Recent U.S. Court Decisions for Recent U.S. Court Decisions for Valid Priority ClaimsValid Priority Claims

AIPLA

AIPLA Mid-Winter InstituteIP Practice in Japan Committee

Pre-Meeting SeminarJanuary 29-30, 2013 Raymond E. Farrell

Carter, DeLuca, Farrell & Schmidt, LLP

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)

22

Domestic Priority - 35 U.S.C. 120

Adequate Disclosure

Common Inventor

Co-pendency

Specific Reference to Earlier Application(s)

33

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

44

Provisional App Priority - 35 U.S.C. 119(e)

Adequate Disclosure

Common Inventor

Filed Within 12 Months

Specific Reference to Provisional Application(s)

55

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

66

Santarus Claim 11. 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, ….

77

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)

88

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)

99

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

1010

Cragg ‘402 (Boston Scientific)

8/19

/94

Martin ‘817

Fogarty ‘836 (Medtronic)

MinTec French app

US ‘681 App4/

23/9

8

2/9/

94

6/5/

95

6/8/

94

1111

Boston Scientific v. Medtronic

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

1212

10/2

9/89

‘917 app

‘955 app

‘985 app

‘814 app

‘812 app

‘494 app

8/31

/93

2/28

/94

3/23

/95

3/25

/02

4/8/

03

6/13

/05

12/2

0/05

Encyclopaedia Britannica v. Alpine Elect.

1313

THANK YOU!

1414

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)

1515

1616

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

1717

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

1818

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