Introduction to Intellectual Property
As my initial entry to this blog, I would like to provide a high-level overview of U.S. Intellectual Property ("IP”) law. This overview will provide background information on the various areas of IP. Future entries will consider how the various aspects of IP effect and are affected by HIPAA/HITECH and the electronic patient record initiatives. The basic components of IP include: patents, copyrights, trademarks and trade secrets.
A patent is essentially a grant from the federal government conveying to the owner the exclusive right to prevent others from making, using, offering for sale, selling or importing the patented invention. It grants these monopolistic powers for a limited period in exchange for full and complete disclosure of invention to the public.
Note that a patent does not convey an absolute right to practice the invention. For example, a patent on an improvement to a product does not invalidate any existing patent on the underlying product, which may be owned by a different inventor. Thus, hypothetically, an inventor holding a patent on a five-legged chair could still infringe a patent to a four-legged chair held by another inventor.
In order to be patentable, the subject matter must be new, useful and non-obvious. U.S. patent law provides certain “statutory classes” of patentable subject matter. These include: processes/methods, machines, articles of manufacture, compositions, and certain business models (a.k.a., “business methods”).
Examples of patentable subject matter in the healthcare, pharmaceutical and biotechnology arenas include: compounds, intermediates, compositions and methods of making these, diagnostic kits, methods for isolation/purification of compounds, methods for analysis, methods for treatment/use, screening methods, improvements to known compositions, improvements to known methods, combinations of active ingredients, microorganisms. cell lines, cellular compositions, viral isolates, vectors or cloning/expression vectors and DNA/RNA promoters, synthetic oligonucleotides, signal sequences, expressed sequence tags (ESTs), proteins, monoclonal antibodies/hybridomas, isolated antigens/vaccine compositions, methods for isolation/purification of biological materials, methods for cloning/protein production, methods for diagnosis, methods for treatment/use, screening methods, and transgenic animals/plants.
Patentability of “business methods” may also be of significant issue in this blog as the era of HIPAA/HITECH and electronic patient records unfolds, and as computer user interfaces, processing software, database structures and other aspects of electronic patient record generation, processing, storage and retrieval are developed.
A trademark is any word, symbol or device used to identify one’s product and distinguish it from the products of others. Trademark rights are available “appurtenant to use” – that is - to be valid, a Federally-registered trademark must be in use in interstate commerce. Also, an active trademark should be policed by its owner, as allowing a trademark to be infringed or diluted by another’s unauthorized use may lead to effective loss of the trademark.
In the U.S., a person may apply for a Federal trademark registration by filing either an intent-to-use or an actual use trademark application. If an intent-to-use application is filed, a Statement of Use identifying actual use in interstate commerce will need to be filed before the trademark will be registered as active.
U.S. trademark law, particularly with respect to the court cases (i.e., “case law”), is particularly voluminous (i.e., “lots of it”). It would be easy to devote entire blogs to discussions of trademark case law. We’ll defer further discussion here for a future entry.
A copyright is the right that the government gives an author of any original work of expression to exclude others from copying or commercially using the work of expression without proper authorization. Examples include books, poetry, plays, songs, catalogs, photographs, computer programs, advertisements, labels, movies, maps, drawings, sculpture, prints and art reproductions, game boards and rules, recordings.
Copyright protection is easy to obtain by filing a form with a sample of the work and a small fee. Authors of copyrighted works should include an appropriate copyright notice on the work.
Applying for Federal registration of a copyright is required prior to filing a lawsuit for copyright infringement in a U.S. Federal District court.
U.S. copyright may very well operate as a speed bump on the road to HITECH, electronic patient records, and government-run universal healthcare. We will particularly address copyright issues in one or more future blog entries.
A trade secret is any information, design, device, process, composition, technique or formula that is not known generally and that affords its owner a competitive business advantage. Reasonable measures to maintain the secret must be made so as to obtain relief against those who wrongfully obtain the information.
These are traditionally the basic components of IP law. Additionally, Internet-related issues are increasingly tied to other IP – such as domain name dispute resolution where the complainant owns a trademark to the domain name.
My next entry will discuss potential patent issues with respect to HIPAA/HITECH and electronic patient records.