India's leading drug maker Ranbaxy Laboratories Ltd. is facing the legal music from a dozen odd multinational companies on at least 11 of its generic molecules in its pursuit to conquer the global generic market through the Para IV challenge route. This includes legal battles with companies like Abbott, AztraZeneca, Aventis Pharma, Wyeth, Scherer, Cardinal Health, Cephalon Inc, GSK, Astella Pharma, Takeda and the much-hyped duel with Pfizer on Lipitor in 16 jurisdictions around the world.
The company is yet to score any significant wins against the opponents except for two not so big favourable rulings in Austria and Norway in the Lipitor case and a supply agreement from Cephalon on Modafinil, and these ongoing legal battles already cost the company over Rs.162 crore as legal and professional charges in 2005. The expenditure, which includes outgo on many other big and small decisive legal duels in the home turf and abroad on other issues, increased by 38.5 per cent when compared to its legal and other spending of Rs.117.2 crore in fiscal 2004.
Ranbaxy challenged Pfizer's patents relating to the $12 billion odd Lipitor in 16 jurisdictions around the world, including an ANDA with Paragraph IV challenge in the USA the big market. Pfizer sued Ranbaxy and the U.S. District Court of Delaware held that Ranbaxy's atorvastatin infringes Pfizer's US patents. Ranbaxy is in the process of pressing the case in the US Court of Appeals for the Federal Circuit. In the United Kingdom, it lost the Lipitor battle and may not be able to launch its generic till November 2011. The UK Court of Appeal recently rejected the appeal ruling its product infringes patent on Lipitor
In Finland, the Helsinki Court of Appeal issued a preliminary injunction against Ranbaxy in February 2006 prohibiting the company from selling its generic version, overruling its earlier decision to allow Ranbaxy to continue sales of its generic drug in that market. However, this decision can be challenged in the Supreme Court of Finland. Ranbaxy got some relief in the Lipitor battle when a Norwegian Court ruled non-infringement of one key Pfizer Norwegian Process Patent. At the same time, Ranbaxy's atorvastatin product was found to infringe another Pfizer Norwegian patent covering a particular intermediate compound of Lipitor. Rambaxy is appealing against this decision. The company also could invalidate Lipitor patent in Austria as the Supreme Patent and Trademark Board of Austria (OPM) affirmed an earlier ruling of the Austrian Patent Office, invalidating claims of Pfizer's Austrian Patent AT 207896, covering Lipitor.
Ranbaxy's saga to conquer Lipitor is going on in several other countries. It has made substantial investments, particularly in India and the United States on plant and machinery for the production of atorvastatin and has built up an inventory of the drug. Its game plan is to use this for other purposes or sell at a loss, if the cases are lost. While an adverse decision in the United States would not have a material adverse effect on profitability, it would have a negative effect on Ranbaxy's return on capital for its current atorvastatin-related investments.
Abbott filed cases against Ranbaxy and Teva for launching extended release generic of Clarithromycin XL against its antibiotic Biaxin, used in the treatment of bacterial respiratory tract infections including chronic bronchitis and acute maxillary sinusitis. The US District Court of Northern Illinois ruled for Ranbaxy on two patents and against on a single claim of a third patent. The court preliminarily enjoined Ranbaxy from marketing its Clarithromycin, one gram extended release product. The issue is now before the Court of Appeals for the Federal Circuit. However, Ranbaxy and Teva got US FDA marketing approval for Clarithromycin XL 1000 mg tablets.
Ranbaxy was the first to file an ANDA with a Paragraph IV certification challenging six of AstraZeneca's patents on the ulcer and heartburn treatment drug Nexium. On 22November 2005, AstraZeneca filed suit in the District Court of New Jersey to stop manufacturing of the generic version of Nexium citing Ranbaxy infringed its patents protecting the drug. As a result of AstraZeneca's filing, the FDA is barred from approving Ranbaxy's ANDA application for 30 months or until the Court decides its ruling. If AstraZeneca win the case, Ranbaxy will not be able to launch this drug in US till 2020.
Aventis Pharmaceuticals Inc. and AMR Technology, Inc. filed suit in the District Court of New Jersey against Ranbaxy, the supplier of the active pharmaceutical ingredient fexofenadine to Barr Laboratories, alleging infringement of its patents for the allergy drug fexofenadine HCl (Allegra). Aventis is also fighting a case on Allegra with Dr.Reddy's. In response to an ANDA filing by Impax Laboratories, Aventis and AMR filed suit in the District Court of New Jersey against Ranbaxy and Impax alleging infringement of its Allegra patents. Barr Laboratories waived its exclusivity to Teva Pharmaceuticals, which launched a generic product containing fexofenadine HCl produced by Ranbaxy. In response to this, Aventis, Merrell Pharmaceuticals and AMR Technology filed for a preliminary injunction against Barr Laboratories, Teva, Ranbaxy and Amino Chemicals to prevent the defendants from marketing unlicensed generic versions of Allegra. The New Jersey Court denied the request. In connection with this, Ranbaxy sued Barr Laboratories and Teva Pharmaceuticals for breach of contract and other claims relating to arrangements with them for the marketing and distribution offexofenadine HCl.
Ranbaxy filed an ANDA for Advil Cold and Sinus Liquigels containing a Paragraph IV certification against the two patents on these owned by Wyeth and Scherer and Cardinal Health, claiming non-infringement process. The two companies and others filed suit in the District Court of New Jersey alleging Ranbaxy infringed the two patents relating to ibuprofen + pseudoephedrine. While the case is going on, the two patents are set to expire in June 2009.
In the case of Modafinil, Ranbaxy filed Para IV ANDA against patents listed against Provigil, owned by Cephalon, Inc. It sued Ranbaxy and others alleging patent infringement. The case has been settled with Cephalon granting Ranbaxy a non-exclusive, royalty-bearing license to market and sell a generic version of Provigil, effective as early as in October 2011 but no later than April 2012, with earlier entry if another generic version of Provigil enters the market. Ranbaxy also entered into agreements on API supply and milestone payments with Cephalon.
Ranbaxy and other parties were jointly first to file ANDAs containing Paragraph IV certifications against patents listed for Actos, an antidiabetic drug of Takeda, co-marketed with Eli Lilley. Two years ago, Takeda filed suit against Ranbaxy in the Southern District of New York for infringement of several patents covering combination therapy involving pioglitazone together with other therapeutic agents. Mylan and AlphaPharm also challenged the validity of Takeda's basic patent on pioglitazone. In February 2006 the court held that Takeda's basic patent was valid and enforceable. A separate trial regarding Ranbaxy and others' potential infringement of Takeda's patents is pending with the court.
A legal war is going on between Teva and Pfizer on quinapril, the generic equivalent to Pfizer's blood-pressure drug Accupril. Ranbaxy also filed an ANDA on quinapril alleging non-infringement, and entered into a supply and distribution agreement with Teva. In a separate suit, Ranbaxy and Teva were enjoined from marketing or selling quinapril products pending resolution of Teva's litigation with Pfizer and Warner Lambert. The Appeal Court has upheld the preliminary injunction against Teva and Ranbaxy, and the case is going on in a US District Court for further proceedings. Ranbaxy could face substantial patent liability damages if the final court decision is adverse, including damages worth many billion dollars on lost sales of Accupril.
Ranbaxy is claimed to be the first to challenge the claims of Astellas Pharma's benign prostatic hyperplasia drug sold as Flomax (tamsulosin hydrochloride) citing double patenting. Astellas Pharma and others sued Ranbaxy on this drug, having its patent set to expire 27 October 2009. Ranbaxy is also engaged in a legal duel with GlaxoSmithKline for challenging the patent claims on its antiviral drug Valtrex (Valacyclovir HCl). GSK sued Ranbaxy in the District Court of New Jersey on the basic patent for valacyclovir HCl and the case is pending in the Court.