Patents are one key way to protect biomedical inventions.
A patent is an official document granted by the government to a patentee conveying specific rights. Such patent rights specifically granted to a patentee are the right to exclude others from making using or selling the patentee’s invention in the country in which the patent is issued.
A patent has a limited life - the patent term of a U.S. patent is 20 years from date of earliest effective filing date of the patent application pertaining to the invention.
A patent has three parts: the specification, claims and drawings.
-The specification is the detailed written description of the invention (substantial portions of a manuscript are incorporated in this part).
-The claims are at the conclusion of the specification; the scope and exact wording of the claim is important because the claims of an issued patent are what defines the invention and the specific rights granted by the government.
-Drawings are included if needed to understand the subject matter of the invention.
How to obtain a patent:
The section below describes some of the key requirements to successfully obtain an enforceable patent.
A. Prior Art based requirements: Novelty and Non Obviousness
Since the U.S. government gives a patent holder a limited monopoly on an invention for 20 years from the first filing date, the government demands that a patent will not be granted if the invention is already in the public domain as defined by patent law. The invention must be new or “novel”.
The patent statute provides that no patent shall issue if the invention:
(a) was known or used by others in the United States, or patented or described in a printed publication anywhere in the world before the applicant’s invention;
(b) was patented or described in a printed publication anywhere in the world or in public use or on sale in the U.S. for more than one year prior to the application for patent in the United States.
An inventor has this one year grace period from the time any of the above “public disclosures” occurred to file a patent application in the U.S. It is important to note that this grace period does not exist in most foreign countries that have a standard of “absolute novelty”.
These two provisions known as §102(a) and §102(b) respectively and deal with what is referred to as “Prior Art” which is all events, information and knowledge that is accessible to the public before the generation of the idea. In order to qualify as Prior Art, the art is expected to provide an enabling description to a person of skill in the art.
Information kept secret is not usually considered prior art provided that people with access to this information have a non-disclosure obligation. In the absence of a non-disclosure obligation, the information is considered to be in the public domain and, therefore, qualifies as Prior Art.
Examples of Prior Art are:
- Publications available to the public (including online publications of articles)
- Public uses or sales
- Conference presentations
- Internet communications
- Posters ( e.g., posters for SAC presentations at MGH)
- Meeting abstracts
- Awarded grant applications
- Non-confidential oral disclosures
- Ph.D. thesis (defense)
Data presentations at laboratory meetings that are not attend by or open to anyone outside the research institution are usually considered confidential and do not constitute public disclosure. The NIH process for review of grant applications is a confidential process and is not considered to constitute public disclosure until the grant is awarded. However, many other funding agencies may not have a confidential review process for grant applications.
In order to assess patentability of an invention, a person (typically the business manager in the technology transfer office with the inventor and a patent specialist) may conduct a novelty or prior art search prior to filing a patent application. A novelty search helps an inventor determine if the invention is patentable, based on novelty, before committing the financial resources necessary to prosecute a patent application.
A novelty search usually includes a search of patent databases, published patent applications, publications and peer reviewed articles and Internet search engines. To effectively locate relevant prior art investigators should search using key search terms that envision the “claims” of a patent (succinct statement of the invention) and/or names of key competitors. A few recommended databases to search are:
Besides being novel an invention must also be “non obvious” to be patentable. While a single novelty-defeating event, based on §102(a) and §102(b), must contain every element in the applicant’s invention (i.e. claims of the patent application), expressly or inherently, an invention application may also be un patentable if more than one prior event, combined with a teaching, motivation, or suggestion, would make the invention obvious. This non obviousness provision is referred to as §103. An invention is considered obvious if teachings from the prior art appear to suggest the invention to a person of ordinary skill in the art.
B. Key Non-Prior Art Based Requirements
(i) Utility: In order to be patentable an invention must also be useful or have utility. The patent claim must recite an idea that has credible, specific and substantial use.
(ii) The specification of the patent application must include and meet the standards for:
Written description: a complete written description of the invention such that it is sufficient to support the specific claims.
Enablement: a description sufficient to allow a peer in the field to make and use the claimed invention without undue experimentation.
Best Mode: the specification must disclose the best mode or method known to the inventor, in his opinion at that time, for carrying out the invention.
C. Key Procedural Requirements
The stated inventorship of the patent claims on the patent must be correct; misnaming or non-naming of inventors of the patent claims could jeopardize the enforceability and validity of the patent.
An invention is characterized by two necessary components, conception and reduction to practice. Conception is the formation in the mind of the inventor, of a definite and permanent idea of the complete and operative invention. Reduction to practice is the carrying out or embodiment of the conception. Although an invention requires a two-pronged process, inventorship is characterized exclusively by the conception prong i.e. inventors are those who contribute to the conception of the patent claims. Unless a person contributes to the conception of the invention, the person is not considered an inventor. Analogously, an inventor is not required to reduce the invention to practice.
A person who borrows and uses ideas gleaned from other sources, even if such sources are a key to the discovery, may be an inventor as long as the person maintains intellectual dominion over the work. Thus, in this example, conception can metaphorically be viewed like the act of a person solving a jig-saw puzzle from individual pieces.
Inventorship is a legal determination and the rules for inventorship are much stricter and different than authorship rules generally used in academic customs. For example,
· An inventor cannot be just a “pair of hands” acting under direction and control of another.
· One does not become an inventor solely by being:
- A contributor of money or other resources
- Head of a research department
- Lab technician
- Research assistant
- Colleague on sabbatical
(ii) Duty to Disclose Information that is Material to the Patentability of the Patent Claims:
Each individual (e.g. inventors and patent attorney) associated with the filing and prosecution of a patent application has a continuing duty to disclose information that is material to the patentability of the patent claims through the prosecution period until the time the patent claims are secured and patent has issued.
Information that may be material to the patentability of the invention includes:
– Public disclosures of or relating to the invention:
• Public disclosure can be oral or written. Any information conveyed under a confidential disclosure agreement (CDA, also non-disclosure agreement, NDA) is considered to be non-public.
• Abstracts, posters, preprints, prepublication “publishing” to web sites, web site information, awarded grant applications, parts of rejected grant applications, and clinical trials can all be public disclosures.
– Substantive negative research data relating to the invention:
• For example, data indicating that a claimed medical device fails when a material named in the patent application is used to make the device should be disclosed.
Failure to disclose information that is material to the patentability of the patent claims may render the patent claims unenforceable or invalid.