GLOBOCAN (WHO) released some unpleasant statistics in 2012 with respect to Breast cancer. The report noted that Breast cancer was the second most common cancer in the world and, by far, the most frequent cancer among women with an estimated 1.67 million new cancer cases diagnosed back in 2012 alone. The following year in June 2013, one of the most landmark decisions was arrived at by the US Supreme Court in the case of Association for Molecular Pathology v. Myriad Genetics.
To provide a brief history of the case, it was a case challenging the validity of gene patents in the United States, specifically challenging certain claims in the issued patents owned and controlled by Myriad Genetics covering isolated DNA sequences, methods to diagnose propensity to cancer by looking for mutated DNA sequences, and methods to identify drugs using isolated DNA sequences. Prior to this case, the U.S. Patent Office accepted patents on isolated DNA sequences as compositions of matter.
The case was originally heard in Southern District Court of New York, which ruled that all the challenged claims were not patent eligible. Myriad then appealed to the United States Court of Appeals for the Federal Circuit. The Circuit Court overturned the previous decision in part, ruling that isolated DNA which does not exist alone in nature can be patented and that the drug screening claims were valid, and confirmed in part, finding the diagnostic claims non-patentable. The plaintiffs appealed to the Supreme Court, which granted certiorari and remanded the case to the Federal Circuit. The Federal Circuit did not change its opinion. The plaintiff then filed a petition for certiorari with the Supreme Court with respect to the second Federal Circuit Decision. On November 30, 2012, the Supreme Court agreed to hear the plaintiffs’ appeal of the Federal Circuit’s ruling and on June 13, 2013, in a unanimous decision, the Supreme Court invalidated Myriad’s claims to isolated genes and held that “merely isolating genes that are found in nature does not make them patentable”.
This decision sent waves of cheers among those against gene patents and serious concerns among the big pharma players.
The story apparently did not end here for Myriad Genetic Inc., as the Australian High Court issued its decision on 7th October, 2015 in the case of Yvonne D’Arcy v. Myriad Genetics Inc & Anor. [2015] HCA 35 in the favor of Ms. D’Arcy (the appellant).
The suit patent contained 30 claims and it was the validity of the first three claims that was challenged in this case. The first three claims of the suit patent are reproduced here below –
“1. An isolated nucleic acid coding for a mutant or polymorphic BRCA1 polypeptide, said nucleic acid containing in comparison to the BRCA1 polypeptide encoding sequence set forth in SEQ.ID No:1 one or more mutations or polymorphisms selected from the mutations set forth in Tables 12, 12A and 14 and the polymorphisms set forth in Tables 18 and 19.
2.An isolated nucleic acid as claimed in claim 1 which is a DNA coding for a mutant BRCA1 polypeptide, said DNA containing in comparison to the BRCA1 polypeptide encoding sequence set forth in SEQ.ID No:1 one or more mutations set forth in Tables 12, 12A and 14.
3.An isolated nucleic acid as claimed in claim 1 which is a DNA coding for a polymorphic BRCA1 polypeptide, said DNA containing in comparison to the BRCA1 polypeptide encoding sequence set forth in SEQ.ID No:1 one or more polymorphisms set forth in Tables 18 and 19.”
The term “nucleic acid” in the above claims is defined is in the complete specification of the suit patent as including DNA, RNA or a mixed polymer and as “one which is substantially separated from other cellular components which naturally accompany a native human sequence or protein, eg, ribosomes, polymerases, many other human genome sequences and proteins.”
The issue with Claims 1-3 is that they are formally expressed as product claims. It basically means that the class of products claimed are those that are derived from naturally occurring sequences of nucleotides in the bodies of individual human beings.
In this context the Court noted that historically, “claims”, as definers of the inventor’s property, emerged in the late 19th century. The function of the claim was described by Lord Russell of Killowen in 1938 as “to define clearly and with precision the monopoly claimed so that others may know the exact boundaries of the area within which they will be trespassers.”
The Court observed that claims 1 to 3 were to any and every isolated example of the BRCA 1 gene, or a portion of the BRCA1 gene, which discloses the existence of one or more specific mutations or polymorphisms. Thus, if a question were to be asked whether specific mutations or polymorphisms of the BRCA 1 gene is the proper subject for the grant of a patent, the answer would be ‘No’.
Further, the Court found it apt to cite the rule of law under the Australian Patents Act with the intention to understand the content and the interpretation of the statute. Section 18 of the Australian Patents Act talks about “patentable inventions” and according to sub section 2 of this Act a patentable invention is an invention, which is a “manner of manufacture” and in the light of prior art is ‘novel’, ‘involves an inventive step’, ‘is useful’ and was not previously patented.
However, a further reading of the Act reveals that “Invention” according to the Act is defined as “any manner of new manufacture”. The difference is obvious to every reader. Whenever there is ambiguity in the words of law, interpretation problems are bound to arise. This has time and again been seen with the Indian Patents Act itself, where working, commercial working, non-working, etc have been subject to a series of different interpretations and opinions.
The strongest argument in the Myriad cases has always been that cDNA is not natural and requires substantial human intervention and technology to be created. For those who do not know what a cDNA is here are a few basics to the science.
DNA or Deoxyribosenucleicacid and RNA or Ribosenucleic acid are found in the nucleus of a cell. The DNA contains genetic information that directs the growth, development, maintenance and reproduction of the human body. DNA undergoes replication in the body and it is possible to create synthetic DNA outside the body too. In such a case, the complementary DNA (cDNA) is made using a form of RNA known as mRNA (messenger RNA) as the template to create a strand complementary to the naturally occurring DNA but not identical to it.
Further, there are certain regions of the DNA which are junk and do not code for any protein. What Myriad does is, it extracts, isolates and sequences the DNA of the BRCA 1 gene. It puts in much effort to remove these useless sequences, however the catch here is that Myriad uses well-established processes of DNA extraction, isolation and sequence comparison.
Making an indirect reference to the US Patents Act, the Australian High Court saw that the distinction between discovery and invention was not precise enough to be anything other than misleading. Terms such as “the work of nature”, “laws of nature”, etc. are very vague and ambiguous as are malleable.
In an important decision made in Australia, in the case of National Research Development Corporation v. Commissioner of Patents, it was said that “…everything that happens may be deemed ‘the work of nature’ and any patentable composite exemplifies in its properties the ‘laws of nature’. Arguments drawn from such terms for ascertaining patentability could fairly be employed to challenge almost any patent”.
With respect to the structure of the claims of the suit patent, the Australian High Court observed that:
- The claim was to multiple products, not a single product;
- Although Myriad claimed a class of chemical compounds as a product, it could not delineate the bounds of its claim by reference to chemical composition;
- Myriad did not create, make or alter the characteristic code;
- There was no idea, concept or principle embodied in a manner of new manufacture;
- The claim was too broad; and
- The Court has provided a detailed analysis and reason of the above mentioned observations.
This post would be too long to discuss all of the reasons provided by the court in its decision to invalidate the first three claims of the suit patent, save where they extend to forms of nucleic acid that have been synthesized in the laboratory, that is the Complementary DNA. For this reason, a link to the original judgment has been given below.
I would like to bring to the reader’s notice that, although the judgment in this case is quite long, about 99 pages to be precise. It is a sheer pleasure to read the judgment. The crispness of the analysis and the interpretation is worth every minute spent on reading this judgment.
Authored by Gaurav Mishra.
Original Judgement here
Image Source/ Attribution here, governed by Creative Common License CC0 1.0
