Author name: Yali Friedman

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After dominating the world tea market since last 170 years, today India became the fourth largest tea exporter. The state Assam, located in the Northeastern end of the country contributes almost 50% of the India’s total tea production and Small tea growers of Assam (STGs) produces around 30% of its total annual production and contributes almost 12% of India’s annual production. Though the use of harmful pesticides and fertilizers by the STGs of Assam is still not recognized and controversial in the state, but it is observed that STGs of Assam hardly follows standard scientific techniques for handling such chemicals. Therefore, maintenance of sound health of STGs and environmental safety is a necessary issue. But, till date no such awareness program was found to be initiated scientifically to teach them about those safety measures. Therefore, there is a great need for immediate implementation of such kind of scientific solutions, basically for storing (micro level) of these harmful chemicals and also for grass root level safety campaign by scientific communities of India including other competent Agencies. 

The field of bioinformatics is flourishing, and strong growth is only projected to continue. Like any cutting edge technology, bioinformatics requires an integrated IP strategy involving patent, trade secret, and copyright laws. The patent system in particular can be a powerful protection for commercializing bioinformatics inventions as long as a corresponding patent application meets certain patent law standards. Recently, the most rapidly evolving of these patent law standards—patent eligibility—came to a crescendo last year when the Supreme Court in Alice v. CLS Bank introduced a two-step test for determining whether computer-implemented inventions are patent-eligible. Since then, other courts and the USPTO have applied the test on inventions implemented on a computer and/or using the Internet with fact-dependent results. Here, we discuss how these decisions relate to bioinformatics inventions. We then analyze bioinformatics patents that have recently issued post-Alice. While the law remains relatively underdeveloped, it becomes clear that relying on a general purpose computer to perform routine or conventional steps in a claim will not infuse patent-eligibility into a claim. However, bioinformatics inventions remain patentable, especially when the patent prosecution team properly and persuasively presents the technical improvements and commercial embodiments.

As a small biotech company embarks on a drug development program, there is a tendency for management to focus on a well-defined set of issues. Is the science behind the drug valid? Does it solve an interesting problem or unmet need? What are the prospects that the medical community and patients will embrace it as a valuable new solution? And what is the range of indications the drug is conceived as addressing? These are all valid questions, but a small biotech can do even more to prepare itself for the drug development process, which is a journey that can take many years and cost a significant amount of money. 

America deserves access to high-quality health care without avoidable medical errors and complications. This achievable goal begins with harnessing and using the power of information. And that begins with clear, accurate, and usable labeling.The Americ…

Historically, innovation in the biotechnology sector has relied to a large extent on the expensive infrastructure provided by universities or large pharmaceutical companies. This prohibitive start-up expense is the basis of why garage-style biotechnolo…

As in the medical biotechnology area some decades ago, the fast technological development within industrial biotechnology (IB) has caused numerous new ventures. Venture capital (VC) has become a major capital source for these companies and VC investors…

The Brazilian human health biotechnology sector was analyzed according to its spacial and sectorial distribution of the following aspects: (i) the scientific production; (ii) dependence of companies on governmental funding for research and development;…

Specialty biologics are the fastest growing class of bio/pharmaceutical products in terms of the number of new brand launches and rates of health care spending in the U.S. and globally. Innovative biologics meant to treat a range of hitherto untreatable conditions in oncology, inflammation, CNS, endocrinology and other chronic conditions seek to offer radical improvements in efficacy and patient well-being. Such products can command premium prices, often costing over $100K per year per patient – triggering a raft of challenges to ensuring that eligible patients have adequate access.

 This article outlines important trends impacting market access to specialty biologics in the U.S. and globally. Particular importance is placed on evolving methods for managing specialty product utilization and reimbursement toward ensuring appropriate access. The reshaping of the specialty product market access landscape in the U.S. through the availability of oral biologic formulations distributed to patients via high-touch, high-involvement specialty pharmacies is examined. The rising role of risk sharing between specialty product manufacturers and insurers as a way to balance rewards of access with the risks inherent in radical new specialty therapeutics is discussed. Challenges posed by specialty biosimilars to traditional ways of ensuring market access and fair reimbursement are outlined. The impact of health care reforms on market access for specialty biologics in the U.S. is discussed in the context of the growing need for comparative outcomes research and the application of the principles of health technology assessments – adapted, in part from their apparent success in ensuring equitable and cost-effective access to biologics in the E.U.