GENERAL FDA
RANBAXY FACES TROUBLE WITH U.S. FDA
Ranbaxy, one of the renowned generic drug manufacturers, facing a lot of trouble with US Food and Drug Administration (FDA).Two consecutive issues put Ranbaxy in tough time. Apotex’s Aricept which raised question on Ranbaxy’s regulatory compliance is a prime issue. Japan's Eisai's patent on Aricept for the treatment Alzheimer's disease is going to be expired in November 2010. Two leading generic-drug maker companies viz. Ranbaxy Laboratories Ltd and Teva Pharmaceutical Industries are ahead of Apotex, a Canadian generic drug maker in obtaining the regulatory approval process from FDA in order to market the generic version of Aricept. Canada's Apotex Inc raised a question in a U.S. court in order to prove that it did not infringe Eisai Co's patents on Aricept. Ranbaxy is entitled to 180-days exclusivity before other companies can bring their drugs to market in the United States because Ranbaxy was the first to file an Abbreviated New Drug Application (ANDA) for getting the permission to market a generic version of Aricept. U.S. FDA revoked Ranbaxy’s approval for the launching of its generic version of valacyclovir, the active ingredient of Valtrex and donepezil hydrochloride, the active ingredient of Aricept for the treatment of herpes and Alzheimer’s disease respectively. According to the research, Valtrex has annual sales of $1.3 billion (Rs 6,360 crore). If Ranbaxy could launch Valtrex in this year it was expected to make market revenue of approximately $150-200 million. In the year 2008, Ranbaxy could not launch the generic version of GSK’s Imitrex for which Ranbaxy had 180-days exclusivity. Dr Reddy’s Laboratories Ltd’s profited from this and could manage to launch its authorized generic version of the drug in November. In the year 2007, Ranbaxy entered in to a settlement with GlaxoSmithKline Plc. (GSK), by virtue of which, Ranbaxy obtained a 180-days marketing exclusivity for the generic version of herpes drug and was supposed to launch by the end of this year.
Generic drug manufacturing company who gets first permission to launch generic versions of drugs get a marketing exclusivity period during which no other successive generic companies will be allowed to launch their generic version of the similar drug. But to enjoy this monopoly in the market the generic manufacture should comply with the rules and norms of the FDA and should maintain the quality and efficacy as standardized by good manufacturing practices (GMP). On 16 September 2008, FDA had issued warning letters to Ranbaxy’s manufacturing plants at Paonta Sahib in Himachal Pradesh and Dewas in Madhya Pradesh. AIP (application integrity policy) of FDA which takes care of this issue and after reviewing all pending and new applications filed from Ranbaxy it terminated the company’s few generic drugs (for eg. Nexium and Lipitor) from being launched in to the market. Ranbaxy has 180-days exclusivity for one of the two drugs which is usually calculated from the date of launch of the generic version. Ranbaxy suffered a significant delay in the launch of these two drugs. As a result Ranbaxy will not be able to enter the market till November 2010. Apotex is trying to trigger Ranbaxy’s exclusivity before time in order to market its own generic version of Aricept.
Ban in the production of new generic drugs at Paonta Sahib Factory of Ranbaxy is another instance of being suffered by US FDA. The U.S. FDA issued an “import alert” on Ranbaxy’s 30 drugs which were labeled as defective product due to the plant’s manufacturing failures, although there was no evidence that the drugs were harmful, Very recently Ranbaxy decided to recall a batch of Isotretinoin, an anti-acne medicine from the U.S. market which caused Ranbaxy’s fall of 1.7 percent to 249.85 rupees in Mumbai trading and also a significant drop of 14 percent in the first-quarter sales in U.S. On February 25th, FDA also added that Ranbaxy won’t be allowed to introduce new generic drugs from its Paonta Sahib factory.
FDA'S ACTION AGAINST CARACO TO HIT SUN REVENUES
The US Food and Drug Administration (FDA) inspectors have seized drugs and raw materials from Caraco's Michigan plants as they found grave violations of manufacturing standards and quality control. Following this, Sun Pharmaceuticals Industries Ltd's overall revenue will be significantly hit in 2009-10 as the USdrug regulator's have effectively barred the manufacturing of drugs there until the firm complies with mandatory quality practices. Caraco Laboratories Ltd accounted for 33% of Sun's $337 million (Rs1,618 crore) US sales in fiscal 2009. Sun Pharmaceuticals Industries Ltd's, India's largest drug maker by market value, has a 76% stake in Caraco and Caraco contributes about 12% to the total business of Sun Pharma.
Indian drug firms like Ranbaxy Laboratories Ltd, Cipla Ltd and Lupin Ltd, have already faced this action in the past year.
As to drugs already distributed from Caraco's Michigan facilities, FDA will issue public alerts and take authoritarian action if it finds impending risks to patient safety from these medicines.
GENERAL IPR
MR. DAVID J. KAPPOS TO LEAD USPTO
The White House has nominated Mr. David J. Kappos, (Vice President and Assistant General Counsel, Intellectual Property Law, for IBM Corporation), for Under Secretary of Commerce for IP and as the Director of the United States Patent and Trademark Office (USPTO).
He has vast industry experience, which is highly valuable for this position. He also has a demonstrated track record of managing a large organization, and has a true appreciation for industrial innovation.
PATENT
RANBAXY SUED BY MEDICIS PHARMA (US CORPORATION) FOR PATENT INFRINGEMENT
Ranbaxy, an Indian Pharma giant was sued by the Medicis Pharma (US Corporation) for infringement of a US patent on Solodyne, a drug for acne treatment. The allegations have been drawn against Ranbaxy based on one or more claims of the Medicis US patent for the method of treatment of acne.
Ranbaxy Labs had filed an ANDA application seeking approval to manufacture, use, offer for sale and sell a generic version of Solodyn, an extended release tablet for the treatment of acne before the expiration of the patent.
In the suit, Medicis Pharma Corporation asked for a permanent injunction against Ranbaxy so that the generic manufacturer would not be able to manufacture, use, sale or market the generic version of solodyn, till the patent litigation is resolved completely.
A GLOBAL PATENTING MODEL FOR INDIA
The United Nations' wing on IP is planning to implement a global patenting model in India. It will mandate all member countries, including India, to grant patent to drugs approved by any two international patent offices. The WIPO recognises patent offices of 11 countries but it does not recognise the Indian Patent Office. Global companies will be able to patent their inventions in India in an easy manner and enjoy a monopoly of 20 years in our country. India has been ranked as the country with the most consumer-friendly IP laws since its copyright regulations allow citizens great freedom to access and utilize information for educational and developmental purposes. The global patenting model should be encouraged, as it will help the Indian pharma companies to get their drugs patented faster in other countries and get easy access to their patented drugs at cheaper rates.
PATENT GRANT FOR DUAL SIM CARD PHONE IN DISPUTE
Champion Impex Pvt Ltd , a mobile import company has approached court to allow them to continue import of dual SIM card mobile phones. Mr. Somasundaram Ramkumar, an electronics engineer, had approached the customs offices in various states and intimated them to stop clearing shipments of the handsets with multiple SIM cards until he receives Rs 35 per phone shipped into the country towards his royalty fees. He had obtained a patent for the device last year. The court granted a stay in March on import, sale and distribution of such mobile phones. Some mobile importers from Gujarat then approached the IPR Appellate Board, Chennai against this patent. And, Champion Impex filed a civil suit before the city civil court challenging Ramkumar's right to intervene in import of handsets claiming that the engineer is not eligible to have a patent right of a device that is being manufactured across the world and technique of which is quite known.
MICROSOFT AND PALTALK SETTLE PATENT DISPUTE
Paltalk, a group messaging outfit had filed a patent infringement suit against Microsoft, alleging violation of its patents. The patents were related to deployment of interactive applications over hosted networks and group messaging servers. These patents may be used in video games, video conferences and in disseminating live communications from an organization to a large audience. Paltalk and Microsoft have settled the infringement suit through a license agreement under which, Microsoft has agreed to take a license over the patents for a royalty.
STANFORD PROFESSOR SEEKS PATENT REEXAM IN HIV DATABASE, LEGAL FIGHT WITH ABL
Advanced Biological Laboratories, Luxembourg, settled a defamation lawsuit against Robert Shafer, a Stanford University professor. The professor had claimed that ABL was discouraging physicians from using his online database for HIV drug resistance by enforcing its own bioinformatics patents.
The patents in this case were the methods of using a computer to guide the selection of therapeutic treatment regimens for known diseases and the Stanford University HIV Drug Resistance Database, a free online resource for guiding HIV treatment, which was maintained by Robert Shafer.
Despite the settlement, Shafer said that he will continue to dispute the validity of ABL's patents with the USPTO. In October last year, Shafer initiated a reexamination of ABL's patents with the USPTO. In response, ABL in December filed its breach of contract and defamation suit against Shafer and Stanford University.
TRADEMARK
SOUTH AFRICAN FIRM FILES FOR OWNERSHIP OF IPL BRANDS
KBJ Asset Holding, a local firm in South Africa has filed for owning trademark rights for popular IPL brands like Deccan Chargers and for other sports like rugby and soccer l. Rodney D Ryder of Kochhar & Co, which is the legal representative of IPL franchise Deccan Chargers, said his client will oppose the application.
KBJ has also sought to register these brands for soccer and rugby sports, besides education and training programmes, before the Patent and Trade Marks Office in South Africa seeking ownership of trademark rights.
The Board of Control for Cricket in India's IPL and Essel group promoted rival ICL (Indian Cricket League) are already in a dispute on ownership of these trademark on 'Twenty-20'.
COPYRIGHT
WTO REJECTS US IPR CLAIMS AGAINST CHINA
The World Trade Organisation rejected US IPR claims against China. The US claims included China's denial of copyright protection to works that have not been approved for publication or distribution in China, the removal of infringing trademarks as the precondition for sale at public auction of counterfeit goods seized by Chinese customs authorities, and the lack of criminal procedures and penalties in China against copyright piracy. This is the fifth time the US has launched appeals against China, but the first case regarding these issues.
"China is committed to IPR protection, and we will strengthen cooperation on IPR issues with nations and regions worldwide," a ministry spokesperson said.
The US appealed to the WTO in May 2007, and its claims focused on 11 specific articles regarding criminal thresholds, customs measures and copyright protection.
