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Senator Orrin Hatch (R-UT), Chairman of the Senate Republican High-Tech Task Force and Former Chairman of the Senate Judiciary Committee, recently wrote an op-ed article on patent reform. Hatch has made significant contributions to the law, including defining generic drug regulation via the Drug Price Competition and Patent Term Restoration Act, or Hatch-Waxman Act, as well as contributing to the America Invents Act (AIA).

Antibiotic resistance is a major problem in the United States and is considered by the World Health Organization (WHO) to be one of the largest threats to human health. The top 12 bacterial threats classified by WHO are shown in Table 21. Researchers are going so far as to send antibiotic resistant bacteria into space in order to determine how the bacteria mutate, with the thought being that in space, bacteria will mutate at an accelerated rate, making it easier to study bacterial resistance patterns and, therefore, develop better antibiotics that are active against resistant bacterial forms.

Although the focus of most of our pieces has been on U.S. patent law, there is occasion to report on developments of note from abroad.  One such patent case decided last month in Great Britain deserves our attention.  On July 12th, the United Kingdom Supreme Court (UKSC) redefined patent infringement laws as related to infringement by equivalents, i.e. under what we know here in the U.S. as the “Doctrine of Equivalents”.  To elaborate, under this doctrine, a party can be found liable for patent infringement even though the accused item or process does not fall within the literal scope of a patent claim.  The current legal test in the U.S. determines whether the difference between the accused item or process and the patent claim is “insubstantial” so that it is equivalent to an invention falling within the scope of the claim.  See Warner-Jenkinson Co. v. Hilton Davis Chem. Co. (1997).  Although well established in the U.S., the doctrine has been anathema under U.K. law.

In April, the Supreme Court heard oral arguments from Amgen and Sandoz (the generic manufacturing arm of Novartis) regarding interpretation of the Biologics Price Competition and Innovation Act (BPCIA), which establishes an alternate pathway for FDA approval of biologics. See Sandoz Inc. v. Amgen Inc. (No. 15-1039, 15-1195). Two key issues were raised: whether a biosimilar manufacturer is (1) required to provide manufacturing information from their abbreviated biologics license application (aBLA) to the manufacturer of the original reference biologic (i.e., the reference product sponsor, or RPS) and (2) whether the biosimilar manufacturer can give the 180-day notice of intent to market the biosimilar (known as the Notice-of-Commercial Marketing) to the RPS prior to receiving FDA approval. The second question is perhaps the more interesting and financially important. If notice cannot be given prior to FDA approval, the RPS can potentially benefit from an additional period of market exclusivity because the generic would essentially not be able to market their product until 180 days after FDA approval.

Late last month, the Supreme Court decided an interesting case at the very cusp of what constitutes a copyright-eligible design as opposed to an ineligible article of manufacture. See Star Athletica, LLC v. Varsity Brands, Inc. (No. 15-866). In 2010, the cheerleading clothing outfit behemoth Varsity Brands claimed that a competitor, Star Athletica, copied several of its cheerleading outfit designs (e.g., chevrons, stripes, etc.) and sued Star for copyright infringement under 17 U.S.C. §101 of The Copyright Act of 1976. The Act mandates that “the design of a useful article” is eligible for copyright if “such design incorporates pictorial, graphic, or sculptural features that can be identified separately from, and are capable of existing independently of, the utilitarian aspects of the article.”1 This aspect of the Act is commonly referred to as the “separate – identification and independent – existence” requirement or, put simply, the “Separability Test”. Varsity argued that since cheerleading uniforms (“the useful article”) could either contain or lack superficial designs, the designs themselves are in fact separate graphic works that make uniforms unique and are therefore subject to copyright protection. Counter to this position, Star claimed that the designs on a cheerleading uniform are inherent to the uniform and are not stand-alone, separate design elements.

Over the past two years, we have been reviewing and reporting on technology and IP issues related to the emerging field of microbiome research. In this latest piece, we have taken a somewhat different approach, in focusing on the difficult clinical challenges faced by one of the key players in this area and the path forward they have announced to overcome these challenges.

Last month, The United States Chamber of Commerce (USCC) released the 5th Edition of the International IP Index, entitled “The Roots of Innovation”. The Index, which posts on the USCC’s Global Intellectual Property Center (GIPC) website, was established to highlight the importance of intellectual property (IP) in catalyzing economic growth and development, as well as to cultivate healthy competition between nations. In the current Edition, David Hirschmann, President and CEO of the USCC GIPC, likens IP to a tree. “Just as a tree cannot grow without roots, innovation cannot thrive without intellectual property.” At the most basic level, IP leads to job creation (statistics can be found here on the GIPC website). On a larger scale, IP promotes cross talk and collaboration between multidisciplinary fields, such as medicine, science, and finance.

Given that the majority of the human microbiome is found in the gut, it is not surprising that most microbiome-based therapeutic approaches have been used to treat gastrointestinal disorders, such as inflammatory bowel disease (IBD) and Clostridium difficile infections. However, growing evidence suggests that targeting the microbiome can have broader therapeutic implications, demonstrating the ever-evolving nature of the microbiome field. Specifically, microbiome modulators could be used to either enhance or suppress the immune response and would thus be considered immunotherapy. Part VIII of this Series reviewed how altering the microbiome could be used in combination with checkpoint blockade. As a continuation to Part VIII, this article will explore how microbiome modulators could be used as single agent immunotherapy to treat autoimmune disease, inflammatory disease, and cancer. Bolded patent documents are further summarized in the table at the end of this ins

Cancer immunotherapy or immuno-oncology (I-O) has gone mainstream. You may have heard about these topics in the media. Along with having surgery and radiation therapy, Former President Jimmy Carter was treated with the monoclonal antibody pembrolizumab (Keytruda®) that stimulated his immune system to fend or fight off melanoma that had metastasized to his brain. His remarkable response has highlighted the power of immunotherapy. After his son Beau succumbed to brain cancer, Vice President Joe Biden helped spearhead the Cancer Moonshot, a national initiative to cure cancer, one of the main goals of which is furthering immunotherapy research. The White House has dedicated $1 Billion to this initiative. This article will introduce you to immunotherapy and how it is now beginning to intersect with the microbiome. Recent patent filings suggest that intellectual property protection will be an important part of the research efforts in this field. Bolded patent documents are further summarized in the table at the end of this installment.