`
`Generic Pharmaceutical Patent and FDA Law § 1:71
`
`Generic Pharmaceutical Patent and FDA Law
`Database updated April 2013
`Shashank Upadhye
`Chapter 1. Basics of Patent Law
`III. Statutory Provisions
`F. Sections 119, 120, and 121: priorities
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`References
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`§ 1:71. Section 119: Claiming foreign priority—Section 102(b) prior art is not affected by section 119(a)
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`West's Key Number Digest
`West's Key Number Digest, Patents
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`90(1)
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`Another portion of § 119(a) worth mentioning is the interaction of §§ 119(a) and 102(b) for the purposes of determining
`prior art dates when the U.S. patent claims priority to a foreign application. In Janssen Pharmaceutica v. Eon Labs Manufact.
`Inc., an issue in the case involved whether § 102(b) activity invalidated U.S. Patent No. 5,633,105. 1 Operatively, Janssen
`filed the foreign application on Sept. 3, 1992. Within one year, Janssen duly filed the U.S. application (via the PCT filing)
`on Aug. 27, 1993. What is the prior art date to invalidate the patent? Most people would believe that the earliest effective
`filing date is Sept. 3, 1992, and hence applicable § 102(b) prior art would have be dated for at least one year before this,
`i.e., Sept. 2, 1991. That is wrong. Because of the last sentence of § 119(a), it states that the foreign priority date cannot be
`used by the patentee/applicant when adjudicating the patentability of § 102(b) prior art. Accordingly, the relevant filing date
`is the PCT filing date of Aug. 27, 1993, and hence the relevant “critical date” for § 102(b) prior art is one year before this
`date, i.e., Aug. 27, 1992. As such, if there is intervening prior art between the foreign priority date and the U.S. filing date,
`it might invalidate the U.S. claims.
`Practice Tip:
`For generic companies attempting to invalidate a U.S. patent that claims priority to foreign applications, the critical date for §
`102(b) prior art is one year before the actual U.S. filing date. For foreign patent applicants, it is important to know the effect
`of waiting the traditional one year after filing the foreign priority document before filing the later U.S. application. It might
`be prudent in circumstances to file the U.S. application shortly after the foreign priority application.
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`Westlaw. © 2013 Thomson Reuters. No Claim to Orig. U.S. Govt. Works.
`
`Footnotes
`1
`Janssen Pharmaceutica, N.V. v. Eon Labs Mfg., Inc., 134 Fed. Appx. 425 (Fed. Cir. 2005).
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`End of Document
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`© 2014 Thomson Reuters. No claim to original U.S. Government Works.
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` © 2014 Thomson Reuters. No claim to original U.S. Government Works.
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