- 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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Linking Intellectual Property Protection to Core Business Objectives
- Most small biotech companies outsource their intellectual property protection.
Most large firms will have an in-house intellectual property protection department – a patent department. Smaller companies may have someone internal who is a patent agent to manage the process, but they typically don't have internal in-house intellectual property lawyers. Or they may only have one, because of the expense. The work of researching and filing paperwork, the nuts and bolts of securing protection, often is is farmed out.
The challenge is that most patent firms will be able to advise you on how to draft, file, and prosecute a patent, but they don't know your core business. They're not able to advise you on how to craft an effective intellectual property protection strategy. And it isn't necessarily in their best interest to do so because, in one sense, they would just as soon have you spend more money filing patents and prosecuting patents because that's what their business is.
- Emerging economies are creating opportunities, and risks, in intellectual property management.
The technical abilities of laboratories and companies in developing countries in Asia, Latin America, and Eastern Europe are growing rapidly and are creating new opportunities, challenges and competitors for biotech product development. The challenge with those countries, however, is intellectual property protection.
Every patent has two aspects. Can you get the patent? And can you protect it? In countries like China or India, you can get the patent. That's not a problem. Protecting your intellectual property from infringement or even outright theft is a problem, however.
Companies have been known to seek patents in India and China, but they didn't think through the task of defending those patents. In most cases they cannot and will not be able to. And if you cannot defend the patent in that country, you should be asking the question: "Is this a reasonable business opportunity?"
That's an emerging trend that still needs to be sorted out. Certainly, China and India – and to some extent some of the Latin American countries as well – are trying to strengthen their intellectual property protection laws so that technology out of other countries will flow in and be protectable, but it's not there yet.
- U.S. intellectual property law is aligning more with the laws of other countries.
There is no doubt that the intellectual property protection system of the United States is moving to be more like that of the rest of the world. Up until fairly recently, U.S. patent law was quite different from the rest of the world and companies had different intellectual property protection tactical applications in the U.S. versus the rest of the world.
But as the U.S. continues to creep toward a system that's going to be more aligned with the rest of the world, It is going to affect how companies tactically protect intellectual property. It may not change the actual strategies, but it will affect how they are implemented. Companies will have to wait to see how the changes unfold to reconfigure their protection tactics.
In the United States, it used to be the first to invent could receive patent protection, even if you were not the first to file for patent protection. If you could demonstrate through documentation that you invented something before someone else, you would not have to be the first to actually file for patent protection. This tended to encourage American inventors to patent as late as possible in order to protect inventions from competitive scrutiny. In the rest of the world, the rule is that the first to file for a patent is the one who gets the protection. This encourages companies to patent as soon as possible.
- International markets for bio-pharmaceuticals can affect intellectual property protection strategies.
Getting protection for intellectual products in China or India, as examples, can be very expensive and you won't know how well you can protect the property. The amount of money a company is willing to spend on protection in those markets, then, needs to be weighed against the potential gains. Sometimes it just doesn't make sense to spend the money in a market.
Take the example of a therapeutic medication for Alzheimer disease. Probably 95 percent of such medication over the next 15 to 20 years is going to be sold in North America, Europe, Japan, and maybe New Zealand, Australia and Korea. Period. Regardless of where you've have patent protection for the medication.
And so if you're a company that's trying to maximize your bang for the buck of your intellectual property strategy, that's where you want to get intellectual property protection: North America, Europe, Japan, and maybe New Zealand, Australia and Korea. You don't need to worry about China and India and Brazil or Argentina and South Africa, because the amount of additional market revenues you can get from those countries, even if you had a defensible product, is only a few percentage points of the total you're going to get in your core markets.
- Companies with successful products are often targets of abusive patent litigation, particularly by non-practicing entities (aka patent trolls).
- A general axiom for small biotechnology companies is that if you succeed with a very successful product you will become the target of abusive patent litigation, typically by non-practicing entities (so called patent trolls). Abusive patent litigation has recently become a hot political topic, though with the political deadlock in Washington little progress is expected from Congress to reduce the problems. While median awards for U.S. patent infringement litigation continue to decrease, it is reported that two-thirds of new patent lawsuits are filed by patent trolls.
An important element of a company's intellectual property protection strategy should be development of a strategy that minimizes the potential for patent litigation and maximizes the potential of prevailing in the event of litigation. This often involves seeking to develop multiple layers of intellectual property and patent protection, particularly for core company products, so if litigation is lost in one area, the company still maintains adequate intellectual property protection.
Thus, a proper intellectual property protection strategy should include both offensive and defensive components that provide the company with an advantage over competitors and minimizes the ability of competitors to restrict activities of the company.