NEW YORK--(BUSINESS WIRE)--Dec. 7, 2007--ImClone Systems Incorporated (NASDAQ: IMCL), a global leader in the development and commercialization of novel cancer therapeutics, today announced that it has signed a settlement agreement with Yeda Research and Development Company Ltd. and Sanofi-Aventis to end worldwide litigation related to U.S. Patent No. 6,217,866 (the "866 Patent") and its foreign counterparts. All terms of the settlement agreement have been finalized and the parties will submit stipulations to the appropriate courts and patent offices in the various jurisdictions.
Under the terms of the settlement agreement, the companies agree that Yeda is the sole owner of the 866 Patent in the U.S., and Yeda and Sanofi-Aventis are co-owners of the 866 Patent's foreign counterparts. Pursuant to the terms of the settlement agreement, ImClone and Sanofi-Aventis will each pay Yeda $60.0 million in cash for full and final settlement of the claims and counterclaims in the matter. ImClone shall be granted a worldwide license to technology patented under the 866 Patent. ImClone will make a contingent payment to Yeda of a low single-digit royalty on sales in and outside of the U.S. and will pay Sanofi-Aventis a low single-digit royalty on sales outside of the United States. ImClone's worldwide royalty rate for ERBITUX sales pursuant to the settlement agreement remains unchanged.
"This settlement agreement with Yeda and Sanofi-Aventis further solidifies our ability to maximize the commercialization of ERBITUX in the U.S. and abroad going forward," said John H. Johnson, Chief Executive Officer of ImClone. "With this settlement, we have now successfully resolved two important patent litigation claims this year through mutually beneficial agreements that enhance the future commercial and financial potential for ImClone and ERBITUX."
Sunday, December 9, 2007
Friday, December 7, 2007
Apotex Loses Patented Process Merck Was Already Using After Court Agrees It Wasn?t Concealed
In an appeal by Apotex, the Court of Appeals for the Federal Circuit affirmed a summary judgment in favor of Merck that Merck had been using a process before it was patented by Apotex. Apotex v. Merck & Co. (06-1405)
Apotex Corp. appeals the decision of the United States District Court for the Northern District of Illinois 1 granting summary judgment in favor of Merck & Co. in an action by Apotex to set aside a judgment on charges of fraud. Apotex also asserted state law claims against Merck for common law fraud and tortious interference with prospective economic advantage, and sought to compel discovery pursuant to the crime fraud exception to the attorney-client privilege. The judgment of the district court is affirmed.
Apotex sued Merck alleging that its process for formulating and producing tablets of the pharmaceutical compound enalapril (Vasotec) used to treat high blood pressure) infringed Apotexs U.S. Pat. No. 5,573,780 and No. 5,690,962 .
Apotex Corp. appeals the decision of the United States District Court for the Northern District of Illinois 1 granting summary judgment in favor of Merck & Co. in an action by Apotex to set aside a judgment on charges of fraud. Apotex also asserted state law claims against Merck for common law fraud and tortious interference with prospective economic advantage, and sought to compel discovery pursuant to the crime fraud exception to the attorney-client privilege. The judgment of the district court is affirmed.
Apotex sued Merck alleging that its process for formulating and producing tablets of the pharmaceutical compound enalapril (Vasotec) used to treat high blood pressure) infringed Apotexs U.S. Pat. No. 5,573,780 and No. 5,690,962 .
Thursday, December 6, 2007
Jubilant in drug discovery pact with Forest Labs
Thursday, December 06, 2007 18:15 IST Our Bureau, Mumbai
Jubilant Biosys, a subsidiary of Jubilant Organosys have entered into the collaboration agreement to discover small molecule drug candidates for a novel metabolic disorders target with Forest Laboratories. Jubilant Biosys will conduct the drug discovery work and Forest will have responsibility for the subsequent pro-clinical and clinical development. Forest will own the drugs discovered under the collaboration with unencumbered worldwide commercialization rights. Under the terms of the collaboration, Forest will pay Jubilant undisclosed amounts towards research funding, development and commercialization milestones.
Commenting on the development, Shyam S Bhartia, chairman and managing director and Hari S Bhartia, co-chairman and managing director of Jubilant Organosys, said, ``We are very pleased to partner with Forest Laboratories, an important pharmaceutical company. This collaboration leverages the innovation capabilities of Jubilant Biosys in pharmaceutical discovery and pre-clinical development, as well as combining these strengths with Forest Laboratories, a proven successful development and commercialization company, to deliver new products with cost effective efficiency that will help patients around the world. This partnership continues to demonstrate Jubilant`s strategy to be Indias`s largest innovation driven integrated pharmaceutical services provider supporting the global pharmaceutical industry``.
Ivan Gergel, senior vice president of scientific affairs and president of the forest research institute, said, "This partnership is part of forest laboratories continued effort in India to access and develop robust partnerships to grow our discovery pipeline and access innovation across the globe. We are very pleased with Jubilant's quality of people capabilities and infrastructure for pharmaceutical discovery".
Jubilant Biosys, a subsidiary of Jubilant Organosys have entered into the collaboration agreement to discover small molecule drug candidates for a novel metabolic disorders target with Forest Laboratories. Jubilant Biosys will conduct the drug discovery work and Forest will have responsibility for the subsequent pro-clinical and clinical development. Forest will own the drugs discovered under the collaboration with unencumbered worldwide commercialization rights. Under the terms of the collaboration, Forest will pay Jubilant undisclosed amounts towards research funding, development and commercialization milestones.
Commenting on the development, Shyam S Bhartia, chairman and managing director and Hari S Bhartia, co-chairman and managing director of Jubilant Organosys, said, ``We are very pleased to partner with Forest Laboratories, an important pharmaceutical company. This collaboration leverages the innovation capabilities of Jubilant Biosys in pharmaceutical discovery and pre-clinical development, as well as combining these strengths with Forest Laboratories, a proven successful development and commercialization company, to deliver new products with cost effective efficiency that will help patients around the world. This partnership continues to demonstrate Jubilant`s strategy to be Indias`s largest innovation driven integrated pharmaceutical services provider supporting the global pharmaceutical industry``.
Ivan Gergel, senior vice president of scientific affairs and president of the forest research institute, said, "This partnership is part of forest laboratories continued effort in India to access and develop robust partnerships to grow our discovery pipeline and access innovation across the globe. We are very pleased with Jubilant's quality of people capabilities and infrastructure for pharmaceutical discovery".
Sun Pharma Announces Settlement of Litigation Over Generic Exelon
MUMBAI, India, Dec. 6, 2007-Sun Pharmaceutical Industries Ltd. announced that it has executed a settlement agreement with Novartis stipulating a dismissal of the lawsuits filed in the United States against the Company regarding submission of an Abbreviated New Drug Application (ANDA) for a generic version of Exelon, rivastigmine tartrate capsules.
Earlier, USFDA had granted final approval for the Company's ANDA to market its generic Exelon®.
Under the terms of the settlement agreement, Sun Pharma will not market generic Exelon® in the U.S. until sometime prior to the expiration of the patents covering Exelon®. The specific date on which Sun may launch and the other terms of the agreement are confidential.
Earlier, USFDA had granted final approval for the Company's ANDA to market its generic Exelon®.
Under the terms of the settlement agreement, Sun Pharma will not market generic Exelon® in the U.S. until sometime prior to the expiration of the patents covering Exelon®. The specific date on which Sun may launch and the other terms of the agreement are confidential.
District Court Upholds Validity of Pfizer's Accupril Patent, Rejecting Teva's Nonenablement Argument
Warner-Lambert v. Teva Pharms. USA, No. 99-922 (D.N.J. 2007)
Warner-Lambert (part of Pfizer) and Teva have been in patent litigation over Teva's ANDA for generic Accupril (quinapril hydrochloride) since 1999, when Warner-Lambert sued Teva for filing its ANDA with a paragraph IV certification to U.S. Patent No. 4,743,450. According to Teva's 2002 approval letter, Teva also filed its ANDA with a paragraph III certification to U.S. Patent No. 4,344,949, which expired on October 3, 2002, and section viii statements to U.S. Patent Nos. 5,684,016 and 5,747,504.
The '450 patent broadly claims pharmaceutical compositions containing an ACE inhibitor, "an alkali or alkaline earth metal carbonate to inhibit cyclization and discoloration," and "a saccharide to inhibit hydrolysis." The '450 patent did not expire until February 24, 2007, with pediatric exclusivity extending until August 24, 2007.
In October 2003, the district court granted Warner-Lambert's motion for summary judgment of infringement of claims 1, 4-10 and 12 of the '450 patent. The court also granted Warner-Lambert's motion for summary judgment of validity of the same claims. Following a trial in May 2004, the district court ruled that claims 16 and 17 are valid, and that the '450 patent is not unenforceable due to inequitable conduct. Teva appealed the findings of infringement, no invalidity for lack of enablement, and no inequitable conduct, and in August 2005, the Federal Circuit reversed the district court's rulings on infringement and enablement and remanded the case for further proceedings. In January 2006, the district court granted Warner-Lambert's motion for summary judgment of infringement, leaving the issue of enablement for trial.
The district court held a trial on the question of enablement on May 2 and 3, 2007, and released an opinion last week finding the claims enabled. The court applied the standard test: whether the specification provides "sufficient teaching such that one skilled in the art could make and use the full scope of the invention without undue experimentation." Teva argued that the claims of the '450 patent are extremely broad and the specification provides insufficient guidance to develop the full range of pharmaceutical formulations encompassed by the claims. In addition, Teva argued that numerous failures to arrive at operative embodiments of the claims proved nonenablement. The court, however, found the testimony of Warner-Lambert's expert witness (who "wrote the book on stability of pharmaceutical formulations") to be more persuasive than the testimony of Teva's expert. The court was convinced by Warner-Lambert's expert that one skilled in the art could readily practice the full scope of the claimed invention through routine experimentation. In addition, the court found that none of the purported "failures" proffered by Teva were evidence of lack of enablement.
Last week's court decision could impact other cases in which the '450 patent has been asserted. For instance, Warner-Lambert filed suit against Teva and Ranbaxy in January 2005, after Teva announced that it began shipping generic quinapril HCl tablets in partnership with Ranbaxy. In addition, Schwarz Pharma AG, an exclusive licensee of the '450 patent, has asserted the patent against in litigation concerning generic versions of Univasc (moexipril).
Warner-Lambert (part of Pfizer) and Teva have been in patent litigation over Teva's ANDA for generic Accupril (quinapril hydrochloride) since 1999, when Warner-Lambert sued Teva for filing its ANDA with a paragraph IV certification to U.S. Patent No. 4,743,450. According to Teva's 2002 approval letter, Teva also filed its ANDA with a paragraph III certification to U.S. Patent No. 4,344,949, which expired on October 3, 2002, and section viii statements to U.S. Patent Nos. 5,684,016 and 5,747,504.
The '450 patent broadly claims pharmaceutical compositions containing an ACE inhibitor, "an alkali or alkaline earth metal carbonate to inhibit cyclization and discoloration," and "a saccharide to inhibit hydrolysis." The '450 patent did not expire until February 24, 2007, with pediatric exclusivity extending until August 24, 2007.
In October 2003, the district court granted Warner-Lambert's motion for summary judgment of infringement of claims 1, 4-10 and 12 of the '450 patent. The court also granted Warner-Lambert's motion for summary judgment of validity of the same claims. Following a trial in May 2004, the district court ruled that claims 16 and 17 are valid, and that the '450 patent is not unenforceable due to inequitable conduct. Teva appealed the findings of infringement, no invalidity for lack of enablement, and no inequitable conduct, and in August 2005, the Federal Circuit reversed the district court's rulings on infringement and enablement and remanded the case for further proceedings. In January 2006, the district court granted Warner-Lambert's motion for summary judgment of infringement, leaving the issue of enablement for trial.
The district court held a trial on the question of enablement on May 2 and 3, 2007, and released an opinion last week finding the claims enabled. The court applied the standard test: whether the specification provides "sufficient teaching such that one skilled in the art could make and use the full scope of the invention without undue experimentation." Teva argued that the claims of the '450 patent are extremely broad and the specification provides insufficient guidance to develop the full range of pharmaceutical formulations encompassed by the claims. In addition, Teva argued that numerous failures to arrive at operative embodiments of the claims proved nonenablement. The court, however, found the testimony of Warner-Lambert's expert witness (who "wrote the book on stability of pharmaceutical formulations") to be more persuasive than the testimony of Teva's expert. The court was convinced by Warner-Lambert's expert that one skilled in the art could readily practice the full scope of the claimed invention through routine experimentation. In addition, the court found that none of the purported "failures" proffered by Teva were evidence of lack of enablement.
Last week's court decision could impact other cases in which the '450 patent has been asserted. For instance, Warner-Lambert filed suit against Teva and Ranbaxy in January 2005, after Teva announced that it began shipping generic quinapril HCl tablets in partnership with Ranbaxy. In addition, Schwarz Pharma AG, an exclusive licensee of the '450 patent, has asserted the patent against in litigation concerning generic versions of Univasc (moexipril).
Wednesday, December 5, 2007
Apotex Buys Spain’s Lareq
Apotex has acquired Spanish generic drugmaker Lareq Pharma in a bid to expand its presence in Western Europe.
Lareq is the 13th-largest player in the Spanish retail pharmacy generics segment, while Spain is the seventh-largest pharmaceutical market in the world, Apotex said.
“The Spanish generics market is a fast-growing market, and all the major international generics competitors are present here,” Andrew Kay, president of Apotex International, said.
Furthermore, the Canadian firm said it sees Western Europe as a launching pad for the products in development for the European market. Last month Apotex announced plans to acquire Topgen, the seventh largest generic drugmaker in Belgium. The company did not disclose the price of either acquisition.
Apotex also has presence in Australia, New Zealand, Mexico, the Czech Republic, Italy, the Netherlands, Poland and the UK. The company said it plans to spend $2 billion on R&D over the next 10 years, and it currently has more than 600 products in development.
Analysts at the International Generic Pharmaceutical Alliance’s annual conference last week said that because growth of the U.S. pharmaceutical market is expected to slow down, it is a good idea for companies to go global. “There’s a huge growth opportunity outside the U.S.,” Randall Stanicky, vice president of global investment research at Goldman Sachs, said. — Breda Lund
Lareq is the 13th-largest player in the Spanish retail pharmacy generics segment, while Spain is the seventh-largest pharmaceutical market in the world, Apotex said.
“The Spanish generics market is a fast-growing market, and all the major international generics competitors are present here,” Andrew Kay, president of Apotex International, said.
Furthermore, the Canadian firm said it sees Western Europe as a launching pad for the products in development for the European market. Last month Apotex announced plans to acquire Topgen, the seventh largest generic drugmaker in Belgium. The company did not disclose the price of either acquisition.
Apotex also has presence in Australia, New Zealand, Mexico, the Czech Republic, Italy, the Netherlands, Poland and the UK. The company said it plans to spend $2 billion on R&D over the next 10 years, and it currently has more than 600 products in development.
Analysts at the International Generic Pharmaceutical Alliance’s annual conference last week said that because growth of the U.S. pharmaceutical market is expected to slow down, it is a good idea for companies to go global. “There’s a huge growth opportunity outside the U.S.,” Randall Stanicky, vice president of global investment research at Goldman Sachs, said. — Breda Lund
Santarus licenses omeprazole rights to GSK
Wednesday, December 05, 2007 10:00 IST San Diego
Santarus, Inc, a specialty pharmaceutical company, said it has signed over exclusive rights related to its prescription and over-the-counter immediate-release omeprazole products including Zegerid to GlaxoSmithKline plc (GSK).
The $11.5 million transaction is to commercialise the drugs for a number of markets in GSK's International Region (including Africa, Asia, the Middle-East, and Central and South America), and to distribute and sell Zegerid brand prescription products in Puerto Rico and the US Virgin Islands (USVI).
Under the license agreement, GSK will be responsible for the development, manufacture and commercialisation of Licensed Products in up to 114 countries, excluding the US, Europe, Australia, Japan and Canada. In addition, under a separate distribution agreement, GSK will distribute, market and sell Zegerid brand prescription products in Puerto Rico and the USVI beginning in the first quarter of 2008. GSK will bear all costs for its activities under the license and distribution agreements.
GSK will pay Santarus an $11.5 million upfront fee and tiered double digit royalties, subject to reduction in certain circumstances, on net sales of any products sold under the license and distribution agreements. The term of the license agreement continues so long as GSK is obligated to pay royalties and the term of the distribution agreement continues as long as GSK sells the products, unless the agreements are terminated earlier by either GSK or Santarus under specified circumstances. GSK has an option to make a buy-out payment 20 years after the effective date of the agreements, after which time, GSK's royalty obligations generally would end. To support GSK's initial launch costs, Santarus will waive the first $2.5 million of aggregate royalties payable under the license and distribution agreements.
"As a leading global pharmaceutical company, GSK has well established international commercialisation capabilities. We believe its demonstrated success in the gastrointestinal therapeutic area make GSK an ideal partner for Santarus in the covered markets," said Gerald T. Proehl, president and chief executive officer, Santarus. "We also believe this relationship with GSK is a major advancement of our strategic objective to leverage our immediate-release proton pump inhibitor intellectual property in international markets and to further diversify our potential sources of future revenues." "This agreement combines GSK's commercial strength in these countries with a great opportunity in the form of ZEGERID immediate-release omeprazole products," commented Dr. Russell Greig, president, GSK Pharmaceuticals International.
Santarus, Inc, a specialty pharmaceutical company, said it has signed over exclusive rights related to its prescription and over-the-counter immediate-release omeprazole products including Zegerid to GlaxoSmithKline plc (GSK).
The $11.5 million transaction is to commercialise the drugs for a number of markets in GSK's International Region (including Africa, Asia, the Middle-East, and Central and South America), and to distribute and sell Zegerid brand prescription products in Puerto Rico and the US Virgin Islands (USVI).
Under the license agreement, GSK will be responsible for the development, manufacture and commercialisation of Licensed Products in up to 114 countries, excluding the US, Europe, Australia, Japan and Canada. In addition, under a separate distribution agreement, GSK will distribute, market and sell Zegerid brand prescription products in Puerto Rico and the USVI beginning in the first quarter of 2008. GSK will bear all costs for its activities under the license and distribution agreements.
GSK will pay Santarus an $11.5 million upfront fee and tiered double digit royalties, subject to reduction in certain circumstances, on net sales of any products sold under the license and distribution agreements. The term of the license agreement continues so long as GSK is obligated to pay royalties and the term of the distribution agreement continues as long as GSK sells the products, unless the agreements are terminated earlier by either GSK or Santarus under specified circumstances. GSK has an option to make a buy-out payment 20 years after the effective date of the agreements, after which time, GSK's royalty obligations generally would end. To support GSK's initial launch costs, Santarus will waive the first $2.5 million of aggregate royalties payable under the license and distribution agreements.
"As a leading global pharmaceutical company, GSK has well established international commercialisation capabilities. We believe its demonstrated success in the gastrointestinal therapeutic area make GSK an ideal partner for Santarus in the covered markets," said Gerald T. Proehl, president and chief executive officer, Santarus. "We also believe this relationship with GSK is a major advancement of our strategic objective to leverage our immediate-release proton pump inhibitor intellectual property in international markets and to further diversify our potential sources of future revenues." "This agreement combines GSK's commercial strength in these countries with a great opportunity in the form of ZEGERID immediate-release omeprazole products," commented Dr. Russell Greig, president, GSK Pharmaceuticals International.
Akorn, Inc. Announces First ANDA Submission For Serum Institute of India, Ltd.
BUFFALO GROVE, Ill.--(BUSINESS WIRE)--Dec 5, 2007 - Akorn, Inc. (NASDAQ:AKRX) today announced that it has submitted the first Abbreviated New Drug Application (ANDA) with the Office of Generic Drugs on behalf of Serum Institute of India, Ltd. Akorn and Serum announced the signing of an exclusive drug development and distribution agreement for 16 anti-cancer injectable products in October 2004. Since then, Serum has constructed and validated a dedicated, state-of-the art manufacturing facility for producing liquid and lyophilized oncolytic drug products.
The submitted ANDA is a drug product that is given as a treatment for many different types of cancer, and has an estimated U.S. market size of approximately $53 million. Akorn expects to launch the drug product in 2010.
The submitted ANDA is a drug product that is given as a treatment for many different types of cancer, and has an estimated U.S. market size of approximately $53 million. Akorn expects to launch the drug product in 2010.
Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Generic Version of Norvasc
DETROIT, December 05, 2007 /PRNewswire-FirstCall/ -- Caraco Pharmaceutical Laboratories, Ltd., announced today that the US Food and Drug Administration (FDA) has granted final approval for the Company's Abbreviated New Drug Application (ANDA) for Amlodipine Besylate Tablets, 2.5 mg, 5 mg, and 10 mg (Amlodipine).
Amlodipine is indicated for the treatment of hypertension, for the symptomatic treatment of chronic stable angina, and for the treatment of confirmed or suspected vasospastic angina. Amlodipine is the bioequivalent to Norvasc(R), a registered trademark of Pfizer Inc. According to IMS Data, based upon the most recent quarterly sales ended September 2007, Amlodipine generic and brand products combined have a run rate of approximately $550 million with ten generic competitors.
Daniel H. Movens, Caraco's Chief Executive Officer, said, "This product marks our seventh final approval since June 30, 2007. We are evaluating the market place and internal production planning in an effort to monetize this approval as soon as possible. This will bring our total product selection to 43 different products represented by 92 various strengths."
Amlodipine is indicated for the treatment of hypertension, for the symptomatic treatment of chronic stable angina, and for the treatment of confirmed or suspected vasospastic angina. Amlodipine is the bioequivalent to Norvasc(R), a registered trademark of Pfizer Inc. According to IMS Data, based upon the most recent quarterly sales ended September 2007, Amlodipine generic and brand products combined have a run rate of approximately $550 million with ten generic competitors.
Daniel H. Movens, Caraco's Chief Executive Officer, said, "This product marks our seventh final approval since June 30, 2007. We are evaluating the market place and internal production planning in an effort to monetize this approval as soon as possible. This will bring our total product selection to 43 different products represented by 92 various strengths."
Tuesday, December 4, 2007
Mylan Announces Tentative FDA Approval Under PEPFAR for Tenofovir Disoproxil Fumarate Tablets
PITTSBURGH, December 04, 2007 /PRNewswire-FirstCall/ -- Mylan Inc. today announced that Matrix Laboratories Limited* has received tentative approval from the U.S. Food and Drug Administration (FDA) under the President's Emergency Plan for AIDS Relief (PEPFAR) for its Abbreviated New Drug Application (ANDA) for Tenofovir Disoproxil Fumarate Tablets, 300 mg. Matrix's Tenofovir Disoproxil Fumarate is the first and only generic tentative approval of Gilead Sciences Inc.'s Viread Tablets, 300 mg.
Matrix's ANDA was tentatively approved in less than six months and is the seventh PEPFAR tentative approval earned by Matrix within the last 12 months. Under PEPFAR, a tentative approval means that a company can immediately sell an HIV/AIDS treatment in certain countries outside of the United States. Although existing patents and/or marketing exclusivity prevent the approval of the product in the United States, a tentative approval indicates that the product meets all safety, efficacy and manufacturing quality standards for marketing in the United States, which helps to ensure AIDS patients abroad who receive these medications get the same quality product as the American public.
Mylan Vice Chairman and CEO Robert J. Coury said: "This is yet another milestone for Mylan and Matrix and their commitment to the Company's growing antiretroviral (ARV) franchise that includes active pharmaceutical ingredients (API) and finished dosage forms for first- and second-line treatments. We applaud Matrix for its high quality science and manufacturing capabilities that resulted in earning this important tentative approval in such a short timeframe. Tenofovir Disoproxil Fumarate will help to meet the urgent and increasing need for high quality, affordable treatment in the developing world where the prevalence of HIV/AIDS is socially and economically devastating."
Matrix's ANDA was tentatively approved in less than six months and is the seventh PEPFAR tentative approval earned by Matrix within the last 12 months. Under PEPFAR, a tentative approval means that a company can immediately sell an HIV/AIDS treatment in certain countries outside of the United States. Although existing patents and/or marketing exclusivity prevent the approval of the product in the United States, a tentative approval indicates that the product meets all safety, efficacy and manufacturing quality standards for marketing in the United States, which helps to ensure AIDS patients abroad who receive these medications get the same quality product as the American public.
Mylan Vice Chairman and CEO Robert J. Coury said: "This is yet another milestone for Mylan and Matrix and their commitment to the Company's growing antiretroviral (ARV) franchise that includes active pharmaceutical ingredients (API) and finished dosage forms for first- and second-line treatments. We applaud Matrix for its high quality science and manufacturing capabilities that resulted in earning this important tentative approval in such a short timeframe. Tenofovir Disoproxil Fumarate will help to meet the urgent and increasing need for high quality, affordable treatment in the developing world where the prevalence of HIV/AIDS is socially and economically devastating."
Watson and Biovail Settle Lawsuit Over Cardizem LA
- Watson to Launch Generic Version in April 2009 -
CORONA, Calif., December 04, 2007 /PRNewswire-FirstCall/ -- Watson Pharmaceuticals, Inc. , a leading specialty pharmaceutical company, announced today that it has reached a settlement with Biovail Laboratories International SRL on outstanding patent litigation against Andrx Pharmaceuticals, Inc., a subsidiary of Watson, related to Andrx's generic version of Cardizem(R) LA (diltiazem extended-release tablets).
Under the terms of the settlement agreement, Biovail has granted Watson an exclusive license to its U.S. patents covering Cardizem(R) LA for a generic version of Cardizem(R) LA. The agreement generally provides that Watson will not commence marketing its generic equivalent product until April 1, 2009. Other details concerning the settlement have not been disclosed.
Forward-Looking Statement Any statements contained in this press release that refer to future events or other non-historical facts are forward-looking statements that reflect Watson's current perspective of existing trends and information as of the date of this release. Except as expressly required by law, Watson disclaims any intent or obligation to update these forward-looking statements. Actual results may differ materially from Watson's current expectations depending upon a number of factors affecting Watson's business. These factors include, among others, the difficulty of predicting the timing and outcome of litigation; risks that resolution of patent infringement litigation through settlement could result in investigations or actions by private parties or government authorities, including the U.S. Department of Justice and /or the Federal Trade Commission; the difficulty of predicting the timing or outcome of product development efforts and FDA or other regulatory agency approvals or actions; and other risks and uncertainties detailed in Watson's periodic public filings with the Securities and Exchange Commission, including but not limited to Watson's Annual Report on Form 10-K for the year ended December 31, 2006.
CORONA, Calif., December 04, 2007 /PRNewswire-FirstCall/ -- Watson Pharmaceuticals, Inc. , a leading specialty pharmaceutical company, announced today that it has reached a settlement with Biovail Laboratories International SRL on outstanding patent litigation against Andrx Pharmaceuticals, Inc., a subsidiary of Watson, related to Andrx's generic version of Cardizem(R) LA (diltiazem extended-release tablets).
Under the terms of the settlement agreement, Biovail has granted Watson an exclusive license to its U.S. patents covering Cardizem(R) LA for a generic version of Cardizem(R) LA. The agreement generally provides that Watson will not commence marketing its generic equivalent product until April 1, 2009. Other details concerning the settlement have not been disclosed.
Forward-Looking Statement Any statements contained in this press release that refer to future events or other non-historical facts are forward-looking statements that reflect Watson's current perspective of existing trends and information as of the date of this release. Except as expressly required by law, Watson disclaims any intent or obligation to update these forward-looking statements. Actual results may differ materially from Watson's current expectations depending upon a number of factors affecting Watson's business. These factors include, among others, the difficulty of predicting the timing and outcome of litigation; risks that resolution of patent infringement litigation through settlement could result in investigations or actions by private parties or government authorities, including the U.S. Department of Justice and /or the Federal Trade Commission; the difficulty of predicting the timing or outcome of product development efforts and FDA or other regulatory agency approvals or actions; and other risks and uncertainties detailed in Watson's periodic public filings with the Securities and Exchange Commission, including but not limited to Watson's Annual Report on Form 10-K for the year ended December 31, 2006.
Monday, December 3, 2007
Pfizer wins lawsuit against Ranbaxy
Bloomberg / Mumbai December 02, 2007
Pfizer, the world’s biggest drugmaker, won a US court ruling that prevents Ranbaxy Laboratories from selling a generic version of the blood pressure medicine Caduet until 2010.
District Judge Joseph J Farnan ruled that Ranbaxy already lost its bid to invalidate one Pfizer patent, so it can’t renew the argument. The patent covers the cholesterol treatment Lipitor, the world’s best-selling medicine. Caduet combines Lipitor with Pfizer’s Norvasc, which has lost patent protection.
Ranbaxy’s challenge to the patent “was raised and litigated to a final judgment on the merits in the Lipitor litigation between these same parties,” said Farnan in an opinion issued yesterday in Wilmington, Delaware.
New York-based Pfizer also is seeking to block generic Caduet until a second patent, for the combination of Lipitor and Norvasc, expires in 2018.
The judge has yet to rule on this request.
Pfizer reported $265 million in Caduet sales in the first half of 2007.
Lipitor had $6.1 billion in sales in the same period.
Pfizer, the world’s biggest drugmaker, won a US court ruling that prevents Ranbaxy Laboratories from selling a generic version of the blood pressure medicine Caduet until 2010.
District Judge Joseph J Farnan ruled that Ranbaxy already lost its bid to invalidate one Pfizer patent, so it can’t renew the argument. The patent covers the cholesterol treatment Lipitor, the world’s best-selling medicine. Caduet combines Lipitor with Pfizer’s Norvasc, which has lost patent protection.
Ranbaxy’s challenge to the patent “was raised and litigated to a final judgment on the merits in the Lipitor litigation between these same parties,” said Farnan in an opinion issued yesterday in Wilmington, Delaware.
New York-based Pfizer also is seeking to block generic Caduet until a second patent, for the combination of Lipitor and Norvasc, expires in 2018.
The judge has yet to rule on this request.
Pfizer reported $265 million in Caduet sales in the first half of 2007.
Lipitor had $6.1 billion in sales in the same period.
Discovery denied in continuations litigation
A court in the Eastern district of Virginia has denied a request from Glaxo SmithKline and Tryantafyllos Tafas for discovery in their case against the USPTO.
GSK and Tafos are involved in litigation over the USPTO's implementation of its final rule on claims and continuations.
The rules were originally set to take effect from November 1, 2007, but the office was enjoined from implementing them on October 31, 2007, when Judge James Chacheris ordered a preliminary injunction in response to requests from GSK and Tafos.
But on tuesday the court refused to grant them discovery.
GSK was seeking discovery of certain documents relating to the USPTO's research into possible alternatives to the final rules. The USPTO moved to block all discovery, and the Judge ultimately decided in its favour.
Despite the setback, neither John Desmarais, GSK's lead attorney, nor Steven Moore, Tafas's Attorney thinks the outcome of the hearing will affect their clients ability to win the case while GSK could appeal the decision in the district court.
GSK and Tafos are involved in litigation over the USPTO's implementation of its final rule on claims and continuations.
The rules were originally set to take effect from November 1, 2007, but the office was enjoined from implementing them on October 31, 2007, when Judge James Chacheris ordered a preliminary injunction in response to requests from GSK and Tafos.
But on tuesday the court refused to grant them discovery.
GSK was seeking discovery of certain documents relating to the USPTO's research into possible alternatives to the final rules. The USPTO moved to block all discovery, and the Judge ultimately decided in its favour.
Despite the setback, neither John Desmarais, GSK's lead attorney, nor Steven Moore, Tafas's Attorney thinks the outcome of the hearing will affect their clients ability to win the case while GSK could appeal the decision in the district court.
Sunday, December 2, 2007
Patent Challenge Taking The Glee Out Of Gleevec
An Indian drugmaker has filed a patent challenge with the FDA against the best-selling cancer med. And already, some patent experts and generic drugmakers are predicting this development will cause problems for Novartis in India, where the company is fighting a rejection of its Gleevec patent application. Novartis already lost one battle in which a court ruled its Gleevec patent lacks innovation.
India’s Sun Pharmaceuticals has filed a so-called Paragraph IV challenge with the FDA in which a generic maker seeks to invalidating a patent, prove there’s nothing novel about the med, or propose to introduce a version without infringing on the patent, as LiveMint reminds us. A Novartis spokesman confirms the Sun challenge, and vows the drugmaker will defend its intellectual property.
Sun is reportedly looking to invalidate the existing patent and experts say a victory will strengthen generic companies in their claims against Novartis in India, where Novartis has challenged the patent office’s decision to turn down its application. “This very disclosure in the US will make Novartis’ appeal against the patent office’s decision to reject its (Gleevec) patent application unacceptable,” Gopakumar Nair, a patent expert in Mumbai, tells LiveMint.
Moreover, some say a successful challenge would open a large generics market for Indian companies in the US. “If the US, which is comparatively liberal in granting patents, invalidates the Gleevec patent, it will look ridiculous for any (of the) patent court(s) in the world, which are (usually) more cautious, to grant a patent for this drug,” Shamnad Basheer, an associate at Oxford IP Research Center in the UK, tells LiveMint.
Rajeev Nannapaneni, ceo at Natco Pharma, which is opposing Novartis at India’s Intellectual Property Appellate Board, tells LiveMint that “the US patent challenge gives us a most important message that the Gleevec patent has been questioned not only in India, but elsewhere also.”
A Novartis spokesman writes us to say such views are premature: “Sun filed the Paragraph IV certification against a Gleevec patent that expires in the US in 2019. The basic compound patent, which expires in 2015 in the US, is not being challenged. So the earliest a generic could be launched - and this is only if Sun is successful in its challenge - would be after the expiry of the compound patent in 2015. We have full confidence in the integrity of these patents.”
India’s Sun Pharmaceuticals has filed a so-called Paragraph IV challenge with the FDA in which a generic maker seeks to invalidating a patent, prove there’s nothing novel about the med, or propose to introduce a version without infringing on the patent, as LiveMint reminds us. A Novartis spokesman confirms the Sun challenge, and vows the drugmaker will defend its intellectual property.
Sun is reportedly looking to invalidate the existing patent and experts say a victory will strengthen generic companies in their claims against Novartis in India, where Novartis has challenged the patent office’s decision to turn down its application. “This very disclosure in the US will make Novartis’ appeal against the patent office’s decision to reject its (Gleevec) patent application unacceptable,” Gopakumar Nair, a patent expert in Mumbai, tells LiveMint.
Moreover, some say a successful challenge would open a large generics market for Indian companies in the US. “If the US, which is comparatively liberal in granting patents, invalidates the Gleevec patent, it will look ridiculous for any (of the) patent court(s) in the world, which are (usually) more cautious, to grant a patent for this drug,” Shamnad Basheer, an associate at Oxford IP Research Center in the UK, tells LiveMint.
Rajeev Nannapaneni, ceo at Natco Pharma, which is opposing Novartis at India’s Intellectual Property Appellate Board, tells LiveMint that “the US patent challenge gives us a most important message that the Gleevec patent has been questioned not only in India, but elsewhere also.”
A Novartis spokesman writes us to say such views are premature: “Sun filed the Paragraph IV certification against a Gleevec patent that expires in the US in 2019. The basic compound patent, which expires in 2015 in the US, is not being challenged. So the earliest a generic could be launched - and this is only if Sun is successful in its challenge - would be after the expiry of the compound patent in 2015. We have full confidence in the integrity of these patents.”
Lovenox Patent Case Back at Federal Circuit; Generic Versions Still Not Yet Approved
The Lovenox patent infringement litigation between Aventis and Teva/Amphastar is making its second trip to the Federal Circuit. In February, following remand from the Federal Circuit last year, a federal district court in California held that the Lovenox patent is unenforceable due to inequitable conduct. The appeal may emerge as a litmus test of how far the CAFC is willing to go in lowering the bar on inequitable conduct, especially in terms of what it takes to prove deceptive intent. In general, the party asserting inequitable conduct must prove each prong of inequitable conduct (i.e., materiality and deceptive intent) by clear and convincing evidence.
In recent cases, the CAFC has expanded the scope of what counts as a material omission, including the omission of information that would have had no bearing on patentability. Thus, a practitioner may even comply with Rule 56 (37 CFR 1.56), and still be found to have withheld material information. This bar-lowering has occurred primarily via the emergence of the "reasonable examiner" standard. Hence, materiality is judged not by the PTO’s rules, but by a post hoc litigation-induced evaluation of what information a hypothetical "reasonable examiner" would (or should) have wanted during the ex parte prosecution of the patent application.
Moreover, defendants may no longer need to prove deceptive intent by clear and convincing evidence. Instead, a "guilt by omission" standard seems to have emerged. If the omitted information is "highly material" and if the patentee cannot proffer a reasonable explanation for the omission, then a court is permitted to infer deceptive intent. (Of course, the line between ordinary materiality and "high materiality" is a bit fuzzy, especially if an omission can be highly material even when it would have had no effect on patentability.)
In the Lovenox district court case, the district court went one step further: The court appeared to have shifted the burden to Aventis to disprove deceptive intent (e.g., after finding that Teva/Amphastar had made out a prima facie case of deceptive intent). It will be interesting to see where the CAFC goes with this one.
The parties appear reluctant to tread into the legal issues surrounding the CAFC’s recent inequitable conduct jurisprudence. After all, a sizeable portion of the judges have not yet bought into the recent trend of making it easier to prove inequitable conduct. Instead, the parties have elected to focus on several alleged clear errors in the district court’s fact-finding. Perhaps that’s the best approach, anyway. By their very nature, inquires into an individual’s intent must be fact-intensive.
Of course, the CAFC may do well to pay more heed to the post-1978 developments in antitrust law, where scholars of all stripes have generally rejected the value of intent-based evidence. Inequitable conduct arose in 1945 and came of age during that era of legal moralism that emerged from antitrust cases like Standard Oil. Antitrust law has now largely unburdened itself of Standard Oil and its progeny. To the degree that inequitable conduct is a relic of that bygone age, why must we retain it in patent law?
Meanwhile, the FDA has still not yet approved any generic versions of Lovenox (enoxaparin sodium). Lovenox consists of a complex mixture of oligosaccharides that has been shown to have improved anticoagulant effects over other low-molecular-weight heparins (LMWHs).
Earlier this month, Momenta Pharmaceuticals announced that the FDA rejected its ANDA for M-enoxaparin, apparently based on concerns about the generic drug’s immunogenicity. In other words, the FDA was concerned that it may provoke an unwanted immune response in humans. Moreover, according to Momenta's press release, "the FDA clarified that all applications for enoxaparin products must address the potential for immunogenicity of the drug product."
Momenta is working with Swiss generic manufacturer Sandoz to develop its generic product. The news of the rejection caused Momenta’s stock to lose nearly 60% of its value in a single day. In the intervening weeks, Momenta’s stock value has continued to tumble another 4 - 5%
In recent cases, the CAFC has expanded the scope of what counts as a material omission, including the omission of information that would have had no bearing on patentability. Thus, a practitioner may even comply with Rule 56 (37 CFR 1.56), and still be found to have withheld material information. This bar-lowering has occurred primarily via the emergence of the "reasonable examiner" standard. Hence, materiality is judged not by the PTO’s rules, but by a post hoc litigation-induced evaluation of what information a hypothetical "reasonable examiner" would (or should) have wanted during the ex parte prosecution of the patent application.
Moreover, defendants may no longer need to prove deceptive intent by clear and convincing evidence. Instead, a "guilt by omission" standard seems to have emerged. If the omitted information is "highly material" and if the patentee cannot proffer a reasonable explanation for the omission, then a court is permitted to infer deceptive intent. (Of course, the line between ordinary materiality and "high materiality" is a bit fuzzy, especially if an omission can be highly material even when it would have had no effect on patentability.)
In the Lovenox district court case, the district court went one step further: The court appeared to have shifted the burden to Aventis to disprove deceptive intent (e.g., after finding that Teva/Amphastar had made out a prima facie case of deceptive intent). It will be interesting to see where the CAFC goes with this one.
The parties appear reluctant to tread into the legal issues surrounding the CAFC’s recent inequitable conduct jurisprudence. After all, a sizeable portion of the judges have not yet bought into the recent trend of making it easier to prove inequitable conduct. Instead, the parties have elected to focus on several alleged clear errors in the district court’s fact-finding. Perhaps that’s the best approach, anyway. By their very nature, inquires into an individual’s intent must be fact-intensive.
Of course, the CAFC may do well to pay more heed to the post-1978 developments in antitrust law, where scholars of all stripes have generally rejected the value of intent-based evidence. Inequitable conduct arose in 1945 and came of age during that era of legal moralism that emerged from antitrust cases like Standard Oil. Antitrust law has now largely unburdened itself of Standard Oil and its progeny. To the degree that inequitable conduct is a relic of that bygone age, why must we retain it in patent law?
Meanwhile, the FDA has still not yet approved any generic versions of Lovenox (enoxaparin sodium). Lovenox consists of a complex mixture of oligosaccharides that has been shown to have improved anticoagulant effects over other low-molecular-weight heparins (LMWHs).
Earlier this month, Momenta Pharmaceuticals announced that the FDA rejected its ANDA for M-enoxaparin, apparently based on concerns about the generic drug’s immunogenicity. In other words, the FDA was concerned that it may provoke an unwanted immune response in humans. Moreover, according to Momenta's press release, "the FDA clarified that all applications for enoxaparin products must address the potential for immunogenicity of the drug product."
Momenta is working with Swiss generic manufacturer Sandoz to develop its generic product. The news of the rejection caused Momenta’s stock to lose nearly 60% of its value in a single day. In the intervening weeks, Momenta’s stock value has continued to tumble another 4 - 5%
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