1. Recent U.S. Court Decisions for Valid Priority Claims AIPLA AIPLA Mid-Winter Institute IP Practice in Japan Committee Pre-Meeting Seminar January 29-30, 2013 Raymond E. Farrell Carter, DeLuca, Farrell & Schmidt, LLP

2. Right of Priority/ Benefit of Earlier Filing Date in the U.S. Domestic – 35 U.S.C. § 120 Foreign – 35 U.S.C. § 119(a-d) Provisional Appln. – 35 U.S.C. § 119(e) 2

3. Domestic Priority - 35 U.S.C. 120 Adequate Disclosure Common Inventor Co-pendency Specific Reference to Earlier Application(s) 3

4. Foreign Priority - 35 U.S.C. 119 (a-d) Nexus of Applicants Same Invention Claim to Priority Filed in the USPTO Certified Copy of Priority Document Filed Within 12 Months 4

5. Provisional App Priority - 35 U.S.C. 119(e) Adequate Disclosure Common Inventor Filed Within 12 Months Specific Reference to Provisional Application(s) 5

6. Adequate Disclosure Santarus v. Par Pharmaceutical (Fed. Cir. 2012) negative claim limitations are adequately supported when the specification describes a reason to exclude the relevant limitation Express disclaimer of the limitation is not required for support listing disadvantages is sufficient 6

7. Santarus Claim 1 1. A method for treating an acid-caused gastrointestinal disorder comprising the step of administering to a subject suffering from said disorder a solid pharmaceutical composition comprising: (a) about 10 mg to about 40 mg of …; and (b) sodium bicarbonate in an amount of …; wherein the composition contains no sucralfate, …. 7

8. Santarus Specification “The only patient whose death was attributed to stress- related upper gastrointestinal bleeding was in the sucralfate arm.” (Summary) “H2-antagonists, antacids, and sucralfate … have certain disadvantages associated with their use....” (Detailed Description) 8

9. Adequate Disclosure Hollmer v. Harari (Fed. Cir. 2012) Incorporation by reference statement at the initial filing stage - identity of the incorporated reference is clear to a reasonable examiner in light of the documents presented (Harari 1) Incorporation by reference statement in intermediate applications - must identify with detailed particularity what specific material is incorporated to a person of ordinary skill (Harari 2) 9

10. Nexus Boston Scientific v. Medtronic (Fed. Cir. 2007) Foreign application may only form the basis for priority under §119(a) if that application was filed by either the U.S. Applicant or by someone acting on behalf of the U.S. Applicant Nexus required between the U.S. Applicant and any entity acting on behalf of the U.S. Applicant at the time of the filing of the foreign priority case 10

11. Cragg ‘402 (Boston Scientific) 8/19/94 Martin ‘817 Fogarty ‘836 (Medtronic) MinTec French app US ‘681 App 4/23/98 2/9/94 6/5/95 6/8/94 11 Boston Scientific v. Medtronic

12. Specific Reference to Earlier Applications Encyclopaedia Britannica v. Alpine Elect. (Fed. Cir. 2010) priority claim is invalid where an intermediate application fails to satisfy the requirements under 35 U.S.C. §120 amendments in later applications cannot cure an otherwise defective priority claim in an earlier application in the priority chain 12

13. 10/29/89 ‘917 app ‘955 app ‘985 app ‘814 app ‘812 app ‘494 app 8/31/93 2/28/94 3/23/953/25/02 4/8/03 6/13/05 12/20/05 Encyclopaedia Britannica v. Alpine Elect. 13

14. THANK YOU! 14

15. References In re Gosteli, 872 F.2d 1008 (Fed. Cir. 1989) (Foreign application must be examined to ascertain if it supports, within the meaning of §112 ¶1, what is claimed in the U.S. application.) Santarus, Inc. v. Par Pharmaceutical, Inc., 694 F.3d 1344 (Fed. Cir. 2012) Hollmer v. Harari, 681 F.3d 1351 (Fed. Cir. 2012) Boston Scientific Scimed, Inc. v. Medtronic Vascular, Inc., 497 F.3d 1293 (Fed. Cir. 2007) Encyclopaedia Britannica, Inc. v. Alpine Electronics of America, Inc., 609 F.3d 1345 (Fed. Cir. 2010) 15

16. 16 35 U.S.C. § 120 (AIA effective 3/16/13)

17. 17 Changes to 35 U.S.C. § 119(a) (AIA effective 3/16/13)

18. 18 Changes to 35 U.S.C. § 119(e) (AIA effective 3/16/13)