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St. Jude Med., Inc. v. Access Closure, Inc - 729 F.3d 1369 (Fed. Cir. 2013)


The safe harbor provision arose from difficulties created by restriction requirements imposed by the U.S. Patent and Trademark Office (PTO) during examination, followed by double patenting challenges in the courts. A restriction requirement arises during examination at the PTO when an applicant pursues what are determined to be multiple patentably distinct inventions in the same application (35 U.S.C.S. § 121). Subsequently, a double patenting challenge may arise when, in an infringement suit, the patentee is charged with having pursued the same or obviously similar inventions in multiple applications, one or more of which later issued as the patent in suit. A successful double patenting defense invalidates the offending claims in the patent.


Plaintiffs, St. Jude Medical, Inc. and St. Jude Medical Puerto Rico, were patentees to certain methods and devices for sealing a "vascular puncture," which occurs when a medical procedure requires a medical professional to puncture through the skin and into a vein or artery to insert a medical device, such as a catheter, into a patient's vasculature. After such a procedure concludes, the medical professional typically removes the medical device from the vasculature. Plaintiss brought an infringement suit against defendant Access Closure, Inc. (ACI). The district court ruled in favor of the plaintiffs and ACI appealed. The district court ruled that: (1) the safe-harbor provision of 35 U.S.C. § 121 protects the Janzen patent from invalidity due to double-patenting; (2) the construction of key terms in the Janzen patent; and (3) ACI was not entitled to JMOL that the Fowler patents are invalid for obviousness.


Is the safe harbor ruling of the trial court justified?




The Court held that in a patent infringement action by patentees against a corporation, the district court improperly found that the safe-harbor provision of 35 U.S.C.S. § 121 protected a patent from invalidity due to double-patenting after the jury found that claims of the patent were not patently distinct from claims of a sibling patent because the safe harbor provision did not apply since the patent and the sibling patent did not maintain consonance.

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