Essayist looks at the ramifications of Therasense

Therasense may well be bigger than even we thought it was. We got a look at a Jason Rantanen (along with Lee Petherbridge, Ph.D.) essay-in-progress about what the ramifications of Therasense might be on the "legal infrastructure of American innovation." Here are some thoughts.

The essay is foundational in its approach to Therasense, with detailed background information, sourcing the seminal beginnings of the patent in suit (and its significance in commerce), Medisense’s unsuccessful attempts to patent the diabetes test strip, and Abbott’s aggressive  strategy and approach that moved it forward and led to the lawsuits (Abbott acquired Medisense and brought new resources to bear).

“Inequitable conduct is a judicially created doctrine designed to punish patent applicants who behave inappropriately during patent prosecution.” The Abbott prosecutions led to an inequitable conduct defense, with which the trial court agreed. Abbott’s appeal of that verdict is what led to what we now think of as Therasense. The original appeal received a forceful rejection from two of the three judges assigned to the case. The dissent was strong, however, and Abbott’s appeal for an en banc review was accepted.

In the authors’ words, “On May 25, 2011, the court issued an opinion that sought to radically reshape the landscape of inequitable conduct.” The court specified a stricter standard for materiality, and raised the bar for establishing intent.

Analysis, beyond the opinion

“From nearly any perspective the Federal Circuit’s holding in Therasense represents a naked attempt to shift economic rents from the public and the patent office to the patent bar and those who seek patents.”
  1. After Therasense, patent applicants no longer have a duty to reveal to a patent examiner information the applicants know will be important to the patent-issuance process, unless the applicant knows if he discloses it to the patent office it will cause the patent office not to allow the claims in his application.
  2. AfterTherasense, a patent applicant must by his actions or omissions specifically intend to mislead the patent office into issuing claims it would not have otherwise issued.
  3. Though the court’s purpose in Therasense was to make “patent creation cheaper for the patent bar and for those who seek patents,” the authors feel this is more burden shift than burden removal; the Patent Office will have to pick up the slack, and their “resources may become more strained than they were before.”
  4. Lower quality patents may now be expected, which will ultimately result in “higher prices for goods and services.”
  5. “If Therasense increases the amount of low quality patents, then competitors will (at least on the margins) spend more to resist the enforcement of patents.”
Though not a true Wiki, this essay-in-progress is designed to trigger comments and input; the author’s email address and solicitation are given on page one of the PDF.