Patents on Human DNA Held Invalid

 

Another in the “Smart Start” Series

 

© 2010, Kane & Co., PLC

 

            On March 24, 2010, in the case of Association for Molecular Pathology et al. v. United States Patent and Trademark Office, Docket 09 CIV 4515 (SDNY 2010), U. S District Judge Sweet invalidated seven patents owned by Myriad Genetics claiming genes linked to cancer.[1]  The court’s 156-page opinion is a blow against pharmaceutical and health care company’s attempts to claim ownership of cellular components normally associated with native DNA, including proteins and other DNA sequences comprising the remainder of the genome, originating from a cell as well as DNA synthesized through chemical or heterologous biological means.

 

            Researchers and scientists have long searched for methods to diagnose and identify the risk of serious health problems before they occur.  This is particularly true of ovarian and breast cancer.  Many women would like to know in advance whether they are at risk of developing these often-incurable cancers.

 

            Myriad Genetics, along with others, conducted research on sequencing genes related to breast and ovarian cancer.  Myriad filed for and obtained patents in the United States and abroad protecting methods for detecting naturally occurring human genes associated with high risk for breast or ovarian cancer.  In all Myriad obtained seven patents in the United States protecting the method and the isolated gene.  Myriad offered testing to other clinics and their patients at a substantial cost.

 

            Other clinics, doctors, and researchers developed methods for isolating the telltale genes using less expensive, and sometimes more accurate methods.  However, these services were halted after the doctors and institutions received letters from Myriad alleging infringement of their patents.  Myriad also did not permit researchers to tell patients involved in research the results of their genetic tests, leading physicians involved in breast cancer care and research unable to meet their ethical obligations to provide genetic test results to research subjects, when requested.  As a result, a number of patients, healthcare providers, and others joined forces to challenge the patents owned by Myriad Genetics.

 

            Before the Court reached the question of infringement, it looked into the question of whether the patents covered subject matter that was protectable by statute in the United States.  The law states that “[w]hoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefore, subject to the conditions and requirements of this title.”  Thus, the principal focus of the Court shifted to whether the patents claimed patentable subject matter.

 

            A substantial dispute between the parties concerned the interpretation and meaning of the terms "DNA" and "isolated DNA".  The plaintiffs argued that the term "DNA" means "a sequence of nucleic acids, also referred to as nucleotides" and therefore constitutes a "nucleotide sequence" or a "polynucleotide."  Myriad disputed plaintiffs' definition of "DNA" insofar as plaintiffs' definition suggested that the term "DNA" referred merely to information, that is, "a description of the linear order of nucleotide units that make up the polynucleotide.”  Myriad instead argued that "DNA" referred to "a real and tangible molecule, a chemical composition made up of deoxyribonucleotides linked by a phosphordiester backbone."

 

            The Court reasoned that the understanding of the meaning of "DNA" was shared by all parties to the litigation.  The term "isolated DNA" was defined as "a fragment of DNA substantially separated from other cellular components and other DNA."  Myriad disputed the definition insofar as it implied that fragments of DNA existed free-floating in the cell, separate from other cellular components, such as proteins and the other DNA in the chromosome.  The patent specifications expressly defined "isolated DNA" as a DNA molecule "which is substantially separated from other cellular components which naturally accompany a native human sequence [such as] human genome sequences and proteins" and "includes recombinant or cloned DNA isolates and chemically synthesized analogs or analogs biologically synthesized by heterologous systems."  “Isolated DNA” was therefore construed to refer to a segment of DNA nucleotides existing separate from other cellular components normally associated with native DNA, including proteins and other DNA sequences comprising the remainder of the genome, and includes both DNA originating from a cell as well as DNA synthesized through chemical or heterologous biological means.

 

            The Supreme Court recognized that scientific principles and laws of nature, even when for the first time discovered, have existed throughout time, define the relationship of man to his environment, and, as a consequence, ought not to be the subject of exclusive rights to anyone person.  Specifically, the Supreme Court recognized three categories of subject matter that fell outside the scope of § 101:  The laws of nature, physical phenomena, and abstract ideas have been held not patentable.  The rule that the discovery of a law of nature cannot be patented rests, not on the notion that natural phenomena are not processes, but rather on the more fundamental understanding that they are not the kind of 'discovery' that the statute was enacted to protect.

 

            The exclusion of products of nature as patentable subject matter under § 101 also reflects the Supreme Court's recognition that phenomena of nature, though just discovered, mental processes, and abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological work.  Thus the reason for this exclusion is that sometimes too much patent protection can impede rather than promote the Progress of Science and useful Arts, the constitutional objective of patent and copyright protection.  For these reasons, manifestations of laws of nature are free to all men and reserved exclusively to none.  The inquiry into an invention's patent eligibility is a fundamental one, and as such, the obligation to determine what type of discovery is sought to be patented must precede the determination of whether that discovery is, in fact, new or obvious.

 

            Accordingly, in deciding whether an invention complies with § 101, the court must decide (1) whether the claimed invention possesses utility; and (2) whether the claimed invention constitutes statutory subject matter.  In other words, whether it is a process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, or whether the claimed invention instead falls within the judicially created "products of nature" exception to patentable subject matter, i.e., "laws of nature, natural phenomenon, and abstract ideas.

 

            Supreme Court precedent has established that products of nature do not constitute patentable subject matter absent a change that results in the creation of a fundamentally new product.  In American Fruit Growers, the Supreme Court rejected patent claims covering fruit whose skin had been treated with mold-resistant borax.  Acknowledging that the "complete article is not found in nature," and "treatment, labor and manipulation" went into producing the fruit, the Court nonetheless held that the fruit did not become an "article of manufacture" unless it "possesses a new or distinctive form, quality, or property" compared to the naturally-occurring article.  The Court went on to observe that manufacture implies a change, but every change is not manufacture, and yet every change in an article is the result of treatment, labor, and manipulation.  Something more is necessary.  There must be transformation; a new and different article must emerge having a distinctive name, character, or use. 

 

            It is very likely this decision will be appealed to the Court of Appeals for the Federal Circuit in Washington.  All in the health care industry will also be monitoring the case with close attention.  The outcome will dramatically impact economic models of many health care programs throughout the country, if not the world.  For the time being, individuals are still the owners of their cellular components normally associated with native DNA, including proteins and other DNA sequences comprising the remainder of the genome, originating from a cell as well as DNA synthesized through chemical or heterologous biological means. 

 

            The question arises if the same result would have been reached if the composition claims were not included in the applications, but contained merely the method claims.  The history of the case does not expressly address the method claims other than in a historical context.  Moving forward, those in the industry should recognize the implications of § 101 of the patent statutes.  Although the United States Patent and Trademark Office may allow composition claims, the patent owner now puts much at risk when considering enforcement of claims directed to naturally occurring human genes.

 

            For more information on how to avoid application of § 101 to your biotechnology, contact Barry Kane or Eric Hultman at Kane & Co., PLC, (616) 726-5905.