1. 1 1 1 AIPLA Firm Logo American Intellectual Property Law Association Obviousness-Type Double Patenting The Pitfalls Heather Champion Brady IP Practice in Japan Pre-Meeting Washington, D.C. October 22, 2014

2. 2 2 2 AIPLA Firm Logo Disclaimer The views expressed in this presentation are solely those of the presenter and are in no way endorsed by Johnson & Johnson.

3. 3 3 3 AIPLA Firm Logo Obviousness-Type Double Patenting (“OTDP”) A rejection “based on a judicially created doctrine grounded in public policy and which is primarily intended to prevent prolongation of the patent term by prohibiting claims in a second patent not patentably distinguishing from claims in a first patent.” MPEP §804

4. 4 4 4 AIPLA Firm Logo Requirements for OTDP Rejection Link between the cited patent/application and the patent/application at issue –Common inventor –Common owner –Joint Research Agreement Subject matter claimed in the patent/application at issue obvious in view of subject matter claimed in the cited patent/application Subject matter pursued in patent/application at issue cannot be the result of a Restriction Requirement

5. 5 5 5 AIPLA Firm Logo Overcoming an OTDP Rejection Demonstrate that the claimed subject matter is patentably distinct Submit a Terminal Disclaimer –Cuts off PTA awarded under 35 U.S.C. § 154 –Does not cut off patent term extension granted under 35 U.S.C. § 156 (for regulatory approval of drug)

6. 6 6 6 AIPLA Firm Logo OTDP Analysis Claim construction –Construe claims in patent/application at issue –Construe claims in the cited patent/application –Determine the differences Do the differences render the claims at issue patently distinct? –Analogous to an obviousness analysis under 35 U.S.C. §103 (Abbvie Inc. v. Kennedy Institute (Fed. Cir. 2014))

7. 7 7 7 AIPLA Firm Logo OTDP Scenarios Genus/Species –Later filed genus claims likely subject to an OTDP rejection over granted species claims –If later filed species claims are patentably distinct (unexpected results?) from earlier genus claims, OTDP rejection may be avoidable Method/Product –Later filed product/composition claims likely subject to an OTDP rejection over granted method of making/using product/composition claims –Method of using a compound/composition claims may be patentably distinct from earlier claims to the compound/composition

8. 8 8 8 AIPLA Firm Logo Gilead Sciences v. Natco Pharma (Fed. Cir. 2014) Question considered by the Federal Circuit: Can a patent that issues after but expires before another patent qualify as a double patenting reference for that other patent? The answer: Yes, it can “[A]n earlier-expiring patent can qualify as an obviousness-type double patenting reference for a later-expiring patent”

9. 9 9 9 AIPLA Firm Logo Gilead Sciences v. Natco Pharma (Fed. Cir. 2014)

10. 10 10 AIPLA Firm Logo Abbvie Inc. v. Kennedy Institute (Fed. Cir. 2014) “[T]he doctrine of obviousness-type double patenting continues to apply where two patents that claim the same invention have different expiration dates” “While often described as a court-created doctrine, obviousness-type double patenting is grounded in the text of the Patent Act.... § 101 forbids an individual from obtaining more than one patent on the same invention, i.e., double patenting. As this court has explained, “a rejection based upon double patenting of the obviousness type” is “grounded in public policy (a policy reflected in the patent statute).”

11. 11 11 AIPLA Firm Logo Questions to Consider After Gilead & Abbvie File Terminal Disclaimer before related patent issues? Review portfolio when a new patent grants? Raise OTDP in Ex Parte Reexamination? Raise OTDP in PGR?

12. 12 12 AIPLA Firm Logo Avoiding/Overcoming OTDP Scenarios Claim entire invention together Use specification to advantage Are the claims really obvious? Consonance of applications When can a terminal disclaimer be filed? Provisional OTDP rejections … know the Patent Office Policy

13. 13 13 AIPLA Firm Logo Thanks for your attention! Questions? Heather Champion Brady Senior Patent Counsel Johnson & Johnson 1 Johnson & Johnson Plaza New Brunswick, NJ 08933 +1-732-524-5266 (office) +1-908-812-5102 (mobile) hbrady@its.jnj.com Heather Champion Brady