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transcript
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)
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Domestic Priority - 35 U.S.C. 120
Adequate Disclosure
Common Inventor
Co-pendency
Specific Reference to Earlier Application(s)
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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
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Provisional App Priority - 35 U.S.C. 119(e)
Adequate Disclosure
Common Inventor
Filed Within 12 Months
Specific Reference to Provisional Application(s)
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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
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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, ….
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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!
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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)
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35 U.S.C. § 120 (AIA effective 3/16/13)
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Changes to 35 U.S.C. § 119(a) (AIA effective 3/16/13)
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Changes to 35 U.S.C. § 119(e)(AIA effective 3/16/13)