Posts Tagged: "materiality"

Examining CAFC Application of §271(g)(1)’s ‘Materially Changed’ Exception to Infringement Liability

35 U.S.C. § 271(g) was enacted in 1988 as part of the Process Patents Amendments Act to address instances where would-be infringers were avoiding infringement liability by using a process, patented in the U.S., outside of the country and then importing the product of the patented process into the U.S. Eli Lilly and Co. v. American Cyanamid Co., 82 F.3d 1568, 1571 (Fed. Cir. 1996). Under Section 271(g), such activity constitutes infringement. 35 U.S.C. § 271(g). The statute, however, carves out two exceptions: (1) where the product of the patented process that was made outside the U.S. is “materially changed” prior to importation; and (2) where the product of the patented process becomes a “trivial and nonessential component” of the product being imported. This article examines Federal Circuit case law addressing the circumstances that will (and will not) give rise to application of the “material change” carve out to infringement liability under Section 271(g).

Federal Circuit declares Regeneron patent unenforceable due to inequitable conduct

The Federal Circuit issued a decision in Regeneron Pharmaceuticals, Inc. v. Merus N.V. upholding the determination that the patent owned by biotech firm Regeneron was unenforceable. The decision affirmed a lower court’s finding based on Regeneron’s inequitable conduct during prosecution of the patent at the U.S. Patent and Trademark Office (USPTO), which was the result of the withholding of references from the USPTO that had but-for materiality. The patent, which the Federal Circuit deemed unenforceable, is U.S. Patent No. 8502018, titled Methods of Modifying Eukaryotic Cells.

CAFC reverses Summary Judgment on inherent anticipation, affirms no Inequitable Conduct

It is inappropriate for a trial court to discount material expert testimony so as to weigh the evidence in favor of a party seeking summary judgment. The presence of a genuine dispute precludes summary judgment in such cases. … Failure to disclose arguments concerning claims of a different scope in a different patent application was not inequitable conduct when differences were apparent to the Examiner.

Outside The Box Innovations v. Travel Caddy: Is a Misstatement of Small Entity Status Per Se Material to Patentability?*

In partially dissenting, Judge Newman’s beef with per curiam panel opinion on the small entity status issue was in “declin[ing] to correct the district court’s ruling that improper payment of the small entity fee is material to patentability.” Newman’s view that filing of an incorrect small entity statement doesn’t render it per se “material” is based on the 1928 Supreme Court case of Corona Cord Tire Co. v. Dovan Chemical Corp. which Newman said had made immaterial to patentability “an affidavit that was not the basis of the patent grant.” Put differently, Newman characterized Therasense as reiterating that the doctrine of inequitable conduct “should only be applied in instances where the patentee’s misconduct resulted in the unfair benefit of receiving an unwarranted claim.” In other words, Newman viewed a potentially incorrect assertion of small entity status as being “immaterial to the patent’s issuance.” But she found the per curiam panel’s opinion as being equivocal “on materiality and intent based on error in small entity status” and thus “simply add[ing] uncertainty when such is unwarranted.

US Patent Office Proposes Adopting Therasense Standard

In view of Therasense, the Patent Office is proposing to revise the materiality standard for the duty to disclose information to the Office in patent applications and reexamination proceedings. It is the belief of the Patent Office that the Therasense standard will reduce the frequency with which applicants and practitioners are being charged with inequitable conduct, thereby reducing the incentive for applicants to submit marginally relevant information to the Office. Thus, the Therasense standard should curtail the practice of filing Information Disclosure Statements that refer to boxes full of prior art that is of marginal significance, allowing patent examiners to focus on that prior art that is most relevant. The USPTO adopting the Therasense standard could, as a result, lead to improved patent quality and even a streamlining of prosecution in at least some cases.