GENE PATENTS
leaves and the conclusion Judge Dyk drew from it were flawed. A plucked leaf does not qualify as “a product of human ingenuity” nor does it have properties that are markedly different from a leaf still attached to the plant. Tere is no new product nor any non-obvious invention in a plucked leaf. In contrast, according to Myriad, isolating the specific BRCA1 and BRCA2 DNA sequences from the hundreds of thousands of base pairs in the human genome required significant human endeavour based on the realisation that those particular sequences had a direct relationship to human disease.
In contrast to Judge Dyk, Chief Judge Rader has reportedly publicly expressed views that suggest he disagrees with the district court holding in Myriad, and the ACLU has filed a motion to request that he recuse himself from any involvement in the case. According to Dennis Crouch’s patent blog, Patently-O, Judge Rader was asked at a conference at Fordham Law School whether a commercially produced bottle of water was patent-eligible. He reportedly replied by asking how many people, over the course of human events, had been killed by drinking polluted water. He then answered his own question: probably billions. Tus, it appears, in Judge Rader’s opinion, that recognising a link between bacterial contamination and fatal illness and purifying the water required ingenuity and imparted distinctive characteristics, making the water safe for drinking (should that be determined to be the standard) or rendering it markedly different from naturally occurring water (should that be upheld as the standard) merits patent protection. Te analogy between “isolated” water and “isolated” DNA is all too clear. If the former is patent-eligible, surely the latter would be as well.
In a surprising move that reversed long-standing policy, the DOJ submitted a brief of amicus curiae on behalf of the US in the Myriad appeal, taking the position that isolated but otherwise unmodified genomic DNA is not a human-made, patent-eligible invention under 35 USC § 101. Te US also advocated, however, that “human- engineered” DNA molecules, such as cDNAs, are patent-eligible subject matter under § 101. It remains to be seen whether the government’s position sways the Federal Circuit to affirm the Myriad decision in part and/or influences a change in USPTO policy.
Under either the district court’s test or Myriad’s proffered standard, a key aspect of the Federal Circuit’s decision may be its articulation of the defining characteristics of naturally occurring DNA, against which a claimed DNA will be measured to determine if it is “markedly different”
or “non-naturally occurring” and “a product of human ingenuity” having a “distinctive name, character and use”. For example, if the Federal Circuit focuses on the informational properties of DNA, it may make it more difficult for Myriad to argue that isolated DNA has been given a distinctive character or use through ingenuity (should that standard be adopted) or that it differs markedly from naturally occurring DNA.
Looking at the evolution of the Federal Circuit’s characterisation of DNA in the context of analysing whether a patent properly describes a claim to a genus of DNA may be instructive. For example, in its 1997 decision in University of California v. Eli Lilly and Co, the Federal Circuit characterised DNA as a type of chemical compound, which could only be described by reciting the sequence of a representative number of DNAs falling within the scope of the claim or by reciting structural features common to a substantial portion of the DNA molecules falling within the claim. However, by 2004, in In re Wallach, the Federal Circuit noted than an amino acid sequence supports a claim to a genus of DNA sequences, because advances in the state of the art made it routine to convert a protein sequence to a nucleic acid sequence encoding the protein. If these cases reflect the Federal Circuit’s shiſt in focus from the chemical nature of DNA to its informational properties, it may increase the possibility that the court will affirm the Myriad district court decision, at least in part.
If the district court’s judgement is affirmed, the validity of any claim directed to a nucleic acid sequence that is simply isolated from the genome in which it occurs would be jeopardised. It seems unlikely that the Federal Circuit will comment directly on other subject matter, but the industry will no doubt be anxious for clarity on other gene-based products and processes. It seems that modified sequences, particularly those with different or improved activities and sequences encoding non-naturally occurring products, such as fusion proteins and humanised antibodies, are certainly on more solid ground than completely naturally occurring sequences or DNA sequences encoding naturally occurring protein sequences, as the modified compositions are even more markedly different than wholly natural products and require even more human ingenuity.
Lee Crews, PhD, practices in the area of intellectual property law. Dr Crews assists clients in the life sciences and medical devices fields with securing patent rights in the United States and abroad. She also represents clients in those industries in licensing and transactional work, and has significant experience in resolving inventorship disputes. Dr Crews’ clients concentrate on antibody engineering, diagnostic agents, gene therapies, high-throughput screening assays, RNAi and microRNAs, implantable devices, pharmaceuticals, vaccines, stem cells, and transgenic plants and animals. Her clients include universities, pharmaceutical companies, and start-up and mid-market biotech companies.
Lee Crews, PhD, is a partner at Duane Morris LLP. She can be contacted at:
llcrews@duanemorris.com
Vicki Norton, PhD, is a partner at Duane Morris LLP. She can be contacted at:
vgnorton@duanemorris.com
32 World Intellectual Property Review November/December 2010
Vicki G. Norton, PhD, practises in the area of intellectual property law with a focus on biotechnology and chemical patent counselling and litigation. She also advises clients on worldwide patent strategy, including identifying patent coverage issues, auditing technology portfolios to assist clients in transactions and venture opportunities, and formulating strategic objectives for prosecution. She has handled patent matters and litigation in a variety of industries, including biotechnology, biopharmaceuticals and small molecule pharmaceuticals, relating to engineering transgenic plants and cells, biochemistry, methods to screen and make gas- absorbing materials, stem cell technologies, molecular biology, nanotechnology, immunology, combinatorial chemistry, probe amplification assays, diagnostics, nutraceuticals, microbiology, and therapeutic drugs and devices for physical therapy.
www.worldipreview.com
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