Tuesday, April 18, 2017

Hypotheticals on the upcoming CRISPR patent wars

The discussion at Patent Docs relating to the reverse doctrine of equivalents pertained to the CRISPR dispute between UC/Berkeley and the Broad. How would a party, practicing CRISPR on eukaryotes, defend against a (hypothetical) patent infringement assertion by UC/Berkeley of a (hypothetical) US patent claim?

An issue would be enablement of a Berkeley claim as to eukaryotes.

Recall the text of Judge Linn in Ariad ( with whom RADER, Circuit Judge, joins, dissenting-in-part and concurring-in-part. ):

The fear that even original claims might "claim[] the invention by what it does rather than what it is," Lilly's Br. 35, is unfounded because all claims must satisfy enablement and other requirements for patentability. The majority agrees that "many original claims will satisfy the written description requirement," but expresses concern that applicants may use "functional language to define the boundaries of a claimed genus," without disclosing "species sufficient to support a claim." Maj. Op. at 19. I agree that such claims should be invalid--but enablement polices those claims effectively. Any claim that uses purely functional language, or covers a broad genus without sufficient supporting examples, will not be enabled. E.g., In re Vaeck, 947 F.2d 488, 495-96 (Fed. Cir. 1991) (affirming enablement rejection of genus claims).

Lilly and several amici caution that the written description doctrine protects the public by requiring patentees to provide specific notice of the scope of their inventions. See, e.g., Br. of Amicus Medtronic, Inc. 11-12. This concern is also misplaced. Generally, under 35 U.S.C. § 122(b), patent applications [**105] publish eighteen months "from the earliest filing date for which a benefit is sought." Therefore, the public receives notice of original claims within a specified time. See Br. of Amicus Monsanto Co. 8 ("Regardless of its breadth, the language of an original claim puts skilled artisans on notice that the inventor is claiming such subject matter as the inventor's own invention."). Even if the application does not publish before the patent issues, the original claims remain part of the public prosecution history and notify the public of the invention's scope.

The government submitted an amicus brief in which it asserted that the written description doctrine is "necessary to permit USPTO to perform its basic examination function" and claimed that the Patent Office applies § 112, paragraph 1 to over "400,000 patent applications each year." Br. of Amicus United States 19-20. However, at oral argument the government could not cite the number of applications that the PTO annually rejects on written description grounds and cannot reject on another basis. See Oral Arg. at 22:42-24:50. [*1372] The government also agreed that "enablement is available to address a large number of these problems." Id. at [**106] 28:01-32. Indeed, a study released after argument that reviewed over 2800 appeals to the Board of Patent Appeals and Interferences ("BPAI") during 2009 found that only 4.3% of those cases decided written description issues, and that none of those outcomes would change if the PTO could continue to issue new matter rejections under 35 U.S.C. § 132. Dennis D. Crouch, An Empirical Study of the Role of the Written Description Requirement in Patent Prosecution 2 (Univ. of Mo. Sch. of Law Legal Studies Research Paper No. 2010-06, 2010), available at http://ssrn.com/abstract=1554949. The study concludes that, "in the context of patent applications appealed to the BPAI, the impact of the separate written description requirement is negligible apart from its role in policing the addition of new matter." Id. at 3. While this research only addressed a small sample of applications and did not consider written description rejections that applicants overcome or do not appeal, these results and the government's lack of empirical evidence undermine the government's hypothesis that our patent examination system would grind to a halt if written description no longer applies to originally filed claims. [**107] The Patent Office survived well enough before 1997, when it was understood that written description was a basis for rejecting broadening amendments to claims or specifications, not [***1188] original claims. See Rasmussen, 650 F.2d at 1214.

The court granted the petition for rehearing in this case to address whether § 112, paragraph 1 contains a written description requirement separate from an enablement requirement and, if so, the scope and purpose of such a requirement. In affirming such requirement, the majority leaves unanswered once again the critical question first presented to the panel of whether the asserted claims of the '516 patent meet the enablement requirement. In my view, the question before the en banc court should have been answered in the negative and the appeal returned to the panel for resolution of the enablement question and Lilly's remaining invalidity and noninfringement defenses. I concur, however, in the majority's reinstatement of the panel's affirmance of no inequitable conduct. For these reasons, I respectfully dissent from Part I of the majority opinion, concur in the ruling of no inequitable conduct, and take no position on the merits of Ariad's compliance with 35 U.S.C. § 112, [**108] paragraph 1.

Recall also Johns Hopkins v. Cellpro, 152 F.3d 1342

CellPro argues that the claims of the '204 patent, which both parties agree are drawn to the genus of antibodies which bind to the claimed antigen, are not enabled as required by 35 U.S.C. § 112, P 1, and that the district court erred in granting summary judgment to the contrary. CellPro contends that the patent discloses only the method of producing the anti-My-10 antibody and is therefore insufficient to enable one of ordinary skill in the art to make and use the broader genus of claimed antibodies. See, e.g., Genentech, Inc. v. Novo Nordisk A/S, 108 F.3d 1361, 1365, 42 U.S.P.Q.2D (BNA) 1001, 1004 (Fed. Cir. 1997) HN13Go to this Headnote in the case.("To be enabling, the specification of a patent must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation.") (citation and quotation omitted). In support, CellPro points to evidence that it believes conclusively shows that one of ordinary skill following the techniques disclosed in the patent could produce other antibodies only after undue experimentation, and contends that this evidence should have precluded summary judgment.


When ruling on Hopkins' motion for summary judgment of enablement, the district court was obliged to have viewed the evidence in the light most favorable to the nonmoving party, in this case CellPro, and to have resolved any evidentiary doubts in CellPro's favor. See C.R. Bard, Inc. v. Advanced Cardiovascular Sys., Inc., 911 F.2d 670, 672, 15 U.S.P.Q.2D (BNA) 1540, 1542 (Fed. Cir. 1990). Moreover, the court must have "viewed the evidence presented through the prism of the substantive evidentiary burden" that would inhere at trial. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 254, 91 L. Ed. 2d 202, 106 S. Ct. 2505 (1986). This burden rested upon CellPro, who had to prove by clear and convincing evidence facts establishing a lack of enablement. See Morton Int'l Co. v. Cardinal Chem. Co., 5 F.3d 1464, 1469, 28 U.S.P.Q.2D (BNA) 1190, 1194 (Fed. Cir. 1993); 35 U.S.C. § 282 (1994). However, CellPro's evidence must have done more than simply raise some doubt regarding enablement: HN15Go to this Headnote in the case."If the evidence is merely colorable, or is not significantly probative, summary judgment may be granted." Anderson, 477 U.S. at 249-50 (citations omitted). Instead, CellPro's evidence must have shown that a material factual dispute existed, i.e., [**49] a dispute upon which a reasonable jury could have resolved enablement in CellPro's favor after a review of the entire record. See Sweats Fashions, Inc. v. Pannill Knitting Co., 833 F.2d 1560, 1562, 4 U.S.P.Q.2D (BNA) 1793, 1795 (Fed. Cir. 1987).

Our review of the entire record leads to the conclusion that CellPro failed to raise a genuine issue of material fact concerning enablement, [p. 1360] and therefore that the district court did not err in granting summary judgment.


CellPro can carry its burden only by showing that all of the disclosed alternative modes are insufficient to enable the claims, because "the enablement requirement is met if the description enables any mode of making and using the invention." Engel Indus., Inc. v. Lockformer Co., 946 F.2d 1528, 1533, 20 U.S.P.Q.2D (BNA) 1300, 1304 (Fed. Cir. 1991). CellPro's silence concerning enablement by use of the KG-1/KG-1a cell lines makes its argument on this point specious.

And recall discussion of Chester v. Miller in Target v Williams Advanced Materials, 2007 U.S. Dist. LEXIS 98344 : See Chester v. Miller, 906 F.2d 1574, 1577 (Fed. Cir. 1990) (discussing possibility that broader claim for a genus might not be enabled by a parent patent's disclosure of a species for purposes of filing date, yet the parent's species claim could still anticipate the later genus claim).

UPDATE on April 22, from a comment on Patent Docs on April 20:

The decisive lack of "Reasonable Expectation of Success" finding whereby inventive skill would have been required to transition the disclosed Doudna CRISPR technology platform from prokaryotes (e.g. bacteria) to eukaryotes (e.g. mammalian cells) seems doubtful when considering the course of the scientific literature that parallels the numerous patent filings.

The technical aspects of Doudna's CRISPR discoveries are embodied in a Science article (Jinek et al) e-published on June 28, 2012.

The BROAD/MIT group filed their "eukaryotic" CRISPR application on December 12, 2012. The counterpart scientific paper was published on January 3, 2013 (Cong et al).

To my knowledge, Science requires a peer review process prior to publication, usually requiring 1-2 months.

Consequently, the incredibly quick turnaround from Jinek to Cong, where Zhang managed to develop and execute extensive lab protocols that produced new, verifiable results in just a matter of weeks suggests that Doudna's findings indeed provided Zhang with a RES that the eukaryotic system would be amenable in supporting Doudna's CRISPR platform, as Doudna suggests in the Jinek article.

This, especially since Zhang merely applied known technologies (NLS sequences, used since the 1980s) in order to guide the CRISPR system into the eukaryotic cell compartments.

Accordingly, it is apparent that the PTAB might have erred in their findings by being dismissive of the science itself.


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