1. PATENTS IN BIOTECHNOLOGY presented to the IEEE Engineering in Medicine and Biology Buenaventura Chapter Nicole Ballew Chang, PhD Lauren E. Schneider, Esq. Christie Parker Hale nbc@cph.com1/30/2013 © Christie, Parker & Hale, LLP

2. Purpose of a Patent Filing a Patent Application Patent Prosecution (Examination) America Invents Act (AIA) Biotech Specifics: Patentability of DNA Importance of Written Description © Christie, Parker & Hale, LLP

3. For Inventor/Applicant: Exclude others Extract a royalty Add to capital of company Enhance reputation of company © Christie, Parker & Hale, LLP

4. U.S. Govt. Grants a Patent: In exchange for up to 20 years of patent protection, invention is then dedicated to public. Encourages innovation. © Christie, Parker & Hale, LLP

5. TYPES OF PATENTS: UTILITY for inventions that perform useful functions. 20 years of protection after filing. PLANT for new strains of asexually reproducing plants. 20 years of protection after filing. DESIGN– for a new design, used for visual ornamental characteristics. 14 years of protection from date of grant. © Christie, Parker & Hale, LLP

6. PARTS OF A UTILITY PATENT APPLICATION: WRITTEN DESCRIPTION: Background, Description, Examples. DRAWINGS: Usually needed, but not required. CLAIMS: Claims are what define the invention. Claims specifically define what the patent rights cover. © Christie, Parker & Hale, LLP

7. Patent prosecution is the back and forth between the Applicant and the Patent Office which ultimately leads to the granting of a patent with claims that the Applicant and Patent Office agree on. After the formal requirements are met, the patent application is examined by an Examiner at the Patent Office. After filing, it typically takes at least 1 year for examination to begin.

8. EXAMINATION: Examiner reviews the claims of the patent application for: Patentable Subject Matter Novelty Non-obviousness Written Description Enablement © Christie, Parker & Hale, LLP

9. Non-Patentable Subject Matter One cannot obtain a patent on: Laws of nature Physical phenomena Abstract ideas A natural product even if it was not previously identified © Christie, Parker & Hale, LLP

10. NOVELTY: Invention cannot already be publicly known or publicly in use. Invention cannot be previously described or published. © Christie, Parker & Hale, LLP

11. NON-OBVIOUSNESS: Invention cannot be obvious to those of ordinary skill in the art. Invention cannot be taught or suggested by the prior art. © Christie, Parker & Hale, LLP

12. WRITTEN DESCRIPTION: Specification must contain a proper written description of the invention that describes the best mode known to Applicant for putting the claimed invention into practice. This was clarified as distinct from enablement in Ariad v. Eli Lilly. ENABLEMENT: Specification must enable those of ordinary skill in the art to make and use the invention. © Christie, Parker & Hale, LLP

13. From FIRST TO INVENT to FIRST TO FILE CURRENT LAW 1) Filing within one year of publication 2) Filing within one year of public use or offer for sale ( Grace Period ) NEW LAW (March 16, 2013) 1) Prior to publication or filing BY ANOTHER. 2) Within one year of disclosure BY APPLICANT or one who derived invention from applicant ( Personal Grace Period ) U.S. only. © Christie, Parker & Hale, LLP

14. Supplemental Examination ( September, 2012) Statutory provision to provide patentees with a Mechanism to immunize a patent from allegations of Inequitable conduct. Examplecited prior art. 14 Post-Grant Review Congress just passed bill to ensure that the entire term of issued patents will be available for a third-party challenge. © Christie, Parker & Hale, LLP

15. Diamond v. Chakrabarty: the question of whether or not an invention embraces living matter is irrelevant to the issue of patentability. The test is whether the living matter is the result of human intervention. Invention claiming naturally occurring DNA (e.g. gene sequence) = not patentable. Invention claiming isolated DNA = patentable © Christie, Parker & Hale, LLP

16. Association for Molecular Pathology et al. v. USPTO, Myriad Genetics, Inc., Directors of the University of Utah Research Foundation, and USA as represented by Secretary of Health and Human Services © Christie, Parker & Hale, LLP

17. Myriad Patents: Breast Cancer Genes: BRCA1 and BRCA2 ACLU, Plaintiff: The claims-in-suit directed to isolated DNA containing human BRCA1/2 gene sequences reflect the USPTOs practice of granting patents on DNA sequences so long as those sequences are claimed in the form of isolated DNA. This practice is premised on the view that DNA should be treated no differently from any other chemical compound, and that its purification from the body, using well-known techniques, renders it patentable by transforming it into something distinctly different in character. Many, however, including scientists in the fields of molecular biology and genomics, have considered this practice a lawyers trick that circumvents the prohibitions on the direct patenting of the DNA in our bodies but which, in practice, reaches the same result. Patentability of DNA © Christie, Parker & Hale, LLP

18. 18 © Christie, Parker & Hale, LLP Patentability of DNA May, 2009 S. District of New York ruled that DNA and the method claims of Myriad patents were unpatentable under 101. Myriad appealed. July, 2011 Federal Circuit reversed the decision with respect to the patentability of DNA. The claimed isolated DNA molecules do not exist as in nature within a physical mixture to be purified. If the law is to be changed, and DNA inventions excluded.. the decision must come not from the courts, but from Congress.

19. 19 Patentability of DNA December, 2011 ACLU appealed to the Supreme Court. The Supreme Court remanded the case back to the Federal Circuit for reconsideration, but the Federal Circuit did not change its opinion. September, 2012 ACLU petition the Supreme Court with respect to the Fed. Cir. Second decision. November 30, 2012 The Supreme Court agreed to hear the ACLUs appeal of the Fed. Circuits ruling. © Christie, Parker & Hale, LLP

20. WRITTEN DESCRIPTION in view of ARIAD v. LILLY David Baltimore et al. (Harvard, MIT, Whitehead Institute) filed a patent application on January 9, 1986 disclosing their discovery that NFκB is a regulator of gene expression in many, if not all, cell types. NFκB is inactive when complexed with IκB in the cytosol. Upon signaling, IκB is released from NFκB, NFκB translocates into nucleus and upregulates gene expression. © Christie, Parker & Hale, LLP

21. From this landmark discovery, 3 classes of molecules were described as being capable of reducing NFκB activity: (i.e. molecules that would bind) 1. Specific inhibitors 2. Dominantly interfering molecules 3. Decoy molecules Of the 3 classes, one single example was provided of a specific inhibitor IκB (the naturally occurring inhibitor). No other specific molecules were identified for reducing NFκB activity. Ariad Patent Issued June 25, 2002. WRITTEN DESCRIPTION in view of ARIAD v. LILLY © Christie, Parker & Hale, LLP

22. WRITTEN DESCRIPTION in view of ARIAD v. LILLY Claims 80 and 95 of Ariad patent read: © Christie, Parker & Hale, LLP

23. April, 2003, Lillys (Evista) Patent Issued. Ariad sued Lilly asserting that Evista infringed their patent. Evista compound is a benzothiophene represented by Formula I below that inhibits NFkB. WRITTEN DESCRIPTION in view of ARIAD v. LILLY © Christie, Parker & Hale, LLP

24. WRITTEN DESCRIPTION in view of ARIAD v. LILLY Result: Ariad claims were ruled invalid. Lillys Evista did not infringe. Conclusions: Inventor must be IN POSSESSION of the invention that is being claimed. One cannot claim a WISH. © Christie, Parker & Hale, LLP

25. Thank you. © Christie, Parker & Hale, LLP