Posts Tagged: "dna"

PTAB Declares New Patent Interference Proceedings in CRISPR-Cas9 Gene Editing Battle

On Tuesday, June 24, the Patent Trial and Appeal Board (PTAB) declared an interference proceeding  between a collection of entities that are on opposing sides in the race to commercialize CRISPR-Cas9 genomic editing technologies. The patent interference will decide if inventors from the Regents of the University of California, the University of Vienna and the Umea University of Sweden were the first to invent certain methods for gene editing in eukaryotic cells, or plant and animal cells, that are covered by patent claims which have been issued to the Broad Institute, the Massachusetts Institute of Technology (MIT) and Harvard College. The patent interference involves 10 patent applications that have been filed by the University of California group and 13 patents that have been filed by the Broad Institute group. These two groups have been facing off in a series of legal battles regarding which side can properly claim to be the rightful inventor of perhaps the world’s most widely applicable gene editing technology useful for treating diseases, improving life science research and increasing the rate of biotechnology innovations.

Two Observations on Last Week’s Senate Hearings on Patent Eligibility Reform

Last week, all eyes were on the first two days of historic Senate Judiciary IP Subcommittee Hearings, led by Senator Thom Tillis (R-NC), Chair of the Subcommittee, and Senator Chris Coons (D-DE), Ranking Member of the Subcommittee. The purpose of the hearing was simple: to determine a fix for the disaster foisted upon the industry by the patent eligibility jurisprudence of the Supreme Court of the United States. The testimony of the first 30 witnesses has already been summarized, so there is no need for me to dive into the particulars of who said what here. Suffice it to say that the Subcommittee heard a range of opinions—some better supported than others.

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.

Universities: Fallen Angels or Stewards of Bayh-Dole?

University discoveries are recognized as critical national assets because Bayh-Dole gave academic institutions the ability to own and manage inventions made with federal funding. The law helped lift the economy out of the doldrums of the 1970’s, re-establishing America’s leadership in every field of technology…. While the critics argue that Cohen-Boyer would have had the same impact without patent protection, there are other more likely scenarios. It could have languished on the shelf as did many other published, but not patented, discoveries. It took a lot of work from Reimers before U.S. companies recognized its potential. That effort would not have been made to promote a scientific paper.

No Bridge Over the Troubled Waters of Section 101

The waters surrounding Section 101 of the Patent Act are as muddied as they come. The statute sets forth only in broad strokes what inventions are patentable, leaving it to the courts to create an implied exception to patentability for laws of nature, natural phenomena, and abstract ideas. It has been difficult for lower courts to determine whether an invention falls within one of these excluded categories, and the U.S. Supreme Court has refused to provide a definition of what constitutes an “abstract idea.” Nonetheless, the Court in recent years has laid several foundation stones in Bilski, Mayo, Myriad and Alice for a bridge over these troubled waters. Trying to build upon these, the Federal Circuit issued two recent opinions dealing with Section 101: Enfish, LLC v. Microsoft Corporation and In re: TLI Communications LLC Patent Litigation. However, these decisions only create more confusion and cannot provide a safe means of passage over the turbulent waters of patent eligibility.