@Ellen North
patents are not supposed to apply to stuff that is "obvious to a skilled practictioner of the art", and any bonehead in a wetlab knows how to "design" primers -- i put "design" in quotes because the usual approach is to have idiot-proof software do the "inventing" -- that will enable you to produce cDNA from a given sequence of DNA (or RNA). it's sort of like saying you can't patent a log, but you can patent a 2x4.

that said, Thomas's decision was better than i would have imagined at the time.

the reality on the ground -- and i know VERY particularly whereof i speak, even as i write i'm running background jobs that are analyzing RNA sequences -- is that the average patent involving any genetic sequence is epistemological nonsense. the language that the lawyers use is scientifically meaningless and puts impossible constraints on everybody everywhere doing any work with DNA or RNA. For example some patents assert that any process that creates certain sequences is by definition in violation of the patent, regardless of whether those sequences are of any interest or value in the "violating" process -- they might even be annoying byproducts or "noise", and it may be impossible to prevent those sequences from being created!

#1.1

http://news.nationalgeographic.com/news/2005/10/1013_051013_gene_patent....

One-Fifth of Human Genes Have Been Patented, Study Reveals
Stefan Lovgren
for National Geographic News
October 13, 2005

A new study shows that 20 percent of human genes have been patented in the United States, primarily by private firms and universities.

The study, which is reported this week in the journal Science, is the first time that a detailed map has been created to match patents to specific physical locations on the human genome.

Researchers can patent genes because they are potentially valuable research tools, useful in diagnostic tests or to discover and produce new drugs.

"It might come as a surprise to many people that in the U.S. patent system human DNA is treated like other natural chemical products," said Fiona Murray, a business and science professor at the Massachusetts Institute of Technology in Cambridge, and a co-author of the study. ...

... The new study reveals that more than 4,000 genes, or 20 percent of the almost 24,000 human genes, have been claimed in U.S. patents.

Of the patented genes, about 63 percent are assigned to private firms and 28 percent are assigned to universities.

The top patent assignee is Incyte, a Palo Alto, California-based drug company whose patents cover 2,000 human genes.

"Gene patents give their owners property rights over gene sequences—for example in a diagnostic test, as a test for the efficacy of a new drug, or in the production of therapeutic proteins," Murray said.

http://news.nationalgeographic.com/news/2005/10/1013_051013_gene_patent_...

One-Fifth of Human Genes Have Been Patented, Study Reveals

"While this does not quite boil down to [the patent holders] owning our genes … these rights exclude us from using our genes for those purposes that are covered in the patent," she said.

Specific regions of the human genome are "hot spots" of patent activity. Some genes have up to 20 patents asserting rights to how those genes can be used. ...

... But critics caution that patents that are very broad can obstruct future innovations by preventing researchers from looking for alternative uses for a patented gene.

"You can find dozens of ways to heat a room besides the Franklin stove, but there's only one gene to make human growth hormone," said Robert Cook-Deegan, director of Duke University's Center for Genome Ethics, Law, and Policy.

"If one institution owns all the rights, it may work well to introduce a new product, but it may also block other uses, including research," he said. ...

Although the response of one geneticist was '..."The marketplace will now be open." ...' and I think it's rather worse than pathetic to speak of 'market-places' and 'consumers' where health care is concerned. Also, what's with people speaking of 'cancer genes'? Such things as irreparable/improperly repaired genetic damage/epigenetic attachments altering functionality produce the potential for disease, do they not?

http://www.usatoday.com/story/news/nation/2013/06/13/supreme-court-gene-...

Richard Wolf, USA TODAY Published 10:28 a.m. ET June 13, 2013 | Updated 4:31 p.m. ET June 13, 2013
Supreme Court decision is a win for women with genetic risk of breast and ovarian cancers, as well as geneticists and researchers who had criticized a Utah company's exclusive patent.
Breast cancer gene

WASHINGTON — The Supreme Court ruled Thursday that human genes cannot be patented, a decision with both immediate benefits for some breast and ovarian cancer patients and long-lasting repercussions for biotechnology research. ...

... But the court held out a lifeline to Myriad Genetics, the company with an exclusive patent on the isolated form of genes that can foretell an increased genetic risk of cancer. The justices said it can patent a type of synthesized DNA that goes beyond extracting the genes from the body.

Justice Clarence Thomas wrote the decision for a unanimous court. "Myriad did not create anything," Thomas said. "To be sure, it found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention."

The decision will allow other scientists and laboratories to provide genetic diagnostic testing, now that the patent on the BRCA1 and BRCA2 genes themselves has been lifted. That should lead to lower costs and greater access.
ADVERTISING

"It is splendid news for patients, for physicians, for scientists and for common sense," Mary-Claire King, the geneticist who in 1990 discovered the abnormality on chromosome 17 that proved to be the breast cancer gene, told USA TODAY. "The marketplace will now be open."

Myriad emphasized the bright side of the decision for the company — that cDNA, which is not naturally occurring, remains patentable. As a result, it said, 24 patents containing more than 500 valid claims remain in effect. ...

Oddly, page two appears to be a repeat of page 1... however, this indicates some of the potential for problems permitted in a culture where 'your money or your life' is the choice presented to sick and injured citizens. And this is important!

https://www.forbes.com/sites/danielfisher/2013/06/13/supreme-court-rejec...

Sun 13, 2013 @ 11:06 AM 29,763 views
The Little Black Book of Billionaire Secrets
Supreme Court Rejects Human-Gene Patents -- Sort Of

Daniel Fisher ,

Forbes Staff

I cover finance, the law, and how the two interact.

Opinions expressed by Forbes Contributors are their own.
English: Clarence Thomas, Associate Justice of...

Thomas: No patents on natural DNA (Photo credit: Wikipedia)

The U.S. Supreme Court today declared human genes off-limits for patent protection, drawing a line between "naturally occurring" DNA sequences and similar genes entirely created in the lab. ...

... By making a distinction between "natural" DNA and a lab-created synthetic version called complementary DNA, however, Justice Clarence Thomas may have seized on a distinction that will be difficult to maintain over the long run.

"It's one of these situations where candidly, it just makes me sad there isn't a higher level of basic biology knowledge in the world," said Brenda Jarrell, a Ph.D biochemist and partner with at Choate, Hall & Stewart in Boston. "Unfortunately, this is the Supreme Court." ...

... The decision comes down to what one commentator has said should be the guiding question for patent examiners: "What did you do with your hands?" In identifying specific gene sequences, Myriad didn't actually create anything, Thomas said. ...

... He also rejected the idea that by isolating the gene and separating it from the surrounding chromosome, Myriad had created something new. The U.S. Court of Appeals for the Federal Circuit approved approved Myriad's "natural" BRCA genes, with one judge saying they were patentable because the act of isolating them cleaved chemical bonds linking them to the rest of the chromosome.

Thomas rejected that argument, saying it wasn't enough to overcome the rule against patents on naturally occurring things. The Federal Circuit is a specialized court for patent appeals, but the Supreme Court has overruled it in several significant cases recently where it felt judges there had been too accomodating to patent owners.

The high court agreed with the Federal Circuit that cDNA is patentable, which was also the stance of the U.S. government. The reasoning is cDNA requires actual work in the laboratory and inverts the normal process found in nature. The synthetic DNA is an edited version of a gene, stripped of non-coding regions. The court said that makes cDNA "not naturally occurring."

Critics say even the edited sequences are directly analogous to naturally occurring DNA. "That may be so," Thomas wrote, "but the lab technician unquestionably creates something new when cDNA is made."

Jarrell, who has a doctorate in biochemistry from the University of California in addition to a Harvard Law degree, said Thomas is wrong. Not only do researchers make cDNA with naturally occurring tools, but the exact same process can occur naturally in the body.

"It's not actually correct to say cDNA is not a product of nature," she said. "There's nothing more inventive about making cDNA than isolating DNA."

The DNA/cDNA distinction also could provide grist for future litigation, since cDNA is a gene sequence consisting only of exons, or nucleotides that code for amino acids.

"What if you took that same cDNA sequence and added non-functional introns?" asked Dalila Argaez Wendlandt, a partner with Ropes & Gray. Would that allow for a successful end-run around the patent?

Thomas was careful to state what the decision is not about. It doesn't concern method patents covering novel new ways to isolate genes. Nor does it concern novel ways of applying genes for treatments. He even held out hope for inventors who alter the order of naturally occurring DNA sequences.

"We merely hold that genes and the information they encode are not patent eligible ...simply because they have been isolated from the surrounding genetic material," he said.

Justice Antonin Scalia gave the faintest hint of concern in a concurrence, where he said he agreed with the judgment but couldn't sign off on the heavily technical parts of the opinion. "I am unable to affirm those details on my own knowledge or even my own belief," he said, although he agreed with the distinction between sequences taken exactly from nature and cDNA synthetically created in the lab.

Jarrell, who represents biotechnology companies, said she worries the decision will introduce more uncertainty into the patent system as examiners try to determine what they are blocked from considering for a patent and what might still be eligible. "It is a valuable discovery to figure out what gene sequences make you susceptible to breast cancer and which ones don't," she said, but patents based merely on those sequences are probably now barred. ...

... Gaede said biotech companies want to patent gene sequences because simply having a patent on a method offers less protection. Rivals can manufacture products according to the method overseas, where U.S. patent law doesn't reach, he said, whereas owners could block those products from coming into the country if they also have a patent on the sequence. ...

Sooooo, it can be guessed what's coming there. And this whole pathology is making me sick.