Pfizer is suing Matrix (Mylan) for filing an ANDA to manufacture a version of the blockbuster cholesterol drug Lipitor in 10-, 20-, 40- and 80-mg strength tablets.
Pfizer Inc., the world’s biggest drugmaker, sued rival Mylan Inc. asking a judge to prohibit sales of a generic version of its cholesterol-fighting medicine Lipitor until 2017.
Pfizer’s patents on Atorvastatin which are in the light:
US5969156 (Expiry: Jan 8, 2017): Which covers crystalline Polymorphic Form I, II and IV
US6087511 (Expiry: July 16, 2016): Which covers a process for the preparation of amorphous Atorvastatin where crystalline Form I of Atorvastatin is dissolved in a non-hydroxylic solvent and after removal of the solvent affords amorphous Atorvastatin.
US6274740 (Expiry: July 16, 2016): Which covers a process for the preparation of amorphous Atorvastatin or hydrates thereof which comprises: (a) dissolving crystalline Form I Atorvastatin in a non-hydroxylic solvent at a concentration of about 25% to about 40%; and (b) removing the solvent by drying to afford said amorphous atorvastatin or hydrates thereof.
As per complaint, Matrix (Mylan) has filed ANDA with amorphous form of Atorvastatin and notified innovator about ANDA filing by Paragraph IV notice letter dated May 1, 2009.
In federal court papers filed today in Wilmington, Delaware, lawyers for New York-based Pfizer contend a Mylan affiliate has applied to the U.S. Food and Drug Administration for permission to sell copies of Lipitor, the world’s best- selling drug, before three Pfizer patents expire.
“Defendants have taken immediate and active steps” to sell Lipitor copies in the U.S. and “Pfizer will be irreparably harmed” if Canonsburg, Pennsylvania-based Mylan succeeds, according to the complaint.
Pfizer officials have said they’re looking for cooperative ventures with other pharmaceutical makers to increase generic sales as patents expire. Lipitor logged $12.4 billion in revenue last year, $7.7 billion of it in the U.S.
Ranbaxy Laboratories Ltd., India’s biggest drugmaker and majority owned by Japan’s Daiichi Sankyo Co., settled a lawsuit filed by Pfizer and plans to enter the market in November 2011. Pfizer already is suing Apotex Inc. and Teva Pharmaceutical Industries Ltd. to prevent them from selling copies of the medicine before then.
Mike Laffin, a spokesman for Mylan, didn’t immediately return voice and e-mail messages seeking comment on the lawsuit.
Pfizer fell 63 cents to $14.13 in New York Stock Exchange composite trading at 4:15 p.m. Mylan fell 56 cents to $13.06 in Nasdaq Stock Market trading.
The case is Pfizer Inc. v. Mylan Inc., U.S. District Court, District of Delaware (Wilmington).
Sunday, June 28, 2009
Friday, June 26, 2009
COMPLIANCE WITH cGMP IS MUST ---OTHERWISE FDA CAN TAKE ACTION
U.S. Marshals, at the request of the Food and drug Adminstration , seized drug products manufactured at Caraco Pharmaceutical laboratories limited (Caraco), at the company’s Michigan facilities in Detroit, Farmington Hills, and Wixom. The seizure also includes ingredients held at these same facilities.
This action follows Caraco’s continued failure to meet the FDA’s Current Good Manufacturing practice (cGMP) requirements, which assure the quality of manufactured drugs. Through this seizure, the FDA seeks to immediately stop the firm from further distributing drugs until there is assurance that the firm complies with good manufacturing requirements.
Since January 2009, Caraco has initiated voluntary recalls of drug products to protect the public from potentially defective medications. The recalls involved manufacturing defects, including oversized tablets and possible formulation error.
The FDA’s most recent inspection of Caraco, completed in May 2009, FDA again found unresolved violations of cGMP requirements. Now this seizure is intended to lead to major changes at Caraco’s facilities.
Now all the pharmaceutical industries intended to sell their product in US, must be aware that their manufacturing facilities should be in compliance with cGMP. As FDA is committed to taking enforcement action against firms that do not manufacture drugs in accordance with our good manufacturing practice requirements, said by Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research.
If the FDA identifies further significant problems, which pose risks to patient safety with any Caraco drug products on the market, the agency will take appropriate additional regulatory action and immediately notify the public. "The FDA will continue to take swift, aggressive enforcement action when firms are identified as being in violation of our manufacturing requirements," said Michael Chappell, FDA acting associate commissioner for regulatory affairs.
Seizure of drug products is considered to be an effective remedy when there is evidence of continued poor compliance with cGMPs. Following a drug product seizure, companies often agree to a wide range of changes and improvements to their drug manufacturing practices at their facilities.
But such drug seizure may create a shortage of the drug product seized. In case of Caraco's drugs FDA has determined that the seizure of Caraco's drugs may create a shortage of one product, magnesium trisalicylate oral tablets, which are commonly used as pain relievers. So FDA recommends in the event of a shortage, health care providers consider alternative treatments that are safe and effective.
Consumers and health care providers who are unable to obtain any of Caraco’s products should contact the FDA Drug Shortage Program by e-mail at drugshortages@fda.hhs.gov.
This action follows Caraco’s continued failure to meet the FDA’s Current Good Manufacturing practice (cGMP) requirements, which assure the quality of manufactured drugs. Through this seizure, the FDA seeks to immediately stop the firm from further distributing drugs until there is assurance that the firm complies with good manufacturing requirements.
Since January 2009, Caraco has initiated voluntary recalls of drug products to protect the public from potentially defective medications. The recalls involved manufacturing defects, including oversized tablets and possible formulation error.
The FDA’s most recent inspection of Caraco, completed in May 2009, FDA again found unresolved violations of cGMP requirements. Now this seizure is intended to lead to major changes at Caraco’s facilities.
Now all the pharmaceutical industries intended to sell their product in US, must be aware that their manufacturing facilities should be in compliance with cGMP. As FDA is committed to taking enforcement action against firms that do not manufacture drugs in accordance with our good manufacturing practice requirements, said by Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research.
If the FDA identifies further significant problems, which pose risks to patient safety with any Caraco drug products on the market, the agency will take appropriate additional regulatory action and immediately notify the public. "The FDA will continue to take swift, aggressive enforcement action when firms are identified as being in violation of our manufacturing requirements," said Michael Chappell, FDA acting associate commissioner for regulatory affairs.
Seizure of drug products is considered to be an effective remedy when there is evidence of continued poor compliance with cGMPs. Following a drug product seizure, companies often agree to a wide range of changes and improvements to their drug manufacturing practices at their facilities.
But such drug seizure may create a shortage of the drug product seized. In case of Caraco's drugs FDA has determined that the seizure of Caraco's drugs may create a shortage of one product, magnesium trisalicylate oral tablets, which are commonly used as pain relievers. So FDA recommends in the event of a shortage, health care providers consider alternative treatments that are safe and effective.
Consumers and health care providers who are unable to obtain any of Caraco’s products should contact the FDA Drug Shortage Program by e-mail at drugshortages@fda.hhs.gov.
Tuesday, June 23, 2009
Sanofi sued Teva over Eloxatin patent: Court Grants Teva Summary Judgment of Non-Infringement on Eloxatin®
Sanofi-Aventis has sued Teva Industries Ltd. over Teva's plans to sell a generic version of the French drugmaker's cancer treatment Eloxatin.
The lawsuit, filed in federal court in New Jersey, comes on the heels of a similar suit filed by Sanofi against Sandoz, a unit of Novartis.
Eloxatin had nearly 1.7 billion euros in sales in 2006 for Sanofi, the world's third largest drugmaker.
In an amended complaint, Sanofi alleged that Teva's plan to make and sell a generic version of the drug infringed a patent for which it was an exclusive licensee.
Teva filed a new drug application with the FDA for a generic product, oxaliplatin injection, according to the complaint. Oxaliplatin is the active ingredient in Eloxatin.
Sanofi is seeking an order blocking Teva from making or selling the generic product in the United States.
Teva and Sanofi could not be reached immediately for comment.
Recently
Teva Pharmaceutical Industries Ltd. announced that the US District Court for the District of New Jersey has granted summary judgment in Teva's favour on the issue of non-infringement with regard to Debiopharm's US Patent No. 5,338,874.
The patent is listed in the Orange Book for Sanofi-Aventis' chemotherapy medication Eloxatin, which had annual sales of approximately $1.3 billion in the United States for the twelve months that ended December 31, 2008, based on IMS sales data. Teva intends to inform the FDA of the court's decision and expects that its 505(b)(2) New Drug Application will receive final approval shortly.
The lawsuit, filed in federal court in New Jersey, comes on the heels of a similar suit filed by Sanofi against Sandoz, a unit of Novartis.
Eloxatin had nearly 1.7 billion euros in sales in 2006 for Sanofi, the world's third largest drugmaker.
In an amended complaint, Sanofi alleged that Teva's plan to make and sell a generic version of the drug infringed a patent for which it was an exclusive licensee.
Teva filed a new drug application with the FDA for a generic product, oxaliplatin injection, according to the complaint. Oxaliplatin is the active ingredient in Eloxatin.
Sanofi is seeking an order blocking Teva from making or selling the generic product in the United States.
Teva and Sanofi could not be reached immediately for comment.
Recently
Teva Pharmaceutical Industries Ltd. announced that the US District Court for the District of New Jersey has granted summary judgment in Teva's favour on the issue of non-infringement with regard to Debiopharm's US Patent No. 5,338,874.
The patent is listed in the Orange Book for Sanofi-Aventis' chemotherapy medication Eloxatin, which had annual sales of approximately $1.3 billion in the United States for the twelve months that ended December 31, 2008, based on IMS sales data. Teva intends to inform the FDA of the court's decision and expects that its 505(b)(2) New Drug Application will receive final approval shortly.
Friday, June 19, 2009
David Kappos: The successor of USPTO after John Dudas
Congratulations to Mr. David Kappos from CGI (CrispyGeneric IP) team!
The White House says “If he is confirmed by the U.S. Senate, Kappos will take control of an office that provides incentives to encourage technological advancement and helps businesses protect their investments, promote their goods and safeguard against deception in the marketplace. The office continues to deal with a patent application backlog of more than 770,000, long waiting periods for patent review, information technology systems that are regarded as outdated and an application process in need of reform.”
The White House has announced its intent to nominate David J. Kappos as Director of the United States Patent and Trademark Office (USPTO) with the official title of Under Secretary of Commerce for Intellectual Property.
Introduction of Mr. Kappos
Mr. Kappos has spent his entire career with IBM – both as an electrical engineer and later as a patent attorney. Kappos will end his IBM career as Vice President and Assistant General Counsel, Intellectual Property Law. He is a board member of both AIPLA and IPO.
From the get-go, Mr. Kappos has been a rumored frontrunner to replace Director Jon Dudas and Interim Director John Doll.
A very necessary quality of being a patent office director who can understand patents and who has been fully involved with all aspects of the patent system for the past twenty years.
I believe that Kappos will be a careful shepherd of the system - leaving it better off in six years than it is today.”
As someone who writes daily about US Patent Law, I am excited about the Kappos nomination because he is likely to open access to previously hidden data and information. He will also work to create systems that work and measures that are meaningful.
I suspect that the biggest challenge for Mr. Kappos will be moving beyond the unique IBM perspective. Big Blue is an atypical patent owner in its internal systems, patenting volume, and licensing power. As I discussed earlier, it will be important for him to spend time understanding how the rest of the patent community operates.
The White House says “If he is confirmed by the U.S. Senate, Kappos will take control of an office that provides incentives to encourage technological advancement and helps businesses protect their investments, promote their goods and safeguard against deception in the marketplace. The office continues to deal with a patent application backlog of more than 770,000, long waiting periods for patent review, information technology systems that are regarded as outdated and an application process in need of reform.”
The White House has announced its intent to nominate David J. Kappos as Director of the United States Patent and Trademark Office (USPTO) with the official title of Under Secretary of Commerce for Intellectual Property.
Introduction of Mr. Kappos
Mr. Kappos has spent his entire career with IBM – both as an electrical engineer and later as a patent attorney. Kappos will end his IBM career as Vice President and Assistant General Counsel, Intellectual Property Law. He is a board member of both AIPLA and IPO.
From the get-go, Mr. Kappos has been a rumored frontrunner to replace Director Jon Dudas and Interim Director John Doll.
A very necessary quality of being a patent office director who can understand patents and who has been fully involved with all aspects of the patent system for the past twenty years.
I believe that Kappos will be a careful shepherd of the system - leaving it better off in six years than it is today.”
As someone who writes daily about US Patent Law, I am excited about the Kappos nomination because he is likely to open access to previously hidden data and information. He will also work to create systems that work and measures that are meaningful.
I suspect that the biggest challenge for Mr. Kappos will be moving beyond the unique IBM perspective. Big Blue is an atypical patent owner in its internal systems, patenting volume, and licensing power. As I discussed earlier, it will be important for him to spend time understanding how the rest of the patent community operates.
Tuesday, June 16, 2009
One more hurdle for Ranbaxy:Medicis Pharma files suit against Ranbaxy for infringing patent claims on its acne drug
US-based speciality pharma company Medicis Pharma Corporation has filed a suit against Delaware-based Ranbaxy Inc, a wholly-owned subsidiary of Ranbaxy Laboratories Ltd, in the district court of Delaware, alleging patent infringement of its acne product-solodyn tablets.
In the petition filed with the District Court of Delaware, US, Medicis alleges that Ranbaxy has violated one or more claims three, four, 12 and 13 of the US Patent No.5,908,838 for method for the treatment of acne, issued on June, 1999. Ranbaxy has filed an abbreviated new drug application (ANDA) with the US Food and Drugs Administration (FDA) to manufacture and sell the minocycline HCL with a Para IV certification.The petition sought an adjudication that will restrain Ranbaxy from manufacturing and selling the generic product prior to the expiry of `838 patent and that the FDA should only issue approval for sales after the expiry of the said patent.
The annual sales of this product stood at approximately $365 million in the US market for the 12 months that ended January 31 this year, as per IMS sales data. Medicis Pharma, which specialises in dermatological products, has accused Ranbaxy of infringing patent claims of the company by attempting to obtain approval from the United States Food and Drug Administration (USFDA) to commercially manufacture and sell the generic version of the said acne product.
“Medicis received a letter dated May 6 from Ranbaxy Inc, stating that Ranbaxy Labs had filed the Ranbaxy abbreviated new drug application (Anda), seeking approval to manufacture, use, offer for sale and sell a generic version of solodyn extended release tablets for the treatment of acne before the expiration of the patent,” Jack Blumenfeld, counsel for Medicis, has told the court.
In its suit, Medicis has sought a permanent injunction against Ranbaxy so that the drug maker is prevented from manufacturing, using, selling the generic version of solodyn and has pleaded with the court to bar Ranbaxy from selling and marketing the drug till the patent litigation is resolved conclusively. A Ranbaxy spokesperson refused to comment on the issue.
Teva is reportedly one of the first companies to file ANDA with a Para IV certification for minocycline HCL. It has also been awarded a 180-day period of marketing exclusivity. It is also learnt that the FDA has denied Medicis' petition seeking a 30 month ban on making generic version of the drug.
The other high-profile patent litigation involving Ranbaxy include an agreement with Pfizer Inc to settle worldwide patent litigation involving Pfizer’s cholesterol-lowering medication, lipitor, which generated $12.7 billion in sales in 2007. The agreement allowed Ranbaxy to introduce a generic version of the drug in November 2011, with 180 days of exclusivity, which implies that no other manufacturers can start selling the drug until 180 days after that in the US. Ranbaxy also settled a patent infringement lawsuit with AstraZeneca in April 2008, which allowed the company to distribute the only generic version of esomeprazole magnesium product in the US.
In the petition filed with the District Court of Delaware, US, Medicis alleges that Ranbaxy has violated one or more claims three, four, 12 and 13 of the US Patent No.5,908,838 for method for the treatment of acne, issued on June, 1999. Ranbaxy has filed an abbreviated new drug application (ANDA) with the US Food and Drugs Administration (FDA) to manufacture and sell the minocycline HCL with a Para IV certification.The petition sought an adjudication that will restrain Ranbaxy from manufacturing and selling the generic product prior to the expiry of `838 patent and that the FDA should only issue approval for sales after the expiry of the said patent.
The annual sales of this product stood at approximately $365 million in the US market for the 12 months that ended January 31 this year, as per IMS sales data. Medicis Pharma, which specialises in dermatological products, has accused Ranbaxy of infringing patent claims of the company by attempting to obtain approval from the United States Food and Drug Administration (USFDA) to commercially manufacture and sell the generic version of the said acne product.
“Medicis received a letter dated May 6 from Ranbaxy Inc, stating that Ranbaxy Labs had filed the Ranbaxy abbreviated new drug application (Anda), seeking approval to manufacture, use, offer for sale and sell a generic version of solodyn extended release tablets for the treatment of acne before the expiration of the patent,” Jack Blumenfeld, counsel for Medicis, has told the court.
In its suit, Medicis has sought a permanent injunction against Ranbaxy so that the drug maker is prevented from manufacturing, using, selling the generic version of solodyn and has pleaded with the court to bar Ranbaxy from selling and marketing the drug till the patent litigation is resolved conclusively. A Ranbaxy spokesperson refused to comment on the issue.
Teva is reportedly one of the first companies to file ANDA with a Para IV certification for minocycline HCL. It has also been awarded a 180-day period of marketing exclusivity. It is also learnt that the FDA has denied Medicis' petition seeking a 30 month ban on making generic version of the drug.
The other high-profile patent litigation involving Ranbaxy include an agreement with Pfizer Inc to settle worldwide patent litigation involving Pfizer’s cholesterol-lowering medication, lipitor, which generated $12.7 billion in sales in 2007. The agreement allowed Ranbaxy to introduce a generic version of the drug in November 2011, with 180 days of exclusivity, which implies that no other manufacturers can start selling the drug until 180 days after that in the US. Ranbaxy also settled a patent infringement lawsuit with AstraZeneca in April 2008, which allowed the company to distribute the only generic version of esomeprazole magnesium product in the US.
Wednesday, June 10, 2009
India again raises issue of seizure of generic drugs by European nations at World Trade Organization (WTO)
Three consignments of Indian-manufactured generic medicines – seized last year while in transit in the EU – have been earmarked for destruction by EU authorities.
These consignments – of clopidogrel, rivastigmine and olanzapine – were being exported from India to other developing countries to treat patients with serious and life-threatening conditions such as heart attacks, strokes, Alzheimer's disease, Parkinson's disease and psychosis. Yet they were seized by Dutch customs authorities on the basis of alleged patent infringement.
Although these medicines are not under patent in India or in the destination countries, EU customs legislation still permits the destruction of these life-saving medicines. A humanitarian organisation, Médecins Sans Frontières (MSF), has highlighted several other recent cases of generic medicines in transit in the EU that have been detained, seized or destroyed.
According to Pharmexcil, companies whose consignments also ran into similar trouble (other than as listed below) include JB Chemicals and Pharmaceuticals Ltd, Medico Remedies Pvt. Ltd, Titan Pharma India Pvt. Ltd, and Mission Pharmaceuticals Ltd, all based in Mumbai, and Hyderabad-based Sainor Pharma Pvt. Ltd.
Listed below are the consignments of Indian companies that were seized on grounds of patent infringement by the Dutch customs authorities.
1.15.10.08: Ind-Swift Laboratories Ltd (Clopidogrel Bilsulphate- API): Destined for Columbia
A consignment valued at some $100,000 (Rs 49 lakh) of Ind-Swift in transit for Venezuela was seized in November by customs authorities in the Netherlands under suspicions of being counterfeit.
The product was the generic drug Pantoprazole, used for treating ulcers, in the form of pellets that were to be filled in capsules and sold in Venezuela, where Ind-swift has marketing rights for it.
2. 27.11.08: Cipla Ltd, through Uni World Pharma Ltd, Dubai
(Olanzapine 10 mg Tabs): Destined for Peru.
3. 27.11.08: Cipla Ltd, through Uni World Pharma Ltd, Dubai
(Rivastigmine 3 mg Tabs): Peru.
4. 24.12.08: Dr Reddy’s Laboratories Ltd (Losartan - API): Destined for Brazil
A DRL shipment of the generic version of losartan was seized in transit in the Netherlands. This shipment, on its way to Brazil, was held by the customs authority at Rotterdam, which said it infringed the patent of the original drug-Cozaar. Losartan is not patented in India or Brazil. The patent for Cozaar in the Netherlands is held by DuPont, while US-based pharma multinational Merck and Co. holds the marketing rights."
5. A consignment of HIV/AIDS medicines by Aurobindo Pharma Ltd meant for use in Nigeria was seized by Dutch officials. The grounds on which they were allegedly seized again is that they contained counterfeit goods.
Concerned over the continued seizure of generic drug consignments at different European ports on charges of counterfeiting and patents infringement, India has once again raised the issue at the WTO seeking the world body's intervention to ask the European Commission (EC) to urgently review the EC Regulation 1383/2003 and the actions of the national authorities based on the Regulation, and bring them in conformity with the letter and spirit of the TRIPS Agreement.
Even though the Indian government had raised the issue at the WTO's last meeting in March this year, the seizure of Indian drugs destined for other developing countries continued at EU ports. On May 5, a shipment of a generic antibiotic, Amoxicillin, manufactured in India and destined for a least developed country, the Republic of Vanuatu in the Pacific, was seized by customs officials, while in transit through Frankfurt, Germany.
Amoxicillin is an essential medicine used to treat a wide range of bacterial infections. The consignment worth approximately 28,000 Euros consisted of 3,047,000 tablets of Amoxicillin (250 mg), equivalent to 76,000 courses of treatment. The seizures were made on grounds of alleged trademark violation although GlaxoSmithKline (GSK) has confirmed to the German authorities that GSK is the former patent holder for 'Amoxil', a brand name for amoxicillin. Seeking WTO intervention on the issue, the Indian representative at the WTO said that there seems to be no valid reason for detaining these medicines especially since the name 'Amoxicillin' is an international non-proprietary name (INN).
Seizures have continued to take place at EC ports. The multitude of allegations and the spread across several EC ports, imply an emerging pattern to disrupt and create barriers to legitimate trade of generic drugs and to challenge the Doha Declaration on Public Health. The basic principle of transparency of procedures has also been violated by the inability of the authorities to share and explain the specific cause of action under EU regulations.
"EC has sought to justify the action of customs authorities to control goods in transit suspected of infringing IPRs as a means to stop traffic of potentially dangerous products, such as fake medicines, even when the shipments were destined for any country. It seems that it has been ingrained very deeply within the EC authorities that IP violative products are synonymous with potentially dangerous substances," the Indian representative said at the WTO.
Widespread and repeated seizures have an adverse systemic impact on legitimate trade of generic medicines, South-South commerce, national public health policies and the principle of universal access to medicines. The importance of generic drugs to public health in developing countries and particularly in the LDCs is obvious. Such barriers to legitimate trade of generic drugs will also seriously impair the efforts of civil society organisations engaged in providing medicines and improving public health in the least developed parts of the world.
It is ironical that while on one hand WTO has taken steps to promote access to affordable medicines and remove obstacles to proper use of TRIPS flexibilities, on the other hand some members seek to negate the same by seizing drug consignments in transit and creating barriers to legitimate trade, the representative said.
These consignments – of clopidogrel, rivastigmine and olanzapine – were being exported from India to other developing countries to treat patients with serious and life-threatening conditions such as heart attacks, strokes, Alzheimer's disease, Parkinson's disease and psychosis. Yet they were seized by Dutch customs authorities on the basis of alleged patent infringement.
Although these medicines are not under patent in India or in the destination countries, EU customs legislation still permits the destruction of these life-saving medicines. A humanitarian organisation, Médecins Sans Frontières (MSF), has highlighted several other recent cases of generic medicines in transit in the EU that have been detained, seized or destroyed.
According to Pharmexcil, companies whose consignments also ran into similar trouble (other than as listed below) include JB Chemicals and Pharmaceuticals Ltd, Medico Remedies Pvt. Ltd, Titan Pharma India Pvt. Ltd, and Mission Pharmaceuticals Ltd, all based in Mumbai, and Hyderabad-based Sainor Pharma Pvt. Ltd.
Listed below are the consignments of Indian companies that were seized on grounds of patent infringement by the Dutch customs authorities.
1.15.10.08: Ind-Swift Laboratories Ltd (Clopidogrel Bilsulphate- API): Destined for Columbia
A consignment valued at some $100,000 (Rs 49 lakh) of Ind-Swift in transit for Venezuela was seized in November by customs authorities in the Netherlands under suspicions of being counterfeit.
The product was the generic drug Pantoprazole, used for treating ulcers, in the form of pellets that were to be filled in capsules and sold in Venezuela, where Ind-swift has marketing rights for it.
2. 27.11.08: Cipla Ltd, through Uni World Pharma Ltd, Dubai
(Olanzapine 10 mg Tabs): Destined for Peru.
3. 27.11.08: Cipla Ltd, through Uni World Pharma Ltd, Dubai
(Rivastigmine 3 mg Tabs): Peru.
4. 24.12.08: Dr Reddy’s Laboratories Ltd (Losartan - API): Destined for Brazil
A DRL shipment of the generic version of losartan was seized in transit in the Netherlands. This shipment, on its way to Brazil, was held by the customs authority at Rotterdam, which said it infringed the patent of the original drug-Cozaar. Losartan is not patented in India or Brazil. The patent for Cozaar in the Netherlands is held by DuPont, while US-based pharma multinational Merck and Co. holds the marketing rights."
5. A consignment of HIV/AIDS medicines by Aurobindo Pharma Ltd meant for use in Nigeria was seized by Dutch officials. The grounds on which they were allegedly seized again is that they contained counterfeit goods.
Concerned over the continued seizure of generic drug consignments at different European ports on charges of counterfeiting and patents infringement, India has once again raised the issue at the WTO seeking the world body's intervention to ask the European Commission (EC) to urgently review the EC Regulation 1383/2003 and the actions of the national authorities based on the Regulation, and bring them in conformity with the letter and spirit of the TRIPS Agreement.
Even though the Indian government had raised the issue at the WTO's last meeting in March this year, the seizure of Indian drugs destined for other developing countries continued at EU ports. On May 5, a shipment of a generic antibiotic, Amoxicillin, manufactured in India and destined for a least developed country, the Republic of Vanuatu in the Pacific, was seized by customs officials, while in transit through Frankfurt, Germany.
Amoxicillin is an essential medicine used to treat a wide range of bacterial infections. The consignment worth approximately 28,000 Euros consisted of 3,047,000 tablets of Amoxicillin (250 mg), equivalent to 76,000 courses of treatment. The seizures were made on grounds of alleged trademark violation although GlaxoSmithKline (GSK) has confirmed to the German authorities that GSK is the former patent holder for 'Amoxil', a brand name for amoxicillin. Seeking WTO intervention on the issue, the Indian representative at the WTO said that there seems to be no valid reason for detaining these medicines especially since the name 'Amoxicillin' is an international non-proprietary name (INN).
Seizures have continued to take place at EC ports. The multitude of allegations and the spread across several EC ports, imply an emerging pattern to disrupt and create barriers to legitimate trade of generic drugs and to challenge the Doha Declaration on Public Health. The basic principle of transparency of procedures has also been violated by the inability of the authorities to share and explain the specific cause of action under EU regulations.
"EC has sought to justify the action of customs authorities to control goods in transit suspected of infringing IPRs as a means to stop traffic of potentially dangerous products, such as fake medicines, even when the shipments were destined for any country. It seems that it has been ingrained very deeply within the EC authorities that IP violative products are synonymous with potentially dangerous substances," the Indian representative said at the WTO.
Widespread and repeated seizures have an adverse systemic impact on legitimate trade of generic medicines, South-South commerce, national public health policies and the principle of universal access to medicines. The importance of generic drugs to public health in developing countries and particularly in the LDCs is obvious. Such barriers to legitimate trade of generic drugs will also seriously impair the efforts of civil society organisations engaged in providing medicines and improving public health in the least developed parts of the world.
It is ironical that while on one hand WTO has taken steps to promote access to affordable medicines and remove obstacles to proper use of TRIPS flexibilities, on the other hand some members seek to negate the same by seizing drug consignments in transit and creating barriers to legitimate trade, the representative said.
Sunday, June 7, 2009
Net profit of top 10 Indian Pharmaceutical companies decline by 61% in 2008-09
Although Indian Pharmaceutical companies done well in this fiscal year but as compared to previous year’s estimation for this year the calculation quite varied.
Here is the overview given regarding performance of top 10 Indian pharmaceutical manufacturers: the study done by Pharmabiz team.
Profitability of the pharmaceutical sector in the country is on steep decline for first time after several years of excellent performance. A Pharmabiz study of top 10 pharmaceutical companies having turnover of above Rs 2500 crore shows that their net profits came down by 60.9 per cent during the year ended 2008-09.
The consolidated net profit of these 10 companies declined to Rs 2,082 crore in 2008-09 from Rs 5,322 crore reported in the previous year. One of the main reasons for the poor performances was the foreign exchange losses. The aggregate provision for foreign exchange loss reached at Rs 3,031 crore during the year under review as against a gain of Rs 628 crore in 2007-08.
Apart from foreign exchange losses, these companies also experienced stiff competition, economic slowdown, volatile exchange rates and regulatory problems in the global markets during the year 2008-09.
Overall sales of the 10 companies, however, moved up during the year. The consolidated sales of the Pharmabiz sample of ten leading companies increased by 26.1 per cent to Rs 43,454 crore during 2008-09 from Rs 34,467 crore in the previous year. Ranbaxy Laboratories, now a subsidiary of Daiichi Sankyo of Japan, has remained on top with consolidated net sales of Rs 7,421 crore followed by Dr Reddy's Labs (Rs 6,791 crore), Cipla (Rs 4,973 crore), Sun Pharmaceutical (4,272 crore), Lupin (Rs 3,776 crore), Wockhardt (Rs 3,593 crore), Jubilant Organosys (Rs 3,518 crore), Piramal Healthcare (Rs 3,281 crore), Aurobindo Pharma (Rs 2,966 crore) and Cadila Healthcare (Rs 2,862 crore).
Pharmabiz analysis shows that there are 21 pharma companies in India with consolidated net sales of above Rs 1,000 crore during 2008-09. Two new companies viz., Dishman Pharma and Strides Arcolab achieved the milestone of Rs 1000 crore during 2008-09 and another two companies viz., Aventis Pharm India (Rs 983 crore) and Ankur Drugs (Rs 964 crore) are very close to touch Rs 1,000 crore marks in the current year.
The highest growth in net sales was recorded by Jubilant Organosys of 41.3 per cent. This was followed by Lupin 39.5 per cent, Dr Reddy's Labs by 38.2 per cent, Wockhardt by 35.4 per cent. Cipla, Sun Pharma, Aurobindo and Cadila Healthcare recorded sales growth of above 20 per cent during 2008-09. Only Ranbaxy achieved single digit growth of 9.4 per cent in sales. These players have established there brand image in cardiovasculars, gastrointestinals, central nervous system, respirator, musculoskeletal and pain management.
The profitability was quite bad for Ranbaxy Laboratories, Dr Reddy's Laboratories, Aurobindo Pharma, Piramal Healthcare and Jubilant Organosys. Out of ten companies, net profit of six companies declined or ended up in net losses. Three companies viz., Ranbaxy, Dr Reddy's Lab and Wockhardt incurred net losses of Rs 951 crore, Rs 917 crore and Rs 139 crore respectively as against profits made during 2007-08. Ranbaxy provided Rs 1,855 crore for foreign exchange loss and DRL provided Rs 1,463 crore for impairment of goodwill and intangibles. The net profit of Aurobind declined by 58.1 per cent to Rs 100 crore from Rs 238 crore in the previous year.
Ranbaxy provided a total Rs 1,855 crore for foreign exchange loss during 2008-09 as against a gain of Rs 508 crore in the previous year. Similarly, Wockhardt, Jubilant Aurobind also incurred a foreign exchange loss of Rs 711 crore, Rs 104 crore and Rs 255 crore in 2008-09. Piramal Healthcare provided Rs 255 crore for foreign exchange loss and Cadila of Rs 23 crore. DRL, Cipla, Sun Pharma and Lupin have not incurred any foreign exchange loss or gain during 2008-09.These provisions put pressure on aggregate profitability of 10 companies.
Sun Pharma remained star performer in profitability terms and its net profit touched to Rs 1,818 crore as compared to Rs 1,487 crore in the last year, a growth of 22.2 per cent. Similarly, net profit of Lupin also moved up by 22.9 per cent to Rs 501.54 crore from Rs 408.25 crore. The net profit of Cipla improved only by single digit of 9.5 per cent to Rs 768 crore. Cadila Healthcare recorded a profit growth of 17.7 per cent to Rs 303 crore.
The aggregate other income, including in-licensing income, of 10 companies increased by 23.6 per cent to Rs 1,373 crore from Rs 1,111 crore in the previous year. The raw material cost remained relatively stable and increased by 22.1 per cent to Rs 16,924 crore as compared to Rs 13,861.07 crore. The interest cost of these 10 companies went up sharply by 77.1 per cent to Rs 904 crore from Rs 511 crore. Though Sun Pharma earned interest income of Rs 122 crore, the interest burden of all other companies moved up during 2008-09. The provision for depreciation increased by 29.6 per cent to Rs 1,797 crore from Rs 1,387 crore.
The huge foreign exchange losses have not stopped Indian pharma companies from investing in R&D activities. Even after demerger of R&D activities the spending is rising. Out of ten companies, six have provided figures for R&D expenditure during 2008-09 which showed an increase of 12.6 per cent to Rs 1,541 crore from Rs 1,368 crore. Lupin's research spending went up by 40 per cent to Rs 232 crore from Rs 166 crore in the previous year. Ranbaxy's R&D expenditure reached at Rs 431 crore, a marginal growth of 0.8 per cent. Dr Reddy's spending moved up by 18.7 per cent to Rs 409.27 crore and that of Sun Pharma, which de-merged its R&D activities, increased by 11.1 per cent to Rs 332.04 crore.
The profit before tax, foreign exchange loss and other adjustments increased modestly by 18.1 per cent to Rs 6,807 crore from Rs 5,762 crore in 2007-08. Aurobindo's profit before tax has taken a quantum jump of 74 per cent and touched to Rs 386 crore from Rs 222 crore. Similarly, DRL's profit before tax moved up by 48 per cent to Rs 806 crore. However, the extra ordinary items of foreign exchange loss and impairment of goodwill and intangibles put pressure on bottom line of these two companies. Sun Pharma's profit before tax reached at Rs 1,949 crore as compared to Rs 1,599 crore, a growth of almost 22 per cent and that of Cipla amounted to Rs 910 crore as against Rs 838 crore representing a growth of 8.6 per cent. Ranbaxy's profit before tax, however, declined by 27.4 per cent to Rs 355 crore.
Despite negative growth in profit, several companies have declared handsome dividend during 2008-09. Sun Pharma recommended equity dividend of 275 per cent, Piramal Healthcare announced dividend of 210 per cent, DRL and Lupin declared 125 per cent; Jubilant stepped up dividend to 150 per cent. But, Ranbaxy and Wockhardt did not declare any dividend for the year.
Here is the overview given regarding performance of top 10 Indian pharmaceutical manufacturers: the study done by Pharmabiz team.
Profitability of the pharmaceutical sector in the country is on steep decline for first time after several years of excellent performance. A Pharmabiz study of top 10 pharmaceutical companies having turnover of above Rs 2500 crore shows that their net profits came down by 60.9 per cent during the year ended 2008-09.
The consolidated net profit of these 10 companies declined to Rs 2,082 crore in 2008-09 from Rs 5,322 crore reported in the previous year. One of the main reasons for the poor performances was the foreign exchange losses. The aggregate provision for foreign exchange loss reached at Rs 3,031 crore during the year under review as against a gain of Rs 628 crore in 2007-08.
Apart from foreign exchange losses, these companies also experienced stiff competition, economic slowdown, volatile exchange rates and regulatory problems in the global markets during the year 2008-09.
Overall sales of the 10 companies, however, moved up during the year. The consolidated sales of the Pharmabiz sample of ten leading companies increased by 26.1 per cent to Rs 43,454 crore during 2008-09 from Rs 34,467 crore in the previous year. Ranbaxy Laboratories, now a subsidiary of Daiichi Sankyo of Japan, has remained on top with consolidated net sales of Rs 7,421 crore followed by Dr Reddy's Labs (Rs 6,791 crore), Cipla (Rs 4,973 crore), Sun Pharmaceutical (4,272 crore), Lupin (Rs 3,776 crore), Wockhardt (Rs 3,593 crore), Jubilant Organosys (Rs 3,518 crore), Piramal Healthcare (Rs 3,281 crore), Aurobindo Pharma (Rs 2,966 crore) and Cadila Healthcare (Rs 2,862 crore).
Pharmabiz analysis shows that there are 21 pharma companies in India with consolidated net sales of above Rs 1,000 crore during 2008-09. Two new companies viz., Dishman Pharma and Strides Arcolab achieved the milestone of Rs 1000 crore during 2008-09 and another two companies viz., Aventis Pharm India (Rs 983 crore) and Ankur Drugs (Rs 964 crore) are very close to touch Rs 1,000 crore marks in the current year.
The highest growth in net sales was recorded by Jubilant Organosys of 41.3 per cent. This was followed by Lupin 39.5 per cent, Dr Reddy's Labs by 38.2 per cent, Wockhardt by 35.4 per cent. Cipla, Sun Pharma, Aurobindo and Cadila Healthcare recorded sales growth of above 20 per cent during 2008-09. Only Ranbaxy achieved single digit growth of 9.4 per cent in sales. These players have established there brand image in cardiovasculars, gastrointestinals, central nervous system, respirator, musculoskeletal and pain management.
The profitability was quite bad for Ranbaxy Laboratories, Dr Reddy's Laboratories, Aurobindo Pharma, Piramal Healthcare and Jubilant Organosys. Out of ten companies, net profit of six companies declined or ended up in net losses. Three companies viz., Ranbaxy, Dr Reddy's Lab and Wockhardt incurred net losses of Rs 951 crore, Rs 917 crore and Rs 139 crore respectively as against profits made during 2007-08. Ranbaxy provided Rs 1,855 crore for foreign exchange loss and DRL provided Rs 1,463 crore for impairment of goodwill and intangibles. The net profit of Aurobind declined by 58.1 per cent to Rs 100 crore from Rs 238 crore in the previous year.
Ranbaxy provided a total Rs 1,855 crore for foreign exchange loss during 2008-09 as against a gain of Rs 508 crore in the previous year. Similarly, Wockhardt, Jubilant Aurobind also incurred a foreign exchange loss of Rs 711 crore, Rs 104 crore and Rs 255 crore in 2008-09. Piramal Healthcare provided Rs 255 crore for foreign exchange loss and Cadila of Rs 23 crore. DRL, Cipla, Sun Pharma and Lupin have not incurred any foreign exchange loss or gain during 2008-09.These provisions put pressure on aggregate profitability of 10 companies.
Sun Pharma remained star performer in profitability terms and its net profit touched to Rs 1,818 crore as compared to Rs 1,487 crore in the last year, a growth of 22.2 per cent. Similarly, net profit of Lupin also moved up by 22.9 per cent to Rs 501.54 crore from Rs 408.25 crore. The net profit of Cipla improved only by single digit of 9.5 per cent to Rs 768 crore. Cadila Healthcare recorded a profit growth of 17.7 per cent to Rs 303 crore.
The aggregate other income, including in-licensing income, of 10 companies increased by 23.6 per cent to Rs 1,373 crore from Rs 1,111 crore in the previous year. The raw material cost remained relatively stable and increased by 22.1 per cent to Rs 16,924 crore as compared to Rs 13,861.07 crore. The interest cost of these 10 companies went up sharply by 77.1 per cent to Rs 904 crore from Rs 511 crore. Though Sun Pharma earned interest income of Rs 122 crore, the interest burden of all other companies moved up during 2008-09. The provision for depreciation increased by 29.6 per cent to Rs 1,797 crore from Rs 1,387 crore.
The huge foreign exchange losses have not stopped Indian pharma companies from investing in R&D activities. Even after demerger of R&D activities the spending is rising. Out of ten companies, six have provided figures for R&D expenditure during 2008-09 which showed an increase of 12.6 per cent to Rs 1,541 crore from Rs 1,368 crore. Lupin's research spending went up by 40 per cent to Rs 232 crore from Rs 166 crore in the previous year. Ranbaxy's R&D expenditure reached at Rs 431 crore, a marginal growth of 0.8 per cent. Dr Reddy's spending moved up by 18.7 per cent to Rs 409.27 crore and that of Sun Pharma, which de-merged its R&D activities, increased by 11.1 per cent to Rs 332.04 crore.
The profit before tax, foreign exchange loss and other adjustments increased modestly by 18.1 per cent to Rs 6,807 crore from Rs 5,762 crore in 2007-08. Aurobindo's profit before tax has taken a quantum jump of 74 per cent and touched to Rs 386 crore from Rs 222 crore. Similarly, DRL's profit before tax moved up by 48 per cent to Rs 806 crore. However, the extra ordinary items of foreign exchange loss and impairment of goodwill and intangibles put pressure on bottom line of these two companies. Sun Pharma's profit before tax reached at Rs 1,949 crore as compared to Rs 1,599 crore, a growth of almost 22 per cent and that of Cipla amounted to Rs 910 crore as against Rs 838 crore representing a growth of 8.6 per cent. Ranbaxy's profit before tax, however, declined by 27.4 per cent to Rs 355 crore.
Despite negative growth in profit, several companies have declared handsome dividend during 2008-09. Sun Pharma recommended equity dividend of 275 per cent, Piramal Healthcare announced dividend of 210 per cent, DRL and Lupin declared 125 per cent; Jubilant stepped up dividend to 150 per cent. But, Ranbaxy and Wockhardt did not declare any dividend for the year.
Tuesday, June 2, 2009
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Recently they have made “Montelukast Sodium” as their target. The U.S. Patent and Trademark Office (PTO) ordered the reexamination of Merck’s biggest selling product, Singulair. The challenged patent, US 5,565,473 was granted on 15/10/1996. This patent covers montelukast sodium, the active ingredient in allergy and asthma drug.
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