2. Life Cycle Management Case Study: Preventing Generic API *Redacted for public/non-client distribution

3. Donepezil HCl Thermodynamically unstable Several known polymorphs; Form VI is more stable

4. Filed international patent 28 July 2004 Unfavorable IPER  Two “X” references  One “E” reference

5. Re-filed in USA, to same result: 2 “X” references, 1 “E” reference

6. Buried in USA NRC, in the Chemical Abstracts report at “L13 Answer 10 of 20”

7. Competitor Competitor won race to the Patent Office... … potentially foreclosing our API entirely

8. Dilemma(e) Patent too “broad”; it encompasses prior art (two X references, one E reference) Patent too “narrow”; it fails to cover competitor’s product Patent too vague; it doesn't specifically define what it covers

9. Alternatives Abandon product entirely Narrow patent ?  Avoid a potential § 102(e) reference  Vitiate the commercial value Request Interference  Both answers are wrong Re-engineer the patent from the ground up?

10. … narrow its patentso much it excludes prior art – and our product Competitor’s Competitor’s Reaction...

11. Our own Reaction... Marketing question: How do amendments impact the ability of our patent to bar competitive product? Scientific question: How is our product the same as, and different from, the prior art and the competitor's product?  The paradox of the 2-product toy store...

12. Broaden our own patent to cover competitor’s product literally & redundantly  Literal: predictable, inexpensive enforcement  Redundant: reliable viz yet-unknown prior art

13. … that claims competitor's API! Last to the Patent Office gets the patent...

14. © 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.