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AIPLA

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

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  1. AIPLA Recent U.S. Court Decisions for Valid Priority Claims 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)

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

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

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

  6. Adequate Disclosure 6 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

  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 9 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)

  10. Nexus 10 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

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

  12. Specific Reference to Earlier Applications 12 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

  13. 13 Encyclopaedia Britannica v. Alpine Elect. 6/13/05 2/28/94 4/8/03 12/20/05 10/29/89 8/31/93 3/23/95 3/25/02 ‘917 app ‘955 app ‘985 app ‘814 app ‘812 app ‘494 app

  14. 14 THANK YOU!

  15. References 15 • 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) • Hollmerv.Harari, 681 F.3d 1351 (Fed. Cir. 2012) • Boston Scientific Scimed, Inc. v. MedtronicVascular, Inc., 497 F.3d 1293 (Fed. Cir. 2007) • Encyclopaedia Britannica, Inc. v. Alpine Electronics of America, Inc., 609 F.3d 1345 (Fed. Cir. 2010)

  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)

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