What Can You Patent in the Life Sciences Field?

In 1998, the EU Parliament introduced an EU Directive on the protection of biological inventions. This Directive, known as the Biotech Directive, harmonised across EU member States the law relating to what can be patented in the field of biotechnology, and established that biological subject matter can be patented provided that it is isolated from its natural environment or produced by means of a technical process (and satisfies the other statutory requirements for patentability including novelty and inventive step).

Examples of patent-eligible biological subject matter include genes, proteins, cells (including stem cells), bacteria, and animals, provided that a plausible use of the biological subject matter is provided in the patent application when it is filed. The Directive also specifies subject matter that cannot be patented in Europe, including processes for cloning or modifying the germ line identity of human beings, and any inventions relating to the use of human embryos for commercial purposes. The Directive also provides that processes for genetically engineering animals that result in suffering being caused to the animal with out substantial benefit to mankind, and animals produced by such processes, are not patent-eligible. This latter provision was included due to a long-running case before the European Patent Office, relating to a Harvard University patent claiming a mouse that was genetically engineered to develop cancer. After a 15 year dispute, the patent was eventually granted on the basis that the benefit to mankind (mouse models for testing cancer drugs) outweighed the suffering to the animal.

In the United States, patent protection has been available for biological subject matter since 1980 when the US Supreme Court decided that a microorganism produced by genetic engineering was not excluded from patentability. This liberal interpretation of Section 101 of the US Patent Act prevailed throughout the nineties and noughties, until two US Supreme Court decisions in the first half of this decade changed the landscape completely.

In the first decision, Mayo Collaborative Services v. Prometheus Laboratories, Inc., the Supreme Court held that claims directed to method of optimising the efficacy of a drug are laws of nature and consequently not patent eligible under Section 101. This decision has had profound effects for the in-vitro diagnostics and personalised medicine industries, with the result th at it is currently difficult to obtain broad patent claims directed to methods of detecting or predicting disease based on biomarker assays, without specifying an element in the claim that limits the scope of protection conferred by the patent (for example specifying a particular assay technique, or particular novel diagnostic reagent). The decision does not prevent the patenting of new diagnostic reagents or devices.

In the second Decision (Association for Molecular Pathology v Myriad Genetics Inc), the Supreme Court found claims directed to genomic DNA, specifically the BRCA1 and BRCA2 breast cancer susceptibility genes, to be products of nature, and consequently not patent eligible. In the same decision, the Court found that claims directed to man made DNA copies of the genes (cDNA) to be patentable due to the difference between the genomic DNA and cDNA. The net result of this Decision is that the USPTO will not grant patents for nature identical products, be they genes, proteins, microorganisms, plants, cells or any product that exists in nature. Patents can be obtained for products that are markedly different to their natural counterparts (for example a bacterium engineered for heterologous expression of a protein, or a DNA construct including genomic DNA), and patents can be obtained for new uses of natural products (for example use of a natural lantibiotic in therapy).

The Prometheus and Myriad decisions have undoubtedly limited the scope of protection that can be obtained in the US for inventions in the life sciences field. With no relief from Congress on the horizon, the damage being done to innovation in the field of diagnostic and personised medicine looks set to continue.

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