- More than 30 years of domestic and international experience in the discovery, development, registration, and commercialization of chemical and biotechnology products.
- Executive leadership roles with Acumen Pharmaceuticals, Mendel Biotechnology and Monsanto, managing corporate and commercial development, negotiating contracts, drafting and executing business plans, developing intellectual property protection strategies, building and leading high performance teams.
- International experience in market analyses, product development, regulatory and public acceptance, and commercialization.
- Author of two published pharmacological research articles related to Alzheimer's Disease and the holder of eight patents or patent applications.
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Protection of that "property," if structured wisely, can in itself be a core company asset:
- It can provide “freedom to operate” with respect to the sale of products or services.
- It can restrict the freedom of operation of competitors with respect to the sale of products or services.
- It can be the actual product or service the company sells.
But IP protection is resource intensive and, if not linked to core company objectives or properly executed, can cause a significant loss of value. IP protection decisions should be business-driven decisions, not technology-driven decisions, and must be clearly and thoughtfully linked to business objectives.
For startups and emerging biotechnology companies, the most important elements of intellectual property that must be protected are typically confidential information and trade secrets, patents and patent applications. They should be treated as fundamental building blocks of the company's business plan, and they should be used to shape an overarching intellectual property strategy. This calls for:
- Careful consideration as to what will be patented or treated as a trade secret; the publication of patents may well reveal far too much information to your competitors.
- Research on the competitive landscape so that you know how your intellectual property fits within existing patent claims and competitors' products.
- Research on both customers and consumers to determine their true needs and behaviors and to define potential social resistance to products, which has been seen widely for such products as genetically modified organisms or some crop protection chemistry.
- Paying attention to when and where patents are sought so as to maximize value, minimize risk and generate the strongest claim to intellectual property:
- It is important to know that U.S. patent rules are different from much of the rest of the world.
- Decisions about international patents need to consider the cost of defending the patents and potential profitability of the markets.
- Developing formal disclosure policies governing scientific reports, publications, presentations, speeches and so on:
- European rules disallow patents for any intellectual property discussed in any public forum
- Patent applications can be shaped to limit information as much as permissible.
- Disclosure of information among scientific peers can undermine patents and market positions.
- Even casual references can alert competitors to research agendas and progress.
Failure to get these and other elements of intellectual property protection done well can lead a company to waste or misallocate significant resources, including wasting valuable research time. Companies also must guard against inappropriately disclosing science that could preclude getting proper intellectual property protection, enable competitors or even lose valuable intellectual property.
On the flip side, a solid intellectual property strategy can protect the company and its intellectual property, while maximizing value to the company. This generates resources to develop new products. Effective strategies also can help gain access to others' intellectual properties through partnerships, licensing or other means.
- Demand from emerging economies around the world.
- Changes in U.S. patent law.
- Ever-changing product introductions from competitors.
- Growing activism from consumers seeking "greener" solutions and a sense of control in decision making.
- Political and regulatory changes.
- Technological advances.