Case Study in Life Cycle Management Supporting Infringement Litigation Against Five Generics With Mission-Critical Patent Prosecution *Redacted for public/non-client distribution

Cefixime is third generation cephalosporin antibiotic. Innovator (Pfizer) removed SUPRAX® from market after patent expired. Abbott Laboratories' Indian subsidiary has significant cefixime sales outside of USA How to protect a product which the innovator itself abandoned?

Life Cycle Management Strategy Combine w/cloxacillin to make CEFI-XL®Combine w/cloxacillin to make CEFI-XL® CEFI-XL® became the largest-selling anti-infective in the Indian subcontinentCEFI-XL® became the largest-selling anti-infective in the Indian subcontinent

Imitation is the sincerest form of flattery: five (5) generics launched in India Innovator, however, had proactively obtained an Indian patent Commenced infringement suits in India

Accused Infringers' Defense The Indian patent should never have issued because the USPTO – the gold standard in IP – rejected the counterpart US application Some merit to this:

Patent filed Dec. ’04, yet US PTO rejected it:

rejected 9x... and counting What's so special about combining 2 antibiotics ?

To address threat to Indian patent, we were asked to step in and help with the US patent. The USPTO accepted our new Power of Attorney on July 10th.

On August 21st, the US PTO issued a Notice of Allowance. We ended five years of unproductive prosecution in one month, quickly neutralizing the threat to the Indian patent.

(C) 2010 Pharmaceutical Patent Attorneys, LLC Morristown, New Jersey For further information on how we can resolve your patent prosecution problems, contact us: +1 (973) This presentation does not constitute legal advice, and does not form an attorney-client relationship between the copyright holder and the viewer. Certain information has been redacted from this presentation to make it suitable for distribution to the public. Clients may obtain an unredacted copy upon request.