WRITTEN DESCRIPTION: ARIAD AND BEYOND. Arti K. Rai Duke Patent Law Institute May 15, 2013

Transcription

1 WRITTEN DESCRIPTION: ARIAD AND BEYOND Arti K. Rai Duke Patent Law Institute May 15, 2013

2 Are Enablement, WD Separate? Enablement historically (post-1836, when claims introduced) considered key requirement Before UC v. Eli Lilly (Fed. Cir. 1997) WD not applied to originally filed claims (Fiers v. Revel (Fed. Cir. 2003) alluded to idea in context of conception ) Applied to later filed claims b/c idea was later filed claims did not provide their own notice New matter prohibition of section 132

3 UC v. Eli Lilly (Fed. Cir. 1997) Eli Lilly: claim to cdna for human insulin -- based on disclosure of rat insulin and method using segment of rat cdna to fish out human cdna Perhaps enabled (not entirely clear) Lourie applies WD to strike down claim Notes Fiers v. Revel (1993) case

4 Reach-through claiming University of Rochester v. Searle (2004) claims selective cox-2 inhibitors (Vioxx etc.) based on ID ing receptor Ariad v. Eli Lilly Claim 80: Inhibition of NF-kB cell signaling pathway through reduction of binding of NF-KB to recognition sites on genes genus claim encompassing the use of all substances that achieve desired result of reducing binding of NF-kB to recognition site *no* actual molecule identified

5 Doctrinal rationale Ariad v. Eli Lilly Judge Lourie: two separate requirements Written description of the invention Written description that satisfies enablement ( manner and process of making the invention ) Note that even Ariad agrees that WD has been used for later-filed claims Lourie: No principled basis for restricting that requirement to establishing priority

6 What is written description? A sufficient description of a genus... Requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus Functional claim language meets the requirement only where correlation between structure, function

7 More WD doctrine Admits that term possession has never been very enlightening Possession as shown in the disclosure Question of fact (!) Applies at the time invention enters patent process

8 What s the difference between enablement, WD No bright line rules Question of fact that depends on type of technology Perhaps there is little difference in some fields Cf. Rader: Yet, if a person of ordinary skill is enabled to make and use a novel and nonobvious invention clearly recited in the claims, I fail to see how that invention can be said to have not been invented or be in need of some undefined level of additional description

9 Application to this case Kadesch evidence not helpful b/c WD determined as of filing date Hypothesized molecules Specific inhibitors (I-kB not disclosed until 1991) Dominantly interfering molecules (no examples) Decoy molecules (here, only prophetic examples)

10 Implications for breadth Rader dissent: no blocking patents in pioneering situations Under enablement can have claim scope that encompasses after-arising technology E.g. Chiron v. Genentech (Fed. Cir. 2004) Chiron argued claim to Her-2 antibody encompassed full human antibodies Rader says claim enabled because fully human antibodies not known at time (citing In re Hogan) But because later-filed claim *not* described

11 Implication for notice Notice for potential infringers, examiners PTO amicus brief: Though certain functional claims may be enabled, USPTO is not an experimental laboratory: it lacks both the facilities and the statutory mandate to determine, through empirical testing, whether any of millions of prior art inventions may have exhibited the recited function.

12 WD Post-Ariad: Centocor v. Abbott (Fed. Cir. 2011) Famous $1.67 billion jury verdict! (from E.D.Tx) TNF-alpha protein: overproduction leads to various autoimmune conditions, including arthritis Abbott: fully human antibody (Humira) Filed patent in 1996, got regulatory approval in 2002 Centocor: started with mouse; then made chimeric (mouse variable, human constant) Spec of 1994 app discloses mouse and chimeric structure in detail (including a.a. structure); mention fully human antibodies 2002: filed continuation application claiming fully human antibodies Are fully human antibodies described in 1994 apps?

13 Centocor: Antibody Exception to WD? PTO Written Description Training Materials, 2001, 2008 Antibody example: applicant is disclosing novel protein and claiming both protein, antibody that bind to it Characterization of protein may be enough where one of skill in the art would have recognized that the disclosure of the adequately described [protein] put the applicant in possession of antibodies which bind to [protein]

14 Centocor v. Abbott, cont d Reads PTO approach narrowly Only get possession where production of antibody in question would have been routine Very little in the 775 patent supports that Centocor possessed a high affinity, neutralizing, A2 specific antibody that also contained a human variable region. Reverses, apply no reasonable juror standard

15 Other post-ariad cases Billups-Rothenberg v. ARUP/BioRad, 642 F.3d 1031 (Fed. Cir. 2011) Patent claims test for detecting gene mutations that lead Type I hereditary hemochromatosis But doesn t contain location of gene or single mutation No written description Enablement problem? Note that district court doesn t rule on enablement challenge

16 Supplementary Examination Guidelines February 2011 Kappos, November 2012: Section 112 rejections up 20%

17 Written Description in Software Emphasized on pp Original claims may fail WD when invention is claimed and described in functional language but spec does not sufficiently ID how to achieve claimed function Lizard Tech claim directed to method of compressing digital images using seamless discrete wave transformation ( DWT ) Claim covered all ways of performing DWT-based compression but spec only included one way, and there was no evidence that spec contemplated a more generic claim Will lack of algorithm cause functional claim to fail WD?