Many biomedical innovations have the potential for commercialization. As there is usually a lag between initial conception of ideas and commercialization of a developed product, it is important to develop a strategy at an early stage for protecting inventions. One way is to obtain a patent.
A patent is a form of intellectual property granted by the government to the inventor. Once a patent is granted in a country, the patent owner has the legal authority to exclude others from making, using or selling the invention in that country without a license. In the United States, patent rights exclude others from making, using, offering for sale, selling or importing the invention in a limited time period. Patents can attract investment and generate income for patent owners because of the granted monopoly rights.
Patent protection in one country does not extend to other countries. Thus, inventors need to obtain patents from each country or territory to protect their inventions. Usually, a nation’s patent office is in charge of the granting of patents in that country. The United States Patent and Trademark Office is the government agency responsible for the examination of patent applications and the granting of patents in the U.S. There are international treaties, such as the Patent Cooperation Treaty (administered by the World Intellectual Property Office and covering more than 140 countries), that centralize some portions of the filing and examination procedures.1
The process of obtaining a patent is called patent prosecution. In the U.S., the first step in prosecution is to file a patent application with the USPTO. A patent application generally contains the following:
- • the title of the invention,
- • the background of the invention,
- • a brief summary of the invention,
- • a brief description of the drawing(s) of the invention (if any),
- • claims, which define the invention the applicant is seeking to protect, and
- • an abstract.
A patent application does not have legal force until it is granted and issued as a patent.
The USPTO examines a patent application for compliance with several legal requirements as discussed below.
First, the subject matter of a given claim must be eligible for a patent. Examples include non-natural products or materials, such as genetically engineered polynucleotides, polypeptides and organisms, humanized antibodies, compounds isolated from nature, and new chemical compounds. Claims that are directed to “laws of nature, natural phenomena and abstract ideas” are not eligible. For example, methods of analyzing a gene sequence in a patient and comparing it with the normal sequence to identify the presence of disease-predisposing mutations are not eligible, because such methods set forth laws of nature – namely, the relationships between gene sequences and the likelihood of developing certain diseases.
In addition, the invention defined by the claims must have utility; in other words, the claimed invention must be useful for any particular practical purpose that would be considered credible by a person skilled in the relevant area of technology. The claim language must also clearly point to and define the boundary of the subject matter that will be protected by the patent. Furthermore, the application needs to adequately describe the claimed invention and provide a description of how to make and use the invention in sufficient detail for a person skilled in the relevant area of technology to make and use the invention. For example, if a patent application claims to have a newly identified mammalian protein, the application needs to disclose the amino acid sequence of the protein from different mammals as well as how to make and use the protein. These requirements ensure that the scope of patent protection granted matches the disclosure provided by the patent. Moreover, the invention must be novel and not obvious based upon what is already known in the field.
In the context of the legal requirements discussed above, the USPTO examination focuses on the claims, which define the scope of protection afforded by a patent. If the USPTO rejects or objects to the claims for failing to meet any one of the legal requirements, the applicant can provide technical data to rebut the examiner, request reconsideration and/or appeal the USPTO’s objections as necessary. A patent will be granted after the objections are overcome and the required fees are paid.
Biomedical inventions, laws governing patentability and patent office proceedings are complex. Careful planning and execution are required to obtain strong patents, which are essential tools in the commercialization process. Bringing biomedical inventions to market and building strong patent portfolios can generate significant economic rewards for both inventors and research institutions.
1 Although under the Patent Cooperation Treaty patent applications can be filed and certain parts are examined, no “PCT patent” is granted. For a patent to be granted from a PCT application, the application needs to enter each individual designated country for examination and compliance with the relevant laws in that country.
Click here to see an easy-to-read graphic explaining how to obtain a patent.
Gaby L. Longsworth (email@example.com) is a director with the law firm of Sterne, Kessler, Goldstein & Fox P.L.L.C. Chenghua Luo (firstname.lastname@example.org) is an associate with the same firm. Longsworth and Luo concentrate their practice in patent law.