1. 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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  2. 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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  3. 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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  4. 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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  5. 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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  6. 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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  7. Decrypting the Human Genome: Next Generation Sequencing – Part I

    Posted on 05.09.17 Jing Zhou, on Articles, Biotech/Pharma

    In 2001, the first entire human genome was successfully sequenced under the support of the Human Genome Project. This endeavor took 15 years and cost nearly 3 billion dollars. Since then, high-throughput sequencing technology, also known as Next Generation Sequencing (NGS), was developed to reduce the time and cost of human genome sequencing. In 2005, the first NGS sequencer was released to the market by 454 Life Sciences.  This sequencer reduced the cost of human genome sequencing by 50,000-fold.

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  8. Patent Exhaustion and Pharmaceuticals

    Posted on 22.08.17 Michael Hinrichsen, on Articles, Biotech/Pharma, Patent Related Court Rulings

    On May 30th, the Supreme Court ruled in Impression Products, Inc. v. Lexmark International, Inc. that all patent rights are automatically exhausted upon the sale of a product irrespective of contract stipulations and regardless of whether the sale is made domestically or internationally. While the dispute in this case involved articles of manufacture, the decision has strong implications for the biotechnology and pharmaceutical Industry, and may make it easier for drugs sold legally overseas to make their way back to the US market.

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  9. Dilworth IP Partner Published in Organic Process Research & Development

    Posted on 11.07.17 Thomas Pia, on Announcements, Biotech/Pharma

    Dr. Anthony Sabatelli, Partner at Dilworth IP, has co-authored an article published in the Organic Process Research & Development journal (OPR&D) with Dr. John Jasper of Molecular Isotope Technologies and Dr. Ann Pearson of Harvard University. The article, entitled “Process Patent Protection via Analysis of Stable Isotope Ratios,” considers “the possibilities afforded by stable isotope analysis for improving process patent protection in relation to pharmaceutical and other value-added products.”

    To download the full text, Click Here

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  10. The Emergent Microbiome: A Revolution for the Life Sciences Part XI: Agriculture and the Microbiome

    Posted on 28.06.17 Nicholas Vincent, on Articles, Biotech/Pharma, The Emergent Microbiome Series

    Knowledge of, and interest in, the human microbiome has rapidly expanded in recent years: each week, there seems to be additional advancements in our understanding of the microbial communities that call our bodies home. As investigations into these microbial communities and their impact on our health continue to develop, many researchers have rightfully begun to untangle the web of microbial communities external to us (See Part VII, The Microbiology of the Built Environment). In particular, we have observed an increased interest in the microbial communities associated with agriculture and crops. Having a clearer understanding of agriculture-associated microbial communities, and how they can be manipulated and modulated, will play an increasingly important role in the safety and security of our food supply. In fact, we have seen several encouraging efforts devoted to the advancement of microbiome research in agriculture, and we expect to see a subsequent increase in the need for intellectual property protection in this space. Importantly, we also see a clear path forward for patent-eligible inventions in this historically challenging area. While this article will focus on agriculture and the microbiome, we have also observed an increase in the attention being given to livestock production and the microbiome. In an upcoming installment of The Emergent Microbiome, we will address the history, importance, and advancements with respect to this field of research and related intellectual property issues and challenges.

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