© 2006 Millennium Pharmaceuticals Inc.

1. Janice Klunder and Sian Griffiths Legal Department, Millennium Pharmaceuticals, Inc. SLA Pharmaceutical & Health Technology Division Spring Meeting Boston March 19th, 2007 © 2006 Millennium Pharmaceuticals Inc.

2. A Beautiful Friendship The information professional and the patent attorney/agent ©2006 Millennium Pharmaceuticals, Inc.

3. Patent and Drug Development Timelines FDA Approval Hatch-Waxman Extension US and International Applications Filed Patent Expiration Patent Grant Years 0 1 6 11 ∕∕ 21 25 Development and FDA Review Maximum of 5 years extended term Maximum of 14 years of total patent term after NDA approval US Provisional Application Filed ©2006 Millennium Pharmaceuticals, Inc.

4. What is a Patent? • A grant of a property right • Property boundaries determined by the claims of the patent • Right to exclude others from making, using, offering for sale, or selling the invention in the United States or “importing” the invention to the United States ©2006 Millennium Pharmaceuticals, Inc.

5. Patent Rights - Exclusionary Right • A patent does NOT furnish the owner with the right to practice the claimed invention Company A Company A • Company B can exclude Company A from practicing the claimed invention Company B BUT, if Company A has a dominating patent • Company A can prevent Company B from practicing the broader claims, including Company B’s own invention ©2006 Millennium Pharmaceuticals, Inc.

6. Requirements for Patentability • New (novel) • Nonobvious • Useful • Adequate Disclosure • Written description • Enablement • Best Mode ©2006 Millennium Pharmaceuticals, Inc.

7. Novelty- 35 U.S.C. § 102 • The invention must be new, and cannot be patented if: • §102(a) - Before the applicant’s invention: • The invention was published (by another) anywhere in the world; or • The invention was known or used by others in this country • §102(b) - More than one year before applicant’s filing date: • The invention was published by anyone anywhere in the world (1-year grace period for applicant’s publications); or • The invention was in public use or on sale in this country • e.g., manufacturing agreements for clinical trial materials ©2006 Millennium Pharmaceuticals, Inc.

8. Prior art Novel compounds Hypothetical Patent Claim: All compounds characterized by having Novelty- 35 U.S.C. § 102-Genus-Species RelationshipsExample 1: Species anticipates a claim to a genus Claim is invalid: Prior art species anticipates the claimed genus ©2006 Millennium Pharmaceuticals, Inc.

9. Novelty- 35 U.S.C. § 102-Genus-Species RelationshipsExample 2: Genus does not anticipate a claim to an overlapping genus Prior art patent claim New claim is valid: Prior art genus does not anticipate the claimed genus Prior art Prior art patent does not disclose any specific compounds in the intersecting area Novel compounds New patent claim ©2006 Millennium Pharmaceuticals, Inc.

10. Obviousness- 35 U.S.C. § 103 • An invention cannot be patented if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains • must be some suggestion or motivation to modify reference or to combine reference teachings • must be a reasonable expectation of success; AND • prior art reference(s) must teach or suggest all claim limitations ©2006 Millennium Pharmaceuticals, Inc.

11. Prior art patent suggests making the combination Novelty- 35 U.S.C. § 102-Genus-Species RelationshipsExample 2: Genus does not anticipate a claim to an overlapping genus Prior art patent claim New claim is invalid: Claimed genus is obvious in view of the prior art patent Prior art Novel compound New patent claim ©2006 Millennium Pharmaceuticals, Inc.

12. Triggers for Conducting a SearchDiscovery and Development • Early stage landscape analysis • Overview of patentability and FTO issues • Competitor assessment • Patent drafting • Patentability analysis • Development decision points • Freedom-to-operate analysis • Competitor assessment ©2006 Millennium Pharmaceuticals, Inc.

13. Triggers for Conducting a SearchBusiness Development • Identification of business opportunities • Competitive intelligence • Due diligence • Patentability • Freedom-to-operate ©2006 Millennium Pharmaceuticals, Inc.

14. Patent Information ProfessionalWho are they? • Information professional/analyst supporting Intellectual Property/Legal group • Specialized in patent information • Technology driven - chemical structure, biological sequence, medical devices • May require different tools and different knowledge ©2006 Millennium Pharmaceuticals, Inc.

15. Patent Information ProfessionalKey skills required • General information skills • Business and company data, literature searching techniques etc. • Knowledge of patent databases • Full-text or indexed • Dates and countries of coverage ©2006 Millennium Pharmaceuticals, Inc.

16. Patent Information ProfessionalKey skills required cont. • Specialized searching techniques and databases for different types of technology • Chemical structure or biological sequence • Data and Reporting • Use of tools for generation of reports • Access to full-text of patent documents ©2006 Millennium Pharmaceuticals, Inc.

17. Patent Information ProfessionalKey skills required cont. • Understanding of patent law basics • Tailor searches appropriately • Provide “value-added” analysis • Patent data analysis • Manual • Using specialized software ©2006 Millennium Pharmaceuticals, Inc.

18. Examples ©2006 Millennium Pharmaceuticals, Inc.

19. Example 1Early Stage Landscape Analysis • Types of searches typically employed • Sequence searches on drug target • Structure searches on high-throughput screening hit families • Keyword based patent and literature searches • Competitor profiles ©2006 Millennium Pharmaceuticals, Inc.

20. Example 1 Early Stage Landscape Analysis • Benefits to project team • May assist in the development of path forward for project team • Only one factor at early stage of project • Project should be science-driven unless significant obstacles are uncovered • Provide ongoing updates as project progresses ©2006 Millennium Pharmaceuticals, Inc.

21. Example 2Patent Drafting – Patentability Analysis • No obligation to conduct a search but a thorough search is essential to identify relevant prior art and to avoid novelty and obviousness issues • More focused searches • Patent literature • Scientific literature • Commercial compounds ©2006 Millennium Pharmaceuticals, Inc.

22. Example 2Patent Drafting – Patentability Analysis • Be aware of publication date vs date available in database • May monitor searches and update during patent application process • May do additional searches during patent prosecution in order to assist attorney in overcoming examiner’s rejections ©2006 Millennium Pharmaceuticals, Inc.

23. Example 3Development Decision Points • Freedom-to-operate search and analyses • Searches on lead compound • Substructure, Markush, multiple sources • Searches on synthetic process route • Extensive keyword based patent searches across multiple databases • Often significant analyses of search results by attorneys required, information analyst assists ©2006 Millennium Pharmaceuticals, Inc.

24. Example 3Development Decision Points • Freedom-to-operate search considerations • What is the question being asked • Breadth and scope will depend on type of decision point • Approach from several different angles • May lead to large results sets – consider displays for result sets that may expedite initial reviews ©2006 Millennium Pharmaceuticals, Inc.

25. Example 3 Development Decision Points • Competitor Assessment • Can be more commercial focused depending on decision point • Provide supplementary patent information as needed • May include analysis of key competitor(s) patent landscape ©2006 Millennium Pharmaceuticals, Inc.

26. Tips and Tricks Successful patent searching • Make the search process iterative • Get input into strategies from other non-patent analysts and clients • Have client sit with you when running searches • Explain clearly the limitations and potential caveats of sources and searches • Talk to clients about the best way for them to view/utilize your results • Keep up-to-date with key changes in patent information eg. IPC8, database coverage ©2006 Millennium Pharmaceuticals, Inc.

27. Tips and TricksKeys to successful relationships with clients • Mutually trusting relationship between patent attorney/agent and information professional is critical • If information professional does not report into Legal, work hard to establish matrix team • One information professional for several attorneys/agents – try to keep up with priorities to effectively manage everyone’s filing dates and deadlines ©2006 Millennium Pharmaceuticals, Inc.

28. Breakthrough science. Breakthrough medicine. ®