By Kevin E. Noonan --
As discussed yesterday, a panel of the Federal Circuit seemingly expanded the scope of the written description requirement in its Boston Scientific Corp. v. Johnson & Johnson decision. At issue was the extent of disclosure required for combination claims, i.e., inventions combining components known in the art to produce a new, useful, and non-obvious article. Rapamycin-coated stents for coronary angioplasty were the subject matter of the lawsuit between the parties, and the basis of the Federal Circuit's decision affirming invalidation on summary judgment by the District Court was that while the claims encompassed various rapamycin analogs, the specifications of the patents-in-suit disclosed only rapamycin itself.
Johnson & Johnson argued that this was a departure from black letter patent law, citing In re Herschler, 591 F.2d 693, 702 (C.C.P.A. 1979), and In re Fuetterer, 319 F.2d 259 (C.C.P.A. 1963), for the principle that "when claiming a combination of known elements, as opposed to a novel compound, the specification 'need not list examples' nor is any 'comprehensive description' required." Johnson & Johnson also argued that the prior art contained "a known correlation between the structure of rapamycin and its analogs and their function," and hence that patentees were entitled to their claims without having a specification that "contains examples of specific macrocyclic lactone analogs of rapamycin." In rejecting these arguments, the opinion expressed agreement with Boston Scientific's position that a patentee is required to show possession of the claimed invention at the time a patent application is filed, and that "[a] written description of an invention involving a chemical genus, like a description of a chemical species, "requires a precise definition, such as by structure, formula, [or] chemical name," of the claimed subject matter sufficient to distinguish it from other materials," citing Regents of the Univ. of Cal. v. Eli Lilly & Co., 119 F.3d 1559, 1568 (Fed. Cir. 1997). The 1997 patents fail this test, according to the Court, due to the complete absence of any examples of a macrocyclic lactone analog in the specification. Citing the en banc decision in Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., the opinion states that 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 so that one of skill in the art can 'visualize or recognize' the members of the genus." While disclaiming any "bright-line rules governing . . . the number of species that must be disclosed to describe a genus claim," the opinion reiterated the "factors" to be considered from Ariad: "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."
Now Johnson & Johnson has petitioned the Federal Circuit for rehearing, by the panel or the en banc court. In its petition, the company poses two questions "of exceptional importance" for the Court's consideration:
(1) Where an inventor claims a novel combination of known elements, does the written description requirement of section 112 require a detailed recitation of information already known in the prior art concerning those known elements, if the specification otherwise teaches one of skill in the art how to make and use the invention?
(2) Where an inventor claims a novel combination of known elements, must the inventor provide examples of possible combinations of those known elements, even if otherwise unnecessary to understand how to make and use the claimed invention?
The panel decision is contrary not only to In re Hershcler, but also to Hybritech Inc. v. Monoclonal Antibodies and Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., according to the petition. Moreover, "the written description defense has been rapidly replacing inequitable conduct as the defense of last resort" because "[n]o matter how much an inventor has disclosed, accused infringers are contending that it was not enough," the petition states. This results in courts "exercising their discretion broadly to invalidate meritorious patents based on perceived insufficiencies that are at best ancillary to a patent's teaching of what is new" and this case, the petitions asserts, is an example. Granting the petition will give the Court the "an opportunity . . . to assure patentees that where a novel combination of known elements is claimed, superfluous information about the prior art need not be disclosed in the text or examples of a patent as long as the patent otherwise teaches how to make and use the invention." Failure to do so "will lead to massive over-disclosure of prior art information to the PTO, senseless invalidations of otherwise meritorious patents, and a general loss of confidence in the reliability of U.S. patent protection."
Taking this asserted precedent in turn, the petition cites Herschler (as it did to the panel) for the principle that "claims to combinations of known compounds require a written description 'only so specific as to lead one having ordinary skill in the art to that class of compounds,' Hershcler, 591 F.2d at 702, and distinguished that level of disclosure from the more extensive disclosure required to support claims to a novel compound, Id. at 701." The contrary holding in Hybritech was the oft-repeated maxim that "a patent need not, and indeed should not, repeat what is already known in the art. 802 F.2d at 1384." Finally, the petition asserts that the panel invalidated the patents-in-suit for failing to provide any examples of a rapamycin analog, which is contrary to the principle that "[a] patent specification . . . need not disclose any examples" (italics in original), citing both Ariad, 598 F.3d at 1352, and Falko-Gunter Falkner v. Inglis, 448 F.3d 1357, 1366 (Fed. Cir. 2006). Making an analogy to the tendency for "excessive and counter-productive disclosures that impeded patent prosecution" caused by an (until recently) expansive inequitable conduct doctrine, citing Therasense, Inc. v. Becton, Dickinson & Co., the petition states that refusing to correct the panel's decision will "likewise increase the burden on applicants, the PTO, and the public by forcing disclosures that go far beyond those needed to describe and enable the patentee's actual contribution to the art."
The question posed by the petition is a fundamental one: "[w]hen an invention is made in an area having an established body of knowledge, how much of that knowledge must the patent recite in order to satisfy the written description requirement?" The petition characterizes as "settled law" that a patentee is not required to repeat (and include within the specification) "what was already known in the art," and that the extent of the adequacy of the written description must be determined in light of what was known to the person of ordinary skill in the art. The panel's error, according to the petition, was in ignoring what was known in the art and focusing too closely on what was expressly disclosed in the specifications of the patents-in-suit. The closest analogy was with Herschler, where the invention was the combination of dimethyl sulfoxide (DMSO) and "physiologically active steroidal agent[s]" and the assertion was whether the disclosure of one example -- dexamethzsone-21-phosphate -- provided an adequate written description. In Herschler, the CCPA held that since the applicant was not "claiming chemical compounds per se," the disclosure of one species of a sub-genus (glucocorticosteroids) of a larger sub-genus (corticosteroids) of an even larger genus ("physiologically active agents") was an adequate written description. One distinction is that the alternate components of the combination claimed in Hershcler's application were "awesome in their diversity. The scope of exemplified 'physiologically active substances' includes iodine (Example 1), pressed pellet feed for rats (Example 4), penicillin (Example 10), procaine (Example 16), various chemotherapeutic agents (Examples 17 & 18), barbiturates (Example 19), oral insulin (Example 21), antihistamines (Example 29), various local anesthetics (Examples 34 & 35), etc." Another distinction is the statement in Herschler that "[w]ere this application drawn to novel 'steroidal agents,' a different question would be posed." Nonetheless, there is no question that the CCPA applied the preclusive effect of the written description requirement more parsimoniously in Herschler than the panel did in this case.
The petition also distinguishes the instant case from the circumstances surrounding the Federal Circuit's decision in Carnegie Mellon University v. Hoffmann-La Roche Inc., 541 F.3d 1115 (Fed. Cir. 2008), which the petition fairly characterizes as a basis for the panel decision. In that case, the claimed subject matter was novel DNA molecules encoding novel DNA polymerases, where only three species of "potentially millions" were disclosed. The petition contends that the difference is that the claims in Carnegie Mellon encompassed new molecules, not ones known in the art, and that where the written description may have been properly applied by the Court there it was not consistent with established law to apply in this case, where the art disclosed species of rapamycin analogs. And the petition also challenged another basis for the panel's decision, that the mechanism of rapamycin action was the subject of continued research when the applications were filed, citing Parker v. Frilette, 462 F.2d 544, 547 (CCPA 1972), for the proposition that "[a]n inventor need not understand precisely why his invention works in order to achieve an actual reduction to practice." (Indeed, the petition notes that "[t]he precise manner" by which many drugs act in the human body, including aspirin, are not fully understood but does not preclude patentability.)
Finally, the petition cites as erroneous the panel's reasoning that multiple examples of rapamycin analogs must be recited in the specification to satisfy the written description requirement, in light of that information being available in the art.
This case represents the consequences of the Federal Circuit's expansive view of the written description requirement, which necessitates a determination of where to draw the line in every case to answer the question of "how much" disclosure is enough. Since this is a fact-specific question, there can be no easy, bright-line answers generally; here, Johnson & Johnson suggests that the line should be drawn so that "combination" inventions require a lesser degree of disclosure than "composition" inventions. Perhaps it is more fruitful to make the distinction between factual situations like that in Herschler where the art discloses a multiplicity of alternative embodiments, in contrast with this case where the universe of rapamycin analogs was more limited (on the order of about 40 or so). Particularly in view of the complexity of the rapamycin structure and the large number of structural analogs with unpredictable effects on function, it might be more productive to perform the analysis (at least for the 1997 patents) on enablement rather than written description grounds (as suggested by concurring Judge Gajarsa). If the Federal Circuit refuses to rehear this case en banc, Johnson & Johnson could petition the Supreme Court for certiorari, giving the Court the opportunity to opine of an area of patent law that has so far escaped its notice.
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