Posts Tagged: "dna"

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.

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.

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.

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.

Right now, behind the walls of the USPTO, there is a fiery interference battle occurring between two scientific teams over who created a groundbreaking, DNA altering technique first. The victor stands to receive incredible gains. In one corner is a team of scientists from UC Berkeley headed by biologist Jennifer Doudna from the University of California, Berkeley and microbiologist Emmanuelle Charpentier from Umeå University in Sweden and the Max Planck Institute for Infection Biology in Berlin. In the other, a group led by synthetic biologist Feng Zhang of the Broad Institute of the Massachusetts Institute of Technology and Harvard in Cambridge, Massachusetts.

This is as straightforward a certiorari candidate as any patent case can be. It is manifestly important: A host of judges and amici have stressed that the result below is untenable— invalidating previously irreproachable inventions and precipitating what Judge Lourie called “a crisis of patent law and medial innovation.” And this is the vehicle this Court needs to provide that clarification: Every opinion below agrees that this case tests Mayo’s uncertain limits by invalidating an otherwise plainly meritorious invention. Here, unlike Mayo, every intuition points towards patent-eligibility. And yet the Federal Circuit felt compelled by Mayo to condemn this meritorious patent—and, a fortiori, the patents underlying an entire, vital field of American healthcare innovation.

The law of patent eligibility is created by the nine least qualified people to make such a determination; the Justices of Supreme Court of the United States. The Supreme Court arbitrarily chooses which of its own prior decisions to follow and ignore, refuses to read and enforce the laws passed by Congress even when the statue is but a single sentence (as is 101), and they openly legislates from the bench by creating judicial exceptions to patent eligibility where no such statutory prerogative exists. If the Federal Circuit will not step up and do the right thing and limit the lawless Mayo decision, which instructs lower courts to ignore the patent statute and drive 100% of the analysis into 101, the U.S. will forfeit our lead in the biotechnology and medical device industries. That will be bad for the economy, but far worse for public health.

The USPTO has released its ‘Report on Confirmatory Genetic Diagnostic Testing,’ which was prepared to fulfill the requirements of §27 of the Leahy-Smith America Invents Act. The USPTO did make an interesting observation that has been reflected in its patent examining guidelines. The USPTO Report concludes that ‘it is unlikely that exclusive provision of a diagnostic test, whether for an original diagnosis or to confirm the original result, will be possible based on patenting and licensing behavior.’ This statement reinforces the USPTO’s prior broad interpretations of the Court’s findings in Mayo and Myriad. Of note is that in the USPTO Report, the USPTO adopts the Supreme Court’s factually and scientifically unsupported distinction between genomic DNA and cDNA.

The USPTO continues to issue patents related to biotechnology and organic chemistry inventions despite the Supreme Court rulings and USPTO guidelines implementing the ruling related to the scope of patentable subject matter. Although the sky has not fallen, applicants must expect more rejections under 35 U.S.C. § 101 and must budget for more office actions before receiving an allowance from TC 1600. Furthermore, applicants can expect these challenges in several art unit groups, particularly in art unit group 1630. As a matter of strategy, if a rapid allowance is sought, applicants should carefully draft applications and claims to comply with the Interim Guidelines and utilize options to speed prosecution. Because of the uncertainty in the relevant case law and its rapidly evolving nature, applicants should consider whether to appeal intractable rejections under § 101. Further analysis is necessary to determine whether appeals of rejections under § 101 by TC 1600 are successful.

There are certainly some signs for hope. One of them came recently from Princeton University, where graduate students worked on a project which identified a treatment for blocking an enzyme which is important for metastasis, or the spread of cancer through a patient’s body. Many methods of treating cancers can be incredibly damaging to a patient’s body. Today there are many cancer treatments that are developed with an eye towards minimizing the difficult side effects caused by a regimen of chemotherapy or radiation.

There have been signs that Samsung is trying to wind down its operations in its medical device businesses, but we found plenty of patent applications filed with the USPTO indicating that healthcare innovation is still very important to this corporation. A technique for the genetic analysis of human subjects to test for diagnosing certain leukemias is featured by U.S. Patent Application No. 20150038360, titled Method for Multiplex-Detecting Chronic Myelogenous Leukemia Gene Using Cleavable Probe. The kit for detecting an e19a2 breakpoint of a BCR-ABL fusion gene claimed here contains five primer sets, each having a primer comprised of a specific nucleic acid. This kit provides for the early detection of chronic myelogenous leukemia, or CML, including rarer varieties of the disease.