The Indian generic pharmaceutical industry currently is witnessing rapid growth resulting in immense opportunities for firms. The generics sector is set to play a considerable role in the pharmaceutical industry of the future. With major therapeutics coming off patent and increased demand for low cost medication, it is no longer just a peripheral provider of low cost basic medicines.

Drugs’ going off patent in the near future is certainly going to give an impetus to an industry which always seems to have strategies of innovation in place. One of the strategies that is believed to dominate thinking in the pharmaceutical industry is that in order to grow fast, companies have to aggressively pursue investment in both new chemical entities and new products, which could successfully challenge existing patented drugs. This is a high risk-high reward business model. Another strategy that has been found very useful is to file for a patent challenge under Para IV of the Hatch Waxman Act, 1984. Generic drug firms now frequently race to file the first Paragraph IV certification in hopes of successfully challenging drug patent(s) in litigation and obtaining the profits of 180-day exclusivity. This process serves as an important patent quality-oversight mechanism that exposes invalid patents and accelerates consumer access to generic drugs.

Paragraph IV is an important aspect of the Hatch-Waxman Act. Under this system, generic drug firms challenge pioneers drug patents in court. The claim is that that the generic version proposed to be launched by the manufacturer/claimant does not infringe the patent holders’ version. If successful, the prevailing generic firm obtains a 180-day marketing exclusivity period as the economic reward for its litigation efforts, and consumers benefit from earlier access to low-cost generic alternatives to the brand name drug.

Lately Shire has filed a patent infringement lawsuit against Natco Pharma over Fosrenol. The British pecialty biopharmaceutical company has filed a patent infringement lawsuit against Natco Pharma Ltd. related to its renal medication Fosrenol or lanthanum carbonate. In the lawsuit, filed in the U.S. District Court for the Southern District of New York, the St Helier, Jersey-based company alleges that Natco has infringed upon two of its patents: U.S. Patent No. 5,968,976, or 976 Patent, and U.S. Patent No. 7,381,428, or 428 Patent. The company stated that it filed the suit in response to an Abbreviated New Drug Application, or ANDA, filed by the Hyderabad-based Natco, which sought the approval of the U.S. Food & Drug Administration, or FDA, for marketing and selling the generic versions of Shire's 500 mg, 750 mg, and 1 g Fosrenol products. In addition, Shire noted that since the lawsuit had been filed within 45 days of receiving Natco's Paragraph IV notification letter, as warranted under the Hatch-Waxman Act, the FDA would have to refrain from approving Natco's application within or 30 months, or until a district court decides that the patents are invalid or not infringed.