US Court Sides With Gene Patents 255
ananyo writes "Gene patents have been upheld in a landmark case over two genes associated with hereditary forms of breast and ovarian cancer. The lawsuit against Myriad Genetics, a diagnostic company based in Salt Lake City, Utah, that holds patents on the genes BRCA1 and BRCA2, has bounced from court to court since 2010. In a 2-1 decision today, a federal appeals court reaffirmed their latest decision that genes represent patent-eligible matter. As noted before on Slashdot, the case will have major implications for cancer researchers, patients and drug makers."
Re:... in the US (Score:3, Informative)
Don't be so sure. [genengnews.com]
promising future treatment (Score:5, Informative)
Here's a fuller explanation from the opinion (not that I agree with it). They appear to be making a distinction between isolated DNA, which is allegedly nonnaturally processed in a way that renders it patent-eligible, and "native DNA" as it exists inside the human body, which is a natural occurring composition of matter.
It is undisputed that Myriad’s claimed isolated DNAs exist in a distinctive chemical form—as distinctive chemical molecules—from DNAs in the human body, i.e., native DNA. Natural DNA exists in the body as one of forty-six large, contiguous DNA molecules. Each of those DNA molecules is condensed and intertwined with various proteins, including histones, to form a complex tertiary structure known as chromatin that makes up a larger structural complex, a chromosome. See supra, Figure 3. Inside living cells, the chromosomes are further encapsulated within a series of membranes and suspended in a complex intracellular milieu.
Isolated DNA, in contrast, is a free-standing portion of a larger, natural DNA molecule. Isolated DNA has been cleaved (i.e., had covalent bonds in its backbone chemically severed) or synthesized to consist of just a fraction of a naturally occurring DNA molecule. For example, the BRCA1 gene in its native state resides on chromosome 17, a DNA molecule of around eighty million nucleotides. Similarly, BRCA2 in its native state is located on chromosome 13, a DNA of approximately 114 million nucleotides. In contrast, isolated BRCA1 and BRCA2, with introns, each consists of just 80,000 or so nucleotides. And without introns, BRCA2 shrinks to approximately 10,200 nucleotides and BRCA1 to just around 5,500 nucleotides. Furthermore, claims 5 and 6 of the ’282 patent cover isolated DNAs, e.g., primers or probes, having as few as fifteen nucleotides of a BRCA sequence. Accordingly, BRCA1 and BRCA2 in their isolated states are different molecules from DNA that exists in the body; isolated DNA results from human intervention to cleave or synthesize a discrete portion of a native chromosomal DNA, imparting on that isolated DNA a distinctive chemical identity as compared to native DNA.
As the above description indicates, isolated DNA is not just purified DNA. Purification makes pure what was the same material, but was combined, or contaminated, with other materials. Although isolated DNA is removed from its native cellular and chromosomal environment, it has also been manipulated chemically so as to produce a molecule that is markedly different from that which exists in the body. Accordingly, this is not a situation, as in Parke-Davis & Co. v. H.K. Mulford Co., in which purification of adrenaline resulted in the identical molecule, albeit being “for every practical purpose a new thing commercially and therapeutically.” 189 F. 95, 103 (C.C.S.D.N.Y. 1911). Judge Learned Hand’s opinion for the district court in that oft-cited case held the purified “Adrenalin” to be patent-eligible subject matter. Id. The In re Marden cases are similarly inapposite, directed as they are to the patent ineligibility of purified natural elements—ductile uranium, 47 F.2d 957 (CCPA 1931), and vanadium, 47 F.2d 958 (CCPA 1931)—that are inherently ductile in purified form. While purified natural products thus may or may not qualify for patent under 101, the isolated DNAs of the present patents constitute an a fortiori situation, where they are not only purified; they are different from the natural products in “name, character, and use.” Chakrabarty, 447 U.S. at 309-10.11.
Re:Wait, what? (Score:5, Informative)
Regarding Judge Lourie from http://www.cafc.uscourts.gov/judges/alan-d-lourie-circuit-judge.html [uscourts.gov]:
Before being appointed to the court, Judge Lourie had been President of the Philadelphia Patent Law Association, a member of the Board of Directors of the American Intellectual Property Law Association (formerly American Patent Law Association), treasurer of the Association of Corporate Patent Counsel, and a member of the board of directors of the Intellectual Property Owners Association. He was also Vice Chairman of the Industry Functional Advisory Committee on Intellectual Property Rights for Trade Policy Matters (IFAC 3) for the Department of Commerce and the Office of the U.S. Trade Representative. He was a member of the U.S. delegation to the Diplomatic Conference on the Revision of the Paris Convention for the Protection of Industrial Property, held in Geneva in October and November 1982, and in March 1984. He was chairman of the Patent Committee of the Law Section of the Pharmaceutical Manufacturers Association from 1980 to 1985.
Judge Lourie was awarded the Jefferson Medal of the New Jersey Intellectual Property Law Association for extraordinary contributions to the field of intellectual property law in 1998; was a recipient of the Intellectual Property Owners Education Foundation Distinguished Intellectual Property Professional Award for extraordinary leadership in the intellectual property community and a lifetime commitment to invention and innovation in 2008; was a recipient of the Philadelphia Intellectual Property Law Association’s Award for outstanding IP achievement in 2010; was a recipient of the Boston Patent Law Association’s Distinguished Public Service Award in 2011...
Good to know that these cases go to truly impartial judges.
Your health doesn't matter to Myriad (Score:5, Informative)
I used to work at Myriad Genetics on their lab software and believe me they don't give a single shit about anybody's health. They care about charging exorbitant amounts for testing and counseling. Remember, these tests do not definitely tell anybody they will get cancer. They are simply and statistical indicator.
What Myriad patented are not the genes themselves (EVERYBODY has them). What they patented are the pattern of specific mutations of the BRCA1 and BRCA2 genes. It is these specific mutations (nucleotide patterns) within the genes that MAY indicate the POSSIBILITY of cancer. You have to also consider the medical and family history of a specific patient and then make a guess as to what the probability of cancer will be in the future. It's never a yes or no answer.
To add insult to injury, the original research for finding the mutations of the BRCA1 and BRCA2 genes was done by the founders of Myriad at the University of Utah which is a state school. The public paid for the original research.
Re:Wait, what? (Score:5, Informative)
Because someone anti-patent would be "impartial"?
No. Someone with no ties to the IP biz would be impartial, smartass.
Re:Wait, what? (Score:5, Informative)
The Intellectual Property Owners Association:
established in 1972, is a trade association for owners of patents, trademarks, copyrights and trade secrets. IPO is the only association in the U.S. that serves all intellectual property owners in all industries and all fields of technology.
The association advocates effective and affordable IP ownership rights and provides a wide array of services to members. It concentrates on: supporting member interests relating to legislative and international issues; analyzing current IP issues; providing information and educational services; and disseminating information to the general public on the importance of intellectual property rights.
Lourie is on the board of directors of this organization, which indicates a pretty clear bias on intellectual property issues. Eligibility for Membership on the Intellectual Property Rights IFAC
He was also ice Chairman of the Industry Functional Advisory Committee on Intellectual Property Rights for Trade Policy Matters (IFAC 3) and:
Committee members are U.S. citizens representing U.S. manufacturing or service firms, trade internationally, and have a special interest in and knowledge of international trade issues. Representatives of industry associations may also participate.
So that's hardly a neutral position.
He was also chairman of the Patent Committee of the Law Section of the Pharmaceutical Manufacturers Association from 1980 to 1985, and clearly the Pharmaceutical Manufacturers Association is not impartial.
The rest of the stuff in there is recognition from all kinds of pro-ip groups. Based in this resume, this is clearly not a judge whose interests lie in exercising prudence when granting intellectual property rights to claimants. I left out the information on his eduction because it really has nothing to say about any potential bias or neutrality. It clearly does show, however, that he should be educated to clearly understand that "Each of the claimed molecules represents a nonnaturally occurring composition of matter" is a load of steaming genetic material. He clearly understands that the patent-holders in this case figuratively used a pair of pruning shears (which they didn't invent) to cut the (figurative) leaf off (still figurative) tree and then claimed the leaf as their own invention. His conceit is that the act of cutting the leaf off the tree is enough to make the "isolated" leaf an invention. That kind of logic effectively makes everything that can be discovered in nature patentable since the act of discovery "isolates" it from the rest of the natural world in which it originated.
Re:Smoking Crack (Score:4, Informative)
At that level of appeals, the judges are one and the same. The only difference between a civil and criminal case is who happens to be paying for the prosecution (criminal cases are almost always paid for by a government entity) and if the defendant has to spend time in prison or not if unsuccessful. A few other minor differences also hold (in terms of threshold of evidence and a few other things).
The court rooms are the same, the judges are the same, and the precedent setting capability is the same in all cases.
That the original grandparent post was suggesting that patent litigation was a criminal matter may have been a confused, but then again changes in "intellectual property law" have indeed criminalized some violations that previously were merely a civil matter. I would dare say that even members of congress often confuse the two kinds of legal actions, and add confusing things into the laws they write which really mucks things up in a hurry.
Re:The sky is falling...not. (Score:5, Informative)
If you read the ruling, it become clear that this is a patent on the gene sequence itself. It applies whether or not it is in the human body. It also applies to most variations of the sequence without limit. This means that no one else is allowed to isolate and work on the naturally occurring genes without paying royalties, even if the genes are present in your own body.
A few quotes from the dissent:
"From a genetic perspective, that claim covers one "composition of matter" --the BRCA1 gene. The isolated chromosomes 13 and 17. They have the same sequence, they code for the same proteins, and they represent the same units of heredity."
"...its composition claims are not defined by any particular chemical formula. For example, claim 1 of the '282 patent covers all isolated DNAs coding for the BRCA1 protein, with the protein being defined by the amino acid sequence encoded by the naturally occurring BRCA1 gene ... And the patent does not identify the upper end of that range because the patent does not identify a unique nucleotide sequence ... Instead, the patent contains a sequence that is just 24,000 nucleotides longs with numerous gaps denoted by "vvvvvvvvvv." An almost incalculably large number of new molecules could be created by filling in those gaps with almost any nucleotide sequence."
Re:Smoking Crack (Score:2, Informative)
Just for everyone wading through the comments below that are all missing the point, here's what the article says:
In March, the US Supreme Court asked the US Court of Appeals for the Federal Circuit to reconsider the case in light of a ruling against patents on a different, non-genetic diagnostic test. In this case, patents were rendered invalid because they merely reiterated ‘laws of nature’.
But according to the latest judges, the patents Myriad holds do not reiterate these laws. In the court’s decision, Judge Alan Lourie writes: “Each of the claimed molecules represents a nonnaturally occurring composition of matter.”
The reason this patent survived was that the process of the test involved creating novel molecules. The novel molecules + the algorithm for the test are patentable. The algorithm on its own is not. The gene on its own is not. The upshot: this patent is easily breakable.