Biotech and life science are fields that are full of intellectual property. Innovation in the fields of biotechnology and life science, includes innovation in biomedical devices and technologies, cosmeceuticals, environmental innovation, food processing, life systems technologies, nutraceuticals, pharmaceuticals, and more. Increasingly, we have seen strong biotech and life science innovation at the intersection of software and biotech, for example in the use of machine learning and analytics applied to life science data sets for diagnostics. RPL attorneys have worked across a wide range of biotech and life science fields, particularly in chemical and biochemical inventions, nutraceuticals, and bio-medical devices.
Like many fields of technology, in biotech and life science, patents and trade secrets protect the innovation and provide the competitive advantage required to build value in the trademarks that identify the products and businesses.
The time and expense required to bring biotech and life science innovations to market is often greater than in other industries. For some products, the difficulties can be due to the extended buying cycles and purchasing hurdles from hospitals and the like. There can be even greater hurdles for products that require regulatory approval, such as the FDA approval required with medical devices, drugs, and biologics.
Because the regulatory pathway can be very expensive and take years to clear, it is exceptionally important to know that you will own solid IP rights before heading down that path. Accordingly, the increased time and expense in bringing biotech and life science innovations to market (contrasted with, for example, mobile applications) make IP strategy especially critical at the early stages of product and business development. For example, it is important to identify whether an innovation is patentable or can be protected by a trade secret early in the process before committing to spending the requisite time and money. It is also important to develop products that don’t infringe others’ rights.
For these examples, in biotech and life science innovation in particular, it is especially important to have a robust and thoughtful IP strategy from the start.
Innovation in the biotech and life science fields can result in intellectual property across any and all of the four IP regimes: patents for securing the exclusive rights to your inventions; trade secrets for protecting the confidential know-how underlying your processes and techniques that can’t be reverse engineered from the customer facing products; copyrights for your written protocols, as well as the creative manner in which you present your innovation to the world through your website, videos, and other marketing materials; and trademarks protecting the branding (e.g., the names, logos, and taglines) that ties each of the previous assets into a valuable business.
In biotech and life science innovation, it is important to assess the patent landscape early in the R&D process. Patent searching can be a valuable tool at this stage; a patentability search or patent landscape search can be used to evaluate whether there is white space to innovate a protectable invention in the space; a freedom to operate search can help identify potential infringement issues and help guide the design process to avoid patent infringement.
Once a promising course is set, the R&D process can lead to the invention of patentable innovations. Preparing and filing patent applications then helps to claim ownership to those innovations. When the patents issue, they provide the owner the ability to prevent others from making, using, or selling the patented invention by granting the exclusive rights to the invention to the patent owner. This can be especially important in biotech and life science innovation where the path to market is long and expensive. The innovator has a tough path to market and, without patent protection securing the rights when the innovation finally starts to pay off, there may not be adequate incentive to bring the innovation to market at all.
When used correctly, the patents provide exclusive rights in the innovation that help to provide a competitive advantage in the marketplace. As discussed more below, that competitive advantage is used to help build the value in the trademarks.
For inventions that are based on, or that incorporate subject matter that is difficult to reverse engineer, trade secret protection is an alternative, and sometimes preferred, mechanism for IP protection. Like patents above, the protection offered by trade secret protection can provide exclusive rights in the innovation that help to provide a competitive advantage and build the value in the trademarks.
There is no registration process for trade secrets, you simply need to maintain the confidentiality of the secret. Using non-disclosure agreements and other confidentiality measures can be helpful in demonstrating the efforts you’ve taken to maintain the confidentiality of a trade secret, but the real key is that trade secret protection is only effective for inventions that competitors won’t be able to figure out based on the public facing aspects of your product and business. And that’s your competitive advantage; if they can’t figure it out, they can’t copy it.
Copyrights protect original works of authorship fixed in tangible media. In biotech and life science-related inventions, copyrights are most often used to protect the licensable protocols you have developed for implementing your technology and processes. Copyrights are also important in protecting your original works of authorship, including your videos, websites, marketing copy, etc.
Although the registration process is not nearly as complex as either the patent or trademark registration processes, it can be helpful to work with an experienced IP attorney to protect your copyrightable materials.
As in every industry in which a business is selling differentiated goods and services, branding is important. In biotech and life science innovation, strong branding represents quality, safety, efficacy, and trust. It is important to avoid infringing others’ trademark rights through trademark searches and opinions and developing rights in distinctive marks yourself by registering trademarks.
In the long run, the business’s trademarks are often their most valuable IP assets. However, trademarks take time and effort to develop recognition and goodwill in the marketplace. In order to have the space in the marketplace to build that goodwill, the patents and trade secrets need to hold competitors from copying your unique offerings and enable you to build your brand. This is one of many reasons it is important to strategically build a coordinated and thoughtful IP strategy from the outset.
RPL’s attorneys have a strong background in IP protection for biotech and life science innovation. RPL’s managing attorney, Patrick Richards has written, licensed, and enforced biotech and life science innovation patents since the first days of his legal career. In fact, the first patent application he wrote in 1999 for the University of Virginia was for a medical device used to deliver medication to the sinuses. In addition to his extensive biotech and life science innovation patent writing and litigating experience, Patrick has taught a course in medical innovation at the Northwestern University Pritzker School of Law each year since 2014. Patrick is also a co-founder and chief strategy officer of Resonance Medical, LLC, a health-tech company developing software for neuromodulation and other sensory enhancing devices. In addition, one of RPL’s most senior patent attorneys has spent the majority of her career working on chemical and biochemical inventions.