Life Cycle Management:Life Cycle Management:How to Resolve a Competitive Threat How to Resolve a Competitive Threat

Quickly and Reliably Quickly and Reliably

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Casodex(R) bicalutamide is a leading prostate cancer treatment.

Faced with patent expiration, an API maker developed a way to make more pure API, less expensively.

Filed US patent on 08 March 2007 (Serial No. 11/574,886

Examination projected to begin ca. 08 March 2010

Pre-exam review of published US applications had surprising revelation:

Apotex had filed a US patent on the same thing

Apotex's U.S. application was filed 26 July 2006 – a year earlier than ours. By 11 Jan 2008, the USPTO had approved 14 of Apotex's 21 patent claims

Options Concede infringement of Apotex's patent and

withdraw our own API? Correct the coverage of our patent to literally

claim Apotex's product? “Possession is 9/10ths of the law,” however; such correction would be difficult to do after Apotex obtains its own patent

Request interference? Both answers are wrong. A successful request would provoke an expensive and slow legal fight; no request would cede the market to Apotex.

For a difficult situation, an innovative solution ...

Difficult situations demand innovative solutions. We thus engineered a way to:

Block Apotex's patent entirely, even though it was on the verge of issuing; and

Avoid the delay and expense of an interference proceeding.

Apotex thus abandoned their patent entirely, and withheld their product from the market.

For further information:Pharmaceutical Patent Attorneys, LLCMorristown, New Jersey 07960 USAwww. LicensingLaw. Net

For further study:

How to Control the U.S. Pharmaceutical API Market ..., Journal of Intel. Prop. Rights, vol. 13, pp. 473-77 (2008)

Orange Book Patent Listing..., Journal of Generic Medicines vol. 1, pp. 219-27 (2004)

© 2010 Pharmaceutical Patent Attorneys, LLC

Morristown, New Jersey

For further information on how this approach can be applied to protect your API, contact:

Mark.Pohl@LicensingLaw.Net+1 (973) 984-0076

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 on request.