In March, following the Federal Circuit's denial of Sequenom's petition for rehearing en banc, Sequenom filed a petition for certiorari for Supreme Court review of the Federal Circuit's decision in Ariosa Diagnostics, Inc. v. Sequenom, Inc.  In response to that petition, twenty-two amicus briefs were filed encouraging the Supreme Court to grant certiorari.  With the Court scheduled to consider Sequenom's petition in conference on Thursday, Patent Docs will examine selected amicus briefs in the coming week.  Today, we review the amicus curiae brief submitted by Dr. Ananda Mohan Chakrabarty.  Dr. Chakrabarty is most recognizable to those in the patent community for developing a genetically engineered organism using plasmid transfer, for which he obtained U.S. Patent No. 4,259,444, which in turn was the subject of the landmark Supreme Court case, Diamond v. Chakrabarty, 447 U.S. 303 (1980).

Dr. Chakrabarty begins his brief by arguing that "the current direction for addressing the issue [of what constitutes patentable subject matter under U.S. patent law], represented by the Mayo/Myriad/Alice framework of analysis, has failed and will continue to fail all stakeholders in the United States patent system," and therefore, "this Court should reconsider the basic issue of how to handle the judicial exceptions to § 101, particularly as [it] relates to the judicial exception categories of 'natural phenomena' and 'law of nature,'" adding that the Ariosa v. Sequenom case "offers an excellent opportunity to do so."  According to Dr. Chakrabarty, the Mayo/Myriad/Alice analytic framework "has turned § 101 into a needle's eye that must be traversed, rather than the broad open archway it was intended to be."  Dr. Chakrabarty acknowledges that "dealing with the judicial exception categories of 'natural phenomena' and 'laws of nature' requires different thinking than dealing with the more ambiguous category of 'abstract concept,'" and contends that for the first two exceptions "the proper analysis should focus on determining whether the thing covered by the patent claims involves an alteration or manipulation by the hand of man and, if so, whether that alteration or manipulation has created useful qualities or characteristics that did not exist in the thing's natural state."

In a section of the brief entitled "A Scientist's View," Dr. Chakrabarty states that "[i]n this case, the Federal Circuit's adherence to Mayo, rather than following its own conviction that Sequenom's significant invention is worthy of patent protection, was exceptionally disappointing to scientists."  Contrasting the Federal Circuit's decision in Ariosa with the Supreme Court's decision in Mayo, Dr. Chakrabarty explains that "[s]peaking as a scientist, it was not surprising that the Mayo patent was held invalid," but suggests that "the Sequenom technology is altogether different, involving innovative and novel ideas for a technology that no longer requires the isolation of rare whole fetal cells."

Quoting from Diamond v. Chakrabarty, Dr. Chakrabarty reminds that "[i]t is beyond dispute that 35 U.S.C. § 101 includes 'anything under the sun that is made by man,'" arguing that "[t]his principle is fully consistent with the judicially created exceptions of natural phenomena and laws of nature because those items -- properly interpreted -- are not new and not made by man."  Turning to his '444 patent, Dr. Chakrabarty posits that while the '444 patent "is unequivocally proper and valid[,] . . . it is easy to realize that the outcome might have been different under the Mayo/Myriad/Alice framework of analysis."  He suggests that "in that altered world of analysis, my patent would have been attacked as merely applying the basics of the genetic code, extracting a known natural DNA sequence from point A and inserting it into another known natural DNA sequence at point B using previously established (read 'conventional') techniques."

Dr. Chakrabarty also asserts that:

[T]he most far-reaching role of patentability in the modern life of a technical economy is to incentivize the formation of capital which leads to invention.  The sophistication of current science requires large amounts of capital to fuel the fire of invention.  The process takes years.  And unless the Mayo/Myriad/Alice framework is revised significantly and soon, its disastrous effect will harm the U.S. (and world) economies for a long time [emphasis in brief].

For Dr. Chakrabarty, Step 1 of the Mayo/Myriad/Alice framework "is distinctly unhelpful," "provid[ing] no guidance on what that statement means or how to do it," and Step 2 of the Mayo/Myriad/Alice framework "is no better."  The whole framework "inherently conflates § 101 with §§ 102-103, if for no other reason than that terms such as 'inventive concept' and 'conventional steps' have a 200 year history of use in the context of distinguishing claimed inventions from the prior art."  Dr. Chakrabarty argues that "[t]he proper application of § 101 should be formulated in a manner that is separate and independent from §§ 101-103 and 112, just as those sections should be left free to do their jobs separate and independent from § 101."  He suggests that Sequenom's petition for certiorari presents "a perfect vehicle to re-define the proper framework of analysis of § 101, at least for the area of life sciences," arguing that:

[T]he proper § 101 analysis should provide that, if the inventor claims a material -- or a process using a material -- that has been altered or manipulated by the hand of man and, if as a result of that alteration or manipulation, the claimed subject matter is shown to have qualities, characteristics, or properties that did not exist in the natural material, then that claimed subject matter passes muster under § 101 and is worthy of being considered under §§ 102-103 and 112.

Applying his proposed analytic framework to Sequenom's invention, Dr. Chakrabarty explains that "the starting point is a sample of maternal blood (claim 21), serum (claim 1), or plasma (claim 1)," that "[t]he sample is altered and manipulated, as disclosed in the patent, with the result of yielding information about sex and genetic deformities of a fetus," and that "[t]here is no dispute in this record that this manipulation by the hand of man is novel, nonobvious, and properly disclosed in the specification."  He then asks "[h]ow can that not be patentable?"