On March 20, 2012, the U.S. Supreme Court handed down its decision in Mayo Collaborative Services, et al v. Prometheus Laboratories, Inc (“Mayo”) and ended an eight-year legal battle over patents covering processes for determining patient-specific dosing for a thiopurine drug to treat autoimmune diseases. In a unanimous decision, the Court held that the claimed processes are not patent-eligible subject matter under 35 U.S.C. §101 of the U.S. patent laws, and overturned the decision of the Court of Appeals for the Federal Circuit.
The Supreme Court decision in Mayo established that the machine-or-transformation test is not the definitive test for determining the patent-eligibility of process claims, including process claims that embody laws of nature or natural phenomena. In its analysis, the Court determined considered whether the claims were drawn to patent eligible subject matter as provided under 35 U.S.C. §101 of the U.S. patent laws, or patent ineligible subject matter excepted from §101. The Court held that the process claims were essentially drawn to the laws of nature themselves and thus fell into the laws-of-nature exception to §101. The process claims did not cover patent-eligible processes of applying certain laws of nature. This decision has clear implications for the biotechnology industry that go beyond diagnostics and personalized medicine. As such, biotechnology companies should consider re-evaluating their patent position and adapting their patent strategies in view of Mayo.Full details at the Journal of Commercial Biotechnology
An earthquake in Japan cuts off the supply of key equipment and/or pharmaceutical ingredients to a biotechnology company with facilities in the U.S. High winds and flooding from a hurricane along the East coast—home to a notable number of biotechnology facilities—causes catastrophic property damage. What these cataclysmic events have in common is the wide scale business interruption that is left in their wake. While no company is immune to the threat that natural disasters pose to operations, biotechnology companies also face an increased risk of manmade disasters, from chemical spills and steam explosions to fires intensified by combustible dust. A business interruption of any kind jeopardizes a company’s critical output and its financial security—a reality that some never recover from. In order to withstand the crisis and return to business, developing and implementing a business continuity plan, which includes the purchase of insurance protection, is integral to the recovery process. Although the development and implementation of a business continuity plan may require a serious initial financial commitment, it can help protect your biotechnology firm against greater physical and financial loss.Full details at the Journal of Commercial Biotechnology
Preparing students for future entrepreneurial activity in the biotechnology industry is an important issue in many parts of the world because most countries seek to reap the benefits of investments in university-based teaching and research through the development of a knowledge-based economy driven by a highly skilled work force. The current generation of biotechnology students will begin their professional lives in a globalized society. This means that flexibility, creativity and critical thinking are essential personal skills that need to be cultivated by students at universities in order for graduates to be competitive in the job market of a fast-moving world. It is no longer sufficient for universities to teach students to be passionate about science and to enjoy learning and discovering new things. Biotechnology students, in particular, need to be trained to identify the connections between science and its commercial applications.Full details at the Journal of Commercial Biotechnology
This article addresses the strategic application of systemic oral transmucosal* (i.e., sublingual and buccal) drug delivery. Circumvention of first-pass hepatic metabolism in the gut, rapid onset of action, easy access via the oral cavity, easy administration for patients with dysphagia and a high level of patient acceptance are the principal advantages of the oral transmucosal route. Key clinical and commercial strategies driving the development of oral transmucosal formulations are addressed. A case study of Cynapsus Therapeutics' APL-130277, a sublingual apomorphine formulation in clinical development for Parkinson's disease exemplifies the scientific, clinical and commercial considerations for systemic oral transmucosal drug delivery.
*Note: In this article, oral transmucosal delivery refers to systemic drug delivery through the sublingual or buccal mucosa. Local delivery to the oral mucosa is not included.Full details at the Journal of Commercial Biotechnology
In 2010 healthcare represented 17.9% of GDP; its cost is growing significantly faster (~5%) than economic growth (~ 2%). This growth presents a challenge to all payers, whether they are governments, employers, or individuals. Within healthcare, one of the most rapidly growing areas is “specialty drugs” which are frequently biotechnology agents, or drugs for cancer or orphan conditions. This article starts by discussing the issues of specialty drug cost and the challenges payers face in managing specialty drugs. It then presents market structure and firm strategy theories that provide insight into firm behavior in specialty drug categories. Lastly, it discusses possible events and actions that could dramatically change the biotechnology industry and lead to increased value within the U.S. health care system.Full details at the Journal of Commercial Biotechnology
Molecular diagnostic (MDx) tests are now commonplace in virtually every hospital and pathology laboratory, however many questions have arisen, such as “What do diagnostic laboratories require from the MDx revolution in order to better improve patient care?” and “Is a fully integrated ‘black-box’ device the answer to simple rapid diagnostic testing or do mainstream laboratories require more in terms of available testing menu and streamlined workflow?” With more and more ‘black-box’ devices available on the market, laboratories need to first decide if they need to make such an investment, and if so, in which to make the most appropriate investment, whilst also considering the cost of consumables. Currently the associated costs of an integrated solution can be prohibitive for small to medium sized laboratories, however this does not necessarily mean that they need to miss out on the many benefits that MDx testing can bring. Here we examine what role an open-platform suite of MDx assays can play in the MDx testing landscape. In order to be successful we assume that open-platform tests will utilise a universal sample preparation method for all sample types and be compatible with a broad range of existing Real-Time PCR hardware. This is in effect the ‘Microsoft’ model, which provides software compatible with existing hardware, compared to the ‘Apple black-box’ model of supplying both the hardware and software. Clearly there is a place for both approaches in the clinical diagnostic sector, but until the ‘black-box’ systems broaden their testing menu for all sample types and reduce the cost of consumables, their use may be limited to single analyte niche testing rather than being a central workhorse in the mainstream hospital and pathology laboratories. The goal for testing laboratories is to provide rapid and definitive identification of pathogens in order to aid optimal patient management. In the current setting this is only available by using a battery of tests from different manufacturers, or by relying on traditional methods that can take several days to generate a result. It is proposed that a true open-platform MDx testing system may bring the benefits of rapid and accurate testing to many small to medium laboratories without the need for a large upfront investment and associated high consumable costs.Full details at the Journal of Commercial Biotechnology