Developments in the CRISPR patent interference: the March 2016 order sets out which motions may proceed

Sharon Begley at STATNews covers the March 2016 order in the CRISPR interference and suggests a tilt toward Broad:


Handicappers had previously laid odds in favor of the University of California, partly because the onus is on the Broad Institute, as the so-called junior party, to demonstrate that the patent office’s original decision awarding it key CRISPR patents was correct. But from the tea leaves offered by the judges’ rulings on which motions can be filed, the odds have shifted toward the Broad.



** There is a bit of an error in Begley's text


The Broad is also making one crucial argument: that UC’s claims are unpatentable because they overreach what Doudna actually accomplished.



IPBiz notes that the issue going forward in the interference is Doudna's "written description," which is NOT synonymous with what Doudna "actually accomplished." Further, "enablement" of Doudna's work is not presently on the table in the interference [proposed motion 48 on enablement was deferred.]

To see the distinction, note what the CAFC set out in the 2014 case of Alcon v. Barr: It is well settled that an invention may be patented before it is actually reduced to practice. Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 61, 119 S. Ct. 304, 142 L. Ed. 2d 261 (1998). Similarly, a patentee is not required to provide actual working examples; we have rejected enablement challenges based on the theory that there can be no guarantee that prophetic examples actually work, as "[t]he burden is on one challenging validity [p. 1190] to show by clear and convincing evidence that the prophetic examples together with other parts of the specification are not enabling." Atlas Powder Co. v. E.I. du Pont de Nemours & Co., 750 F.2d 1569, 1577 (Fed. Cir. 1984).

As set out in the March 2016 order, the motion of Broad/Zhang that may proceed in the interference pertains to "written description," rather than "enablement." This was in Broad's proposed motion 47, which becomes substantive motion 4. [Order p.6, lines 13-17: That is, if the motion is granted, judgment may be entered against UC because it might lack standing in the interference. See 37 14 C.F.R. § 41.201 (definition of threshold issue, wherein a threshold issue may be “[i]n the case of an involved application claim first made after . . . issuance of the movant’s patent . . . .”) ]

The Alcon court discussed "written description":


"[T]he hallmark of written description is disclosure." Ariad, 598 F.3d at 1351. The standard for satisfying the written description requirement is whether the disclosure "allow[s] one skilled in the art to visualize or recognize the identity of the subject matter purportedly described." Enzo Biochem, Inc. v. Gen-Probe Inc., 323 F.3d 956, 968 (Fed. Cir. 2002). There is no requirement that the disclosure contain "either examples or an actual reduction to practice"; rather, the critical inquiry is whether the patentee has provided a description that "in a definite way identifies the claimed invention" in sufficient detail that a person of ordinary skill would understand [p. 1191] that the inventor was in possession of it at the time of filing. Ariad, 598 F.3d at 1350, 1352; Koito Mfg. Co. v. Turn-Key-Tech., LLC, 381 F.3d 1142, 1154 (Fed. Cir. 2004). That assessment [p. 1016] "requires an objective inquiry into the four corners of the specification." Ariad, 598 F.3d at 1351.




The March 2016 order sent this message to UC/Doudbna:


Though UC characterized this motion as threshold, it relates only to whether Broad’s claims are unpatentable over the prior art, not whether Broad has standing in the interference. Whether Broad’s claims are unpatentable over prior art is not dispositive of issues of priority. The interference may proceed to determine if UC was not the first to invent the common subject matter under 35 U.S.C. § 102(g) even if Broad’s claims were held not to be patentable. Because UC suggested the interference it chose to challenge Broad’s claims in a priority contest instead of through another procedure. UC has not provided a sufficient reason why its prior art challenge to Broad’s claims should preempt the priority contest




The March 2016 order includes the text:


Additionally, priority proofs need not establish invention of the full scope of the claimed subject matter. Proof of a sole embodiment meeting all the limitations of the count is sufficient. Therefore, whether or not the UC disclosure enables the full scope of its claims, is not necessarily informative of whether UC can provide proof of invention of an embodiment within the scope of the count




**Cases supporting requirement of enablement for full scope of claim


--
Azure v. CSR, 771 F.3d 1336, 1354; 2014 U.S. App. LEXIS 21188; 112 U.S.P.Q.2D (BNA) 1817

Azure cannot have it both ways. If the term "MAC address" is properly construed to refer only to addresses assigned to peripheral devices by a hub device, then the accused products do not infringe. If, on the other hand, the [***1831] term is broadly and unreasonably expanded to cover addresses assigned at the time of manufacture, then the asserted claims are invalid. See MagSil, 687 F.3d at 1381 ("[A] patentee chooses broad claim language at the peril of losing any claim that cannot be enabled across its full scope of coverage."); Liebel—Flarsheim Co. v. Medrad, Inc., 481 F.3d 1371, 1380 (Fed. Cir. 2007) ("The irony of this situation is that [the patentee] successfully pressed to have its claims include a jacketless system, but, having won that battle, it then had to show that such a claim was fully enabled, a challenge it could not meet.").



--
Teva v. Sandoz, 723 F.3d 1363; 2013 U.S. App. LEXIS 15208; 107 U.S.P.Q.2D (BNA) 1655

A patent's specification must describe the invention and "the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains . . . to make and use the same." 35 U.S.C. § 112(a). "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." MagSil Corp. v. Hitachi Global Storage Techs., Inc., 687 F.3d 1377, 1380 (Fed. Cir. 2012) (internal quotation marks omitted). Enablement is a question [p. 1661] of law that we review without deference, based on underlying factual inquiries that we review for clear error after a bench trial. Cephalon, Inc. v. Watson Pharms., Inc., 707 F.3d 1330, 1336 (Fed. Cir. 2013).


--
Convolve v. Compaq (nonprecential), 527 Fed. Appx. 910; 2013 U.S. App. LEXIS 13612

By choosing such broad claim language, Convolve put itself "at the peril of losing any claim that cannot be enabled across its full scope of coverage." Magsil Corp. v. Hitachi Global Storage, Techs., Inc., 687 F.3d 1377, 1381 (Fed. Cir. 2012). Dr. Singer's testimony that his later advancement allowed him to figure out why the '635 patent method was not working for disk drives is a strong indication that the patent was not enabling when it was filed. Indeed, HN16Go to this Headnote in the case."[t]he enablement doctrine's prevention of over broad claims ensures that the patent system preserves necessary incentives for follow-on or improvement inventions." Id. at 1384. Here, the inventor himself concedes that he was unable to fully [**58] implement the claimed method in disk drives for nine (9) years after the filing date. As such, we affirm the district [*932] court's finding of invalidity regarding claims 1-4 and 7 of the '635 patent.


--
Wyeth v. Abbott, 720 F.3d 1380; 2013 U.S. App. LEXIS 13070; 107 U.S.P.Q.2D (BNA) 1273

Claims are not enabled when, at the effective filing date of the patent, one of ordinary skill in the art could not practice their full scope without undue experimentation. MagSil Corp. v. Hitachi Global Storage Techs., Inc., 687 F.3d 1377, 1380-81 (Fed. Cir. 2012). Enablement is a question of law based on underlying facts. Id.

--As to both enablement and written description

Alcon v. Barr, 745 F.3d 1180; 2014 U.S. App. LEXIS 5023; 110 U.S.P.Q.2D (BNA) 1008

-->enablement
In light of those disclosures, the district court's nonenablement ruling was premised on testimony that many "variables" including the number of prostaglandins and the range of PECOs encompassed by the claims, as well as "[v]arious parameters including pH, buffer, buffer concentration, preservatives, chelating agents, and other excipients may affect the chemical stability of prostaglandins in ophthalmic formulations." Alcon, 837 F. Supp. 2d at 382-83 (emphasis added). Indeed, Barr's expert observed that "when 'you have a lot of variables on top of one another, the experimentation gets out of control quickly.'" Id. at 383 (citing J.A. 6009). But such an unsubstantiated conclusory statement is not sufficient. Cephalon, Inc. v. Watson Pharms.., 707 F.3d 1330, 1339 (Fed. Cir. 2013). Barr adduced no evidence at trial that changing any of the "variables" or "[v]arious parameters" identified by the district court would render Alcon's claimed invention inoperable, nor was there any evidence that experimenting with those variables was required for an ordinarily skilled artisan to be capable of increasing the chemical [**20] stability of a prostaglandin by adding PECO. Adjusting variables may be relevant to optimizing the stability of a given prostaglandin composition, [***1015] but Barr proffered no evidence that any experimentation, let alone undue experimentation, with those variables would be necessary in order to practice the claimed invention. Without that evidence, there is no foundation for the district court's nonenablement ruling.

Furthermore, HN8Go to this Headnote in the case.a patent does not need to guarantee that the invention works for a claim to be enabled. It is well settled that an invention may be patented before it is actually reduced to practice. Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 61, 119 S. Ct. 304, 142 L. Ed. 2d 261 (1998). Similarly, a patentee is not required to provide actual working examples; we have rejected enablement challenges based on the theory that there can be no guarantee that prophetic examples actually work, as "[t]he burden is on one challenging validity [p. 1190] to show by clear and convincing evidence that the prophetic examples together with other parts of the specification are not enabling." Atlas Powder Co. v. E.I. du Pont de Nemours & Co., 750 F.2d 1569, 1577 (Fed. Cir. 1984). Nor is it "a requirement of patentability that an inventor correctly set forth, or even know, how or why the invention works." Newman v. Quigg, 877 F.2d 1575, 1581-82 (Fed. Cir. 1989) (citing Diamond Rubber Co. v. Consol. Rubber Tire Co., 220 U.S. 428, 435-36, 31 S. Ct. 444, 55 L. Ed. 527, 1911 Dec. Comm'r Pat. 538 (1911)). Thus, it is likewise irrelevant here, as a legal matter, whether the '287 and '062 patents contain data proving that PECOs enhance the chemical stability of prostaglandins.

Accordingly, because Barr did not show that any claimed embodiments would be inoperable and that a person of ordinary skill in the art would have been unable to practice the asserted claims without resorting to any experimentation, let alone undue experimentation, we conclude that the district court erred as a matter of law in holding that Barr proved its invalidity case based on nonenablement by clear and convincing evidence. Barr had the burden of proof to show that Alcon's patents lacked enabling disclosures, but failed to carry that burden. We therefore reverse the district court's judgment that claim 12 of the '287 patent and claim 19 of the '062 patent are invalid for lack of enablement.

-->written description
We agree with Alcon that the specifications provide an adequate written description of the claimed invention. "[T]he hallmark of written description is disclosure." Ariad, 598 F.3d at 1351. The standard for satisfying the written description requirement is whether the disclosure "allow[s] one skilled in the art to visualize or recognize the identity of the subject matter purportedly described." Enzo Biochem, Inc. v. Gen-Probe Inc., 323 F.3d 956, 968 (Fed. Cir. 2002). There is no requirement that the disclosure contain "either examples or an actual reduction to practice"; rather, the critical inquiry is whether the patentee has provided a description that "in a definite way identifies the claimed invention" in sufficient detail that a person of ordinary skill would understand [p. 1191] that the inventor was in possession of it at the time of filing. Ariad, 598 F.3d at 1350, 1352; Koito Mfg. Co. v. Turn-Key-Tech., LLC, 381 F.3d 1142, 1154 (Fed. Cir. 2004). That assessment [p. 1016] "requires an objective inquiry into the four corners of the specification." Ariad, 598 F.3d at 1351.

The '287 patent details the claimed invention and provides a step-by-step description of how a person of ordinary skill in the art may use it. It discloses the "unexpected[] discover[y] that the use of . . . polyethoxylated castor oils in [pharmaceutical] compositions," especially those "topically applied to the eye," "enhances the chemical stability of prostaglandins." '287 patent col. 1 ll. 46-51; col. 6 l. 16-col. 7 l. 25. It provides exemplary formulations that embody the claimed invention, reciting concentrations of every ingredient. Id. col. 7 ll. 26-46. It also discloses data generated by the inventor from accelerated stability testing showing the effect of PECO and prostaglandin concentration on stability and comparing the effect of PECO to that of a more commonly used surfactant, polysorbate 80. Id. figs. 2 & 3, col. 1 ll. 59-62, col. 8 ll. 32-39. The patent also describes various classes of prostaglandins to which the invention was understood to relate, which are covered by the term "prostaglandin" under the district court's construction of that term, as well as preferred concentrations and thirty-two specifically preferred examples of those prostaglandins. Id. col. 2 l. 23-col. [**25] 6 l. 15. It describes various types of PECOs that may be used in the invention, again with preferred types and concentrations. Id. col. 2 ll. 7-21. And the patent describes the various formulation parameters, including osmolality and pH, that may be selected when practicing the invention. Id. col. 7 ll. 8-14.
--

link to Begley post: https://www.statnews.com/2016/03/18/crispr-patent-dispute/

See also the previous IPBiz post
CAFC decides Bamberg v. Dalvey interference in favor of junior party; insights for CRISPR patent interference which discusses how a "junior party" won an interference based on "written description" issues

UPDATE: May 7, 2016

http://www.genengnews.com/gen-articles/crispr-moves-from-butchery-to-surgery/5759/