Intellectual Property Management

One of the key drivers of Lupin's move up the pharmaceutical value chain has been the work done by our Intellectual Property Group The group has not only created and cultivated a high-value patent portfolio but ensured that we judiciously protect our research and technology assets. Making sure our products do not infringe any valid patents or invalidating patents is a key part of Lupin's generics strategy and this is driven by the IP team. In April 2011, the Company's IP group entered into a license agreement with Abbott Laboratories and Laboratoires Fournier S.A. for various Abbott patents for Antara® (Fenofibrate) Capsules. The licensed patents and the agreement help build the patent estate around Antara®, Lupin's second largest brand in the US market.

Lupin also entered into a strategic alliance with Natco Pharma to jointly commercialize generic equivalent of Glaxo'sTykerb® (Lapatinibditosylate) 250 mg tablets. Natco and Lupin believe that they are the first-to-file an ANDA containing a Paragraph IV certification for Lapatinib. In addition, Lupin had 2 first-to-files for the generic versions of Lo Loestrin® Tablets and Pristiq® Extended Release Tablets during FY 2012. The cumulative first-to-files now stand at 22.

In FY 2012 Lupin launched 4 products in the US Market with 180 days of shared exclusivity. The Company also launched its first licensed Authorized Generic in the US. The IP group played a pivotal role in the US launch of the generic version of Fortamet® tablets (Metformin Hydrochloride XR) in September 2011. In December, 2011 Shionogi's request for a preliminary injunction was granted by the US courts and prevented Lupin from supplying additional quantities. The efforts of the IP Group at the US Court of Appeals for the Federal Circuit resulted in granting Lupin's request to stay the preliminary injunction that had earlier barred sales of its generic Fortamet® tablets. The company has since then re-launched the product.

Lupin also settled all ongoing litigation over SOLODYN® (Minocycline HCI, USP) Extended Release Tablets with Medicis Pharmaceutical Corporation. In addition, the Company entered into a settlement agreement with Santarus Inc. and Depomed Inc. to resolve pending patent litigation involving GLUMETZA® (extended release metformin tablets) 1000 mg and 500 mg.

Total Lupin's Patents filed/granted till date would be: 1024