![Overview ,[object Object],[object Object],[object Object],[object Object]](data:image/gif;base64,R0lGODlhAQABAIAAAAAAAP///yH5BAEAAAAALAAAAAABAAEAAAIBRAA7)
Recommended
Recommended
More Related Content
Similar to Ariad and Written Description
Similar to Ariad and Written Description (20)
Ariad and Written Description
- 1. The Implications of the Federal Circuit Reaffirming the Written Description Doctrine in the Ariad v. Eli Lilly Decision Paul M. Rivard John P. Iwanicki May 6, 2010
- 13. “Possession” Test “ Possession is nine-tenths of the law.” -Anonymous
- 36. Questions?
Editor's Notes
- This single paragraph of the statute – actually a single sentence – contains three separate requirements: written description, enablement, and best mode. The way the paragraph is structured, it’s easy to see that best mode is a separate requirement (“shall contain . . . and shall set forth the best mode”). But what is less clear is whether written description and enablement are separate requirements or aspects of a single requirement.
- When we get to the parties’ arguments in Ariad, we’ll see how they argued different ways the statute should be read. As the case law developed at the Federal Circuit, the court held that written description was a separate requirement from enablement. Ariad involved this question going before the en banc court, which reaffirmed the existing law.
- Vas-Cath (1991) involved a catheter for removing blood from arteries, with joined semi-circular lumens (tubes) that come to a single tapered tip. The design reduced the puncture area significantly relative to prior coaxial configurations, making injury to blood less likely. Mahurkar had an earlier filed design application that contained the same drawings.
- Vas-Cath really involved two main questions: (1) can drawings alone provide a written description, and (2) is there a written description requirement separate from the enablement requirement? There was no dispute that the design drawings were enabling. The patentee argued Section 112 first paragraph was therefore satisfied. Vas-Cath argued that the design application didn’t provide a “written description” of the invention, and the district court agreed. Without the priority date, a published Canadian design was prior art. The Federal Circuit disagreed, holding that a drawing alone may be a sufficient written description. A picture says a thousand words. The court also squarely addressed the issue of whether 112 has a separate written description requirement.
- Fiers was one of the early biotech cases on written description. As we see from this quote, written description is intertwined with conception: for chemical compounds (inc. DNA) need structural features not just function. Conception is defined as a definite and permanent idea of the complete and operative invention, as it is thereafter to be applied in practice. In Fiers, the court said the specification gave no more than a “wish” or “plan” for obtaining the claimed DNA.
- In University of California v Eli Lilly (1997), at issue was whether the patents’ example of rat insulin cDNA (complementary DNA) was an adequate written description for claims directed to human cDNA. Describing the human DNA only functionally with a general method of how to make it, was not enough.
- In the Univ. of Rochester case in 2004, the question of a separate written description requirement again was before the court. The patent claimed methods of selectively inhibiting the COX-II enzyme for treating inflammation. Although the patent didn’t claim the active compound itself, a selective COX-II inhibitor was necessary to the practice of the method.
- Four judges dissenting from the denial of rehearing en banc – so this same question almost went to the en banc court back in 2004. As an aside, this case also involved perhaps the greatest conflict of interest in the history of patent law. The now-defunct Pennie & Edmonds had attorneys representing Pfizer while attorneys literally down the hall procured this patent for the U of R specifically targeting Pfizer’s Celebrex product. I believe the terms of the settlement were undisclosed, but it contributed to the demise of the firm.
- So out of these cases comes the “possession” test, which has turned out to be a fuzzy concept. For those who might not recognize this photograph, it is David Tyree’s famous reception in Super Bowl XLII where he somehow trapped the football against is helmet as he was tackled to the ground. Also, we all know that possession is an important legal concept since it’s nine-tenths of the law.
- Enzo involved biological deposits. The patentee argued the deposit showed possession of the invention, in quite a literal sense. Possession is “ancillary” to having written description but not the end-all. The court said ‘possession’ is “especially meaningful” when examining whether claims are entitled to priority application, whether interference count is supported, or whether new claims are supported. The first time this case was at the Federal Circuit (Enzo I) the panel held that actual possession by the inventors (via deposit) was not sufficient to cure a lack of written description in the specification, and the claims were invalid. On rehearing, the court reversed itself.
- The patent was based on an important discovery – the inventors’ identification of a particular protein and its relationship to how the body develops immune responses to infection.
- Kappa B inhibitors The classes of molecules were only identified in a very general sense.
- Basically, if there was only a single requirement you wouldn’t need to break the statute into having a description “of invention” and “of the manner and process of making and using.”
- Since 112 first paragraph didn’t significantly change after claims requirement was introduced (now second paragraph), it became unclear whether there remained any purpose of written description other than enablement.
- Schriber-Schroth - The Court found that the even if the specification was enabling for a flexible web, it “was not the invention which [the patentee] described by his reference to an extremely rigid web.” Morse – claim 8 covered every conceivable way of printing characters at a distance using electric or galvanic current. Morse did not “describe” and “had not invented” what was claimed. Festo (probably dicta at most) - specification “must describe, enable, and set forth the best mode of carrying out the invention.”
- The court criticized, but didn’t eliminate the “possession” test. The court clarified that it is an objective standard – focus is on the “four corners of the specification” and specification must demonstrate that inventor actually invented claimed invention. p. 24: “The level of detail required to satisfy the written description requirement varies depending on the nature and scope of the claims and on the complexity and predictability of the relevant technology. Id. For generic claims, we have set forth a number of factors for evaluating the adequacy of the disclosure, including ‘the existing knowledge in the particular field, the extent and content of the prior art, the maturity of the science or technology, [and] the predictability of the aspect at issue.’”
- p. 21: “merely drawing a fence around the outer limits of a purported genus is not an adequate substitute for describing a variety of materials constituting the genus and showing that one has invented a genus and not just a species.” Court noted there is no limiting language in statute (“for purposes of priority” etc.) and no policy reason to read one into it.
- Many amici argued that the doctrine fails to adequately compensate many important research breakthroughs. The court was unpersuaded by these arguments and emphasized the patent laws are intended to reward the not the search but the successful conclusion.
- Last point: identify things like binding sites and types of chemical structures that would be expected to exhibit the desired function.