Recognizing that you have created an invention is one thing; knowing how to protect it, claim its value, and ultimately seeing it through to a patent is another.
A patent tangibly documents a scientist’s contribution to innovation. For women in science, recognizing, documenting, and receiving credit for those contributions has always mattered. To celebrate women whose scientific work resulted in a patent, we are kicking off a new series: Claiming Innovation: Women Scientists Making Their Mark Through Patents. In each installment, we will meet a woman whose scientific work resulted in a patent and explore the invention, the science behind it, and the path from research to intellectual property.
Before we can celebrate these patent success stories, we need to better understand the process of obtaining a patent. I spoke with Lisa “Lee” Matovcik, PhD, JD, an intellectual property attorney and scientist with experience in medical research, academia, biotechnology, pharmaceuticals, and patent strategy.
What Is a Patent?
Dr. Matovcik first explains that a patent is a form of intellectual property protection awarded by a government for an invention. Importantly, patents are territorial: a US patent protects an invention in the United States, while protection in other countries or regions generally requires separate filings.
A patent is a “negative right,” Dr. Matovcik states. In other words, it gives its owner the right to prevent others from making, using, or selling the claimed invention. She emphasizes that this distinction matters. A patent does not necessarily mean that the patent owner can commercialize an invention. Other patents, regulations, licenses, and considerations can still affect whether the owner can bring the product to market.
For scientists, the more immediate question is often simpler: What makes an invention patentable?
According to Dr. Matovcik, an invention’s patentability relies on three basic requirements: It must be novel, inventive, and useful. Novel means that it is new. If the invention was publicly available before the relevant filing date, it may not meet the eligibility bar for a patent. Public availability, by the way, encompasses more than exposure in scientific publications. Posters, articles, press releases, oral presentations, and other public disclosures can affect patentability. The second requirement, that the product is inventive, means the product cannot simply be obvious to someone with ordinary skill in the relevant field. The third requirement, that the product is useful, however, is generally straightforward in biotechnology and pharmaceutical applications. The common issues in determining patentability usually revolve around novelty and inventiveness.
Dr. Matovcik notes that scientists often underestimate their own work, when it comes to patents. “What scientists see as routine may have aspects that are patentable,” she explains. Researchers routinely optimize protocols, identify unanticipated operating ranges, discover unexpected interactions, and develop new approaches to existing problems. While not every such modification is patentable, some work that scientists do in the ordinary course of research may be entirely new to the field and not at all obvious to those less cognizant of the finer points of the work. These activities can potentially result in patentable inventions.
She also says that biotech and pharmaceutical inventions can include chemical compounds, such as small molecules, protein therapeutics, antibodies, vectors, genetically modified organisms, formulations, combinations of products, methods of treating diseases, manufacturing processes, purification methods, and specific methods of administration. Sometimes innovation lies in such details as a new way to solve a problem, an unexpected result, or an improvement that makes an existing technology work better. Recognizing when you have an invention on your hands kickstarts the patent application process.
A Patent Application Is Not a Patent
One of the easiest ways to become confused, according to Dr. Matovcik, is to treat a patent application and a patent as the same thing. They are not. A patent application describes an invention and asks a patent office to grant protection for it. A granted patent results from an examination process during which the patent office determines whether the application meets the applicable requirements. The distinction becomes particularly important when looking at claims.
Patent claims consist of numbered statements that define what the patent legally protects. An application may describe an invention broadly, while the claims that the patent office ultimately issues may be narrower. “The claims define what is legally protected,” Dr. Matovcik explains. For scientists, this distinction marks an important shift in perspective. They cannot view a patent as simply a scientific description of an interesting discovery. They instead need to understand that precisely granted claims establish the legal boundaries of the protection.
From Ideation to Patent
So, what happens when a scientist thinks they may have invented something? They first need to identify the potential invention and then determine whether it may actually be new. Dr. Matovcik recommends that a scientist looking into a patent talk to the appropriate professional early on. In a company, that may be a patent attorney or intellectual property team. In an academic environment, they may need to reach out to the technology transfer office as an appropriate starting point. From there, the scientists and patent professionals can work together to develop an application that describes the invention and its potential uses in sufficient detail and breadth.
Patent seekers in the United States commonly first file a provisional patent application. A provisional application can establish an early US filing date and is not examined by the United States Patent and Trademark Office (USPTO). It provides up to a 12-month period in which the applicant can decide whether to proceed with a corresponding non-provisional application. That timeline is important because the provisional filing date can determine what information a patent office can consider to be prior art — evidence of the invention’s previous use or knowledge of its existence.
After the provisional period, an applicant may file a non-provisional patent application. The USPTO then examines the application to determine whether the invention is novel and nonobvious and whether the application meets other legal requirements. The examination process can involve multiple rounds of communication between the applicant and patent examiner and can continue for years, according to Dr. Matovcik.
Why Go Through All of That?
The answer to why this process has merit, particularly in the pharmaceutical and biotech industries, is commercialization. Dr. Matovcik explains that research and development require significant investments in time and money. Patents can help organizations protect their investments by preventing competitors from using protected inventions to enter the market. Patents can also create opportunities for licensing, in which another organization pays for the right to use the patented technology. Companies can even use patents in cross-licensing arrangements to help obtain freedom to operate, i.e., to commercialize their product without infringing on the patent rights of others.
Dr. Matovcik points to an important business consideration: “Sustainable R&D requires a return on R&D investment.” A patent portfolio represents one part of a larger business strategy rather than serving simply as a record of scientific achievement. That broad strategy must involve scientists. “Filing a patent is a joint strategic decision by a company’s R&D and patent offices,” she says. Development of this strategy includes considering the company’s business objectives, the commercial value of the invention, the competitive environment, existing information in the field, and the amount and quality of experimental support.
In other words, patent strategy should not begin after the science is finished. R&D and patent professionals should work together throughout a project to identify inventions and to mutually decide when filing makes sense.
Three Mistakes Scientists Should Avoid
Some of the most important patent lessons for scientists are surprisingly practical. Dr. Matovcik summarizes these lessons as follows:
- Don’t assume your work is too routine to be valuable. Scientists become experts partly by learning what experts in their field already know. That expertise can make genuinely inventive work feel obvious in retrospect. Dr. Matovcik cautions scientists against “undervaluing the inventiveness of the work.” If you have developed an unconventional approach, significantly optimized a process, identified an unexpected interaction, or found a new application for an existing technology, you should consider asking about intellectual property potential. You do not need to determine whether something is patentable yourself. That is what patent professionals are for.
- Do not publish first and ask about patents later. This mistake applies particularly to academic science, where publication is a major professional currency. If a researcher publishes before filing a patent application, they destroy the novelty of the invention and preclude their discovery’s patentability. A scientist may be excited to present a new result at a conference or to submit a manuscript as soon as the data are ready. If their result represents a patentable invention, however, they should consider their patent strategy before they make a public presentation. The practical takeaway is simple: If you think you have an invention, talk to the appropriate patent professional or technology transfer professional before presenting it publicly in any form. This of course includes not talking to reporters or to any media representative.
- Don’t assume a casual conversation is harmless. Scientists collaborate constantly, but they should keep their potentially patentable information within the appropriate confidentiality boundaries until they file an application. That includes being thoughtful about conversations with people outside their organization, including friends, colleagues, and the media. Dr. Matovcik advises, “Do not disclose outside the confidentiality ring of your organization before the patent is filed.” This does not mean scientists should stop communicating. It means communication needs to happen in the right order. Also, be sure to erase that whiteboard in the conference room before leaving it to the next occupants!
Why Should Scientists Care?
Patents can be an important part of an individual scientist’s professional record, “an important part of a resumé that documents the scientist’s value to their organization,” Dr. Matovcik says. In many corporate and academic environments, it is the organization, not the individual scientist, that ultimately owns the patent rights. However, being named as an inventor documents a scientist’s contribution to innovation. That’s why understanding patents — and recognizing your own contributions — are key parts of professional development.
Scientists do not need to become patent attorneys, but they should understand enough about intellectual property to recognize when their work might warrant a conversation with one. That conversation might happen after an unexpected result, during development of a new protocol, while optimizing a product, or when a research team realizes that they can use an existing technology in a new way. The earlier the conversation happens, the more options may be available.
There is a tendency to think of patents as something that happens after the science: Researchers make a discovery, and lawyers turn it into intellectual property. In practice, as Dr. Matovcik indicates, patents are part of a more collaborative process.
Scientists identify problems and develop solutions. Patent professionals help evaluate whether they can protect those solutions and how that protection fits into a larger strategy. Business teams consider commercial value and competitive positioning. Their collaborative efforts become much more than a legal document. They become a mechanism for translating scientific work into something that can potentially benefit the organization commercially.
Understanding the basics of patents gives us women scientists a better starting point for recognizing and protecting our contributions. This knowledge also gives us a framework for appreciating the people who have successfully completed this process and earned a patent.
Lisa M. Matovcik, PhD, JD, is an intellectual property attorney and a scientist who has provided strategic business counsel to biotech and pharmaceutical companies. She has blended an early career in medical research and teaching with a legal career, resulting in the ability to build scientific and business relationships that support the development of comprehensive global patent strategies.
Savanah Saldaña-Shumaker, PMP, is a dedicated chemist and entrepreneur with a passion for scientific outreach and communication. For nearly ten years, Saldaña-Shumaker worked as a research scientist in industry, government, and academia before transitioning to undergraduate education two years ago. In her free time, she is the cofounder of 8 Count Cosmetics, and she serves as a volunteer leader for multiple scientific organizations.
This article was originally published in AWIS Magazine. Join AWIS to access the full issue of AWIS Magazine and more member benefits.