1. U.S. Tops Leaderboard on Chamber of Commerce 2018 IP Index – Slips to #13 in Patent Protection

    Posted on 20.02.18 David Puleo, on Articles, Patent Trends & Activity, Recent News & Articles

    The United States Chamber of Commerce (USCC) released the 6th Edition of the International IP Index on its Global Intellectual Property Center (GIPC) website last week.  The Index highlights the importance of establishing a strong intellectual property infrastructure to catalyze economic growth, development, and innovation.

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  2. Does It Still Cost $2.7B to Develop a Drug? Regardless, Patent Protection is Key!

    Posted on 23.01.18 David Puleo, on Articles, Biotech/Pharma

    We have previously reported that the cost to develop a new drug is roughly $2.7B (inflation adjusted).  This price tag was determined by the Tufts Center for the Study of Drug Development (CSDD).  However, a new study published in JAMA Internal Medicine calls this number into question.  The disparity in drug development cost estimates between the CSDD and other groups prompted the JAMA authors to conduct their own study.  For instance, the independent group Public Citizen estimated the cost to be around $320M (inflation adjusted).  Unlike other estimates, the JAMA study places the cost of developing a new cancer drug to be around $648M.  The authors go into further detail to compare and contrast the metrics and methods by which other groups have calculated drug costs.  Whereas the CSDD study used private information from ten large pharmaceutical companies, the Public Citizen study used publicly available Securities and Exchange Commission filings.  Both analyses looked at companies with multiple drugs on the market.  However, the JAMA study focused on ten companies that each only developed a single drug, which, the authors argue, yields a more “transparent” analysis.

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  3. Federal Circuit Further Clarifies Inventive Concept Under The Two-Part Mayo/Alice Test

    Posted on 12.12.17 David Puleo, on Articles, Patent Related Court Rulings, Recent News & Articles

    In Two-Way Media Ltd. v. Comcast Cable Communications, LLC, the Federal Circuit affirmed the decision of the District Court of Delaware that the Two-Way Media patents and claims were ineligible under 35 U.S.C. § 101.  See the Federal Circuit decision here.  Two-Way sued Comcast, alleging that Comcast violated U.S. Patent Nos. 5,778,187 (‘187); 5,983,005 (‘005); 6,434,622 (‘622); and 7,266,686 (‘686) relating to a “Multicasting method and apparatus”.  These patents are directed to a “scalable architecture … or delivery of real-time information over a communications network”.  This essentially refers to methods for streaming data over the internet to multiple users at a time.  The outcome of this case teaches important lessons on how and where to define inventive concept under the two-part Mayo/Alice test.

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  4. Berkeley Hatches a Plan for Patent Reform

    Posted on 08.11.17 David Puleo, on Patent Trends & Activity, Recent News & Articles

    The Berkeley Center for Law & Technology (BCLT) held a round table discussion workshop with opinion leaders from science, technology, and the law to discuss patent subject matter eligibility.  A Report on the workshop, which is quite extensive and contains a number of tables and charts, should be of interest to a wide audience.  This Report comes on the heels of Senator Orrin Hatch’s op-ed article that also called for reform of subject matter eligibility (reviewed by Dilworth IP here).  A number of recommendations, some of which are detailed below, were proposed by workshop participants to clarify subject matter eligibility as related to 35 U.S.C. § 101.  Of note, this workshop was further detailed in a blog piece on PatentlyO.

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  5. Patenting the Microbiome: Trends, Challenges and Insights

    Posted on 31.10.17 David Puleo, on Articles, Biotech/Pharma

    We may not realize it, but the human body is home to an astonishingly large number of microorganisms that live both in us and on us. This resident microbial population, which is estimated to number over 100 trillion microorganisms, is collectively known as the ‘microbiome’ or, more specifically, the ‘human microbiome’ [1].The microbiome can also refer to microbial communities in or on other living organisms such as our pets, livestock and food crops, as well as those external to us, for example, those found in the air, soil and sea, or those found in or on inanimate objects ranging from computer keyboards to office buildings

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  6. Senator Orrin Hatch Comments on Patent Reform

    Posted on 09.10.17 David Puleo, on Articles, News and Events, Patent Trends & Activity

    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).

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  7. The Emergent Microbiome: A Revolution for the Life Sciences – Part XIII, The Microbiome and Antibiotic Resistance

    Posted on 03.10.17 David Puleo, on Articles, Biotech/Pharma, The Emergent Microbiome Series

    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.

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  8. UK Supreme Court Redefines Patent Infringement

    Posted on 11.08.17 David Puleo, on Articles, Patent Related Court Rulings

    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.

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  9. Sandoz Wins Battle Over Biosimilars Against Amgen

    Posted on 20.07.17 David Puleo, on Articles, Biologics/biosimilars, Patent Related Court Rulings

    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.

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  10. Varsity Brands Prevails 6-2 Over Star Athletica In Battle Of The Uniforms

    Posted on 18.04.17 David Puleo, on Articles, Patent Related Court Rulings

    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.

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