Is Judge Kavenaugh an Enemy of Agency “Chevron Deference”?

FDA Application and Gov. RegulationOther commentators have noted that they believe that Judge Kavanaugh (“K”) does not like “Chevron deference” of the courts to the interpretation of agency regulations. I skimmed recent decisions and note, that in technical areas, the judge recognized that deference should be given to an agency’s implementation of their own regulations. In Ivy Sport Medical, a 2014 decision relating to FDA’s inherent authority to reclassify a medical device, K recognized that deference should be given to agency “expertise.” (He still found that the FDA lacked the power to circumvent the procedures required to reclassify a medical device, but does this contradict deference to the technical aspects to the device, in this case, a surgical mesh?)

In a 2013 decision Cytori Ther. v. FDA, K again wrote a court should not second guess an agency’s “scientific expertise.” In that case the plaintiff argued that its cell collection an storage device was equivalent to earlier devices and so was entitled to a simplified review. K. agreed with the FDA that there was a reasonable basis for the FDA’s ruling that the devices in question were not equivalent to earlier approved devices.

That being said, K was unafraid of doing deep analyses of the technical aspects of Cytori’s devices and of the FDA’s power to decide what classification should be applied to a particular device (or to change a classification). In other words, K could accept the agency’s characterization of the device in question but still interpret the FDA’s application of the governing regulations.

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Finjan, Inc. v ESET, LLC: Can Billing Records Evidence Intent Element of Inequitable Conduct?

In an odd Order relating to a discovery request made by ESET for the billing records of plaintiff’s patent attorney, Bey, the Magistrate Judge in Case No. 17CV183 CAB (BGS)(S. D. Cal., June 25, 2018) ordered discovery of “non-privileged” billing records and annual total billings generated by Bey on the patents subject to counterclaims of laches, inequitable conduct and attorney bias.

The diligence of the attorney preparing and filing a patent application may be relevant to diligence in a prosecution laches defense. But the other rationale for ordering production of the billing records escape me. While citing Therasense for setting a high bar for inequitable conduct, the defendant essentially argued that, if Finjan was a big client of Bey’s, that she would be more likely to intentionally deceive the PTO, than if the client were not important. Defendant also argued that if the billings showed that Finjan was an important client of Bey’s, she would be more likely to lie on the stand to protect the client (the “bias” issue). Continue reading

Posted in Federal Court, Litigation Issues | 1 Comment

Supreme Court Permits Recovery of Foreign Profits for 271(f)(2) Infringement

Infringement of patentsSection 271(f)(2) reads:
“Whoever without authority supplies…in or from the [US] any  component of a patented invention that is especially made…for use in the invention and not a staple article of commerce….where stccg component is uncombined in whole or in part, knowing that such component is so made of adapted and intending that such component will be combined outside of the [US] in a manner that would infringe the patent if such combination occurred within the [US], shall be liable as an infringer.”

Patent owners who prove infringement under s. 271 are entitled to relief under s. 284. Section 284 reads:
“Upon finding for the claimant, the court shall award the claimant damages adequate to compensate for the infringement, but in no event less than a reasonable royalty for the use made of the invention by the infringer….”

In WesternGeco LLC v. Ion Geophysical Corp., No. 16-1011 (June 22, 2018), the Supreme Court decided that patent owner WesternGeco (“WG”) was entitled to profits lost outside of the US due to Ion’s infringement under 271(f)(2). Ion had sent components of WG’s patented “system,” that allowed improved mapping of the ocean floor, abroad where they were assembled into the system by a third party that competed for business with WG–presumably by undercutting WG’s price. Continue reading

Posted in Federal Circuit, Federal Court, Infringement | Leave a comment

Kathleen “Kay” Terry, Esq. (1934-2018)

Warren and Kay in the early 80’s

We should all note and be saddened by the death of Kay Terry, who was a “godmother” to Schwegman, Lundberg & Woessner from our start in 1993, when she was a head of life science patenting and licensing in the Tech Transfer Office at the University of Minnesota. She had held that position since at least 1984, when we took the BarBri course to prepare for the Minnesota Bar Exam. (I had to sit for the MN Bar Exam since I had not been in practice in NYC long enough to waive in.)

It was a good time to build a practice around patenting inventions originating a universities and non-profit institutions, since they were all scrambling to set up tech transfer offices after the passage of the Bayh-Dole Act in 1980, which permitted universities that originated inventions with Government funding to elect title if they filed for patent protection. She would tell me, “I come across like a naïve little old lady, but the licensees end up facing a negotiator who drives a hard bargain.” Continue reading

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