Case Study in Case Study in Life Cycle Management Life Cycle Management

Supporting Infringement Litigation Supporting Infringement Litigation Against Five Generics Against Five Generics

With Mission-Critical Patent ProsecutionWith Mission-Critical Patent Prosecution

*Redacted for public/non-client distribution*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 StrategyLife 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 CEFI-XL® became the largest-selling anti-infective

in the Indian subcontinentin 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, yetUS PTO rejected it:

0 8 /2 0 0 6 R e je c t io n

1 2/2 0 0 4 U S A 1 1 /0 1 3 ,1 1 0

0 9 /2 0 0 6 R e sp o n se

0 2 /2 0 0 7 R e sp o n se

1 2 /2 0 0 6 R e je c t io n

0 8 /2 0 0 6 R e je c t io n

rejected 9x ... and counting

0 8 / 2 0 0 6

1 2 / 2 0 0 4

0 9 / 2 0 0 6

0 2 / 2 0 0 7

1 2 / 2 0 0 6

0 3 / 2 0 0 7

0 6 / 2 0 0 7

0 6 / 2 0 0 8

1 0 / 2 0 0 7

0 2 / 2 0 0 9

1 2 / 2 0 0 8

0 5 / 2 0 0 9

0 5 / 2 0 0 7

1 0 / 2 0 07

0 2 / 2 0 0 7

0 2 / 2 0 0 8

0 9 / 2 0 0 8

0 3 / 2 0 0 9

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, LLCMorristown, New Jersey

For further information on how we can resolve your patent prosecution problems, contact us:

Stefanie.Truppi@LicensingLaw.Net+1 (973) 984-6159

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