Identifying Biomarker Patent Infringement Risks

Patents give the patent owner the right to exclude others from practicing the patented invention. The patent, however, does not provide the patent owner with an affirmative right to practice the invention. For example, the owner of a patent that claims a method of using a biomarker can exclude others from the use of that biomarker. If another party owns a composition of matter patent on the biomarker (i.e., a patent to the biomarker itself), the owner of the method of use patent would not be able to make or use the biomarker for any purpose without the permission of the composition of matter patent owner. This second patent is said to dominate the biomarker use patent. These patents are also referred to as blocking patents. If a blocking patent exists, a person or company could be sued for using the biomarker without permission from the owner of the biomarker composition of matter patent. It is important to understand this distinction in order to avoid the feeling that possession of a patent on an invention protects the patentee from a charge of infringement when using that invention.

It is possible to research if a planned use of a biomarker infringes someone else' s patent. This process is known as determining if there is f reedom to operate around the use of the biomarker, sometimes referred to as freedom to practice. To determine if there are any patents that pose a risk of infringement, a laboratory scientist or drug development team first needs to search for patents that would cover the making and use of the biomarker. Typically, a fee .based patent search firm is employed to use text-based searching and sequence -based searching to identify potentially relevant patents. It is also possible to conduct some initial searching on one's own. There are currently several free Internet-based public databases that are available for searching patents such as the USPTO database available at http://www.uspto.gov, http://www.patentlens.net, http://www.google.com/patents, and http://www. freepatentsonline.com .

The next step is to interpret if any of the potentially relevant patents identified in the search pose a significant risk of patent infringement to the planned activities. The layperson or scientist may find the scope of patent claims to be difficult to understand. Often, a patent specialist such as a patent attorney is needed to review the search results and provide advice on potential infringement concerns. If there are any potential infringement issues, the scientist and the patent attorney can work together to address those issues. Potential ways to reduce infringement risks include licensing the problematic patent from the owner, designing around the patent, or deciding not to use the biomarker. The potential availability of certain exceptions and exemptions to infringement is also discussed below.

Licensing a Patent

If there is concern that a planned use might infringe a patent, one way to address this issue is to obtain a license from the patent owner that would allow the licensee to practice the patented invention. Different types of licenses are common in the biomarker arena. The license may involve an up-front payment with no further obligation to the patentee. In other circumstances, during the license term the license terms might require payments such as royalty payments or payments when certain development milestones are met. For example, a license to a diagnostic kit might include a $20,000 payment upon signing the license and a 2% royalty paid annually based on that year 's net sales from the diagnostic kit.

Designing Around a Patent

For cases in which a license is not available or the terms of the license would not be reasonable, another option is to design around the claims of the patent.

A typical design around strategy involves designing a biomarker in a way that is outside the scope of the blocking patent. A skilled patent attorney can examine the scope of the claims and advise if there is a potential design-around. For example, a patent may claim only the full-l ength sequence of a protein or a nucleic acid biomarker. If the full-length sequence is not necessary for the use being considered, use of a modified sequence that is shorter than the full-length sequence may not infringe the problematic patent claim. Successful design-around strategies can realize cost savings in research and development costs, legal fees, and potential litigation costs, as well as minimize the delay in commercializing a product or method. Designing around a patent is one of the ways in which the patent system works to promote new advances in technology.

Another design-around strategy is sometimes called a geographic design-around. As noted above, patents are territorial and can only be enforced in the countries in which the invention is patented. Therefore, it may be possible to make and use a specific biomarker in a country where the patentee has not yet obtained patent protection or will not be obtaining patent protection. For example, it might be that a desired biomarker has been patented in the United States but not in Canada. If use of the biomarker can be limited to Canada (or to any other country where the invention is not patented), there would not be a need to license that biomarker.

Ceasing Use of the Biomarker

One option to address a significant infringement risk is to stop using the bio-marker. This may not be a preferred option, but in certain cases it may be the only appropriate course of action.

Exemption from Infringement Under 35 U.S.C. § 271(e)(1)

Under 35 U.S.C. § 271(e)(1), the use of a biomarker to discover a drug or in clinical trials might be exempted from infringement if the use is "reasonably related to the development" of information that might be submitted to support U.S. Food and Drug Administration (FDA) approval. Although the boundaries of the exemption are not completely clear, the courts have exempted the use of a patented compound under 35 U.S.C. § 271(e)(1). The courts, however, have not addressed directly whether the use of a research tool such as a bio-marker in drug development would fall under the 35 U.S.C. § 271(e)(1) exemption. Thus, the boundaries of the exemption are somewhat uncertain with regard to research tools. Once the drug is approved, however, further use of a patented biomarker will generally not be exempted from infringement.

Experimental Use Exception

For private institutions such as companies and private universities, there is generally no immunity from a patent lawsuit under an experimental use excep tion.11 This was made clear in the private university arena in the Madey v. Duke case in 2002. The federal circuit court held that the "very narrow and strictly limited experimental use defense" was applicable only if a patented invention was used "solely for amusement, to satisfy idle curiosity, or for strictly philosophical inquiry."12 Duke's use of a patented invention was related to obtaining research funding which was in furtherance of their legitimate business. It would seem, then, to be the rare case where even a private university would not be subject to a patent lawsuit if its activities relate to obtaining research grants. Accordingly, the research use exception in the United States does not provide much protection from a patent lawsuit.

Immunity Under the 11th Amendment

In general, a state institution such as a state university may not be sued for patent infringement. The 11th amendment of the Constitution prevents a private party from suing a state university for patent infringement.13 Thus, an individual or a for-profit corporation would not be able to sue a public university for use of a patented biomarker. The state immunity does not transfer to a licensee of a patent from a state university. Therefore, if such a biomarker patent is licensed from a state university, the licensee could be subject to a patent lawsuit from the holder of the biomarker patent even though the university would not.

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