INTRODUCTION ¶3 People who decry the rising prices of their medicines probably do not recognize one cause of that rise-a relatively obscure patent law doctrine called double patenting. The double patenting doctrine, which actually prohibits double patenting, should promote competition for improvements but has often failed. In a series of rulings, the Federal Circuit has weakened the double patenting doctrine and removed it from its historical Supreme Court roots. This has allowed pharmaceutical companies to obtain second patents for compositions covered by their earlier patents and to extend their exclusive rights in the applicable composition beyond the term permitted for a single patent. The Supreme Court can and should reinvigorate the double patenting doctrine as a prohibition on such second patents. This reinvigorated double patenting prohibition will promote innovation and competition for pharmaceuticals by third parties and limit price gouging resulting from unjustified extensions of patent rights. ¶4 To put this in patent law terms, pharmaceutical companies have been obtaining broad U.S. patents that cover all compositions containing common elements, a genus, that sometimes includes millions of compositions. 3 As a result, patentees have acquired what the U.S. Supreme Court has characterized as a right to "cripple competition" 4 because a genus patent gives the holder (a "First Inventor" and the patent a "First Patent") the right to exclude for 20 years any other company from making, using, selling or offering to sell any of those millions of embodiments (a "First Invention"). 5 These patents (1) hinder others from determining which species within the genus have the most promising medical 3 JANICE M. MUELLER, PATENT LAW 176 (Wolters Kluwer 4th ed. 2012) ("A genus is a grouping or category made up of multiple species that share some characteristic"); see, e.g., Sanofi-Synthelabo v.
To implement this obviousness standard prior to 2007, the Federal Circuit 11 generally ruled that prior art had to teach, suggest or motivate PHOSITA (the "teaching, suggestion, motivation" or "TSM" test) to combine elements of prior art references before a court would hold the invention obvious. 12 However, during a 2007 oral argument before the Supreme Court, KSR International Co. v. Teleflex, Inc., Justice Scalia referred to this test as "gobbledygook." 13 Earlier in the same argument, Chief Justice Roberts said, referring to the same test, "it seems to me that it's worse than meaningless because it complicates the inquiry rather than focusing on the statute." 14 In its unanimous decision, 15 discussed below in Part II-C, the Court in 2007 rejected the rigid application of the teaching, suggestion, motivation test and increased the likelihood that inventions would be found obvious. 16 Professor Miller said then that it was "plain that, for the Susuggested by that article were long felt demand, commercial success, commercial acquiescence, simultaneous solution, professional approval and progress through the Patent Office. Subtests, at 117-18. The article emphasized the non-technical nature of these subtests. Id. at 1171-72. The Federal Circuit subsequently took the position that when secondary considerations are present, the court must take those into account.
Myriad Genetics, Inc. ("Myriad") obtained patents in the 1990s on two "isolated" human breast and ovarian cancer susceptibility genes ("BRCA"). Myriad did not list all the isolated sequences it claims to have a right to monopolize, but instead claims a patent on the physical phenomena itself-all DNA segments that code for the BRCA1 polypeptide, even the sequences Myriad has not identified and even those someone else in the future creates or isolates the sequences of through a method or methods not contemplated by Myriad. An impressive array of non-profit medical societies, doctors and patients sued to have the Myriad patents declared invalid. In 2010, the District Court for the Southern District of New York held in Association for Molecular Pathology v. United States Patent and Trademark Office that the claimed product patents for isolated DNA segments constituted unpatentable subject matter under 35 U.S.C. §101. On July 29, 2011, a divided panel of the Federal Circuit reversed the District Court and held that the isolated DNA segments constituted patentable subject matter.
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