Posts Tagged: "roche"

CAFC Orders New Damages Trial for Roche, Clarifies Standard for Patent Damages Limitations Period

On April 8, in a mixed and split precedential decision, the U.S. Court of Appeals for the Federal Circuit (CAFC) affirmed, reversed, vacated, and remanded a decision by the U.S. District Court for the district of Delaware in a patent infringement suit brought by Meso Scale Diagnostics (Meso) against Roche Diagnostic Corporation and BioVeris Corporation (collectively Roche). Judge Pauline Newman dissented. Meso brought suit claiming that Roche violated exclusive license rights belonging to Meso by both direct and induced infringement of their patents. The CAFC affirmed the district court’s findings on the direct infringement claim, reversed the induced infringement finding, vacated the awarded damages, and remanded for a new trial on damages.

Federal Circuit Upholds Patent for Biologic Drug Enbrel; Judge Reyna Dissents

On July 1, the U.S. Court of Appeals for the Federal Circuit (CAFC) affirmed a holding of the U.S. District Court for the District of New Jersey in Immunex Corporation, Amgen Manufacturing, Limited, Hoffman-La Roche Inc. v. Sandoz, Inc., Sandoz International GMBH, Sandoz GMBH, holding that Sandoz failed to prove that the asserted claims were invalid for obviousness-type double patenting (ODP), failure to meet the written description requirement, and obviousness for lack of motivation to combine the prior art references. The ruling for now blocks Sandoz from marketing its biosimilar version (Erelzi) of the popular rheumatoid arthritis drug, Enbrel. Judge Reyna dissented, arguing that certain clauses of the licensing agreement were illusory, thereby rendering the agreement an effective assignment for purposes of ODP.

CAFC Holds Sequenom’s Prenatal DNA Patent Claims Eligible Under 101

The U.S. Court of Appeals for the Federal Circuit (CAFC) has reversed a district court decision finding certain claims of two patents covering prenatal DNA testing patent ineligible. The CAFC held that “the claimed methods utilize the natural phenomenon that the inventors discovered by employing physical process steps” and thus were patent-eligible. The patents at issue in the case acknowledge but are not related to the patented invention held invalid in Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, 1373 (Fed. Cir. 2015). The opinion was authored by Judge Lourie, with Judge Reyna dissenting.

Post-Myriad Legal and Policy Considerations for Patenting Genetic Inventions

The U.S. Supreme Court’s 2013 ruling in Association for Molecular Pathology v. Myriad Genetics changed the landscape of what is considered patentable material in the context of genetic inventions. In the five years since Myriad, companies have pushed the boundaries of patenting certain types of genetic materials. Despite Myriad’s express statement that it was not considering “the patentability of DNA in which the order of the naturally occurring nucleotides has been altered,” the courts have not yet established the contours of how much nucleotide sequences need to be altered in order to “create something new” in order to be patentable. However, as we discuss in the next section, we expect the Court to address these questions as biotechnology companies increasingly invest resources into emerging, expensive technologies involving genes and seek to protect their investments through patents.

The CRISPR Tug of War

The University of California (“UC”) and The Broad Institute, Inc. (“Broad”) are among the leaders in the development of CRISPR technology.  Both UC and Broad filed patent applications for claims broadly drawn to CRISPR-Cas9 systems and methods of DNA editing.  These parties are currently engaged in litigation over patents concerning the potentially most lucrative application of CRISPR technology – the use of CRISPR-Cas9 in plant and animal (eukaryotic) cells.  The outcome of this litigation will affect control of the CRISPR platform and development of the technology.

Present Assignment of Future Invention Rights: Some Heretical Thoughts on the Stanford Case*

One of the critical issues in the Stanford case that is glossed over (or at least not addressed directly) by the Supreme Court majority (as well as others in the patent “blogosphere”) is what happens when you have a present assignment (or at least a contractual obligation to assign) of invention rights that don’t exist at the time of the assignment (aka “future invention rights”). Should (as the Federal Circuit held) Roche (or more appropriately its predecessor, Cetus) by using the language “I will assign and do hereby assign” (aka the “Cetus Assignment Clause”) trump what may have been an earlier obligation by a Stanford University researcher (Mark Holodniy) to assign invention rights to Stanford University (aka the “Stanford University Assignment Obligation”)? I would argue, as did Justice Sotomayor’s concurring opinion and Justice Breyer’s dissenting opinion (joined by Justice Ginsburg) that a “yes” answer to that question defies logic, reason, and prior case precedent (other than the Federal Circuit’s 1991 case of FilmTec Corp. v. Allied Signal, Inc. whose logic, reasoning, and adherence to prior case precedent was challenged by both Justice Sotomayor’s concurring opinion, as well as Justice Breyer’s dissenting opinion).

After Stanford v. Roche: Bayh-Dole Still Stands

Finally, we believe that in the interest of fairness a word about the person who has his name attached to this case – Dr. Mark Holodniy—is required. Rather than being a rogue inventor, or a naïve academic wandering around signing invention rights away, another portrait emerges from this case. Dr. Holodniy did exactly what he was asked to do by his employer through instructions from his superior. He dutifully signed an agreement giving Stanford rights to his inventions, and agreed to go to Cetus as he was requested to do. At Cetus he complied with their policies.

Did the Supreme Court Rule First to File is Unconstitutional?

The ink is hardly dry on the Supreme Court decision in Stanford v. Roche and already those who oppose patent reform are concocting one of the most ridiculous arguments I have ever seen to oppose first to file provisions. There are some, including at least one Member of Congress, that have started saying that the Supreme Court’s decision in Stanford v. Roche makes it clear that the first to file provisions of patent reform are unconstitutional. Just sit right back and allow me to explain to you exactly why that is perhaps the most specious argument I have ever heard.

Supreme Court Affirms CAFC in Stanford v. Roche on Bayh-Dole

At issue in the case, essentially, was whether the extraordinarily successful Bayh-Dole legislation (enacted in 1980) automatically vested ownership of patent rights in Universities when the underlying research was federally funded. In a blow to the convention wisdom of Supreme Court patent-watchers, the Supreme Court actually affirmed the United States Court of Appeals for the Federal Circuit. Unlike some recent decisions where the result of the Federal Circuit was affirmed but a wholly new test announced, the Supreme Court simply concluded: “The judgment of the Court of Appeals for the Federal Circuit is affirmed.” Perhaps even more surprising, the Supreme Court seems to have objectively reached the correct conclusion.

Stanford v. Roche: An Academic/Industry Collaboration Gone Wrong

This morning the first panel discussion is focusing on Stanford v. Roche, titled Who’s Rights Are They Anyway? The first speaker, Maggie Shafmaster, Ph.D., Vice President and Chief Patent Counsel, Genzyme Corporation, lead off by pointing out something that everyone largely seems to agree with, namely that the facts of the case are still largely in dispute, which makes me wonder why would the Supreme Court take such a case. Be that as it may, Shafmaster went on to say that this case is one that makes in-house attorneys and those representing Universities lay awake at night. She characterized the case as “an academic/industry collaboration gone wrong.” And we are off to the races!