Over the past decade, the patent system has been used with increasing frequency to protect and cultivate the significant amount of innovation provided by today’s biotechnology and pharmaceutical companies, universities, and research institutes. Indeed, such organizations regularly call upon patent agents and attorneys to protect the fruits of their research. The extremely complex nature of this area of research often requires that such patent agents and attorneys have substantial education in the life sciences, such as Ph.Ds. or M.Ds. In recent years, individuals holding such degrees have become interested in pursuing careers in patent law. For those individuals who may be considering a career in patent law, but are unfamiliar the patent system, the following provides a general introduction to patent law.

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A patent is an exclusive property right that is granted by the government to one or more inventors, and can be obtained by filing a patent application with the United States Patent & Trademark Office ("PTO"). The PTO thoroughly examines the application and determines whether the claimed invention is useful, novel and nonobvious. During examination, the PTO may issue certain correspondence to the inventor, which indicates whether the invention is indeed patentable. The inventor is provided an opportunity to respond to any objections that the PTO may have to allowing the invention to be patented. This process is commonly referred to as "prosecution" of the patent application. If the PTO determines that the invention - as defined by the patent claims as originally filed or as amended by the inventor during prosecution - is useful, novel and nonobvious, the PTO will allow the patent to issue. Because the PTO conducts an extensive and substantive review of each patent application, an issued patent is "presumed valid" and is a form of what is generally known as "intellectual property."[1]

Patent holders are awarded the right to exclude others from making, using and selling the patented invention for a limited period of time. To clarify, a patent does not per se grant the right to practice the subject invention; rather, it only provides the right to exclude others from doing so, i.e., it is an exclusive right. In exchange for this exclusive right, the patentee must disclose the invention to the public and explain, in detail, how to make and use the invention without undue experimentation. What’s more, this description must reflect the "best mode" for practicing the invention. This disclosure is published in the patent itself, and is often referred to as the patent’s "written description" or "specification." The government’s purpose behind requiring patentees to adequately disclose their invention is to encourage and enable others to improve upon the patented invention. This way, inventors and research-driven organizations are encouraged to innovate by the exclusive rights afforded by patents, while at the same time they must disclose their inventions in a way that enables others to improve upon them as well.

The written description of a patent concludes with one or more claims particularly pointing out and distinctly claiming the subject matter that the inventor regards as the invention. The patent claims dictate the scope of the invention, and therefore, the scope of rights the patentee has to exclude others from making, using and selling the invention. The patentability of an invention is always measured by its description in the patent claims, which must be drafted in a way that satisfies the statutory requirements for patentability. In short, for an invention to be considered patentable, it must be useful, novel and nonobvious. As you might expect, "useful," "novel" and "nonobvious" are terms of art that have specific legal meanings.

In determining whether a claimed invention is "novel," patent examiners determine whether the invention, as defined in each patent claim, is "anticipated" by any single prior-art reference, e.g., a prior patent or publication that discloses the claimed invention in its entirety. If every element of a patent claim is present in a single prior art reference, then the claim is "anticipated" and is therefore unpatentable. If all elements of a patent claim cannot be found in any single prior art reference, then the claim is not "anticipated" and is considered novel. There are several types of prior art references that may destroy an invention’s novelty.

The term "prior art," generally, refers to publications or know-how that existed prior to the inventor’s date of invention. The most significant and commonly-referenced types of prior art include: (i) things that were known or used by others in the U.S. prior to the date of invention, (ii) things that have been published or offered for sale or placed in public use in the U.S. more than a year before the filing date of the patent application, regardless of the patent applicant’s date of invention and (iii) things that were disclosed in publications or patents prior to the date of invention anywhere in the world. The term "things" was purposely used in a vague manner. In general, such "things" may include a chemical compound, nucleic acid sequence, amino acid sequence, transformation vector, methods of using such compositions, and the like. In short, "things" should be interpreted broadly.

The utility requirement for patentability is typically the easiest to satisfy. In general, inventions that have a "credible" real-world utility will be assumed to be useful. This requirement, however, has been the subject of considerable debate in certain fields, such as in the biotechnology industry where some companies and researchers have pursued patent protection for methods and compositions that are only, or in large part, used as "research tools," such as the debate over the patentability of single nucleotide polymorphisms ("SNPs"). Despite this ongoing debate, the general rule stands. If the invention has a "credible" real-world use, then it probably will satisfy the utility requirement for patent protection.

Finally, if the claimed subject matter would have been "obvious" to a hypothetical "person of ordinary skill" in the relevant art(s) at the time the inventor invented it, then the claim cannot be patented. This is often the basis on which the PTO determines that a particular invention is unpatentable. Of course, to support such a rejection, the patent examiner must identify specific prior art references that contain information which, together, render the claimed invention obvious.

An examiner’s argument as to why an invention is believed to be unpatentable is typically set forth in what is known as an "Office Action." In most cases, patent applicants are provided the opportunity to respond to such Office Actions – regardless of whether the rejection is based on an alleged lack of novelty, utility and/or nonobviousness. In general, patent applicants (usually through their patent agent or patent attorney) respond to such rejections by submitting written arguments to the examiner - specifically showing why the examiner’s opinion is wrong. In addition, patent applicants may amend the originally-filed claims to further distinguish the prior art that the examiner cited. Again, this process of responding to a patent examiner’s findings is generally referred to as "prosecution" of the patent application.

The amount of time that transpires between the point where a patent application is filed and until, and if, it is eventually considered by the PTO to be "in a condition for allowance" (i.e., patentable) can be significant. It is not unusual for a patent application to take several years before it actually issues. In fact, new developments are often made to an invention while a corresponding application is pending. When this occurs, inventors may file one or more additional applications to cover the improvements to the invention. These subsequent applications may be filed in addition to the original application, and, if certain procedural and substantive requirements are satisfied, the filing date of the original application may be accorded, at least in part, to the later-filed application. The processes and legal nuances involved in filing such additional applications are things that every patent practitioner must know.

Now that you have some information regarding what a patent is and how one can be obtained, you may be wondering how they are used. Because an issued patent grants the legal right to exclude others from practicing the claimed invention, patent holders may assert those rights in court. As you can imagine, research and development in today’s world is not cheap. Thus, many parties that successfully develop and patent technology want to ensure that others do not wrongfully benefit from their efforts and monetary investments. This brings us to the definition of patent infringement.

Under 35 U.S.C. §271(a), whoever without authority makes, uses, offers to sell, or sells any patented invention (product or process) within the infringes the patent. Determining whether a patent is infringed, generally, entails two steps. First, the asserted patent claims must be construed to determine their meaning and scope. Second, whether the properly construed claims encompass the accused product or process must be determined. In general, during litigation, the patentee must show by a preponderance of the evidence that every limitation (or element) of the asserted patent claim is present (or an equivalent is present) in the accused product or process to prove infringement. When every limitation or its equivalent is present, the claim is said to "read on" or "cover" the accused product or process, and the claim is infringed. Of course, this description of patent infringement is an over-generalization, and is only provided to give you an idea of how licensed patent professionals go about analyzing issued patents and determining whether a product or process might be infringing.

As you may have gathered, the above introduction to patent law relates to law only, and does not reflect the laws of any foreign jurisdiction. Most industrialized countries today have their own patent laws. Although there are many apparent similarities between the patent laws of such countries and the , each system is unique in its own way – and some more than others. This notwithstanding, the World Intellectual Property Organization, a.k.a. WIPO, is the international body that promulgates rules and procedures relating to the enforcement of intellectual property on a global level, and consists of more than170 nations as member states. The headquarters for WIPO is located in Geneva, . If you are interested in learning more about the applicability of patent laws on an international level, you should consider visiting the website for WIPO, which is located at www.wipo.int.