Volume 93, Issue 4

  • Dicta on Adrenalin(e): Myriad Problems with Learned Hand’s Product-of-Nature Pronouncements in Parke-Davis v. Mulford  -Jon M. Harkness
  • An Empirical Study on the Use of Technical Advisors in Patent Cases  -Joshua R. Nightingale
  • AN OVERVIEW OF PATENT REFORM ACT OF 2011: Navigating the Leahy-Smith America Invents Act Including Effective Dates for Patent Reform   -Hung H. Bui, Esq
  • Post-Issuance Proceedings in the America Invents Act   -Andrei Iancu and Ben Haber
  • Annual Index (2011)

Dicta on Adrenalin(e): Myriad Problems with Learned Hand’s Product-of-Nature Pronouncements in Parke-Davis v. Mulford  

By: Jon M. Harkness

Gene patents of the type at issue in the Myriad case, which might soon be heard by the U.S. Supreme Court, arise from an exception to the rule that products of nature cannot be patented.  This exception allows that isolated products of nature can be patented if they have commercial utility, which is widely recognized as traceable to language from an opinion issued by Judge Learned Hand in Parke-Davis v. Mulford.  This 1911 case was a patent dispute over a therapeutic version of the hormone adrenaline.  This article is based on a detailed historical examination of Parke-Davis and the patent application process that predated the litigation by roughly a decade.

Parke-Davis was a classic (and protracted) priority dispute; the litigants gave no discernible attention to whether isolated products of nature could be patented.  Hand’s now-famous Parke-Davis pronouncements on the patentability of isolated products of nature were under-informed dicta, which conflicted with existing patent law.  Between 1900 and 1903, a senior patent examiner repeatedly rejected the Adrenalin patent application because he believed that the hormonal product was merely an isolated product of nature and, therefore, unpatentable according to principles articulated in Ex parte Latimer (an 1889 case denying a patent on a pine-needle core used for making textiles, because the core was an isolated product of nature).  The Adrenalin patent applicant accepted Latimer as controlling and succeeded in obtaining a patent by arguing that his medical product was different than the hormone—not just a purified version thereof.  

Hand’s dicta from Parke-Davis essentially lay dormant until 1958, when it was relied upon by Fourth Circuit judges grappling with the patentability of vitamin B12.  By 1958, Hand had become a living legal legend, and his judicial colleagues did not recognize that, in 1911, a 39-year-old district court judge—less than two years removed from law practice on Wall Street (handling one of his first patent cases)—had made an uninformed mistake in Parke-Davis. In the years since 1958, Hand’s errant Parke-Davis pronouncements have ascended from obscurity to conventional wisdom. 

These revelations have potentially important implications for the outcome of Myriad.  The significance of this historical analysis is, perhaps, further amplified because Judge Kimberly Moore acknowledged that her recent Federal Circuit swing vote in Myriad was largely determined by a history of “settled expectations,” which she identified as starting with Parke-Davis. 

An Empirical Study on the Use of Technical Advisors in Patent Cases 

By: Joshua R. Nightingale

Patent infringement cases pose considerable challenges to federal district court judges. First, patent cases involve a specialized, nuanced body of law with which the majority of federal district court judges have very little experience. District court judges, however, are expected to be generalists who can quickly get up to speed in cases involving nearly any field of law. [M]ost district court judges are not technologically trained. Indeed, the average district court judge may be described as “a smart, accomplished, and legally sophisticated person who is technologically ignorant: an able and successful lawyer before appointment, but a person who might have been a history or English major and who may never have taken a course in calculus or in any basic science at all.” Furthermore, this typical judge is asked not only to grasp broad scientific principles but also to make sophisticated determinations about ambiguities in patent claim language, which can turn on “technologically forbidding material at its most obscure.” Commentators have noted that patent claim construction, the key issue of most infringement cases, is usually less about legal principles of document construction than it is about science and technology: “The construction of the patent claim is inexorably intertwined with the science that underlies, indeed shapes, them.”

This Article seeks to shed light on the use of technical advisors in federal district court patent litigation. [It] provides a basic primer on patents, patent law, and patent claim construction; to understand the plight of the district judge, the contours of his technical decision-making must be set forth. [It] describes the means by which a district judge can gain technical assistance in patent cases, including the use of court-appointed experts, patent special masters, and technical advisors. These technology teachers are compared and contrasted. [It] discusses TechSearch, L.L.C. v. Intel Corp.,25 a watershed case in which the Federal Circuit addressed the use of technical advisors in the patent context for the first time. [It], the heart of this Article, details the results of an empirical study on the use of technical advisors in federal district court patent litigation. The analysis was largely based on the 26,380 district court cases filed between April 11, 2002 and December 31, 2010, that have been identified by the federal judiciary as “patent cases.” After identifying these 26,380 patent cases, a search of their docket sheets revealed that technical advisors were contemplated in 434 of these cases, and a technical advisor was actually appointed by the court in 287 of them. Tabular material set forth in [the article] further details the results of the analysis, including the incidence of use of technical advisors by year and by district court. The docket sheets were further analyzed to identify the average profile of the individuals who serve as technical advisor.  Finally, [It] details the issues addressed by technical advisors when appointed and the specific functions performed by them in assisting the court.

AN OVERVIEW OF PATENT REFORM ACT OF 2011: Navigating the Leahy-Smith America Invents Act Including Effective Dates for Patent Reform 

Hung H. Bui, Esq 

This article provides a detailed overview of the changes to patent law made in the Leahy-Smith America Invents Act, also known as, Patent Reform Act of 2011, signed into law by President Obama on September 16, 2011.  [T]he Patent Reform Act of 2011 still represents the most significant reform of U.S. patent law in nearly 60 years, since the 1952 Patent Act,36 including: Moving the U.S. from a “first-to-invent” system to “first-to-file” system with a limited one-year grace period only for an inventor’s own prior publication and inventor derived public disclosure; Eliminating “interference proceedings” and replacing therewith “derivation proceedings” to ensure first to file is actually an original inventor and not derived from another;  Eliminating best mode failure as a litigation defense; Prohibiting the issuance of patents claiming “any strategy for reducing, avoiding or deferring tax liability” and “human organisms;” Eliminating the incentive to sue for false patent marking and to join multiple defendants in a single lawsuit;  Codifying existing regulations for 3rd party submission of prior art in published applications and expanding time period for 3rd party submission of prior art; Expanding prior user rights as a defense to infringement to all technologies (not just business method claims);  Creating new USPTO proceedings for Post-Grant Review and Inter Partes Review (where any person can challenge the validity of a patent within the USPTO with limited discovery) and Supplemental Examination (where a patent owner can correct problems with a patent and strengthen the value of the patent in anticipation of litigation); and  Creating a new Patent Trial & Appeal Board to replace “Board of Patent Appeals and Interferences” to handle, among others, new Post-Grant Review and Inter Partes Review.

Post-Issuance Proceedings in the America Invents Act 

By: Andrei Iancu and Ben Haber 

The current American system [for post-issuance proceedings] exists in stark contrast to practice in other countries. For example, opposition proceedings are available to challenge the validity of patents recently issued by the European Patent Office. Additionally, both pre- and post- issuance opposition has long existed for United States trademarks. It is against this backdrop that Congress revamped the options available in the PTO for post-issuance review of recently issued patents. [This article] describe[s] the post-issuance proceedings available in the PTO when the America Invents Act is fully implemented. [It] provide[s a] brief summary of the procedures that were available before passage of the Act. [The article] provide[s] a detailed description and analysis of the options made available by the Act. Finally [it] conclude[s] that Congress clearly intends to make the PTO a viable alternative to district court litigation for answering questions of patent validity. 

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