ACLU’s successful challenge of genetic patents is promising for cancer treatment, but perturbing for patent lawyers

Matthew Thorpe is a JD candidate at Osgoode Hall Law School and is taking the Patent Law course.

In a landmark victory the American Civil Liberties Union (ACLU) and the Public Patent Foundation succeeded on a motion for summary judgement to invalidate patents held by Myriad Genetics over two genes linked with breast and ovarian cancer.  Prior to the March 29th ruling by a New York District Court, so-called “gene patents” were widely understood to be valid subject matter for patent protection within the United States, and Canada as well.  Currently approximately 20% of the human genome is currently subject to patent protection.  If this decision is upheld by the Federal Circuit on appeal it could usher in a new era for genetics research, medical treatment and patent law.

Patent law in the U.S. and Canada recognizes that certain types of subject matter, including “products of nature” are ineligible for patent protection.  The genesis of this doctrine can be traced to a decision by the U.S. Supreme Court decision of Leroy v. Tatham (55 U.S. 155, 157 (1852)) where a patent on purified lead was rejected on grounds that products of nature “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 any one person”.

Following the Tatham decision the products of nature exception remained rather broad in scope as patents were denied for other purified metallic elements like tungsten (but purification processes can be patented), as were patents for modified natural substances. For instance, In American Fruit Growers (283 U.S. at 12-13) the court found that oranges treated with mold-resistant borax were not patentable despite the fact that the “complete article is not found in nature” because the treatment did not amount to a sufficient change in the orange to produce a “new and different article” with a “distinctive name, character or use”.

While purified metallic elements have remained patent ineligible (see In re Marden) later decisions indicated that purified organic compounds such as vitamin b12, prostaglandins and adrenaline are patentable.  The rationale for allowing patents on biological molecules (in this case adrenaline) given by Judge Learned Hand in Parke-Davis & Co. v. H.K. Mulford Co., (198 F.2d 95 (S.D.N.Y. 1911)) was that through the isolation of adrenaline from gland tissue adrenaline became “a new thing commercially and therapeutically”.  Given the reasoning in Parke-Davis it is unsurprising that human genes, or more accurately, isolated DNA molecules with identical genetic sequences to human genes, were viewed as patentable subject-matter.  Although human genes occur naturally, polynucleotide sequences identical to the coding regions of human genes (those sequences that directly dictate polypeptide sequence) are not found in isolation outside of the cell.

Certainly the US Patent Office was under the impression the genes were patent-eligible, as it has previously issued a guideline to this effect (see the Utility Examination Guideline 66 Fed. Reg. 1092, 1092-1099 (Jan. 5, 2001)). As was Myriad Genetics, who had been issued 7 patents relating to Breast Cancer Susceptibility Genes 1 and 2 (BRCA1/2) which covered specific polynucleotides used to screen for mutations in the BRCA 1/2 – genes which can predispose individuals to cancer. The patents also covered the screening process itself.

In rendering its decision to invalidate the Myriad patents the District Court cited the rule from American Fruit Growers that subject matter must sufficiently distinct from a naturally occurring substance to be eligible for patent protection. The Court also relied on the Supreme Court’s ruling in Diamond v. Charkrabarty (447 U.S. 303). In Chakrabarty a patent was upheld for a genetically modified bacterium designed to break down crude oil and thus is useful for oil-spill remediation. While both the genes and the bacterium existed in nature the Court in this case found that the organism had “markedly different characteristics from any found in nature and one having potential for significant utility”.

Most interestingly, the District Court revived the rule that “purification” of a natural compound alone is insufficient to render a product of nature patentable, finding that Parke-Davis spoke to novelty and not patentability, and even went so far as to suggest Judge Learned Hand’s statement “if it were merely an extracted product without change, there is no rule that such products are not patentable” is no longer good law in light of Charkbarty (see pp 116 of the decision).  For the court, purification is not enough – the product must have markedly different characteristics from the natural form.

Applying this reasoning to the Myriad patents the Court found that the claimed DNA molecules were not markedly different from those found in nature, despite structural and functional differences in the molecules.  For the Court, DNA must be treated as unique from other chemical compounds because it is a physical carrier of information – information vital to the sum of biological processes within an organism.  In the Court’s own words “DNA…serves as the physical embodiment of laws of nature – those that define the construction of the human body” (pp. 124).   Therefore, while chemical differences might exist between isolated and naturally BRCA1/2 DNA, the identical informational content of these molecules means that they are not markedly different from each other, and are thus patent ineligible.

The Court also invalidated Myriad’s process patents finding that the claims were so broadly worded that they failed the “machine or transformation test” from Bilski (545 F 3d at 953). Myriad’s claims were loosely worded methods for “comparing” and “analyzing” sequences from the BRCA1/2 genes from individual samples to test for the presences of cancer-predisposing mutations.  The claims-in-suit did were not tied to a specific machine or apparatus as they did not specify a method for DNA isolation and sequencing, and so were not patent-eligible.

From the perspective of a cancer patient, the Court’s decision is reassuring.  Myriad’s patents provided it with a monopoly over screening for BRCA1/2 mutations.  The Myriad tests are costly (approximately 3000 USD per test, with two tests necessary for a complete screen) and not fully covered by Medicaid and some private insurers.  Furthermore, patents like those of Myriad have been criticized for chilling the development of improved genetic tests for cancers due to fears of patent infringement.  Similarly BRCA1/2 may be associated with other cancers, but research in this area is restrained by the patents.

As an aside, in Ontario the Myriad patents have been ignored and the screening for the BRCA1/2 genes is provided at a third of the cost charged by Myriad.

The ramifications of the decision for patent-law are not so favourable, as the Court seems to have overturned a long line of jurisprudence suggesting that purified biological molecules are not patent-ineligible under the products of nature exception.  If upheld on appeal hundreds of patents pertaining to isolated polynucleotides used in a host of biotechnical applications may be vulnerable to challenge.

While as a matter of public health care policy it might be best restrict the patenting of human genes in an effort to reduce the cost of medical treatments and improve research through greater information sharing, this type of policy shift is best accomplished through legislature, not the court.

The full decision is available online at: www.aclu.org/free-speech-technology-and-liberty-womens-rights/association-molecular-pathology-et-al-v-uspto-et-al