A central pillar of US law holding that human genes cannot be patented is teetering in the wake of a high-profile appeal ruling. The long-awaited outcome of the case Association of Molecular Pathology (AMP) v United States Patent and Trademark Office (USPTO) could trigger a reassessment of patent registration in the biotech sector, following unusual circumstances in which appeal court proceedings were heard twice over.
NewLegal Review first reported on the case in April 2010. At that stage, New York District Court Judge Robert Sweet ruled that breast-cancer types BRCA1 and BRCA2 were ineligible subject matter – overturning patents on the genes that the USPTO had granted to US biotech company Myriad Genetics. Plaintiff AMP had argued that the USPTO’s move was unconstitutional as US law prevents the patenting of natural processes, adding that the patents would hinder research bodies such as itself from finding out more about breast cancer. Myriad had originally filed for the genes as part of a diagnostic therapy that it had developed.
In 2011, Sweet’s District Court ruling was overturned in the Court of Appeals for the Federal Circuit (CAFC), restoring credibility to Myriad’s patents. However, in March this year the Supreme Court unanimously rejected a series of gene patents challenged in Mayo v Prometheus Laboratories – a case that examined a range of similar issues. Recognising those parallels, the Supreme Court ordered the CAFC to re-hear AMP v USPTO. But contrary to the Supreme Court’s ruling in Prometheus, the CAFC came to the same conclusion as it had in 2011, ruling in favour of the USPTO.
Three circuit judges presided over the re-hearing, with judges Moore and Lourie upholding the patents and judge Bryson dissenting. In his written opinion, Bryson stated that that extracting a gene is ‘akin to snapping a leaf from a tree’, and that plucking the leaf prematurely ‘would not turn it into a human-made invention’.
Lourie, though, wrote that it was ‘important to dispute’ Bryson’s analogy. ‘With respect,’ he asserted, ‘no one could contemplate that snapping a leaf from a tree would be worthy of a patent, whereas isolating genes to provide useful diagnostic tools and medicines is surely what the patent laws are intended to encourage and protect.’ Lourie went on to say that each BRCA gene was a ‘new chemical entity’ as a result of being isolated by Myriad’s patented process.
AMP’s litigation backers the Public Patent Foundation (PUBPAT) and American Civil Liberties Union (ACLU) were quick to criticise the ruling.
PUBPAT executive director Daniel B Ravicher said: ‘Human genes are not like new genetic tools or drugs, which can be patented because they are manufactured. It is absurd to think that a company can own naturally-occurring human genes simply because they removed them from the body.’
Meanwhile, ACLU staff attorney said: ‘This ruling prevents doctors and scientists from exchanging their ideas and research freely. Human DNA is a natural entity like air or water. It does not belong to any one company.’
In industry terms, the ruling could lead to a wave of patent filings from biotech companies as they seek to protect genes that they have discovered. But it remains to be seen whether the case will be pursued to the Supreme Court, which could overturn the CAFC decision.