How does the Hatch-Waxman Act affect patent infringement related to regulatory approval?
The Hatch-Waxman Act, codified in part as 35 U.S.C. 271(e), provides a safe harbor for certain activities that would otherwise be considered patent infringement. According to the MPEP: “Congress legislatively overruled Roche Products v. Bolar Pharmaceuticals, 733 F.2d 858, 221 USPQ 937 (Fed. Cir. 1984) as to products covered by 35 U.S.C. 271(e) and provided…
Read MoreHow does a voluntary divisional application affect the 35 U.S.C. 121 safe harbor?
How does a voluntary divisional application affect the 35 U.S.C. 121 safe harbor? A voluntary divisional application, which is not filed in response to a restriction requirement, does not benefit from the safe harbor provision of 35 U.S.C. 121. According to MPEP 804.01: “The U.S. Court of Appeals for the Federal Circuit has concluded that…
Read MoreWhat is the “safe harbor” provision in 35 U.S.C. 121?
What is the “safe harbor” provision in 35 U.S.C. 121? The “safe harbor” provision in 35 U.S.C. 121 protects patent applications and patents that result from restriction requirements. As stated in MPEP 804.01: “35 U.S.C. 121 provides that: If two or more independent and distinct inventions are claimed in one application, the Director may require…
Read MoreCan an applicant retroactively obtain 35 U.S.C. 121 safe harbor protection?
No, an applicant cannot retroactively obtain the safe harbor protection of 35 U.S.C. 121 against nonstatutory double patenting. The MPEP clearly states: “A patentee cannot retroactively recover the safe harbor protection of 35 U.S.C. 121 against nonstatutory double patenting by amending a patent that issued from a continuation-in-part application to only subject matter in the…
Read MoreHow does a restriction requirement affect double patenting rejections?
How does a restriction requirement affect double patenting rejections? A proper restriction requirement can protect against certain double patenting rejections due to the safe harbor provision of 35 U.S.C. 121. According to MPEP 804.01: “35 U.S.C. 121 prohibits the use of a patent issuing on an application with respect to which a requirement for restriction…
Read MoreHow does a restriction requirement affect the safe harbor provision of 35 U.S.C. 121?
How does a restriction requirement affect the safe harbor provision of 35 U.S.C. 121? A restriction requirement plays a crucial role in triggering the safe harbor provision of 35 U.S.C. 121. According to MPEP 804.01: “The protection of 35 U.S.C. 121 does not extend to all types of continuing applications, stating that ‘the protection afforded…
Read MoreWhat are the limitations of the safe harbor provision in 35 U.S.C. 121?
What are the limitations of the safe harbor provision in 35 U.S.C. 121? The safe harbor provision in 35 U.S.C. 121 offers protection against certain double patenting rejections, but it has several important limitations. According to MPEP 804.01: “The protection of 35 U.S.C. 121 is limited to divisional applications, and does not extend to continuation-in-part…
Read MoreHow does the filing date of a divisional application affect the safe harbor protection?
How does the filing date of a divisional application affect the safe harbor protection? The filing date of a divisional application is crucial for determining whether it qualifies for the safe harbor protection under 35 U.S.C. 121. According to MPEP 804.01: “The U.S. Court of Appeals for the Federal Circuit has concluded that the protection…
Read MoreDoes the 35 U.S.C. 121 safe harbor protection apply to all types of continuing applications?
No, the safe harbor protection of 35 U.S.C. 121 does not apply to all types of continuing applications. According to the MPEP, the Federal Circuit has concluded that: “The protection afforded by section 121 to applications (or patents issued therefrom) filed as a result of a restriction requirement is limited to divisional applications.“ This means…
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