Indefiniteness: Bad Translation/Lack of Definition Redux

Attorney: Daniel J. Pereira, Ph.D.
April 15, 2021

            I previously wrote about a Federal Circuit Opinion that affirmed a lower court ruling that the term “half-liquid” was indefinite despite the apparent mis-translation of the original Italian term “semiliquido” https://www.lifesciencesipblog.com/indefiniteness-bad-translation-lack-of-definition-or-both. On March 1, 2021, the losing party (IBSA Institut Biochimique, S.A., Altergon, S.A., IBSA Pharma Inc.) filed a petition for writ of certiorari in the U.S. Supreme Court and so I thought it would be interesting to take another look at this case. Indeed, the petitioner presented a novel question for review of the lower courts’ decision of indefiniteness of the term at issue. The question presented in the petition is:<... Read more

Two-Step Eligibility for Genomic Analysis Systems

Attorney: Daniel J. Pereira, Ph.D.
February 4, 2021

For practitioners at the USPTO, the reversal of a 101 rejection in Ex parte Patil (PTAB January 7, 2021), APJs Grimes, Scneider and Valek, in Appeal 2020-002775 should be interesting if not provide some light on the dance floor for doing the two-step with the USPTO.

The invention focused on assessing genetic variability with a system including databases and processors and as recited in Claim 27 U.S. 15/169,498:<... Read more

What is "About" All About?

Attorney: Daniel J. Pereira, Ph.D.
December 4, 2020

The meaning and scope of the term “about,” which was used to modify numerical ranges in patent claims was a central issue in Par Pharmaceutical, Inv v. Hospira (Fed. Cir. November 23, 2020). The two patents at issue (U.S. Patent Nos. 9,119,876 and 9,295,657) pertain to Par’s Adrenalin® products and methods using epinephrine and the case arose from Hospira’s ANDA to make and market the generic of Par’s product, which as one might expect caused Par to file suit against Hospira for patent infringement under 35 USC 271(e).<... 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

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

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

The Federal Circuit Provides a Refresher on Joint Inventorship

Attorney: Daniel J. Pereira, Ph.D.
July 28, 2020

The decision in Dana-Farber Cancer Institute, Inc. v. Ono Pharmaceuticals Co., Ltd, Tasuku Honjo, E.R. Squibb & Sons, L.L.C., Bristol-Myers Squibb Company (Fed. Cir., July 14, 2020) was an appeal of a determination of joint inventorship from the United States District Court for the District of Massachusetts.... Read more

USPTO Launches "IP Marketplace" Related to COVID-19

Attorney: Daniel J. Pereira, Ph.D.
May 6, 2020

The USPTO created a web-based platform that identifies patents that may be useful in the creation of technologies to combat the coronavirus/COVID-19 disease (https://developer.uspto.gov/ipmarketplace/search/patents). The website lists various patents and patent publications, seven pages with about 24 per page, that include links to the patents or publications, Issue/Publication dates and other bibliographic information. There is also a column indicating if Licensing is available for the patents/patent applications listed. The patents and applications listed have been apparently asked by the patentee/patent applicant to be included (from the tab “About the Platform):<... Read more

The Flip Side of Reasonable Expectation of Success is Unpredictability

Attorney: Daniel J. Pereira, Ph.D.
October 11, 2019

The Federal Circuit in a precedential opinion in Osai Pharmaceuticals, LLC v Apotex et al (Fed. Cir., October 4, 2019) reversed the USPTO's determination of obviousness in an IPR for patent claims directed to the treatment of non-small cell lung cancer (NSCLC). Just reading the background of the first three or four pages of the decision, it was already apparent that the Court was not going to be affirming the PTAB's decision. Notably:... Read more

Non-Limiting Clauses and Written Description Based on Substantially Equivalent Disclosure

Attorney: Daniel J. Pereira, Ph.D.
August 16, 2019

Nalpropion Pharmaceuticals, Inc. v Actavis Laboratories FL, Inc (Fed. Cir. Aug. 15, 2019) is a precedential opinion written by Judge Lourie with Judge Wallach and a dissent from Judge Prost in a case centered on an ANDA litigation in which Actavis sought approval for their generic version to Nalpropion's patents for the Contrave® product. Footnote 1 in the opinion outlines the rather complex history of the ownership/license interests as they changed over time.... Read more