The ACLU should be sanctioned for its frivolous lawsuit challenging gene patents, which was filed Tuesday in the United States Federal District Court for the Southern District of New York. This lawsuit is nothing more than grandstanding, it presents frivolous arguments and outright lies. The ACLU would have you believe that the patents cover naturally occurring genes, which is simply not true, and the primary reason they should be sanctioned. The patents they are challenging relate to altered genes and diagnostic methods, so they are making assertions that are factually false, and challenging the patent system as being unconstitutional, which if successful would only bring an end to the biotechnology industry and perhaps even pharma. This would mean no new drugs, not diagnostic advances and hundreds of thousands of jobs lost, not to mention a stock market crash. This is about as dumb as making arguments in court that would seriously undermine national security.
There are only two paragraphs in the entire complaint that can at all be characterized as legal argument or basis to support this frivolous lawsuit filed by the ACLU. These are:
102. Because human genes are products of nature, laws of nature and/or natural phenomena, and abstract ideas or basic human knowledge or thought, the challenged claims are invalid under Article I, section 8 of the United States Constitution and 35 USC 101.
103. All of the challenged claims represent patents on abstract ideas or basic human knowledge and/or thought and as such are unconstitutional under the First and Fourteenth Amendments to the United States Constitution.
Pharmaceutical and Biotech Patent Law
Perhaps the ACLU is unfamiliar with patent law, which as I write that seems terribly humorous to me. That is like saying “perhaps water is wet” or “perhaps breathing is good.” Of course the ACLU knows nothing about patents, and this complaint proves that, and many other things as well. Patent claims are not invalid for constitutional reasons. The Supreme Court has time and time again reviewed US patent laws, which have been around since 1790, never once finding the law unconstitutional, and no court has ever ruled a patent claim invalid because the claim violates the US Constitution. This is grandstanding pure and simple, and it is disgusting that the ACLU is using cancer patients to forward its own political agenda and profile. If change is what you want ACLU then go to Congress. You are asking the courts to legislate, and that is not their role. I feel your pain and understand that getting Congress to do anything with respect to patents has about as much chance as pigs flying, but that is the way it is. Welcome to the world of patent reform!
Lets take a minute to actually look at some of the claims that the ACLU says are invalid because they cover laws of nature or naturally occuring things. Before we jump into the text of the claims, which I am sure the ACLU doesn’t want average people to look at because you could tell they are lying if you did, let me state the obvious. A diagnostic method does not naturally occur, but rather is a process conjured up by humans; and when something is “isolated” and “altered” it is not how God, the creator, spirits or luck (whichever you prefer) caused things to be naturally ordered. With this basic, factually inarguable understanding, lets proceed.
US Patent No. 5,693,473 is being challenged, specifically claim 1:
1. An isolated DNA comprising an altered BRCA1 DNA having at least one of the alterations set forth in Tables 12A, 14, 18 or 19 with the proviso that the alteration is not a deletion of four nucleotides corresponding to base numbers 4184-4187 in SEQ. ID. NO:1.
US Patent No. 5,709,999 is being challenged, specifically claim 1:
1. A method for detecting a germline alteration in a BRCA1 gene, said alteration selected from the group consisting of the alterations set forth in Tables 12A, 14, 18 or 19 in a human which comprises analyzing a sequence of a BRCA1 gene or BRCA1 RNA from a human sample or analyzing a sequence of BRCA1 cDNA made from mRNA from said human sample with the proviso that said germline alteration is not a deletion of 4 nucleotides corresponding to base numbers 4184-4187 of SEQ ID NO:1.
US Patent No. 5,710,001 is being challenged, specifically claim 1:
1. A method for screening a tumor sample from a human subject for a somatic alteration in a BRCA1 gene in said tumor which comprises gene comparing a first sequence selected form the group consisting of a BRCA1 gene from said tumor sample, BRCA1 RNA from said tumor sample and BRCA1 cDNA made from mRNA from said tumor sample with a second sequence selected from the group consisting of BRCA1 gene from a nontumor sample of said subject, BRCA1 RNA from said nontumor sample and BRCA1 cDNA made from mRNA from said nontumor sample, wherein a difference in the sequence of the BRCA1 gene, BRCA1 RNA or BRCA1 cDNA from said tumor sample from the sequence of the BRCA1 gene, BRCA1 RNA or BRCA1 cDNA from said nontumor sample indicates a somatic alteration in the BRCA1 gene in said tumor sample.
US Patent No. 5,753,441 is being challenged, specifically claim 1:
1. A method for screening germline of a human subject for an alteration of a BRCA1 gene which comprises comparing germline sequence of a BRCA1 gene or BRCA1 RNA from a tissue sample from said subject or a sequence of BRCA1 cDNA made from mRNA from said sample with germline sequences of wild-type BRCA1 gene, wild-type BRCA1 RNA or wild-type BRCA1 cDNA, wherein a difference in the sequence of the BRCA1 gene, BRCA1 RNA or BRCA1 cDNA of the subject from wild-type indicates an alteration in the BRCA1 gene in said subject.
US Patent No. 6,033,857 is being challenged, specifically claim 1:
1. A method for identifying a mutant BRCA2 nucleotide sequence in a suspected mutant BRCA2 allele which comprises comparing the nucleotide sequence of the suspected mutant BRCA2 allele with the wild-type BRCA2 nucleotide sequence, wherein a difference between the suspected mutant and the wild-type sequences identifies a mutant BRCA2 nucleotide sequence.
Let me try and put this in terms that even the ACLU can understand… A METHOD IS NOT A GENE! Also… SOMETHING IN ALTERED STATE DOES NOT OCCUR NATURALLY!
Trying a Biotech Patent Case
Patentable Biotech Subject Matter
The complaint also makes the popular, and completely baseless, assertion that patents undermine innovation, which has also worked its way into popular press reports. “Scientific research and testing have been delayed, limited or even shut down as a result of gene patents, stifling the development of new diagnostics and treatments,” said Tania Simoncelli, ACLU science advisor. “The government should be encouraging scientific innovation, not hindering it.”
It seems as if those who hate the patent system think that if they say this a lot it will eventually become true, or be believed to be true. The trouble with this, however, is that there are absolutely no historical facts to support the claim that patents harm or undermine innovation. Patents simply do not harm innovation, they spur innovation. The patent system is set up to encourage engineering around and improving upon protected inventions of others. The only legitimate argument that patents harm innovation goes like this: “I am soooo lazy and simply have no desire to undertake the hard work necessary to innovate, so I want to copy what others have spent exorbitant amounts of time, money and energy creating, after all, that is the only fair thing!”
If patents stand in the way of innovation that is a YOU problem, not a patent system problem!- - - - - - - - - -
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Posted in: Biotechnology, Gene Patents, Gene Quinn, IP News, IPWatchdog.com Articles, Patent Litigation, Patents, Pharmaceutical
About the Author
Gene Quinn is a Patent Attorney and the founder of the popular blog IPWatchdog.com, which has for three of the last four years (i.e., 2010, 2012 and 2103) been recognized as the top intellectual property blog by the American Bar Association. He is also a principal lecturer in the PLI Patent Bar Review Course. As an electrical engineer with a computer engineering focus his specialty is electronic and computer devices, Internet applications, software and business methods.