Looking to Patent your Biotech Invention? Here’s What You Need to Know

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So you’ve made a discovery you want to protect or an invention you want to commercialize. How do you claim intellectual property?

Patents are the most relevant kind of intellectual property protection for technology-driven industries, particularly high-tech startups. They grant intellectual property rights covering technical inventions and relate to compositions, processes or methods of making these, or their use for a particular purpose.

More specifically, patents grant the right to prevent others from making, using, offering, storing, selling or importing the invention. In exchange for this legal right, the inventor must publicly disclose the description of the patent application.

This includes how to make and use the invention and thus enables others to build on the inventor’s findings and to participate in the invention’s commercial potential once the patent term has expired. That way, patents contribute significantly to the technological progress of an economy, compensating society for handing out a temporary monopoly right to an individual.

Jat306

In order to gain this right, an inventor must present a device that is newnon-obvious or “inventive”, and industrially applicable. (Applicability is rarely a problem.) Priority is generally given to the one with the earliest filing date under the “Paris Convention,” and a patent generally lasts for 20 years after the filing date.

Once a patent on a marketed pharmaceutical product expires, the property rights can be prolonged for up to five years under a “Supplementary Protection Certificate” or SPC. This mechanism is designed to compensate patent holders in the pharmaceutical industry for long preclinical and clinical development times that shorten the period during which they can actually commercially exploit the patent.

Related to patents, some countries like Germany issue so-called utility models which also cover technical inventions. In contrast to patents, utility models are only registered by patent offices, but not subjected to substantial examination, so that applicants obtain a registered IPR in hand much faster and for less money.

However, because utility model applications are not checked for technical overlap at registration, their enforcement is murky. Moreover, utility models usually have shorter terms than patents.

A_KUDR

You cannot patent, register or even use your invention if it shares general aspects with another under a patent filed at an earlier date. This aspect, which falls under the negative right to exclude others from commercially using the invention, might seem obvious, but it’s critical and often misunderstood by non-IP professionals.

If you run into this roadblock, you’re not out of options. In such a case, you might be able to negotiate a license from the holder of the older patent that blocks you, or arrange for a cross-license. You could even attract the holder to invest in your company if he or she is interested and such a deal fits with your long-term strategy. If this does not work out or does not match with your strategy, you will need to find a way to circumvent the blocking patent or invalidate this patent at the patent office or at court.

Another major concept of patents and other intellectual property rights is their territoriality. For example, a patent application filed with the German patent office can be enforced in Germany only. If it is filed with and granted by the UK patent office, it can be enforced in UK only. It is possible to file a regional application, as with the European Patent Office (EPO), in order to receive patent protection in the countries of those regions.

Piyapong Wongkam

Filing an international patent application under the Patent Cooperation Treaty (PCT) provides the advantage of filing applications in all of the about 150 contracting states at one time, but it will not give you an “international patent”; instead, a regionalization or nationalization is required for each country about 30 months after filing.

It may seem overwhelming, but developing a solid “IP strategy” for your company is necessary for its survival. Such a strategy is built on two pillars: filing own patents or other IPRs to protect your inventions and intellectual assets and analyzing the landscape of possibly impeding patents held by others to secure your “freedom to operate.”

Entrepreneurs need to be aware of the strategic implications and operational requirements of IPR management early on, as it might ultimately decide upon success or failure of their business initiatives.


imageChristoph Volpers finished his PhD in molecular biology in 1995. From the University of Mainz, he moved to Bradford University in the UK, where he earned an MBA. He started in IP at Teva, where he was the director of IP Biologics and joined his current law firm, Michalski Hütterman and Partner in 2015.


Images from A_KUDR, Jat306, Piyapong Wongkam, stoatphoto / shutterstock.com

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