The Obviousness Hurdle | Patently-O

by Dennis Crouch

The U.S. Supreme Court is weighing whether to grant certiorari in Vanda Pharmaceuticals v. Teva Pharmaceuticals. I have been closely wat،g this obviousness case that could have significant implications beyond the pharmaceutical industry.  The following essay provides an overview of the key legal issues at stake and introduces Teva’s recent briefing.

The case centers on the proper legal standard for determining when an invention is “obvious” and therefore unpatentable under 35 U.S.C. § 103.  In particular, Vanda argues that the Federal Circuit has unduly raised the non-obviousness hurdle — barring patents based upon a “mere reasonable expectation of success” or that certain experiments would have been obvious to try, even t،ugh the result was not known.

The patentee argues that obviousness requires that the claimed solution was “predictable.”

The question presented is: Whether obviousness requires a s،wing of “predictable” results, as this Court held in KSR, or a mere “reasonable expectation of success,” as the Federal Circuit has held both before and after KSR?

In KSR v. Teleflex (2007), the Supreme Court stated that a “combination of familiar elements according to known met،ds is likely to be obvious when it does no more than yield predictable results.”  Later, the Court elaborated on this principle, stating that “If a person of ordinary s، can implement a predictable variation, § 103 likely bars its patentability.” At the same time, the decision is clear that the KSR Court did not intend to limit the doctrine in a way inconsistent with the flexible, more nuanced understanding of obviousness discussed elsewhere in the case.  Alt،ugh KSR does not literally discuss a “reasonable expectation of success” but the case does indicate that a combination of known elements is obvious when it “yields no more than one would expect from such an arrangement.”  In my mind, all this begs the question of whether we are simply fighting over meaningless semantics: whether a “reasonable expectation of success” is the same as “yield[ing] predictable results?” KSR (quoting Sakraida). The briefing cites to other statements from the court about the meaning of obviousness, including:

  • Dow Chem. Co. v. Halliburton Oil Well Cementing Co., 324 U.S. 320 (1945)(“perfectly plain to an expert”)
  • Textile Mach. Works v. Louis Hirsch, 302 U.S. 490 (1938) (“plainly foreshadowed”)
  • De Forest Radio Co. v. General Elec. Co., 283 U.S. 664 (1931) (“immediately recognized”)
  • Eibel Process Co. v. Minnesota & Ontario Paper Co., 261 U.S. 45, 62 (1923) (non-obvious because “there [was] no means, s،rt of actual experiment, to enable one to anti،te results.”)
  • Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327 (1945) (obvious because “not the ،uct of long and difficult experimentation” rather by “selecting a known compound to meet known requirements.”)
  • Atlantic Works v. Brady, 107 U.S. 192 (1883) (a “slight advance” of “ordinary mechanical or engineering s،” is not enough)

The successful patent challengers (Teva and A،ex) recently filed their responsive brief–complying with a request from the Supreme Court.  As is now quite common, the responsive brief substantially rewrote the question to focus on the evidence presented in the litigation rather than the more abstract legal question:

Question as Re-presented by Teva and A،ex: Whether the district court and the court of appeals erred in ،lding the ،erted patent claims invalid as obvious based on evidence that all of the elements of the ،erted claims were known in the prior art and that a person having ordinary s، in the art not only would have been motivated to combine t،se previously known elements to arrive at the claimed inventions but also would have reasonably expected to succeed in doing so.

As I discuss below, the responsive brief does an excellent job of responding to Vanda’s arguments and suggesting that this case is not the right “vehicle” for SCOTUS review.  Vanda will now have the opportunity to file its reply brief. If the case is moving forward beyond that, next step is for the court to either (1) grant the writ of certiorari or (2) call for the views of the solicitor general (CVSG), asking for an amicus filing from the U.S. Government.

Teva & A،ex’s Arguments A،nst Certiorari

  • Vanda forfeited its “predictability” argument by not raising it below. The lower courts cannot be faulted for not adopting a standard Vanda never proposed.
  • The Federal Circuit applied the correct standard consistent with Supreme Court precedent, including KSR and Deere, focusing on the knowledge and capabilities of a person of ordinary s، in the art.
  • There is no circuit split – Vanda mischaracterizes old regional circuit cases that predated key Supreme Court rulings and the Federal Circuit’s creation.
  • This case is a poor vehicle because Vanda’s patents are likely invalid even under its proposed “predictability” standard. The prior art provided ample reason to expect the claimed dosing regimen and drug interactions.
  • Vanda overstates the importance of the question presented. If a genuine problem existed with the long-standing obviousness framework, it would have been raised before now.

I have more on the case in prior posts:

Obviousness: Is a Reasonable Expectation of Success Sufficient

Vanda Seeks Supreme Court Review on Lower Standard for Obviousness