Must a "Human Antibody" Be Entirely Human? Or May It Also Be "Partially Human?"

Attorney: Marina I. Miller, Ph.D.
October 16, 2020

This is a consolidated appeal from two Patent Trial and Appeal Board (“Board”) decisions in inter partes reviews (“IPRs”) of U.S. Patent 8,679,487 (“the ’487 patent”), owned by Immunex Corp. (“Immunex”). Sanofi-Aventis U.S. LLC, Genzyme Corp., and Regeneron Pharmaceuti-cals, Inc. (“Sanofi”) challenged the ’487 patent. The Board invalidated all challenged claims in IPR 2017-01884. Immunex appealed, contesting the construction of the claim term “human antibodies.” The Court of Appeals for the Federal Circuit (“the Court”) agreed with the Board’s claim construction and affirmed the invalidity decision.<... Read more

Safe Harbor (35 U.S.C. 271(e)(1)) and Medical Devices

Attorney: Richard D. Kelly
October 13, 2020

In two decisions this year district courts have addressed the “safe harbor” provision of 35 U.S.C. § 271(e)(1) in motions to dismiss a patent infringement count. The first involved the display of artificial heart valves by Meril Life Sciences Pvt. Ltd. (Meril) at the 2019 Transcatheter Cardiovascular Therapeutics Conference (“TCT Conference”) in San Francisco, California. Edwards Life Sciences Corporation (Edwards) asserted that the display infringed its 5 patents on the displayed valves under §§ 271(a) and (g) by importing the valves made using its patented process. Meril defended by asserting that such display was protected by the safe harbor provision. The facts were not favorable. First, Meril did not have a marketing application pending with the FDA. While a pending application is unnecessary there must be evidence that the acts were calculated to lead to the possible submission of such evidence. See Merck KGaA v. Integra Lifesciences I, Ltd., 545 U.S. 193, 202 (2005).    Alternatively, the activity was at least in part to attract clinical investigators for FDA trails. See Telectronics Pacing Systems, Inc. v. Ventritex, Inc., 982 F.2d 1520, 1523 (Fed. Cir. 1992). There was no evidence that defendants  recruited or could have recruited investigators for studies that could be submitted to the FDA. Edwards asserted that Meril’s sole objective was to promote sales in Europe. Thus, Teletronics was deemed irrelevant.<... Read more

GSK vs. Teva: Induced Infringement, Skinny Labels and Fat Damages

Attorney: Jeffrey B. McIntyre
October 6, 2020

Last week, in GlaxoSmithKline (GSK) v. Teva, the Federal Circuit reversed the district court's granting of judgment as a matter of law (JMOL) of no induced infringement by Teva. The JMOL had reversed a jury verdict finding of induced infringement by Teva. The Federal Circuit also sustained the jury's award of $234 million to GSK.... Read more

When are Recombinant Proteins Structurally Different Than Their Natural Counterparts?

Attorney: Daniel J. Pereira, Ph.D.
September 29, 2020

The answer to this question was central to the remand for a new trial on a judgement as a matter of law (JMOL) decision from the District Court overturning the jury verdict of anticipation in the Federal Circuit’s September 28, 2020 decision in Biogen MA Inc. v EMD Serono, Inv. Pfizer Inc. See http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/19-1133.OPINION.9-28-2020_1659873.pdf.<... Read more

The USPTO Strikes Again: More First Action Final Rejections = More Money + Diminished Quality

Attorney: Vincent K. Shier, Ph.D.
September 17, 2020

While looking at a first action final rejection after an RCE that I received this week from an Examiner that I respect, I was asking myself why I had received what appeared to be such a shockingly improper action. The answer was provided to me during part of the on-going IPO annual meeting.... Read more

USPTO Launches National Council for Expanding American Innovation

Attorney: Daniel J. Pereira, Ph.D.
September 16, 2020

On Monday, September 14, 2020, the USPTO issued a press release announcing the launch of "a major initiative aimed at expanding invention, innovation, and entrepreneurship in the United States." As the USPTO describes, the initiative stems from recommendations to facilitate women and minority participation in innovation and invention because the USPTO's own 2018 "Success Act" study found that both women and minorities were underrepresented in patents as inventors.... Read more

Invalidity Based on Enablement: McRO, Inc. dba Planet Blue v. Bandai Namco Games America Inc., et al., No. 2019-1577 (Fed. Cir. May 20, 2020)

Attorney: Marina I. Miller, Ph.D.
September 1, 2020

McRO, Inc. (“McRO”) filed a lawsuit against multiple video game developers (“the Developers”), alleging that the Developers infringed three method claims of U.S. Patent No. 6,611,278 (“the ‘278 patent”), owned by McRO. The district court held the claims invalid for ineligibility under 35 U.S.C. § 101, but the Federal Circuit (“the Court”) reversed that holding in McRO, Inc. v. Bandai Namco Games America Inc., 837 F.3d 1299 (Fed. Cir. 2016) (McRO I). On remand, the district court held that the Developers were entitled to summary judgment of non-infringement, because the accused products do not practice the claimed methods and to summary judgment of invalidity because the specification fails to enable the full scope of the claims. McRO appealed.<... Read more

Indefiniteness: Bad Translation, Lack of Definition or Both?

Attorney: Daniel J. Pereira, Ph.D.
August 17, 2020

The Federal Circuit affirms the lower court ruling that “half-liquid” translated from the original Italian “semiliquido” is indefinite in IBSA Institut Biochimique, S.A., Altergon, S.A., IBSA Pharma Inc. v. Teva Pharmaceuticals USA, Inc. (Fed. Cir. July 31, 2020). http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/19-2400.OPINION.7-31-2020_1628842.pdf<... Read more

RCE/National Stage Kerfuffle: PTO Creates a Nightmare Scenario

Attorney: Vincent K. Shier, Ph.D.
August 6, 2020

Much has been written lately about the USPTO's recent enforcement of its controversial interpretation of filing Requests for Continued Examination (RCE) in National Stage applications (i.e., applications under 35 U.S.C. ยง371) where the oath/declaration was not filed prior to filing the RCE. This post will not address the legal merits of the USPTO's position.... Read more

A Diagnostic Patent Is Found Patent Eligible At the Federal Circuit

Attorney: Richard D. Kelly
August 4, 2020

In March the Federal Circuit reversed a lower court decision finding Illumina’s patents (U.S.Ps. 9,580,751 and 9,738,931) for diagnosing Down’s Syndrome to be patent ineligible, 952 F.3d 1367 (Fed. Cir. 2020). On August 3, the Federal Circuit denied a petition for rehearing and rehearing enbanc but did issue a new decision adding the term “human-engineered” in several portions of the opinion discussing the separation of fetal DNA from maternal DNA which the inventors had discovered were of different sizes, fetal cell DNA is shorter than the maternal DNA. The inventors recognized that the DNA to be analyzed for genetic aberrations was that of the fetus. The problem was to isolate the small amount of fetal DNA from the maternal DNA so the fetal DNA could be analyzed for genetic aberrations. Prior to the invention there was no known way to distinguish and separate maternal DNA from the tiny fraction of fetal DNA present. The inventors found that by selectively removing DNA having more than 500 or 300 base pairs they could produce a sample where the fetal DNA content in the sample would be enriched and analyzed. The following claim is exemplary:<... Read more