- 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
- Intellectual property, and particularly patent endeavors, often are driven from the technology side of a company rather than the business side.
Companies need to ensure – when seeking intellectual property rights for technologies – that they have a clear linkage to a product of interest to the company. Companies also want to avoid pushing forward technology to be patented too early – when it is at a a stage of development before the technology has been fully developed into a product concept. A company can shoot itself in the foot by having an early patent that might not adequately protect the product from competitors while alerting them to the technology.
Companies sometimes spend a huge amount of money on intellectual property protection even when that protection is not relevant to the core business objectives of the company. In other words, they waste resources that could be better applied for the benefit of the company if done so in a more strategic manner.
- A natural tension exists between the need and desire to file an early patent and the value of waiting for a fully developed concept.
Working with intellectual property is like a knife-edge you have to walk. You want to file patents as early as possible to ensure that you have freedom to operate with your invention and that you own the invention. At the same time you want to file as late as possible to ensure that the lifetime of the patent is as long during the commercial phase as possible. Also, it can be valuable to demonstrate and flesh out intellectual property so that you can get stronger and broader claims.
Likewise, there is a balance between filing early to ensure that you own the technology and have freedom to operate and waiting as long as you possibly can to have maximum benefit from that technology. If you have not fully developed that technology to the point that you actually have created a product, you may fall into this trap of potentially establishing a barrier to your own subsequent inventions.
As an example, take a firm that is developing a product. Early patent applications are filed, discovery is made but the product hasn't been fully developed. Still, the scientists throw it over the fence to the patent attorney. They have described a process that can be used to develop a product for a particular use. So the patent gets published. They haven't actually described that product, though. They just say it can be done.
So, two or three years later, that same research organization actually exploits the technology. They create the product that originally was envisioned. And they try to get a patent application covering that product, which is a specific product that can add value to the company. But their old previous patent that envisioned being able to create that product is now what is known as published prior art that prevents them from getting patent coverage when they actually get the product.
- Technology is important, but the law can trump technology.
- Intellectual property protection is part technology, but it also is part law. A company needs a strategy that can navigate the legal aspects of patent law and intellectual property. But it needs to do that within the boundaries of what a company is trying to achieve.
In short, companies need an intellectual property protection strategy that supports the development and commercialization of company products. After all, the company is about selling a product, and the intellectual property should be about protecting that product.
Senior management of a firm doesn't have to be intimately involved in the making of patent sausage. But it does need to find those individuals who understand how to craft an overarching intellectual property strategy to support the business objectives of the company, and then make sure that they are held accountable for executing that strategy.
- Senior management understands the importance of intellectual property management, but doesn't always understand the best way to do it.
Sometimes a company will make a discovery, or an invention, and will file a patent on it, but there's no further technology resourcing to support and continue to build out that product concept. And so they have a patent, or a family of patents, and they'll spend hundreds of thousands of dollars protecting them, but they never follow up with the resources to convert it into a product.
One solution is to have a senior member of your business strategy team be part of the "yay or nay" decision-making on filing for patents. Very simple to execute. That person doesn't need to understand the technology. He or she doesn't need to understand the details of patent law, which is different in the U.S. from the rest of the world and which makes it more complicated. This person simply has to be convinced that the intellectual property, for which somebody's going to ask the company to spend several hundreds of thousands of dollars on over the next few years, actually can be reasonably linked to a product that the company can sell. Just that little tiny bit of rigor could greatly reduce the amount of wasted resources that occur in the company on intellectual property protection.
- Enormous resources are required to bring new biotech products to market.
- Budgets typically get developed around research and development funding or personnel funding. You rarely hear anyone say: “Gosh, we're going to have to spend a million dollars a year on intellectual property.” That is something a small company can easily spend in a year. Budgets don't necessarily need to be built around intellectual property protection, but companies would be better managed if there were a better understanding of how much needs to be allocated toward the task.
For some companies, their whole strategy is not to actually develop something and take it to the marketplace. It is to develop especially strong intellectual property around the technology that can enable a larger company to develop the actual products. This is very important to understand because the way you spend your resource dollars developing newer products will be different. So, by building up intellectual property versus actually developing the product, a company won't have to worry about manufacturing or distributing the product. It may not be necessary, for example, to go to clinical trials. Companies in that mode can spend money on research fleshing out the intellectual property space and protecting that intellectual property. And so early on a company needs to decide just what its product, or products, will be – an actual, physical product or the intellectual property itself? Then, they can tailor their intellectual property protection strategy to the products or services they will actually sell.