval for more affordable versions almost right away.

                                                                                                                                              

“It’s past time we created a way for generic versions of these expensive drugs to come to market. We have a bipartisan plan that we know consumers will support and we believe the President will, too. The savings reaped from this will be a down payment on health care reform,” Senator Schumer said. “Biologic drugs provide effective treatments for some of our most devastating diseases,” said Senator Collins. “Unfortunately, however, these drugs are often prohibitively expensive and can cost tens of thousands of dollars a year.  For example, the cancer drug Avastin has an annual cost of up to $100,000. People who need these drugs should not be denied access solely on the basis of cost.  Using competition to bring generic versions of these medicines to the market will help offer patients, employers, and federal and state health programs cost savings.”

 

“This bill is about containing health care costs by encouraging competition in the pharmaceutical marketplace,” said Senator Brown. “The bill would create a pipeline for generic biologics by creating a safe and efficient evaluation and approval process at the Food and Drug Administration (FDA). Biologics are a new generation of life-saving treatments for diseases like cancer, arthritis, and diabetes, but they are often prohibitively expensive. Just as the availability of generic drugs have helped bring down the costs of medicines for millions of Americans, competing versions of brand-name biologics will make these breakthrough treatments more accessible and affordable for middle class families.” 

“By striking the right balance between competition and rewarding innovation, we can encourage the development of new treatments while driving down the cost to consumers,” said Senator Martinez, ranking member of the Senate’s Special Committee on Aging.

 

“Families in Michigan and across the country are struggling with the skyrocketing cost of prescription drugs. We need to do everything that we can to keep those prices under control,” said Senator Stabenow.  “Lowering the cost of prescription drugs is not only good for patients, it is good for business.  It helps America to protect jobs and stay competitive in the global economy. Opening the market to generic biological drugs will provide real savings to businesses and consumers who use some of the most costly medications.” “All Americans deserve access to safe and affordable medication and bio-generics provide a cost-effective alternative to high-cost, name-brand drugs,” said Senator Vitter.  “This is a truly non-partisan issue that resonates with families across the country.” Rep. Henry Waxman (D-CA) and Nathan Deal (R-GA) have introduced a similar measure in the House.

 

The senators said that FDA approval for generic biologics would bring patients much needed relief from the high costs of the brand-name versions of these medicines. One of the most popular biotech drugs is Avonex, which treats multiple sclerosis. It costs almost $20,000 a year even though its patent expired in 2003.Avastin, which treats colorectal cancer, costs $43,000 per course of treatment.AndEnbrel, a drug for rheumatoid arthritis, can cost up to $25,000 per year. Under the senators’ bill, an application for a generic version of a biological drug must demonstrate to FDA that there are no clinically meaningful differences between the two products.  The application must also show that the two products are highly similar in molecular structure and share the same mechanisms of action, if known. Importantly, the legislation establishes tracks for two different types of generic drugs: “biosimilars,” which means the generic is “like” the brand drug, and “biogenerics,” which means a doctor will be able to substitute it for the brand. 

The bill also establishes a procedure for resolution of patent disputes before a biosimilar is approved, and establishes penalties for failure to litigate patents in a timely fashion.

 

The senators said Thursday they look forward to working with Senator Edward Kennedy, Chairman of the Senate Committee on Health, Education, Labor and Pensions, to develop a pathway based on their legislation. In 2007, Kennedy was a critical leader of a bipartisan group of senators that hatched a compromise proposal on generic biologics. Several aspects of the bill introduced today remain true to that compromise—for instance, today’s bill gives the FDA full discretion to determine what studies are necessary to establish that a biogeneric is as safe and effective as the original product. The senators said they look forward to kicking off negotiations on this issue anew now that Congress is considering broader health reform.

Mylan Confirms Four First-to-File Challenges

Mylan Inc.  yesterday announced that it and/or a subsidiary have been sued in connection with four separate “first-to-file” Abbreviated New Drug Applications filed with the U.S. Food and Drug Administration.  Mylan and Alphapharm Pty. Ltd were sued by Sepracor Inc. in the U.S. District Court of New Jersey in connection with the ANDA filing for Eszopiclone Tablets, 1 mg, 2 mg and 3 mg. Eszopiclone Tablets are the generic version of Sepracor’s insomnia treatment Lunesta Tablets, which had approximately $796 million in U.S. sales for the twelve months ending Dec. 31, 2008, according to IMS Health.

Mylan Pharmaceuticals Inc. was sued by OSI Pharmaceuticals Inc., Pfizer Inc. and Genentech Inc. in the U.S. District Court in Delaware in connection with the ANDA filing for Erlotinib Hydrochloride (HCl) Tablets, 25 mg, 100 mg and 150 mg. Erlotinib HCl Tablets are the generic version of OSI Pharmaceuticals’ lung cancer treatment Tarceva Tablets, which had approximately $492 million in U.S. sales for the twelve months ending Dec. 31, 2008, according to IMS Health.

Mylan, Mylan Pharmaceuticals and Matrix Laboratories Limited, in which Mylan owns a majority interest, were sued by Shire Canada Inc., Shire International Licensing B.V. and Shire U.S. Inc. in the U.S. District Court for the Southern District of New York in connection with the ANDA filing for Lanthanum Carbonate Chewable Tablets, 500 mg, 750 mg and 1000 mg. Lanthanum Carbonate Chewable Tablets are the generic version of Shire’s kidney disease treatment Fosrenol, which had approximately $108 million in U.S. sales for the twelve months ending Dec. 31, 2008, according to IMS Health.

Mylan Pharmaceuticals was sued by Galderma Laboratories Inc., Galderma Laboratories LP, The Research Foundation of the State University of New York and New York University in the U.S. District Court of Delaware in connection with the ANDA filing for Doxycycline Delayed-release  Capsules USP, 40 mg. Doxycycline DR Capsules are the generic version of Galderma’s adult rosacea treatment Oracea Capsules, which had approximately $82 million in U.S. sales for the twelve months ending Dec. 31, 2008, according to IMS Health.

Mylan believes it is among the first companies to have filed substantially complete ANDAs containing a Paragraph IV certification for three of these products and expects to be awarded 180 days of shared marketing exclusivity once final approvals are obtained. With Doxycycline DR Capsules, Mylan believes it could have sole marketing exclusivity for the 180 day period. Currently, Mylan has 118 ANDAs pending FDA approval, 33 of which are potential first-to-file opportunities.

For further details, please visit www.mylan.com.

Teva Announces FDA Response to Citizen Petition

Teva Pharmaceutical Industries Ltd.  announced on March 25, 2009, that the Food and Drug Administration has responded to their Citizen Petition (CP: 32.14, -0.61, -1.86%) regarding COPAXONE(R: 28.26, -1.5492, -5.2%) (glatiramer acetate injection). The FDA declined to review the CP “without comment on the approvability of any Abbreviated New Drug Application (ANDA: undefined, undefined, undefined%) or New Drug Application (NDA: undefined, undefined, undefined%) for a glatiramer acetate injection drug product because it would be premature and inappropriate to do so at this time.” The Agency’s guidelines required a response to this Citizen Petition by March 26, 2009. The FDA has not yet addressed or taken action on the requests that Teva presented in its Citizen Petition. According to the Agency, it is not possible to render a final decision on specific requirements for approval of any ANDA or NDA for glatiramer acetate injection “when a decision on the approvability of any such application has not been made.” A generic version of COPAXONE(R: 28.26, -1.5492, -5.2%) cannot be introduced before it receives final approval of its ANDA from the Agency. COPAXONE(R: 28.26, -1.5492, -5.2%) is a glatiramoid, a complex mixture of the acetate salts of synthetic polypeptides, non-uniform with respect to molecular weight and sequence. Due to the variability of the composition of the polymers, Teva believes that fully characterizing this mixture would be extremely difficult, if not impossible. Moreover, once subcutaneously injected, it is rapidly hydrolyzed locally and no level of the intact drug can be measured in the blood, rendering a bioequivalence study comparing two formulations extremely difficult. Therefore, Teva believes that evidence supporting the effectiveness of a generic copy of glatiramer acetate cannot be derived from bioequivalence studies but rather must be derived from full-fledged clinical studies using clinical outcomes.

For additional information regarding Copaxone’s complexities and their potential implications, please visit http://www.tevapharm.com.

Cubist Files Patent Infringement Lawsuit Against Teva

Cubist Pharmaceuticals, Inc. confirmed today that it has filed a patent infringement lawsuit against Teva Parenteral Medicines, Inc. (TPM), Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries Ltd. The complaint, which was filed in the U.S. District Court for the District of Delaware, alleges infringement of US Patent Nos. 6,468,967 and 6,852,689, which expire on September 24, 2019, and US Patent No. RE39,071, which expires on June 15, 2016.

Cubist filed the lawsuit in response to an Abbreviated New Drug Application (ANDA) filed by TPM seeking U.S. Food and Drug Administration (FDA) approval to market a generic version of daptomycin prior to the expiration of Cubist’s patent rights. Daptomycin is marketed in the U.S. and internationally under the brand name CUBICIN^® (daptomycin for injection) as therapy for serious skin and bloodstream infections caused by certain Gram-positive bacteria.

Under current U.S. law, the filing of the lawsuit automatically prevents the FDA from approving the ANDA for 30 months from Cubist’s receipt of TPM’s Paragraph IV notification letter in February 2009 unless the court (1) enters judgment in favor of TPM in less than 30 months, or (2) finds that a party has failed to cooperate reasonably to expedite the lawsuit.

Additional information can be found at Cubist’s web site at www.cubist.com.

CHI Joins California Companies to Urge Caution on Patent Reform

Today, CHI joined with more than 100 California-based companies and organizations in submitting a letter to Senator Dianne Feinstein, expressing important concerns about recently reintroduced patent reform legislation. CHI represents more than 250 life sciences companies and academic research organizations whose inventions are the basis of California’s global leadership in the life sciences industry, representing more than 270,000 jobs across our state and improving the lives of millions around the world.

California’s innovative high-tech industries lead the world in biotechnology, electronics, green technology, medical technology, information technology and telecommunications, and more. The biomedical industry’s advanced research and development is extremely risky and expensive in nature, with the average biotech drug, for example, taking almost 15 years and a billion dollars to reach the market. Strong patent protections enable companies to attract the risk capital they need in order to continue to innovate new technologies that save lives. The hundreds of smaller, venture capital-backed firms in the state, many spun out of California’s world-class research universities and private research institutes, could not attract funding without strong intellectual property protection.

The letter submitted to Feinstein describes how these same provisions raised concerns and objections in the last Congress. In the current economic crisis, CHI believes the enactment of this legislation would cause even greater harm today—delaying promising research and development, reducing investment, diminishing innovation and slowing job growth.

CHI believes the proposed legislation fails to account for recent court decisions that have transformed the patent law landscape and corrected certain alleged failings of the current system in terms of excessive damages awards. While the full effects remain to be seen, decisions such as Ebay v. MercExchange (limiting the availability of injunctive relief), Seagate (limiting treble damages), KSR v. Teleflex (reinforcing the non-obviousness standard), and Microsoft v. AT&T (limiting offshore infringement liability) have clearly limited the legal options of patent holders. As for damage awards, the premier example of excessive damages raised in the past—the Alcatel-Lucent v. Microsoft decision—was overturned on the basis that the damages awarded were indeed excessive under the existing law. This suggests that the present system works and is not in need of fundamental overhaul in the form of mandatory apportionment.

CHI’s Web site is www.chi.org.

Impax confirms that Warner Chilcott and Mayne Pharma filed suit for patent infringement in connection with Doryx®

Impax Laboratories, Inc. today confirms that Warner Chilcott Laboratories Ireland Limited, Warner Chilcott Company, Inc., Warner Chilcott (US), LLC, and Mayne Pharma International Pty. Ltd. filed suit for patent infringement against Impax in the United States District Court for the District of New Jersey in response to Impax’s challenge of the patent listed in connection with Doryx® (doxycycline hyclate) delayed-release tablets, 150 mg.

Impax filed its Abbreviated New Drug Application (ANDA) containing a paragraph IV certification for a generic version of Doryx® 150 mg with the U.S. Food & Drug Administration (FDA). Following receipt of the notice from the FDA that Impax’s ANDA had been accepted for filing, Impax notified the New Drug Application holder and patent owner of its paragraph IV certification. Based on the filing date of the ANDA, the Company expects to be entitled to 180-day market exclusivity. Global Pharmaceuticals, Impax’s generic division, will commercialize the products.

For more information, please visit the Company’s Web site at: www.impaxlabs.com

Norway’s Pronova to defend Lovaza patent

Pronova BioPharma, which makes diet supplements from fish oil, said U.S. drug group Par Pharmaceutical aimed to launch a generic version of Pronova’s prescription drug Lovaza, sending its shares down. ‘Pronova has full confidence in its intellectual property portfolio protecting Lovaza and will vigorously defend and enforce its patents,’ the Norwegian company said in a statement.

 

Pronova’s Lovaza, branded in Europe and Asia as Omacor, is a dietary supplement based on fish oil, a rich source of omega-3 fatty acids. Pronova said it and its partner GlaxoSmithKline had received notice in a March 17 letter advising it that Par Pharmaceutical had submitted an application to the U.S. food and drug administration (FDA) for approval to market a generic version of Lovaza.

GlaxoSmithKline snapped up U.S. rights to Pronova’s product in 2007 by acquiring Reliant Pharmaceuticals for $1.65 billion.

OSI Pharmaceuticals Files Patent Infringement Lawsuits Against Teva and Mylan

OSI Pharmaceuticals, Inc. announced yesterday that the Company has filed two lawsuits in U.S. District Court in Delaware against Teva Pharmaceuticals USA, Inc. (“Teva”) and Mylan Pharmaceuticals, Inc. (“Mylan”) for infringement of US Patent No. 5,747,498, US Patent No. 6,900,221 and US Patent No. 7,087,613. All three patents are associated with Tarceva^® (erlotinib).

The lawsuits are based on Abbreviated New Drug Applications (ANDAs) filed by Teva and Mylan seeking permission to manufacture and market a generic version of Tarceva before the expiration of the three patents. The filing of these lawsuits restricts the FDA from approving Teva and Mylan’s ANDAs until May 18, 2012 (the statutory stay period), unless an adverse court ruling occurs prior to such time.

OSI plans to vigorously protect and enforce the intellectual property rights of Tarceva.

For additional information about OSI, please visit www.osip.com