A Biotechnology Dilemma: Patent Your Inventions (if you can) or Keep Them Secret

2017 ◽  
Vol 23 (2) ◽  
Author(s):  
Craig Robert Smith

Biotechnology companies rely on patents to protect their most valuable inventions.  Patent protection helps support billions of dollars in research and development of life-saving drugs and treatments.  Protecting biotechnology inventions has become more difficult in the last few years, however, because legal trends have created uncertainty regarding what subject matter is eligible for patent protection.  Specifically, courts have narrowed the scope of what is patentable and have increasingly invalidated patents because they claim abstract ideas or laws of nature.  As biotechnology companies wait for more clarity on the scope of patentable subject matter, they face a dilemma of whether to patent their inventions or keep them secret.  Keeping inventions secret offers some benefits to companies, but may not be sufficient to protect the significant investment made in research and development.  The biotechnology industry will continue to grapple with this dilemma until the courts, the Patent Office or new legislation clarifies the boundaries of what subject matter is patentable.

Author(s):  
Justine Pila ◽  
Paul L.C. Torremans

This chapter considers the subject matter for which European patents may validly be granted under the European Patent Convention (EPC), and the substantive European (EPC and EU) legal principles governing their identification and conception. To this end it discusses the two-fold role of the requirement for an invention in European patent law: first, as a means of filtering protectable from non-protectable subject matter; and second, as a means of denoting the object of patent protection, i.e. that which must be new, inventive, susceptible of industrial application, and clearly and sufficiently defined and described in the patent specification, and that with reference to which the scope of the patent monopoly is defined under Article 69 EPC. It also discusses the range of public policy-based exclusions from European patentability, and their relation to the requirement for an invention itself.


2012 ◽  
Vol 18 (3) ◽  
Author(s):  
Jennifer A. Camacho

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.


2014 ◽  
Vol 20 (3) ◽  
Author(s):  
Stefan Michael Miller

With passage of the Leahy-Smith America Invents Act (AIA), new rules and procedures related to the application of prior art now apply to patenting under a “first-inventor-to-file” system. This article summarizes certain key prior art provisions that biotechnology companies should be aware of and details practical steps that can be implemented to help stake a competitive advantage under the new law including the use of patent liaisons, early provisional and patent application filings, and in certain circumstances, defensive publication of patentable subject matter.


1969 ◽  
Vol 16 (4) ◽  
Author(s):  
Yali Friedman

The fates of biotechnology companies can be fairly described as volatile. Clinical trial progress, patent grants and invalidations, and funding announcements can yield great swings in stock price. Building any company is a challenging endeavor, and these dramatic responses only compound the problem and complicate the management of biotechnology companies. Companies have employed a diversity of tactics to buffer the impact of individual setbacks – having multiple products in development, using a hybrid product/service strategy, and in-licensing externally partially developed leads are just a few.One consequence of these buffering strategies is reduced investor interest. The duration of biotechnology product development, combined with the long gap between funding and (potential) revenues, and the uncertainty of profitability encourage investors to favor either late-stage companies or those likely to ‘fail fast’. Late-stage companies often present more measurable investments than early-stage companies – and a shorter timeline to returns – and companies that can fail fast allow investors to conserve time and financial resources. The problem with these investment preferences is that for a company to mature to late-stage, it must find early- and mid-stage funding somewhere, and an excessive focus on failing fast is at odds with the long-term patient support needed for many projects.Therefore, how can biotechnology executives bridge the gap between biotechnology funding preferences, chaotic development progress and the sustained support needed for research projects? One answer is to seek opportunities in compatible industries. Seeking funding and revenue opportunities outside the biotechnology industry can effectively dissociate biotechnology companies from the negative constraints of the biotechnology industry, enabling them to mature in more supportive environments while still keeping a long-term focus on lucrative opportunities in biotechnology.Consider the example of Mission Motors. The company, which recently produced the world's fastest motorcycle, is not a motorcycle company; they used the motorcycle (which they are selling for nearly US$70 000 each) to help attract interest in their primary interest, which is software.1 BBK Technologies is an example from the biotechnology industry. BBK has applied fragment-matching algorithms from DNA sequence analysis to matching video sequences.2 With applications in stemming piracy and enabling image or video-based search, the technology clearly has robust applications beyond biotechnology. The extra biotechnology applications also serve as robust evidence of the utility of BBK's technology.What is not to like about these indirect paths? They can be slower than maintaining a strict focus on biotechnology-related goals. An oft-heard plea in biotechnology is the need for speed in development. Although it is true that patients may be suffering while treatments are in development, and that delays in development may result in a shorter duration of patent protection, a balance must still be maintained between speed of development and corporate sustainability. After all, an excess focus on near-term positive outcomes may lead to corporate collapse, likewise depriving patients of treatments. Leveraging opportunities outside of biotechnology to establish proof of principle or to build revenue streams can increase resilience, and can thereby provide a stronger foundation for corporate sustainability.References Dumaine, B. (2010) A motorcycle on a mission. Fortune, 14 June, p. 30.The physics arXiv blog. (2010) Sequencing the video genome. 31 March, http://arxiv.org/abs/1003.5320.


Author(s):  
Stephen Yablo

Aboutness has been studied from any number of angles. Brentano made it the defining feature of the mental. Phenomenologists try to pin down the aboutness features of particular mental states. Materialists sometimes claim to have grounded aboutness in natural regularities. Attempts have even been made, in library science and information theory, to operationalize the notion. However, it has played no real role in philosophical semantics, which is surprising. This is the first book to examine through a philosophical lens the role of subject matter in meaning. A long-standing tradition sees meaning as truth conditions, to be specified by listing the scenarios in which a sentence is true. Nothing is said about the principle of selection—about what in a scenario gets it onto the list. Subject matter is the missing link here. A sentence is true because of how matters stand where its subject matter is concerned. This book maintains that this is not just a feature of subject matter, but its essence. One indicates what a sentence is about by mapping out logical space according to its changing ways of being true or false. The notion of content that results—directed content—is brought to bear on a range of philosophical topics, including ontology, verisimilitude, knowledge, loose talk, assertive content, and philosophical methodology. The book represents a major advance in semantics and the philosophy of language.


2020 ◽  
Vol 17 ◽  
Author(s):  
Biswajit Panda ◽  
Amal Kumar Gooyee

: Oceans can play a major role in supplying life-saving medicines in the world in future. Although considerable progress has been made in finding new medicines from marine sources, large efforts are still necessary to examine such molecules for clinical applications. Xyloketals are an important group of natural products with various powerful and prominent bioactivities such as inhibition of acetylcholine esterase, antioxidant activity, inhibition of L-calcium channels, radicalscavenging behavior, suppression of cell proliferation, reduction of neonatal hypoxic-ischemic brain injury, etc. This review describes the isolation and structural characterization of all xyloketal natural products giving major emphasis on their bioactivity.


2021 ◽  
pp. 088506662199232
Author(s):  
Xiaojuan Zhang ◽  
Xin Li

Septic shock with multiple organ failure is a devastating situation in clinical settings. Through the past decades, much progress has been made in the management of sepsis and its underlying pathogenesis, but a highly effective therapeutic has not been developed. Recently, macromolecules such as histones have been targeted in the treatment of sepsis. Histones primarily function as chromosomal organizers to pack DNA and regulate its transcription through epigenetic mechanisms. However, a growing body of research has shown that histone family members can also exert cellular toxicity once they relocate from the nucleus into the extracellular space. Heparin, a commonly used anti-coagulant, has been shown to possess life-saving capabilities for septic patients, but the potential interplay between heparin and extracellular histones has not been investigated. In this review, we summarize the pathogenic roles of extracellular histones and the therapeutic roles of heparin in the development and management of sepsis and septic shock.


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