1. Patent Beauty: IP and the Cosmeceutical Industry

    Posted on 26.04.18 Shin Hee Lee, on Articles, Biotech/Pharma

    The cosmeceutical industry is ever more competitive and continues to grow with a myriad of new cosmeceutical products entering the market every day. Well-established and new companies are busily adapting to new trends created by people’s changing tastes. The total revenue of the U.S. cosmeceutical industry has only been increasing since 2009, marking $62.46 billion in 2016. While this revenue comes from a number of cosmeceutical product categories, skin care has always been the most profitable category, covering 36% of the global market.

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  2. The I-O Movement:  Priming the Immune System to Fight Cancer – Part I:  Chimeric Antigen Receptor T (CAR-T) Cell Technology

    Posted on 27.03.18 David Puleo, on Articles, Biotech/Pharma

    There has been a lot of recent buzz about chimeric antigen receptor (CAR) T cell technology.  Novartis and Gilead have FDA-approved CAR-T therapies offering complete patient remission from certain cancers.  A flood of new CAR-based technologies is likely to hit the market.  As with any novel therapy, patent protection is essential.  The large number of patent filings suggest that intellectual property protection is an important part of the research efforts in this field.  The bolded patent documents cited in this article are further summarized in the table at the end of this installment.

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  3. Protecting Pharmaceuticals at the Intersection of Patent and Regulatory Law

    Posted on 14.03.18 John Wizeman, on Articles, Biotech/Pharma, Recent News & Articles

    Over three decades ago, the United States Congress passed the Drug Price Competition and Patent Term Restoration Act[1]. This piece of legislation, known as the Hatch-Waxman Act, tackled the difficult task of protecting pharmaceutical innovator intellectual property while ultimately providing increased competition and decreased cost to consumers through accessible generic drugs. This legislative task was accomplished with two pieces of intersecting laws:  (i) the patent provisions under 35 USC which provide for up to five additional years of patent term extension and (ii) the drug exclusivity provisions under 21 USC 355 which provide certain regulatory and marketing exclusivity periods upon drug approval.  The intersection of these patent and regulatory/marketing exclusivity periods provide innovator drug developers with a net exclusivity period. Given the immense monetary and time investment for developing new drugs, maximizing this net exclusivity should be a major focus of patent practitioners in the pharmaceutical field. By maximizing this net exclusivity, innovator drug developers can recoup their investment, as well as provide a stable foundation and incentive for continued drug discovery. To understand how to maximize this window, those involved need to understand the important role this intersection of patent and regulatory law holds.

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  4. The Emergent Microbiome: A Revolution for the Life Sciences – Part XIV, Revisiting Immunotherapy and Combination Therapies

    Posted on 08.03.18 David Puleo, on Articles, Biotech/Pharma, The Emergent Microbiome Series

    Three recent articles in Science discuss how the composition of the gut microbiome affects anti-PD-1 therapy for the treatment of melanoma, metastatic melanoma, and epithelial tumors, further bolstering the idea of gauging immunotherapeutic efficacy based on one’s microbiome composition.  We first reviewed this concept in Part VIII of The Emergent Microbiome Series and are revisiting it here.  Bolded patent documents are further summarized in the table at the end of this installment.

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  5. 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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  6. Decrypting the Human Genome: Next Generation Sequencing – Part II

    Posted on 06.11.17 Jing Zhou, on Articles, Biotech/Pharma

    Sequencing whole human genomes presents many technical challenges. Whole human genomes have a large number of long repetitive sequence segments of more than 1,000 bp, which cannot be distinguished by short-read instruments. Since it has been reported that each individual human genome has 2.7 to 4.1 million variants, then, for the 3.2 Gigabyte whole human genome, there is at least one variant per every 1,000 bases. These long repetitive sequence segments could include structure alteration and gene mutations relating to diseases, but might not be efficiently and accurately characterized by short-read NGS technologies.  To address these challenges, long-read sequencing technologies have been developed and have already provided some astounding applications. For example, in 2014, scientists successfully applied nanopore sequencing technology developed by Oxford Nanopore Technologies (ONT) to monitor the transmission history and disease evolution of the Ebola virus, essentially in real time, during its outbreak. In this installment, we will discuss two of the main long-read sequencing technologies: (i) the synthetic approach and (ii) the single-molecule sequencing approach, and will review the relevant patents.

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  7. 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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  8. Dilworth IP Presents at the SAPA-CT 4th Annual Conference

    Posted on 12.10.17 Thomas Pia, on Biotech/Pharma, News and Events, Recent News & Articles

    Dr. Anthony Sabatelli and Dr. Jing Zhou of Dilworth IP presented a talk entitled “Pharmaceuticals: At the Intersection of Patent and Regulatory Law” at the SAPA-CT 4th Annual Conference on Saturday, October 7th. The Sino-American Pharmaceutical Professionals Association (SAPA) was founded in 1993 as an independent and nonprofit organization seeking to bridge the U.S. and Chinese pharmaceutical worlds by providing training in drug research and development, creating a broad network, and hosting delegations from China. The theme of this year’s conference was “Adapting to the Changes in Biotech/Pharmaceutical Industry” and was held at the Yale School of Management from 8:00 am to 6:30 PM.

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  9. 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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  10. The Emergent Microbiome: A Revolution for the Life Sciences. Part XII: Taking Stock of Livestock

    Posted on 20.09.17 Nicholas Vincent, on Articles, Biotech/Pharma, The Emergent Microbiome Series

    As we have discussed in previous installments of “The Emergent Microbiome,” we have seen a distinct growth in the interest of the microbial communities found in our environment beyond the confines of the human body. Earlier articles in this series have focused on the microbiology of the built environment (See Part VII: The Microbiology of the Built Environment) and the microbial communities of plants that have been characterized and manipulated to maximize their growth and crop yield (See Part XI: Agriculture and the Microbiome). In both circumstances, we noted robust intellectual property activity. Likewise, we have also observed an increased interest in the microbial communities found in livestock animals, and how manipulations of these communities could result in more effective, productive, and sustainable means of food production. Although this area is less well developed than other areas of microbiome research, including that of plant agriculture, we see it as a promising area of development in terms of both the science and the innovation that will inevitably flow from it.

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