Improved Method of Operating a Flow Cytometry Apparatus Is Not Abstract

In XY, LLC v. Trans Ova Genetics, LC, [2019-1789] (July 31, 2020), the Federal Circuit reversed the district court’s judgment that the asserted claims of RE46559 are ineligible under §101, and vacate the district court’s determination that claim-preclusion judgment, and remand for further proceedings certain claims of U.S. Patent Nos. 6,732,422, 7,723,116, and 8,652,769 were claim-precluded based on a prior lawsuit filed by XY against Trans Ova.

The ‘559 patent is directed to a method of operating a flow cytometry apparatus with at least n detectors to analyze at least two populations of particles in the same sample.  At Alice step two the district court found that the claims were directed to the mathematical equation that permits rotating multi-dimensional data.  At Alice step two, the district court held that the asserted claims lacked an inventive concept because XY admitted that each claim element was known in the art.

Beginning its analysis with Alice step one, the Federal Circuit concluded that the district court erred when it held that the claims are directed to the mathematical equation that permits rotating multi-dimensional data.  The Federal Circuit found that the claims are directed to a purportedly improved method of operating a flow cytometry apparatus.  The Federal Circuit found the asserted ’559 patent claims were analogous to the claims at issue in Diehr and Thales.  Like the claims in Diehr, the asserted claims “describe in detail a step-by-step method” for accomplishing a physical process.  Like the claims in Thales, the claims are directed to a method in which at least two sensors or detectors gather data about an object before mathematical operations are applied to the gathered data to generate more accurate information about the object than was previously possible in the art.  Having concluded that the asserted claims of the ’559 patent are not directed to an abstract idea at Alice step one, the Federal Circuit did not reach Alice step two.

Turning to the issue of claim preclusion, the Federal Circuit said that the parties’ only dispute concerned whether the district court properly concluded that XY’s 2012 and 2016 lawsuits present the same cause of action. XY argues that the district court erred by failing to compare the currently asserted patent claims to the previously asserted patent claims to determine whether the causes of action in the two lawsuits are essentially the same, and the Federal Circuit agreed.  The district court’s holding was based solely on the fact that the earlier-asserted patents and the later-asserted patents shared a common specification and were continuations of, and terminally-disclaimed to, the same parent patent.  The Federal Circuit concluded that the district court erred in its claim-preclusion analysis by failing to compare the scope of the patent claims asserted in the 2012 lawsuit with the scope of the patent claims asserted in the 2016 lawsuit, and vacated and remanded the case.

Posted in 101

“Half-Liquid” is Wholly Indefinite

In IBSA Institut Biochemique, S.A. v. Teva Pharmaceuticals USA, Inc., [2019-2400] (July 31, 2020), the Federal Circuit affirmed claims the district court determination that claims 1, 2, 4, and 7–9 of U.S. Patent No. 7,723,390 were invalid as indefinite under 35 U.S.C. § 112.

Central to the appeal was the parties’ dispute over the construction of “half-liquid,” which appears in independent claim 1.  IBSA proposed that the term “half-liquid” should be construed to mean “semi-liquid, i.e., having a thick consistency between solid and liquid.” Teva argued that the term “half-liquid” is indefinite or should be construed as “a non-solid, non-paste, non-gel, non-slurry, non-gas substance.”

The district court determined that IBSA’s proposed construction was not supported by the record, and that a skilled artisan could not otherwise ascertain a reasonably certain meaning for “half-liquid.”

The Federal Circuit began by noting that a claim is invalid for indefiniteness if its language, read in light of the specification and prosecution history, fails to inform, with reasonable certainty, those skilled in the art about the scope of the invention.  The Federal Circuit then turned to the language of the claim to determine whether the meaning of “half-liquid” is reasonably clear. Neither party meaningfully disputed that the claim language did not make the meaning of “half-liquid” reasonably clear. The Federal Circuit found that the claim language clarifies only that a “half-liquid” differs from a liquid.  The Federal Circuit then turned to the specification and prosecution history, which did not help. In fact, the fact that at one time a claim to a semi-liquid depended from the claim to the half-liquid established that half-liquid and semi-liquid were not synonyms.

Because the intrinsic evidence failed to establish the boundaries of a “half-liquid,” the  Federal Circuit turned to the extrinsic evidence, and found no error in the district court’s determination that the extrinsic evidence does not supply “half-liquid” with a definite meaning under § 112.

The Federal Circuit concluded that taken together, the intrinsic and extrinsic evidence fail to inform, with reasonable certainty, those skilled in the art about the scope of the invention, and affirmed the judgment of the district court.

It is important to make sure the meaning of every claim term is clear from the specification, particularly where the claims have been translated from another language.

Lack of Likelihood of Success and Irreparable Harm Doomed Preliminary Injunction

In Takeda Pharmaceuticals USA, Inc. v. Mylan Pharmaceuticals Inc., [  2020-1407, 2020-1417] (July 31, 2020), the Federal Circuit affirmed the denial of a preliminary injunction on the grounds that Takeda failed to show that it was likely to succeed on the merits or that it would be irreparably harmed absent a preliminary injunction.

A plaintiff seeking a preliminary injunction must establish [1] that he is likely to succeed on the merits, [2] that he is likely to suffer irreparable harm in the absence of preliminary relief, [3] that the balance of equities tips in his favor, and [4] that an injunction is in the public interest.”

On the likelihood of success, the Federal Circuit agreed that the final judgment in the prior litigation likely triggered Section 1.2(d) of a License Agreement, permitting Mylan to market its generic colchicine product, and therefore Takeda was unlikely to succeed on the merits.

The Federal Circuit then considered the issue of irreparable harm. Takeda primarily relied on Section 1.10 of the License Agreement, which created a presumption of harm if the license agreement were breached, to prove irreparable harm. The Federal Circuit by its terms, Section 1.10 only offers Takeda a basis for establishing irreparable harm in the event Mylan breached Section 1.2.  However, because it concluded that it is unlikely Takeda can show that Mylan breached the License Agreement, the Federal Circuit further conclude that Section 1.10 is not useful for establishing irreparable harm.

Judge Newman in dissent argued that there was no accelerating event and thus Mylan breached the Agreement, entitling Takeda to a preliminary injunction.

Axles are Still Abstract Ideas

In American Axle & Manufacturing, Inc., v. Neapco Holdings LLC, [2018-1763] (July 31, 2020), the Federal Circuit modified and reissued its October 3, 2019 opinion. In American Axle & Manufacturing, Inc., v. Neapco Holdings LLC, [2018-1763] (July 31, 2020). On petition for rehearing en banc, the Federal Circuit denied rehearing en banc.  DYK, wrote a concurrence, joined by WALLACH and TARANTO.  CHEN, also wrote a concurrence, joined by WALLACH.  NEWMAN wrote a dissent, joined by MOORE, O’MALLEY, REYNA, and STOLL.  STOLL wrote a dissent, joined by NEWMAN, MOORE, O’MALLEY, and REYNA. O’MALLEY wrote a dissent joined by NEWMAN, MOORE, and STOLL. LOURIE, dissented without opinion.

Posted in 101