Patent Protection in the Era of Accelerating Medical Advances

The completion of the Human Genome Project at the beginning of this century, which mapped all the genes in the human body, offered scientists and researchers the opportunity to determine the characteristics of many genes and their relationships to certain diseases. The vast investment of resources necessary to conduct this research prompts those undertaking such painstaking scientific inquiry to secure patent protection for their discoveries.  The Supreme Court decision in Association for Molecular Pathology v. Myriad Genetics, Inc., et al., 133 S.CT. 2107 (2013)issued last year further defines the subject matter that is eligible for patent protection and that which is not.

The pharmaceutical company, Myriad Genetics, Inc., through considerable effort, discovered the precise location and sequence of two human genes, BRCA1 and BRCA2, mutations of which can substantially increase the risks of breast and ovarian cancer.   Myriad filed, and received, various patents for its discovery.   The patents were directed, in part, to naturally occurring segments of deoxyribonucleic acid (DNA) obtained merely through the isolation of the DNA segments, wherein the segments contained genetic code identical to genetic code residing in the DNA segments prior to their isolation.

The patents were also directed to the isolation of synthetic DNA, known as complementary DNA (cDNA), which was created by removing certain nucleotides from a segment of DNA.  As the owner of these patents, Myriad could prevent others from conducting diagnostic tests to determine the risk of breast and ovarian cancer in an individual.  Myriad refused to license these patents, and thus, controlled this type of diagnostic testing, that is, until the Supreme Court decision.

Section 101 of the Patent Act provides that “whoever invents or discovers any new and useful….composition of matter, or any new and useful improvement thereof, may obtain a
patent therefor, subject to the conditions and requirements of this title.”  35 U.S.C. §101.  With respect to Section 101 the Supreme Court noted that “[w]e have ‘long held  this provision contains an important implicit exception[:] Laws of nature, natural phenomena, and abstract ideas are not patentable.'”  Natural phenomena are the tools of
scientific investigation not the products of creative development which patents are intended to protect.

The issue presented was whether Myriad’s discoveries were ‘new and useful …composition of matter’ or simply a naturally occurring phenomena, and thus, simply an attempt to patent life.  The Supreme Court ruled that the discoveries of genes
identified by merely segmenting a tiny portion of the naturally occurring DNA strands does not constitute a patentable invention; however, the creation of complementary DNA is
entitled to patent protection because it is not a “product of nature”, but rather, constitutes a composite containing sequences of nucleotides that are not naturally
occurring, and thus, is subject matter which is eligible for patent protection.   It will be interesting to see how this ruling will be applied in other biotechnology inventions.

Patent Protection for Medical Advances

Attorney Anna M. Vradenburgh counsels and represents clients regarding trademark, copyright, patent and other intellectual property issues, providing expert advice regarding intellectual property protection, exploitation and rights enforcement.  To discuss your particular matter with Ms. Vradenburgh, please contact her at the Eclipse Group, located at 6345 Balboa Blvd, Suite 325, Encino, California 91316, by calling (818) 488-8146 or going to her website or her profile on LinkedIn.

This article is not intended to be, nor should it be considered to be, legal advice.

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