Rapid advances in biotechnology have posed challenges for legislators and biotechnology companies as legal systems struggle to determine the patentability of biological matter. Key issues include the ownership of genes, the law of nature in diagnostic methods, GMOs and biopharmaceuticals.
Litigation that has reversed decades of US precedent is best demonstrated by the ‘Myriad’ case. Mutations in the BRCA1 and BRCA2 genes are well known in the medical community for being linked to increased risk of developing breast and ovarian cancer. The issue in this case, is whether the isolation of DNA is patent eligible. The US Supreme court invalidated previous claims that upheld the patent eligibility of the BRCA genes, by claiming that isolated DNA is a product of nature and therefore not patent eligible. The court later clarified that nucleic acids in which the order of the nucleotides has been altered do remain patentable. But the question remains how much of a ‘change’ is necessary or considered ‘significantly different’ for companies to retain their IP.
The question of ‘what is natural’ was also raised in the ‘Prometheus’ case. Diagnostic methods that apply a high level of generality to laws of nature were deemed patent ineligible. For instance, diagnostic methods that measure an increase in metabolite levels in a patient, is considered a naturally occurring phenomenon and too ‘general’. Any additional steps in the diagnostic process are considered well-understood and conventional activities that are routinely performed, e.g. administering the drug, determining metabolite levels, etc. Claims that cover application of the natural law or involve conventional steps are therefore not patent eligible. This raises the question for many diagnostic companies. Is the methodology in their diagnostic step sufficiently inventive and ‘significantly different’ from the natural law for them to retain the IP?
The US legal system is currently dealing with these challenges of ownership. An alternative strategy for inventors is to pursue narrower claims on items, items that are clearly novel and ‘significantly different’, e.g. a novel molecule, a new medical device, new formulations, etc. Further patent applications can then be filed if necessary, once the issue of patentability is more clear-cut.
Ownership of IP is pivotal in the commercialisation process. If you are looking to file a patent in the US that relates to genetic material, be wary of the challenges in patentability. Inner Maven can provide introductions to patent attorneys that can give consultation and advice on this matter and often work together with them through gaining IP protection.