Taapsi Johri, a practising IP lawyer, has sent us this very interesting guest post on the ongoing Myriad, 'gene patents' case before the CAFC. The focus of her post is on the amicus brief filed by Dr. James Watson, the Nobel Laureate who discovered the double helix structure of DNA. Taapsi's post below captures the essence of the debate and its applicability to India, which apparently has been granting gene patents.
Myriad’s Gene Patent Case Receives an Amicus curiae brief by Nobel Laureate Dr. James D. Watson
In March 2012 the U.S. Supreme Court remanded Myriad Genetics’ case (Association for Molecular Pathology, et. al. v. United States Patent and Trademark Office, et. al.) to the Court of Appeals for the Federal Circuit (CAFC) for “reconsideration”. The matter involves questions on patentability of (isolated and unaltered) genes and was due for hearing on Friday, July 20, 2012.
|Dr. James Watson. (Image from here)|
My interest in this case was result of something I happened to chance upon - an amicus curiae brief filed by, none other than, ‘Father of the DNA Double Helix’, Dr. James D. Watson. While a number of amici briefs have been filed in support of the Plaintiffs (6), in support of the Defendants (5) and in support of neither party (12), I found this one rather intriguing, for obvious reasons. Dr. Watson is one of the key persons responsible for discovery of what lies at the heart of all the controversy, the DNA molecule and its ever-engaging double helix structure. How the Supreme Court will look at Dr. Watson’s submission is yet to be seen, but his brief, 15 pages long, is simple and thought provoking with three major arguments: (1) because human genes are unique and convey information about the essence of being human, they should not be patented; (2) the human genome project was intended to benefit all, not just select companies and (3) patents on human genes are not necessary, but if they are granted, compulsory licenses should be required to ensure fair access.
In his brief Dr. Watson argues that patentability of genes is not and never was the goal of genome research. The Human Genome Project was in fact funded in part by taxpayer money and hence intended to benefit all and not certain select companies. Quoting from the brief, “The Human Genome Project was a multi-agency, international effort. It was funded in large part by taxpayer money, and the primary expectation was that the information derived from the sequenced human genes would be available for all scientists to use.”
In his opinion the general perception that patent protection is necessary to encourage scientists to discover human genes, is incorrect and that companies undertaking biotech/pharma research do not derive major revenues from selling or licensing human genes but from selling pharmaceuticals or actual research tools. While as lawyers we might not like to believe this, but he does when he says “A scientist does not—and should not—expect to obtain a legal monopoly controlling the information encoded by human genes”…“Research on human genes is one of those rare endeavors which should be—and is done—with the understanding that, although inventions based on those genes may later be commercialized, the genes themselves are to be employed for the maximum benefits of humankind”. Finally, he goes on to suggest that if gene patents are granted, patent holders should be required to license their patents to ensure reasonable access and social progress. He touches upon the aspect of public interest and access to drugs and states, “Implementing a compulsory license protocol will also reduce the risk that a patient is denied access to life-saving medicines and technologies using human genes and the information encoded in the genes”. All in all, the brief does not venture into complicated claim construction or any lengthy analysis, but puts across some basic arguments that we are bound to struggle with in coming times.
|The DNA 'double helix' structure - Image from here.|
Since the controversy is over BRCA genes, a little something about them: BRCA1 and BRCA 2 genes are naturally occurring genes in humans and are responsible for encoding proteins that suppress mutations that could cause breast and ovarian cancer (also termed caretaker genes). Researches on familial breast cancer claim that the hereditary nature of cancer is a result of dominant inheritance of a major “susceptibility locus” (such as genes BRCA1 and BRCA2) present on a particular chromosome and mutations in such susceptible genes indicate a predisposition for cancer. For instance, mutations to the BRCA genes are believed to be responsible for 45% of familial (hereditary) breast cancer.
US Patent No. Patent Nos. 5,747,282
The main patent in controversy before the Supreme Court, Myriad’s patent no. ‘282, deals with, to say the least, ‘methods and material’ used to isolate and detect human breast cancer genes. The patent specifically claims isolated gene sequences as well as diagnostic methods which provide isolated gene sequences containing the BRCA genes or their mutations, identifying a BRCA1 locus and methods for either diagnosis of the predisposition to cancer or the diagnosis or prognosis of cancer. Interestingly, the patent specification defines an “Isolated nucleic acid” (i.e. DNA/Gene sequence) very broadly, as “one which is substantially separated from other cellular components which naturally accompany a native human sequence or protein, e.g., ribosomes, polymerases, many other human genome sequences and proteins. The term embraces a nucleic acid sequence or protein which has been removed from its naturally occurring environment, and includes recombinant or cloned DNA isolates and chemically synthesized analogs or analogs biologically synthesized by heterologous systems”. (emphasis supplied)
Hence, the patent covers an isolated, unaltered, naturally occurring BRCA1 gene sequence when outside its natural environment (human body). The big question is whether a naturally occurring, isolated, unaltered gene sequence outside its natural environment will qualify as an 'invention'? If yes, then humans have 22,000 genes waiting to be spliced out of their natural environment and become prized possessions of some private owner.
Gene Patents in India
The Indian Patent Office has, of course, granted gene patents. While the (Indian) Patents (Amendment) Act, 2005 does not have any specific reference to gene patents nor does it define the term “gene”, the Manual of Patent Office Practice and Procedure (as modified on March 22, 2011) provides that while claiming a single inventive concept for a genetically modified gene sequence/amino acid sequence, claims may be directed to:
- a gene sequence/amino acid sequence
- a method of expressing the sequence
- an antibody against that protein/sequence
- a kit containing such antibody/sequence
(Please note, they use the term ‘genetically modified gene’. Now, what that means…is subject to interpretation and whims & fancies!)
Further, Section 3 of the Act lays down what does not qualify as patentable subject matter and sub-section (c) therein relates to “the mere discovery of a scientific principle or the formulation of an abstract theory or discovery of any living thing or non-living substance occurring in nature”.
Section 3(c) is a likely objection to be raised in case of a gene patent. A naturally occurring gene sequence should qualify as a non-living substance occurring in nature and hence disqualify as patentable subject matter, unless "genetically modified gene sequence" encompasses a naturally occurring gene outside its natural environment.
This led me to look up the Patent Office website to see if any gene patents for naturally occurring genes have been granted in India and I did find one (there must be more). Patent no. 239147 titled, AN ISOLATED POLYPEPTIDE, describes its invention in the abstract as, “The present invention relates to a novel human gene that is differentially expressed in human carcinoma. More specifically, the present invention relates to a polynucleotide encoding a novel human polypeptide named C35 that is overexpressed in human breast and bladder carcinoma. This invention also relates to C35 polypeptide, in particular C35 peptide epitopes and C35 peptide epitope analogs, as well as vectors, host cells, antibodies directed to C35 polypeptides, and the recombinant methods for producing the same. The present invention further relates to diagnostic methods for detecting carcinomas, including human breast carcinomas. The present invention further relates to the formulation and use of the C35 gene and polypeptides, in particular C35 peptide epitopes and C35 peptide epitope analogs, in immunogenic compositions or vaccines, to induce antibody or cell-mediated immunity against target cells, such as tumor cells, that express the C35 gene. The invention further relates to screening methods for identifying agonists and antagonists of C35 activity.”
Incidentally, this patent has an uncanny similarity with Myriad’s patent no. ‘282. Both patents relate to breast cancer genes and claim isolated gene sequences as well as diagnostic methods. Also, just like in Myriad’s patent, “Isolated” has been defined here as: “material removed from its native environment (e.g., the natural environment if it is naturally occurring), and thus is altered "by the hand of man" from its natural state. For example, an isolated polynucleotide could be part of a vector or a composition of matter, or could be contained within a cell, and still be "isolated" because that vector, composition of matter, or particular cell is not the original environment of the polynucleotide”. It further defines “C35 polypeptides”, the subject matter of the patent, to include (among others) “isolated naturally occurring polypeptides” (emphasis supplied).
Two things come to my mind: (1) ‘anything made by man’ or in this case ‘altered by the hand of man’ is the law in America, and not (as per my knowledge) officially subscribed to in India; and (2) how does isolation of a naturally occurring polypeptide qualify as an invention in light of Section 3(c)? Apparently it does. The Indian Patent Office had in the first examination report raised the Section 3(c) objection. The reply to the examination report filed by the Applicant states, “The claimed "polypeptide comprising two or more C35 peptide epitopes" ought not to be objected to under Section 3(c) of the Indian Patents Act because the claimed polypeptides are isolated and/or engineered by recombinant DNA methods and are produced by substantial human intervention”. The patent stands granted.
Myriad’s hearing before CAFC on July 20, 2012
CAFC heard arguments in the matter on July 20, 2012. A recording of the oral arguments can be accessed here. While the Defendant’s lawyer submitted that the situation is akin to turning a tree into a baseball bat, where the bat is wood from a tree but the process is what makes it eligible for a patent. On the other hand, Plaintiff’s lawyers equated this to claiming a patent over coal just because they were the first ones to remove it from the ground. What remains to be seen is Court’s analysis of Myriad’s patents in light of Mayo v. Prometheus. The U.S. Supreme Court had in the Mayo judgment opined, “This Court has repeatedly emphasized a concern that patent law not inhibit future discovery by improperly tying up the use of laws of nature and the like. See, e.g., Benson, 409 U. S., at 67, 68 Rewarding with patents those who discover laws of nature might encourage their discovery. But because those laws and principles are “the basic tools of scientific and technological work,” id., at 67, there is a danger that granting patents that tie up their use will inhibit future innovation, a danger that becomes acute when a patented process is no more than a general instruction to “apply the natural law,” or otherwise forecloses more future invention than the underlying discovery could reasonably justify.”