Bio-reflections: the patentability of DNA and other biological molecules in Australia, the USA and C

Bio-reflections: the patentability of DNA and other biological molecules in Australia, the USA and C

Bio-reflections: the patentability of DNA and other biological molecules in Australia, the USA and C

This article, authored for the June 2010 Chinese-language edition of Managing Intellectual Property, discusses recent developments on the patentability of DNA and other biological materials. The Chinese-language version may be downloaded here (PDF).

The need for a dynamic global biotechnology industry is fuelled by the enormous potential the industry has to the enhancement of life and well being. Areas such as human and animal healthcare and crop science can, and have, benefited greatly from innovative contributions, made by the commercial and academic biotechnology sectors. From a business perspective, the potential for high demand of biotechnology products and processes can lead to substantial profits. These profits can not only benefit private operations but also communities through taxation.

Despite the importance of the global biotechnology phenomenon, the industry faces constant challenges. An important aspect of biotechnology is the use of genes and other biological molecules in a range of diagnostic assays and in the development of therapeutic products and genetically modified plants and animals.

However, a question has now arisen on the patentability of biological molecules when isolated away from their natural sources. In a recent decision of the United States District Court, South Court of New York, Association for Molecular Pathology et al. v United States Patent and Trademark Office et al., the “Myriad” decision, it was held that “isolated” DNA must be “markedly different” from DNA as it exists in nature in order to constitute patentable subject matter.

The decision indicates that, in the United States, purification of a product of nature, without more, cannot transform the product into patentable subject matter. Specifically, isolated DNA was deemed to maintain the natural biological function of the DNA as well as its utility, i.e., that “isolated” DNA was considered to have identical properties to its non-isolated form. Therefore, “isolated” DNA is not markedly different from its non-isolated form.

By way of background, the decision considers whether claims contained in a number of patents-in-suit held by defendants, Myriad Genetics and the University of Utah Research Foundation, the “Myriad patents”, relating to the human BRCA1 and BRCA2 genes (Breast Cancer Susceptibility Genes 1 and 2) cover products of nature, laws of nature and/or natural phenomona, and abstract ideas or basic human knowledge and thought.

The challenged claims were directed to: 1) isolated DNA containing all or portions of the BRCA1 and BRAC2 sequences; and 2) methods for comparing or analysing BRCA1 and BRCA2 gene sequences to identify the presence of mutations correlating with a predisposition to breast or ovarian cancer.

The Court held that the act of isolating a naturally-occurring DNA molecule and determining its sequence is not patentable subject matter. Moreover, analysing or comparing the sequences of two naturally-occurring nucleic acid molecules in order to identify sequence differences was deemed to be merely a mental process independent of any physical transformation of the DNA molecules and to represent only data-gathering steps. The Court also found that observing the growth rate of potentially cancerous cells in the presence of a test substance, and concluding that slower growth is indicative of a cancer therapeutic, represented only a data-gathering step. The Court considered that none of this subject matter is patentable.

In coming to its conclusion, the Court considered whether DNA should be treated differently from chemical compounds and consequently whether its purification from the body renders it patentable by transforming it into something distinctly different in character. It was concluded that DNA’s existence in an “isolated” form alters neither the fundamental quality of the DNA as it exists in the body nor the information that it encodes.

The term “isolated” DNA has a well-known and specific legal definition in the United States. Specifically, it refers to a DNA which exists separately from other cellular components normally associated with native DNA, including proteins. The term includes both DNA originating from a cell as well as DNA synthesized through chemical or heterologous biological means. Whilst this decision is now the subject of an Appeal, the Court’s position does cause some concern.

In Australia, the patentability of DNA and other biological molecules is the subject of a Government inquiry. Currently, in Australia, DNA per se is patentable provided that it is distinguished from its naturally-occurring form, i.e., it is claimed as “isolated” DNA. No Australian Court or Patent Office decision has considered the meaning of “isolated” in the context of an isolated DNA or other biological molecule. However, it is standard Australian patent practice to interpret this word as meaning that the molecule has been separated to some extent from its natural environment. This meaning is consistent with the meaning according to United States patent practice, at least until the Myriad decision, and indeed is consistent with global patent practice.

The Australian Government inquiry into human gene patents is expected to report in June 2010. Moreover, a parliamentary inquiry into plant gene patents has recently been announced and will begin on 30 June 2010. It is expected that these inquires will determine whether claims to isolated DNA sequences per se should be patentable in Australia.

On a more positive note, the passage of the historic “Health care reform” bill in the United States gives brand-name drug developers 12 years of data exclusivity. This will be encouraging to the investment community. Tax credits will also be available in the United States under the Therapeutic Discovery Project Tax to off-set employment and clinical trial costs. All these initiatives will benefit the biotechnology industry in the United States with positive flow-on effects globally.

The global biotechnology industry has shown that it is robust enough to withstand the challenges it faces. Indeed, the ability to protect biotechnology innovation varies substantially on a jurisdictional basis. For example, some countries such as Europe and New Zealand do not allow a claim to a diagnostic assay if there is a step which involves performing a function on a human subject. In these countries, claims need to be limited to in vitro assays. In China, methods of diagnosis per se are not patentable, and so, the in vitro limitation is generally not applicable. By way of contrast, Australia, has no such restriction.

Until recently, diagnostic assays were regarded as patentable subject matter in the United States. However, in light of a 2008 Federal Circuit decision, this situation has become uncertain. In re Bilski 545 F.3d 943 (Fed. Circuit, 2008) stated that for a process to be a patentable invention it needs to: (1) be tied to a particular machine or apparatus; and/or (2) transform a particular article into a different state. This case is now on Appeal at the Supreme Court. However, it was applied in Cassen Immunotherapeutics, Inc v Biogen Idea where the Federal Circuit invalidated US Patent No. 5,723,283 on the basis that the process claims satisfied neither criterion. It has also been applied in Prometheus Lab, Inc. v Mayo Col. Services Wh 878910 (S.D. Cal, 2008) on the basis that the assay outcome was merely a natural phenomenon or mental step.

As far as China is concerned, in Administrative Judgement (2008) Gaoxingzhongzi No. 378, the trial Court held that “use” claims for pharmaceuticals do not extend to the behaviour or actions of a medical practitioner. In particular, treatment by a medical practitioner is not an engagement in economic endeavour. Furthermore, reciting dosage form in a medical use claim would not restrict a doctor’s freedom to treat a patient. Such a position can affect the type of claims which one should pursue in China.

For the global biotechnology industry to continue to grow and prosper, a consistent and considered approach is required at the political, judicial and even cultural levels. The ongoing success of the industry is a testimony to its resilience and the commitment of its participants.

Acknowledgements

  • Gatsis, K, Davies Collison Cave
  • Leuty, R, Biotechs, VCs Shoot, Score with reform, San Francisco Business Times, March 22, 2010
  • Noonan, K.E., Applying In re Bilski to Diagnostic Method Claims
  • Mark Roberts, Partner, Davies Collison Cave