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Patently Obvious

April 2, 2012

Many an experiment has been saved by "tweaking." That term might not be in any scientific textbook or dictionary, but it's an essential part of science. Tweaking, for the uninitiated, is making that small adjustment in a variable to get the right result. You turn a control to get a little more temperature, add a little more water to get that solid to solvate, or turn a screw to optimize your signal.

Experimentalists do this all the time, so the idea of tweaking could never be patented, right? Well, the Supreme Court of the United States has just decided that matter in a specific case. As we all know, rules of law can be specific, arbitrary, and as changeable as the weather, so it will be some time before the matter is actually settled.

The US Patent and Trademark Office (USPTO) has some rules as to what can be patented. Things that can't be patented are recited on its web site, as follows:[1]
• Laws of nature
• Physical phenomena
• Abstract ideas
• Literary, dramatic, musical, and artistic works (Copyrighted, instead)
• Inventions which are not useful (such as perpetual motion machines)
• Inventions which are offensive to public morality

I wonder what an "invention offensive to public morality" might be. They can't mean sex toys, since there are many patents on those.[2]

Inventions must also be novel, non-obvious, adequately described or enabled for one of ordinary skill in the art to make and use the invention, and claimed by the inventor in clear and definite terms.[1] A proper patent application must teach how to make or use the invention. I once needed to convince a patent attorney that one of my applications needed more "teaching."

On March 20, 2012, the Supreme Court unanimously struck down a patent on a medical diagnostic test.[3-9] The Supreme Court case was a dispute between the Prometheus unit of Nestle SA and the Mayo Clinic as to whether certain types of diagnostic tests meet the patent eligibility requirements. The full text of this decision, Mayo v. Prometheus, is available on the web site of the Electronic Frontier Foundation.[3]

The patent, and the reason for the lawsuit that spurred this decision, are easy to understand. The dosage of thiopurine drugs, used in the treatment of inflammatory bowel diseases, and other diseases, is difficult to determine for a patient. As is usual for drugs, too low a dose is not helpful, and too high a dose causes side effects.

The patent involved in the Supreme Court decision, US No. 6,680,302, involved "tweaking," as its first claim demonstrates:[10]
"A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder, comprising:

(a) administering a drug providing 6-thioguanine to a subject having said immune-mediated gastrointestinal disorder; and

(b) determining a level of 6-thioguanine or 6-methyl-mercaptopurine in said subject having said immune-mediated gastrointestinal disorder,

wherein a level of 6-thioguanine less than about 230 pmol per 8x108 red blood cells indicates a need to increase the amount of said drug subsequently administered to said subject

and wherein a level of 6-thioguanine greater than about 400 pmol per 8x108 red blood cells or a level of 6-methyl-mercaptopurine greater than about 7000 pmol per 8x108 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.

The Supreme Court decided that the Prometheus patent expressed a law of nature, and an obvious method of using it, so it was not patentable.[4] Not only that, but the court cited an 1853 precedent involving a Samuel F.B. Morse patent that tried to secure rights to all electrical transmission of messages.[6] The court thereby rebuffed attempts to broadly patent very general ideas. Laws of nature and abstract ideas are two of the bullet points cited on the USPTO web site as things that can't be patented. To quote from the court decision,
"...simply appending conventional steps, specified at a high level of generality, to laws of nature, natural phenomena, and abstract ideas cannot make those laws, phenomena, and ideas patentable..."[3]

Justice Stephen Breyer is to be commended for delving into primary sources with his statement that Archimedes could not have "secured a patent for his famous principle of flotation by claiming a process consisting of simply telling boat builders to rely to that principle."[6]

Prometheus claimed validity in its patent, citing Gottschalk v. Benson (409 U.S. 63, 71, 1972) that it involved a transformation of the human body. The argument here is that a machine or apparatus is patentable if it changes something to a different state or thing. It was an argument with which the Supreme Court did not concur.[8] Although the Supreme Court decision was unanimous, there are expressions of dissenting opinion on the Internet. One of these questions the "Law of Nature" concept as being ill-defined, expressing an outmoded eighteenth century view of the world.[9]

The first US patent was issued to Samuel Hopkins, who discovered that burning potash a second time made it a better carbonate. Hopkins' discovery was empirical, an observation, and it was patented. The Prometheus patent seems to have the same empirical basis, but it was shot down by the court.[9]

Patents were originally designed to encourage innovation, by giving inventors a short monopoly on their invention in exchange for full disclosure. Today, patents are stifling innovation. Patent trolls are a problem. Unless an inventor has considerable legal and other resources, his patent will never prevail. For example, 40,000 software patents are issued every year, each of which might be infringed by another software patent.[6]

Printed DNA sequenceA chapter from the book of life.

Does this fall under copyright, or patent protection?

(Via Wikimedia Commons).

Of major concern are the 2,645 DNA patents issued in the last 30 years.[7] Many people claim that gene patents stifle innovation, and they improperly permit a monopoly on part of the human body. As a consequence, personalized medicine, which is just beginning to blossom, may not progress as fast as it should, to the detriment of human life and health.

References:

  1. What Can And Cannot Be Patented? - US Patent and Trademark Office Web Site.
  2. As a somewhat benign example, see Paul Lyons, "Amusement device for use during sexual intercourse," US Patent No. 5,524,638, June 11, 1996.
  3. Supreme Court Of The United States, Mayo Collaborative Services, DBA Mayo Medical Laboratories, et al. v. Prometheus Laboratories, Inc., Certiorari To The United States Court Of Appeals For The Federal Circuit No. 10–1150. Argued December 7, 2011 - Decided March 20, 2012.
  4. Julie Samuels, "The Supreme Court Gets it Right: No Patents on Laws of Nature," Electronic Frontier Foundation Press Release, March 21, 2012.
  5. Debra Cassens Weiss, "Supreme Court Orders Federal Circuit to Reconsider Ruling Allowing Gene Patents," ABA Journal, March 27, 2012.
  6. L. Gordon Crovitz, "Could Morse Have Patented the Web?" Wall Street Journal Online, March 25, 2012.
  7. Greg Stohr and Susan Decker, "Myriad's Human-Gene Patent Rehearing Ordered by High Court," Bloomberg News, March 26, 2012.
  8. Caroline Gousse, "'Law of Nature' Bars the Patentability of Determining the Adequate Dosage of a Drug," IP Brief, March 29, 2012.
  9. Robert R. Sachs, "Punishing Prometheus: The Supreme court's Blunders in Mayo v. Prometheus," Patentlyo.com, March 26, 2012.
  10. Ernest G. Seidman and Yves Thort, "Methods of optimizing drug therapeutic efficacy for treatment of immune-mediated gastrointestinal disorders," US Patent No. 6,680,302, January 20, 2004.

Permanent Link to this article

Linked Keywords: Experiment; tweaking; scientific; textbook; dictionary; independent variable; temperature; water; solid; solvate; screw; signal; experimentalist; patent; Supreme Court of the United States; rule of law; weather; US Patent and Trademark Office; laws of nature; physical phenomenon; literature; drama; music; art; copyright; invention; perpetual motion machine; public morality; medical diagnostic; Prometheus; Nestle SA; Mayo Clinic; Electronic Frontier Foundation; dosage; thiopurine drug; inflammatory bowel disease; side effect; US Patent No. 6,680,302; Samuel F.B. Morse; telegraphy; electrical transmission of messages; Justice Stephen Breyer; Archimedes; Archimedes' principle; principle of flotation; human body; eighteenth century; Samuel Hopkins; potash; carbonate; empirical; innovation; inventor; monopoly; patent troll; software patent; Wikimedia Commons; DNA; gene patent; personalized medicine; US Patent No. 6,680,302.

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