Patent laws on Genes and Gene Sequences

2nd October, 2011 - 12:22 pm Categories: IP Practice in India Patent Litigation Pharma/Biotech Patent Litigations 0 Comments

Advancement in science and genetic application, with enhanced knowledge of Human Genome has been the main focus in the field of medicine and biotechnology areas. Continuous and ongoing researches in genome project, identifying specific target genes and their respective response and functional activities, have evolved genetic therapeutics in treatment of multifactor disorders such as heart disease, diabetic, neurological disorders, muscular dystrophy and so and so forth.

Gene patents have been the most debated matter since years. The economic and policy issues surrounding patents on genes, gene sequences, nucleotide sequences, expressed sequence tags (ESTs), single nucleotide polymorphism (SNPs) have posed the potency  to present unique challenges in science, innovations and legal fraternity around the  globe.

Patent Issues regarding Gene Patents:

A number of gene/DNA sequence patents grew dramatically during the Human Genome project. Researchers have obtained patents for isolating genes or gene sequences that occur in nature. Whether this should be permitted or not is still an open debate since decades.

Generally to seek a patent-protected gene, there are certain issues that a researcher comes across.

(1) Stop or avoid researching the particular gene;

(2) License the rights to research the gene from the patent holder; or

(3) Continue research regardless of legal liability.

Indeed, the choice made is often dependent on the DNA sequence in question and the line of research pursued. Regardless, the exercise of any of these three options could potentially work to reduce fundamental R&D in human genetics.

Considering an instance of gene patent invalidation of Myriad Genetics by US federal court. The American Association of Pathologists and others have challenged several patents relating to the breast cancer genes BRCA1 and BRAC2 held by Myriad Genetics and the University of Utah Research Foundation. BRCA1 and BRCA2 genes are associated with an increased risk of breast and ovarian cancer. The patent claimed products of nature, law of nature and naturally occurring phenomena. The US district court for the Southern District of New York upon decision by Judge Robert Sweet, invalidated Myriad’s patents. The decision that isolated but otherwise unaltered DNA should not be patentable is now being appealed by Myriad.

The US Government stated that:

“The fact that a particular segment of the human genome codes for the BRCA1 protein in a human cell, for example, rather than for adrenaline or insulin or nothing at all, is not within the power of science to alter. Such basic natural relationships may not be the subject of a patent.” (Case 1:09-cv-04515-RWS)

Secondly, it is been argued that Myriad patents and it being the sole provider of BRCA1/2 testing has highly hindered cancer patients to receive cancer genetic testing. It is impeded that genes are the natural heritage of animals and/or human and its use should not be restricted by patent protection.

Indian Patent Laws on genes:

India, like other major countries have immensely involved in various biotech and medical research area, being one of the topmost competitor in commercial market in biological therapeutic and diagnostic domains globally

Section 3(c) of Indian Patent Act, states that “mere discovery of scientific principle or the formulation or the discovery of any living/non living substance occurring in nature” is not considered to be an invention. Pertaining to this law, mere isolation of naturally occurring genes from animal or plant body cannot be patentable.

Accordingly, section 3 (i) define diagnostic methods is not patentable. Further, it explains that in vivo diagnostic methods practiced on human/animal body cannot be patentable but if diagnosis is performed in vitro i.e. on tissue or fluids that have been removed from body are entitled to be patentable in light of inventive measures. Hence, diagnostic methods employing DNA primers or probes or the like that are different from naturally occurring genes/DNA sequences that exhibits modified functions  would be considered as patentable inventions.  Considering Bilski (30 S.Ct. at 3225), new and useful methods of identifying, isolating, or using genes or genetic information may be patented (prohibiting patenting abstract ideas), that are basically man-made transformation or manipulation of the raw materials of the genome, such as cDNAs.

Section 3(j) “plant and animals as whole, seeds and species which involve in its propagation or biological processes are not considered to be patentable”. In addition to this section 3(j) also states that apart from naturally occurring embodies, living entities of artificial origin such as transgenic plants and animals and/or parts thereof are not patentable. Microorganisms are construed to be patentable under section 3 (j). However, section 3(j) and section (c) when combined, states that isolated microorganisms from naturally occurring bodies are not construed to be patentable. Nevertheless, artificially developed genetically engineered microorganisms, vaccines and recombinant DNA are all considered to be patentable.  For instance , as seen in the case law of  Diamond v. Chakrabarty, 447 U.S. 303 (1980), ruled that “anything under the sun that is made by man” is patentable. The Supreme Court established that the man-made products of genetic engineering are eligible for patent protection under 35 U.S.C. § 101. The Patent and Trademark Office responded to Chakrabarty by granting patents on a wide range of engineered DNA molecules and useful genetic methods.

The basic fact about genes/gene products being patentable is that when a genetically engineered gene/DNA/amino acid sequence is novel and holds an inventive step thereby ensuring its industrial application, the patents can be claimed as:

• Gene sequence/amino acid sequence.
• A method of expressing the above sequence.
• An antibody against that sequence/protein.
• A kit made from the antibody/sequence.

In a more brief sense, it should be noted that rDNA, plasmids and process of forming the same are allowed to be patentable under substantive inventive steps employed. Further, unidentified functions of gene/DNA sequences and without any industrial application cannot be construed to be patentable.

One such example of gene patents in India, as seen in Indian Patent No. 243373 (279/MUM/2004) assigned to Sichuan Biotechnology Research Center, discloses artificial gene sequence for encoding recombinant super compound interferon with enhanced activity. The independent claim of the patent states:

1. A method for producing a recombinant interferon for inhibiting HBV-DNA replication as well as secretion of HBsAgs and HBeAg comprising steps of;
   1. Synthesizing and interferon DNA having a sequence as depicted in Fig.1 or 2 designed according to the codon usage;
   2. Placing said interferon DNA in an appropriate host preferably E.Coli and;
   3. Expressing said recombinant interferon in said host having an amino acid sequence encoded by interferon DNA shown in said Fig.1 or 2.

Wherein Fig 1 or 2 is a gene sequence of interferon DNA. (see Patent)

Again looking into Biocon’s story on genes, Using patent information as an integral tool, Biocon determined are as on which the company’s R&D should focus on.One such example is how the company used patent information to gain initial access to the field of human insulin production, where it is now a major player. The product patent on human insulin had long expired, but it was still protected by strong patents on processes of production.

Key take aways:

In most prosecution cases, it is been observed that the examiner objects claims directed towards isolated DNA/gene sequences in context to section 3 (c). Such objections can be dealt sating that the applicant’s/individuals claimed isolated DNA/gene sequence is purely recombinant and in modified form and its functions are not identical to that occurring naturally. But nevertheless, there are certain granted patent claims where isolated DNA/gene sequences are not substantially different from that occurring in nature. Such claims have been granted based on the previous precedence of such issued claims.

About the Author: Ms. Minusmita Ray, a Senior Patent Consultant in Institute of Intellectual Property Research & Development (IIPRD) and can be reached: minusmita@iiprd.com.