Ortho-McNeil Pharmaceutical v. Mylan (CAFC 2007-1223)

Backdrop. Note that the drug is Topamax, not Topomax. Topamax is marketed as an anti-migraine treatment.

Topiramate (marketed by Ortho-McNeil as TOPOMAX® ) is a significant epilepsy drug with sales exceeding $1 billion annually. Ortho-McNeil scientist Dr. Bruce Maryanoff invented this pharmaceutical during a search for new antidiabetic drugs. Topiramate is a reaction intermediate in the synthesis Dr. Maryanoff ran as part of his antidiabetic efforts. Unexpectedly, Dr. Maryanoff discovered that this particular intermediate had powerful anticonvulsant properties. After extensive testing, clinical trials, and substantial investment, Ortho-McNeil showed that the compound was safe and effective leading to FDA approval.

This cause of action arose under the Hatch-Waxman Act. 21 U.S.C. § 355. Under that Act, Mylan filed an ANDA with the FDA with a paragraph IV certification asserting that Ortho-McNeil's '006 patent is invalid or not infringed. Within 45 days, Ortho-McNeil filed an infringement suit under 35 U.S.C. § 271(e)(2) against Mylan thus triggering the 30-month stay on approval of Mylan's ANDA.

Mylan lost claim construction, and "its affirmative defenses of inequitable conduct, obviousness, and non-enablement" were dismissed on summary judgment, hence the appeal.

The crucial claim term was "and," which was construed to mean "or."

[T]he claim language depicts two subsets of compounds, but does not require their simultaneous existence... Thus, as used in this claim, and conjoins mutually exclusive possibilities.

The claim also does not use and in isolation but in a larger context that clarifies its meaning. Specifically, and appears in conjunction with the adverbs independently and together. As the district court explained, these terms signal that and links alternatives that occur under the different conditions of independence or togetherness.

The larger context of this patent also supports this claim meaning. Construing claim 1 to require a conjunctive meaning of and would render several dependent claims meaningless. Claims 2, 5, 9, and 10 would cover nothing if the and at issue must be conjunctive. This court has explained: "Other claims of the patent in question . . . can also be valuable sources of enlightenment as to the meaning of a claim term." Phillips v. AWH Corp., 415 F.3d 1303, 1314 (Fed. Cir. 2005) (en banc) (citing Vitronics Corp. v. Conceptronic Inc., 90 F.3d 1576, 1582 (Fed. Cir. 2003)). Thus, this court strives to reach a claim construction that does not render claim language in dependent claims meaningless. Rambus Inc. v. Infineon Tech. AG, 318 F.3d 1081, 1093 (Fed. Cir. 2003).

The specification also supports the district court's reading of and. The specification thus uses the word and to link alternative chemical structures.

While extrinsic evidence "can shed useful light on the relevant art," this court considers such evidence "less significant than the intrinsic record in determining 'the legally operative meaning of claim language.'" Phillips, 415 F.3d at 1317 (citations omitted). Because the plain language of claim 1, the dependent claims, and the specification support the district court's reading, this court does not need to consult extrinsic evidence. Nonetheless, this court notes that dictionary definitions of and, while most often listing the additive sense as the most common usage of the term, also show usage of the term to connote alternatives. Webster's Third New International Dictionary (2002). In the circumstances of this case, the use of and to express alternatives was chosen and adequately expressed by the applicant. Thus, extrinsic evidence too offers support for the district court's reading of the disputed term.

In Chef America Inc. v. Lamb-Weston, Inc., this court explained that a patent must be interpreted "as written, not as the patentees wish they had written it." 358 F.3d 1371, 1374 (Fed. Cir. 2004). In other words, courts may not redraft claims, whether to make them operable or to sustain their validity. Id. Even "a nonsensical result does not require the court to redraft the claims of the . . . patent." Id. (citing Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357 (Fed. Cir. 1999)). However, Chef America does not require this court or the district court to interpret and according to its most common usage in the dictionary. To the contrary, this court and the district court must interpret the term to give proper meaning to the claim in light of the language and intrinsic evidence. Giving and its most common dictionary meaning would produce in this case the nonsensical result of not covering topiramate and rendering several other dependent claims meaningless. In Chef America, the only possible interpretation of the claim led to a nonsensical result. This situation is distinguishable because claim 1 can and should be interpreted as the patentees intended, with the meaning of and connoting alternatives.

Mylan argued that, in searching for a diabetes drug, topiramate would be obvious, as its activity as an FBPase inhibitor would help regulate glucose level. But topiramate would have been an unpredictable choice, the courts found. The appeals court panel found Mylan guilty of hindsight reasoning.

Dr. Laurens Anderson, Mylan's expert, asserts that a person of ordinary skill in the art faced with finding a diabetes drug (as Dr. Maryannoff was) would necessarily design an FBPase inhibitor. Mylan cites KSR International Co. v. Teleflex Inc., for the proposition that "[w]hen there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp." 127 S. Ct. 1727, 1742 (2007). The record, however, shows that even if an ordinarily skilled artisan sought an FBPase inhibitor, that person would not have chosen topiramate. Moreover this invention, contrary to Mylan's characterization, does not present a finite (and small in the context of the art) number of options easily traversed to show obviousness. The passage above in KSR posits a situation with a finite, and in the context of the art, small or easily traversed, number of options that would convince an ordinarily skilled artisan of obviousness. In this case, the record shows that a person of ordinary skill would not even be likely to start with 2,3:4,5 di-isopropylidene fructose (DPF), as Dr. Maryanoff did. Beyond that step, however, the ordinarily skilled artisan would have to have some reason to select (among several unpredictable alternatives) the exact route that produced topiramate as an intermediate. Even beyond that, the ordinary artisan in this field would have had to (at the time of invention without any clue of potential utility of topiramate) stop at that intermediate and test it for properties far afield from the purpose for the development in the first place (epilepsy rather than diabetes). In sum, this clearly is not the easily traversed, small and finite number of alternatives that KSR suggested might support an inference of obviousness. Id. at 1742.

In other words, Mylan's expert, Dr. Anderson, simply retraced the path of the inventor with hindsight, discounted the number and complexity of the alternatives, and concluded that the invention of topiramate was obvious. Of course, this reasoning is always inappropriate for an obviousness test based on the language of Title 35 that requires the analysis to examine "the subject matter as a whole" to ascertain if it "would have been obvious at the time the invention was made." 35 U.S.C. § 103(a) (emphasis added). In retrospect, Dr. Maryanoff's pathway to the invention, of course, seems to follow the logical steps to produce these properties, but at the time of invention, the inventor's insights, willingness to confront and overcome obstacles, and yes, even serendipity, cannot be discounted.

Speaking before KSR, the district court endorsed a "rigorous application" of the teaching, suggestion, or motivation (TSM) test. In KSR, the Supreme Court explained that a "rigid" TSM test "is incompatible with our precedents." KSR, 127 S. Ct. at 1741. Mylan thus contends that the district court erred by rigorously applying the TSM test. The Supreme Court explained its reason for castigating a "rigid" TSM test: "The obviousness analysis cannot be confined by a formalistic conception of the words teaching, suggestion, and motivation, or by overemphasis on the importance of published articles and the explicit content of issued patents." Id. Indeed a rigid requirement of reliance on written prior art or patent references would, as the Supreme Court noted, unduly confine the use of the knowledge and creativity within the grasp of an ordinarily skilled artisan. Id. at 1742.

As this court has explained, however, a flexible TSM test remains the primary guarantor against a non-statutory hindsight analysis such as occurred in this case. In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007) ("[A]s the Supreme Court suggests, a flexible approach to the TSM test prevents hindsight and focuses on evidence before the time of invention."). The TSM test, flexibly applied, merely assures that the obviousness test proceeds on the basis of evidence - teachings, suggestions (a tellingly broad term), or motivations (an equally broad term) - that arise before the time of invention as the statute requires. As KSR requires, those teachings, suggestions, or motivations need not always be written references but may be found within the knowledge and creativity of ordinarily skilled artisans.

In this case, the record amply supports the district court's finding of nonobviousness. This court detects no rigid application of the evidentiary requirements for obviousness in the district court's analysis. As noted above, the challenges of this inventive process would have prevented one of ordinary skill in this art from traversing the multiple obstacles to easily produce the invention in light of the evidence available at the time of invention. Of particular importance beyond the prima facie analysis, this court also detects evidence of objective criteria showing nonobviousness. Specifically, the record shows powerful unexpected results (anticonvulsive activity) for topiramate. The record also shows skepticism of experts and copying - other respected sources of objective evidence of nonobviousness - as well as commercial success. As this court has repeatedly explained, this evidence is not just a cumulative or confirmatory part of the obviousness calculus but constitutes independent evidence of nonobviousness. Catalina Lighting, Inc. v. Lamps Plus, Inc., 295 F.3d 1277, 1288 (Fed. Cir. 2002) ("Objective indicia may often be the most probative and cogent evidence of nonobviousness in the record.") (internal citation omitted). See also Pharmastem Therapeutics Inc. v. Viacell, Inc., 491 F.3d 1342; Eli Lilly & Co. v. Zenith Goldline Pharms., Inc., 471 F.3d 1369.

Mylan asserts that method of use claims 6-8 are also obvious. But if claim 1 is not obvious then claims 6-8 also cannot be obvious because they all depend from a nonobvious claim. In re Fritch, 972 F.2d 1260, 1266 (Fed. Cir. 1992) ("[D]ependent claims are nonobvious if the independent claims from which they depend are nonobvious."). Accordingly, the method of use claims are nonobvious as well.

Mylan argued dependent claims "are not enabled because an anticonvulsively effective amount is unclear and its determination would require undue experimentation." Not so, the CAFC agreeing with the district court. The spec specified and provided guidance on dosage. The case law snippet:

A specification that enables an invention will teach those ordinarily skilled in the art to make and use the full scope of the claimed invention without undue experimentation. Genentech Inc. v. Novo Nordisk of N. Am. Inc., 108 F.3d 1361, 1365 (Fed. Cir. 1997).

Mylan's inequitable conduct charge also went nowhere.

Affirmed. Mylan is permanently enjoined from infringing '006.