1. Life Cycle Management: How to Resolve a Competitive Threat Quickly and Reliably *Redacted for public/non-client distribution

2. 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.

3. 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:

4. 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

5. 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.

6. For a difficult situation, an innovative solution...

7. 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.

8. For further information: Pharmaceutical Patent Attorneys, LLC Morristown, New Jersey 07960 USA www. 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)

9. © 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.