1. The A-B-C’s of R-N-A-i: Therapeutic Applications and §101 Implications

    Posted on 06.11.18 David Puleo, on Articles, Biotech/Pharma, Patent Resources

    Now that the first RNA interference (RNAi)-based therapeutic, ONPATTROTM (patisiran, developed by Alnylam Pharmaceuticals), recently received FDA approval, it is not surprising that such drugs are gaining considerable attention.  However, the underlying technology has been around for quite some time.  Craig Mello and Andrew Fire won the 2006 Nobel Prize in Physiology or Medicine for their discovery of RNAi.  There has since been a trend towards developing RNAi-based therapeutics, which is reflected in the number of patent applications that have been filed in this area.  In this article, we will be reviewing the RNAi methodology and relevant patents, as well as potential challenges for patenting this technology going forward.

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  2. Patent Beauty: IP and Hair Coloring Products

    Posted on 05.09.18 Shin Hee Lee, on Articles, Biotech/Pharma

    The global hair coloring product market is projected to grow into a 200 billion-dollar industry by 2025. Coty reported in 2017 that more than half of all women color their hair regularly. For example, these figures have reached 62% in the United States, 67% in the United Kingdom, 69% in Germany, and 88% in Russia. An in-depth data analysis reported by Grand View Research, Inc. attributes this rapid growth to a global increase in the aging population, environmental insults such as air pollution, and new trends in the fashion industry. Alongside the other lucrative sectors in the beauty industry that were discussed in our previous articles (see link https://www.dilworthip.com/patent-beauty-ip-cosmetics, and link https://www.dilworthip.com/patent-beauty-ip-and-hair-care), the hair coloring sector also deserves a great amount of attention, especially in view of advancing technologies and the intellectual property covering it.

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  3. Antibody Drug Conjugates: The Patent Landscape for a New Class of Cancer Treatment

    Posted on 07.08.18 Steve Kennedy, on Articles, Biotech/Pharma

    Over the last decade, antibody-drug conjugates (ADCs) have emerged as a highly promising new class of biopharmaceuticals. By taking advantage of the specificity of monoclonal antibodies and the potency of small-molecule chemotherapy drugs, ADCs have proven to provide a highly effective combination – particularly in the oncology space,. The recent FDA approvals of Kadcyla (Genentech), Adcetris (Seattle Genetics), Mylotarg (Wyeth Holdings / Pfizer), and Besponsa (Wyeth Holdings / Pfizer), as well as the over sixty other ADCs in clinical trials, show that these drugs represent an increasing proportion of newly approved cancer therapies and will generate growing revenues for firms innovating in the field.  Accompanying this burst in ADC development is the corresponding activity in the patent space.  This article summarizes some of the important developments.

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  4. Patent Beauty: IP and Hair Care Products

    Posted on 21.06.18 Shin Hee Lee, on Biotech/Pharma

    “Your hair is your crowning glory” is an often-quoted phrase with biblical roots.1 Perhaps more importantly, one’s hair is a visible barometer of one’s health and age. Hair care products are also big business. The global hair care market reached $85.5 billion in annual sales in 2017. This figure is expected to climb to over $100 billion by 2024. The U.S. hair care market outcompeted the Asia-Pacific market in 2017, now making it the largest market in the world at about $15 billion. This highly lucrative hair care market continues to grow rapidly with advances in nanotechnology and other areas. A sampling of patents from the hair care sector is summarized at the end of this article.

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  5. 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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  6. 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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  7. 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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  8. 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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  9. 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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  10. 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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