PATENT CASE OF THE WEEK 

Mark A. Barry v. Medtronic, Inc., Appeal No. 2017-2463 (Fed. Cir. Jan. 24, 2019)

On Thursday, the Federal Circuit issued a significant decision affirming the district court’s rulings related to the public-use and on-sale statutory bars, including what it means to be “ready for patenting,” and the experimental use exception. 

The patents at issue concerned treatments for scoliosis, and concerned the use of a tool that Dr. Barry invented that manipulates vertebrae with screws.  After inventing the tool, Dr. Barry had used his method in three surgeries in August 2003.  He then saw the patients for follow-up visits between August 2003 and January 2004.

Dr. Barry filed his patent application on December 30, 2004, resulting in a critical use date of December 30, 2003 for pre-AIA 35 U.S.C. § 102(b) purposes.  Defendant Medtronic alleged that the August 2003 surgeries rendered the patent invalid under Section 102(b) both as prior public uses and prior “sales” of the inventions.  A jury found the patents valid and awarded Dr. Barry damages.  The district court denied Medtronic’s motion for judgment as a matter of law that the patents were invalid under Section 102(b).  Medtronic appealed.

No Public Use

The Federal Circuit affirmed.  Under the Supreme Court’s decision in Pfaff v. Wells Elecs., Inc., 525 U.S. 55 (1998) and subsequent Federal Circuit decisions, the public use and on sale bars of Section 102(b) only apply where the invention is “ready for patenting.”  That requires a finding that the invention (in this case, a method) was reduced to practice, which means that the method was both performed and “shown or known to work for its intended purpose.”  The Court first addressed whether Dr. Barry’s invention was “ready for patenting” prior to December 2003, and concluded that the jury’s verdict was supported.  In summary, it held that “there is substantial evidence that Dr. Barry’s invention was not ready for patenting” because the final follow-up appointments with the patients were “reasonably needed for the determination that the invention worked for its intended purpose.”

Importantly, the Court rejected the argument that only a single surgery was needed to determine whether the invention worked for its intended purpose based on the language in the patent claims.  The Court offered an extended discussion of how to determine the “intended purpose” of an invention.  Analyzing numerous cases dating back nearly a century, the Court held that “[t]he ‘intended purpose’ need not be stated in claim limitations that define the claim scope.”  Rather, it can come from the specification.  In this case, Dr. Barry was addressing three types of scoliosis, and three separate surgeries were required to ensure that the invention worked for the intended purpose of addressing each type of scoliosis, and follow-up visits were required for ensuring that the surgery was effective for each.

Second, the Court held that the invention was not “in public use.”  Contrasting the case with the famous Supreme Court corset case, Egbert v. Lippmann, 104 U.S. 333 (1881), the Court pointed to evidence showing that very few people in the operating room had a clear view of the surgical field where Dr. Barry was using his invention, and those in the operating room were under an implied duty of confidentiality covering at least the tools and techniques used.

Experimental Use

Following its discussion of public use in general, the Court provided a lengthy discussion concerning the experimental use exception.  The Court considered factors such as: (1) Dr. Barry was not sure that the device would work on different types of scoliosis; (2) the technique is not why he attracted the patients; (3) he was the only one to perform the method using his device; and (4) he did not surrender control of the invention before the critical date.  The Court noted, “In the context of this medical patent, as we have discussed, it is reasonable, to truly determine whether a method works, to engage in such testing for a brief time on a small but representative range of expected circumstances of use and to rely on follow-up.”  The Court also distinguished Sinskey v. Pharmacia Ophthalmics, Inc., 982 F.2d 494 (Fed. Cir. 1992), in which experimental use was not found because the doctor charged his normal fee and did not inform his patients about the experiment.  In this case, the Court found that those involved understood that the surgery was experimental, and that, unlike in Sinskey, Dr. Barry did not surrender control of the invention when he performed his surgeries.

On Sale Bar

With respect to the on sale bar, Medtronic further challenged a jury instruction that said that “there is a difference between ‘experimental use’ in the context of patent law and the way that the word ‘experiment’ is used in the context of medicine.”  The Federal Circuit rejected Medtronic’s argument, holding that this instruction was appropriate given the context of the case.

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In other parts of the opinion, the Court affirmed that there was no inequitable conduct and that Medtronic was liable for induced infringement.  The induced infringement issue largely rested on the reliability of survey evidence.  The Court also affirmed the jury’s damages awards.

In a dissenting opinion, Chief Judge Prost concluded that Dr. Barry’s performance of the surgical method on three different patients, charging each his normal fee, was prima facie “on sale” or in “public use.” Citing Pfaff, Judge Prost determined that the invention was the “subject of a commercial offer for sale” and it was “ready for patenting.”  In particular, Judge Prost noted that Dr. Barry appreciated that his invention worked for its intended purpose no later than the second surgery’s completion—thus reducing the invention to practice. And even if the invention was not reduced to practice, it was, at minimum, ready for patenting.

The opinion can be found here.

ALSO THIS WEEK 

Supernus Pharmaceuticals, Inc. v. Andre Iancu., Appeal No. 2017-1357 (Fed. Cir. Jan. 23, 2019)

In an appeal from the United States District Court for the Eastern District of Virginia, the Federal Circuit determined that the USPTO exceeded its statutory authority when issuing a reduction in patent term adjustment (PTA) for a drug patent based on unavoidable delay.  The question before the Court was whether the USPTO may reduce PTA by a period that exceeds the “time during which the applicant failed to engage in reasonable efforts to conclude prosecution.” 35 U.S.C. § 154(b)(2)(C)(i). The Federal Circuit agreed with Supernus that there were no efforts that it could have taken during the vast majority of the delay. As such, the USPTO’s assessment was contrary to the plain meaning of the statute because the total reduction was not equal to a period of time during which Supernus failed to engage in reasonable efforts to conclude prosecution. As such, the Federal Circuit reversed the District Court’s final judgment.

The opinion can be found here.

Princeton Digital Image Corp. v. Office Depot Inc., Appeal No. 2017-2597 (Fed. Circ. Jan. 22, 2019)

In this appeal from a final judgment entered in the U.S. District Court for the District of Delaware, the Federal Circuit addressed the issue of jurisdiction under 28 U.S.C. § 1295.  Princeton Digital had sued Adobe for patent infringement, but Adobe showed that the case was baseless.  Adobe sought damages from the baseless lawsuit.  But the district court substantially limited Adobe’s request for damages prior to trial, rendering further litigation possibly financially unreasonable.  To accelerate the district court’s damage-limiting decision toward appeal, Adobe had requested that final judgment be entered because it claimed it had no damages to present.  The Federal Circuit reversed, holding that the “final judgment” entered in the district court lacked the finality required by the Federal Rules to warrant appellate jurisdiction.  Likening the district court’s damages ruling to a claim construction order that does not resolve the issue of infringement, the Court found that because Adobe could have proceeded to trial on one of its claims, there was no final decision on the merits, even though Adobe “persuade[d] [the] district court to issue an order purporting to end the litigation.”

The opinion can be found here.