Supreme Court Rules Against Patenting Of Human Genes

220px-Clarence_ThomasDNA_orbit_animated_static_thumbI previously wrote a column opposing the claim of Myriad Genetics over patenting human genes in the case of Pathology v. Myriad Genetics, No. 12-398. The Supreme Court appears to have the same concerns. The Court unanimously ruled this afternoon against the Utah company and by extension of the Federal Circuit in claiming such property rights.


At issue is the patent by Myriad Genetics to genes (BRCA1 and BRCA2) that it found correlate with increased risk of hereditary breast and ovarian cancer. This test was recently made famous by Angelina Jolie who had a preventive double mastectomy after taking the Myriad test (which costs more than $3000). The company has been trying to stop other companies from offering the test at a lower cost.

Thomas drew a bright line that “A naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated.” Despite the ruling of the Federal Circuit (which has been in a series of sharp disagreement with the Supreme Court over the scope of patents, Thomas saw the question in simple terms: “It is undisputed that Myriad did not create or alter any of the genetic information encoded in the BRCA1 and BRCA2 genes.”

Notably, the Court acknowledged that the company “found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention. Groundbreaking, innovative, or even brilliant discovery does not by itself satisfy the [patent law] inquiry.” There was interest in how the Court would define the applicability of patent law to synthesized DNA, or “complementary DNA,” or cDNA. Yet in a footnote the Court expressly stated that it was not ruling or indicating that even cDNA is specifically entitled to a composition patent.

We have been following the increasingly draconian copyright and trademark laws used against citizens and companies — laws secured by an army of lobbyists, lawyers, and an obedient Congress and White House.

This specific patent issue is different but raises many of overall issues. The Court has been pushing back on the expansion of patent law into areas considered part of the “law of nature.” What is key about this decision is that it is based on 35 U. S. C. §101. This has been in the past treated as a highly generalized provision that does not seriously narrow the scope of patents. It was the later section that has been used to narrow the scope until now. This creates a threshold determination on patents that a wide array of academic and public interest groups have long advocated.

Here is the decision: Myriad Decision

102 thoughts on “Supreme Court Rules Against Patenting Of Human Genes

  1. Because I have the law – which describes what is patentable and was cited – and the plain meaning of words in the English language on my side which happens to be the side of logically irrefutable argument, Ralph. Words have meaning and laws such as patent laws include definitions of what they cover. Too bad for you and Myriad, naturally occurring DNA isn’t covered by U.S. patent law. As I said, if it were, whomever isolates the gene for blue eyes could patent it and start demanding licensing fees to every blue eyed devil on the planet. And that’s simply an absurd outcome but inevitable outcome of following the logic that a discovered gene is patentable. That’s why I initially gave the reductio ad absurdum example – it illustrates the absurdity of your logic extrapolated out to it’s logical conclusion.

    I don’t need to appeal to authority to refute your assertion.

    Watching you try to argue is like watching a brain cramp in slow motion having a train smash into it at an intersection.

    Or that dog chasing its tail until it runs into the box.

    However, just to shut you up . . . here’s a patent attorney and a doctor in one package. Note his specialty in medicine is molecular biology and genetics and his sub-specialty in patent law is biotech companies.

    The decision is actually not too disruptive for the industry, as it leaves open many ways for companies to build patent exclusivity around manipulated nucleic acids, methods of using even naturally occurring nucleic acids, etc.,” Cooley LLP patent lawyer Michael S. Tuscan said in an emailed statement. “Much of what this decision pertains to is research and discoveries that took place more than 10 years ago, not what is generally new to the life sciences industry in this day and age.”

    “Michael S. Tuscan is co-chair of the Firm’s Patent Counseling & Prosecution practice group and a member of Cooley’s Litigation department. He joined the Firm in 2005 and is a resident in the Washington DC office.

    Dr. Tuscan specializes in patent issues and has spent his legal career serving the biotechnology industry in the U.S. and abroad in all aspects of intellectual property law. He focuses on the development, execution and enforcement of worldwide market exclusivity strategies for products and technologies that are the core asset of biotechnology companies of all sizes. He is also adept at counseling clients to help turn those assets into business opportunities, such as capital transactions, strategic partnerships, product acquisitions and the like. He has extensive experience in the drafting and prosecution of patent applications, business-focused opinions, due diligence, patent interferences and oppositions.

    Prior to joining Cooley, Dr. Tuscan was a partner at Morgan Lewis. He holds a PhD in Molecular Biology from Emory University, an MS in Genetics, did postdoctoral work in human ion channel biology and served as a patent examiner in the biotechnology group of the United States Patent and Trademark Office. His practice focused on the pharmaceutical and biotechnology arts, including genomics, bioinformatics, micro-array technologies, recombinant antigens and vaccines, gene therapy, genetic engineering, rational drug design, pharmaceutical chemistry and human viruses. He has also published and has been an invited speaker on intellectual property issues facing the genomics and bioinformatics industries.

    Dr. Tuscan is a graduate of the Georgetown University Law Center and is admitted to practice before the United States Patent and Trademark Office and in the jurisdictions of Maryland and the District of Columbia.”

    Now run along, lil’ doggy! I’m sure there’s a box out there waiting for you to beat your head against it some more.

  2. Your reference to Dr. Tuscan proves nothing. Dr. Tuscan does not say anywhere that he agrees with the decision or that Thomas is correct in any shape or form. He merely tries to put a more positive spin on a bad decision.

    For example, Dr. Tuscan says: “While a fair number of existing patent claims are now likely invalid, many of these patents are at or near the end of their term” and the “decision will not prove too disruptive for the industry” because it leaves open many ways for companies to build patent exclusivity around manipulated nucleic acids, methods of using even naturally occurring nucleic acids. “Much of what this decision pertains to is research and discoveries that took place more than 10 years ago, not what is generally new to the life sciences industry in this day and age.”

    Others also similarly try to put a positive spin on a bad decision. The Myriad decision is “unlikely to move the needle on biotech investment,” said Edward Reines, partner in Weil, Gotshal & Manges’ technology litigation practice. BUT, Reines adds, “It’s obviously not a good decision to incentivize investment, but it’s not the end of the world.”

    However, patent litigator Timothy Worrall of Dorsey & Whitney predicted the decision would discourage investment in diagnostic and personalized medicine.

    Again, bottom line, you cannot name even one qualified scientist/patent attorney who agrees that Myriad’s invention is not patentable.

    As for the size of Myriad, the company is most definitely a SMALL business. Yes, it’s not like the mom-and-pop neighborhood luncheonette small business, but it IS small business by today’s corporate standards. It is ranked as one of the SMALL-CAP stocks by Morningstar, and its business enterprise value is less than 5% of Pfizer’s. Myriad is actually a victim of its small size. Had it been Pfizer (or any other major big-pharma-player) with the patent, the SCOTUS would not have dared to interfere with their business. It’s strictly a political decision. From a patent law standpoint, the US Patent office and the Federal Circuit, which SPECIALIZES in the application of patent law have properly applied the law, whereas Thomas, who probably was a mediocre student in science, and was not even a particularly good attorney took the opposite stance of the most learned specialists in the field. So no, I am not applying any political views of my own to an interpretation of the law. The REAL experts have already spoken.

    Try again.

  3. This is not the first time the SCOTUS has rejected patenting a natural phenomenon. I don’t have a cite, and it was many decades ago, but back when zoom lenses first came out, somebody tried to get a patent on the physics of the optics of a zoom lens. It was rejected, because the physics of refraction cannot be patented. On the other hand, IIRC, they let the patents for individual lens system through as meeting the standard. If they had allowed a patent on the Laws of Refraction, that would have opened a huge can of worms. It is easy to see that an aggressive legal department of the patent holder would be able to go after royalties on everything from eyeglasses to big telescopes. Overly broad.

    Just a couple of weeks ago, the SCOTUS rejected an overly broad applicant for a patent on a procedure to determine proper dosage of a medication.

    Justice Breyer wrote, “To transform an unpatentable law of nature into a patent-eligible application of such a law, one must do more than simply state the law of nature while adding the words ‘apply it,'”

  4. I don’t have to try again, Ralph. I didn’t have to provide Tuscan’s statement to refute your assertion.

    35 U.S.C. § 101 describes what is patentable.

    Naturally occurring chemical compounds are not patentable no matter how many times you bang your head on the wall.

    Myriad did not make the genes in question.

    Invalidating their patents on human genes will open competition which drives innovation.

    End of story.

    Also, Dr. Tuscan seems to think the decision will have little impact on the industry. Since he is both patent attorney and an appropriate kind of scientist, that ought to tell you something. However, you seem to be fact proof. Just because he doesn’t agree with you doesn’t mean it is spin. There is no loaded language there or other deceptive language. It’s a straight out opinion that the decision is not a negative factor for biotech businesses by a guy who specializes in both patent law as related to the biotech industry.

    Your frustration is really quite amusing.

    Also, any company capitalized with $195 million dollars is not a small business by any reasonable measure of small business. Most small business are valued at less than a million dollars.

    There are plenty of decaffeinated brands out there that taste just as good as the real thing, Ralph.

  5. So Ralph:

    What is the measure of a business in terms of market capitalization that affords it universal protection by the SCOTUS? Is it over 1 billion dollars to make it generally a large cap stock? Does it need to have a PE ratio of 1:100? What are the fundamentals?

    And, what would happen if a large cap company entered into receivership and its bankruptcy resulted in litigation that went to the SCOTUS. Where would your logic fall into? The company was once a large cap company but now it is bankrupt, what would the automatic judgement be from the SCOTUS in this position?

  6. Did I mention . . .

    [T[he decision is more of a win than a loss for medical device and diagnostics makers, says Jennifer Camacho, partner at international law firm Greenberg Traurig.

    Myriad maintained that its manipulation and identification of the BRCA1 and BRCA2 genes, which suggest a heightened risk of breast or ovarian cancer, had made the genes themselves an patentable invention. The Justices today ruled 9-0 that Myriad’s patents were invalid, setting a landmark precedent for research & development in genetics and diagnostics.

    The decisions closes some doors for industry, but it opens others, Camacho told us. For medical device companies that have relied on patents that are “to the gene” or dependent upon the DNA itself to demonstrate novelty and patentability, the patent portfolio is likely to suffer.

    “However, on the flip side all the other companies’ protection based on the gene itself is also at risk, which means that that opens the door to potentially use more information for screening, but putting on their diagnostic tools, for personalized medicine, those sorts of things,” Camacho said.

    Ultimately the Supreme Court ruling strips back just 1 part of patent protection for gene-based inventions, she added. Patent claims that rely solely on the gene in question, like Myriad’s BRCA1 and BRCA2 patents, are basically out the window, but many companies’ patents also claim novelty for methods of identification and use of the gene in a particular assay or in producing a recombinant protein.

    “We’ve lost 1 layer here, intended in part to open up the field for additional invention and research and work that would be the subject of patent protection,” she said. “There is meaningful patent protection still out there and available for genetic inventions.”

    “Jennifer A. Camacho’s practice is focused on intellectual property counseling. Jennifer has broad experience in intellectual property due diligence, patentability and product clearance studies, licensing and related transactional matters, patent infringement and validity analyses, freedom to operate evaluations, worldwide patent and trademark portfolio development, patent reexamination proceedings, intellectual property litigation, and pre-litigation counseling.

    Jennifer frequently works with clients in the life sciences and chemical industries, including biotechnology companies, pharmaceutical companies, and chemical companies as well as venture capital and institutional investors. Representative clients include a venture-backed gene synthesis company, a publicly-traded biofuels company, a publicly-traded biosynthetic chemistry company, and a publicly-traded regenerative medicine company. Additional representative fields of technology for her clients include synthetic biology, industrial biotechnology, pharmaceuticals, regenerative medicine, protein engineering, metabolic pathway engineering, industrial enzymes, hydrocarbon chemistry, biocatalytic synthesis and biofuels, and nucleic acid synthesis and sequencing.

    Jennifer also works with academic and nonprofit research institutions on patent, licensing and technology transfer matters. Her experience includes patent prosecution for technology that has not yet been licensed, positioning technology for pre-formation academic spin-off companies, and exclusive and non-exclusive licensing transactions.

    Jennifer’s recent experience also includes serving on the litigation team representing a large international pharmaceutical company in an infringement action related to certain biomarkers used in drug discovery. Jennifer has served on the litigation team in multiple ANDA patent litigations representing a large pharmaceutical company seeking to enjoin the defendants from manufacturing and selling generic versions of two of the company’s branded oral contraceptives. Jennifer was also on the litigation team defending a major pharmaceutical company as the plaintiff in a breach of contract suit concerning a licensing agreement for foreign marketing rights for a monoclonal antibody.”

    Really, Ralph.

    Give it up.

  7. The Federal Circuit already applied 35 U.S.C. § 101. THEY know FAR MORE about the application of patent law than Thomas and other SCOTUS paper-shuffling ideologues put together and multiplied by 1,000. Oh, but I’m sorry, I forgot: Gene knows 35 U.S.C. § 101, and the Federal Circuit judges are just amateurs.

    Now, back to reality.

    The best that you could come up with now, is Jennifer Camacho, after doing research all day on the subject. Yet, she says NOTHING to support the SCOTUS ruling. Again, like Dr. Tuscan, she only tries to put a positive spin on a bad decision.

    Brenda Jarrell, on the other hand, whom I have cited–and is a REAL EXPERT in the relevant science field AND patent law says Thomas is flat wrong. Wrong, get it?

    It is very unusual for a lawyer to criticize the SCOTUS is such a direct way. In contrast, it is very common to find lawyers who will publicly state that the SCOTUS made the right call and explain why. Yet, you still cannot cite me anyone. Nonetheless, you still stubbornly cling to the notion that Thomas followed patent law.

    As for finance, you disclose that you don’t know your basics when you say: “Also, any company capitalized with $195 million dollars is not a small business by any reasonable measure of small business. Most small business are valued at less than a million dollars.”

    A market cap of $200 or even $400 million is considered to be a SMALL-CAP COMPANY in the real world. See the following for proof of that: http://corporate.morningstar.com/ib/documents/PublishedResearch/ApplySizePremiumMetrics.pdf.

    As for what market cap would make a Company large enough that it would compel the SCOTUS to defer to that Company’s interests–it is not just a matter of market cap, but of political power. Sure a market cap in excess of $1 billion would probably qualify, but to be a genuine corporate power-player, the company also has to have the political and economic strength to influence, and compel when necessary, government agencies and politicians to do their bidding. That is what really counts.

    Try again.

  8. So if the SCOTUS is only interested in pandering to the large corporations of America, due to their political influence and control of the three branches of gov’t, then why would the SCOTUS even grant certiorari to cases such as these below?

    Adoptive Couple v. Baby Girl, 12-399

    Chafin v. Chafin, 11-1347

    Dan’s City Used Cars v. Pelkey, 12-52

    Trevino v. Thaler, 11-10189

  9. I did not say that the SCOTUS is ONLY interested in pandering to the large and powerful corporations. What I said was that the SCOTUS will always side with Big Business against the rights of Small Business.

    But the SCOTUS very clearly has strong interests in trampling on the civil rights of individuals as well. I’ve made that point before here as well. Thus, if a case comes down to the power of, say, the government vs. an individual whose rights were trampled on by the government, then the SCOTUS, of course, would come down on the side of Big Government.

    Are we getting the principle now? Apparently not.

    Try again.

  10. Speaking of reality, you apparently you have no clue as to how appellate jurisdiction works, Ralph.

    MyrIad lost the original case filed in the U.S. District Court for the Southern District of New York. The Court of Appeals for the Federal Circuit reversed the trial court at which point the plaintiff’s filed for certiorari. It was granted and Myriad lost on the gene patent issue again. They lost based on existing patent law whether you think so or not.

    SCOTUS is the final court of appeal.

    You’re free to be as wrong as to the legal technicalities of this matter as you like.

    Oops.

    And I’ve got some more bad news for you.

    They’re likely to lose their case in Australia later this year when it goes to the Full Bench of the Federal Court as this decision has already been referenced for the upcoming hearing. If it goes to the High Court of Australia? They’ll probably lose there too.

    Why?

    Because discoveries are not patentable.

    Only processes, products and machines are patentable.

    And the U.S. and Australia both have legal systems based in English common law.

    Sleep tight.

  11. You are good at diversions. But your pseudo-arguments are worthless because you cannot escape the fact that the Federal Circuit is the nation’s leading authority on patent law. The SCOTUS are legal servants working for big government and big corporations, and none of the members or staff of the SCOTUS have any expertise in patent law.

    I have asked you repeatedly to name one individual who is both a scientist and an expert in patent law who would agree that the SCOTUS reached the correct decision. You failed to name anyone, after researching the matter all day and all night. That is the tale of the tape.

    Try again, and try not use misdirection and ipse dixitisms.

    Either admit that you cannot find a qualified scientist and an expert in patent law who would agree that the SCOTUS reached the correct decision, or shut up.

  12. Ralph wrote:
    “because you cannot escape the fact that the Federal Circuit is the nation’s leading authority on patent law. The SCOTUS are legal servants working for big government and big corporations, and none of the members or staff of the SCOTUS have any expertise in patent law”
    ~+~
    You’re delusional.

  13. More to the point, you have no idea how SCOTUS works, Ralph. If any justice hearing a case isn’t familiar with a given area of law, their clerks do extensive research on the matter and brief them and/or prominent experts are consulted. All of this informs their reasoning and decisions. That being said, sometimes personal politics does unduly inform decisions, however, this isn’t one of those instances. The law and legal principles here are both basic and clear and the holding comports with them. If they had ruled the opposite? Given Thomas’ specific history of catering to corporations of any size, such a ruling would have been both suspect and in contravention of laws created by the legislature governing what is permissible to patent.

  14. You have been given ample opportunity to find a qualified scientist and an expert in patent law who would agree that the SCOTUS reached the correct decision. You failed. The argument is over. You lost.

    But perhaps there’s a silver lining for you. With your newfound admiration for Clarence Thomas, perhaps Prof. Turley will set up a subgroup, “The Clarence Thomas Fan Club.” Gene, you could be president and Darren could be vice president of the club.

    I will leave you now so that you may post more irrelevant comments to attempt to distract attention away from your blatant failure to find a qualified scientist and an expert in patent law who would agree that the SCOTUS reached the correct decision.

  15. You seem to not grasp the fact that I don’t need anything more than the plain letter of the law and the plain meanings of words in English to support the logic that naturally occurring genes are not patentable as they are a discovery of a natural phenomenon and not an engineered innovation, Ralph.

    Or that I was providing those quotes simply to humor you.

    The appeals to non-adjudicative authority are the meaningless distraction here and have nothing to do with the legal arguments against the patents.

  16. http://www.genengnews.com/keywordsandtools/print/1/19375/

    “The gene patentability question long predates this decision. Genes are the basic units of heredity in a living organism; each one contains instructions (in the form of its sequence) to build a machine (usually a protein) that does the work of living cells. Clearly, genes in their natural state are products of nature.

    On the other hand, genes that have been isolated from their natural state or have been manipulated by scientists are not products of nature. For example, a rock is a product of nature; a rock carved into a statue is not.

    The patent law has always held that, once a natural product has been manipulated by the hand of man, it is no longer a product of nature and is now available for patenting. The fundamental patent statute, 35 U.S.C. §101, states: “Whoever invents or discovers any new and useful . . . composition of matter . . . may obtain a patent therefore . . .”, and this statute has been broadly interpreted. The Supreme Court’s landmark decision Diamond v. Chakrabarty (1980) held that “Patentable subject matter includes . . . anything under the sun that is made by man.”

    The U.S. Patent and Trademark Office (USPTO) has issued about 35,000 patents reciting a gene sequence in their claims. These gene patents protect isolated or purified DNA sequences (many of which encode to therapeutic proteins including biologic drugs), RNA sequences (many of which relate to therapeutic RNAs such as interfering RNAs, antisense RNAs, and ribozymes), vectors, nucleic acid-based vaccines, cells engineered with gene sequences, and various uses of gene sequences (e.g., methods of treatment, methods of diagnosis, or the use of genes as research tools).”

  17. Darren: Is something like this possible?

    Sorry I am so late answering; but YES, in fact there are services right now that will produce any DNA sequences you desire based on a digital file which you can email them; detailing the letter sequence you want.

    The equipment already exists to construct novel chains, and although it is expensive, there is nothing in principle preventing a “printer” device that can automatically convert an arbitrary sequence of letters, of any length, into a strand of DNA. The trick is that DNA does nothing by itself, just like a computer program does nothing if not loaded into a computer; the DNA has to be inserted into a cellular environment which is the “processor” that dumbly reacts to the code. You cannot form proteins without a soup of amino acids, ribosomes to read the DNA, spliceosomes and other mechanisms that manipulate the DNA to extract and prepare genes that the ribosomes can form around, to translate the code into a protein.

  18. Bron: The problem is that BRCA1 and 2 are NOT manipulated in any way by man, they are still ‘rocks’, unchanged. They are not in any way “statues.”

    That should be obvious from the fact that they exist unchanged in humans, or the very idea of the test would not function. Myriad did not modify these carcinogenic genes and then inject them into women and then offer them a test to see if they had been infected. Human genes are the rocks, trees, and natural material that already exist. Patenting BRCA1 or 2 is like patenting Gold, in its raw, natural form unchanged by man. Or, perhaps more relevantly, Lead: I can devise a novel new test to see if a child is suffering from lead poisoning; but that doesn’t mean I get to patent Lead, or the idea of testing for Lead.

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