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‘KSR' has made it easier to prove obviousness Particularly in pharmaceutical cases, this is an increasingly viable patent invalidity defense.
By Mark Jansen and Byron Chin
In KSR International Co. v. Teleflex Inc., 550
U.S. 398 (2007), the U.S. Supreme Court heralded more promise in obviousness challenges to patent validity. The Court rejected the U.S. Court of Appeals for the Federal Circuit's "teaching, suggestion and motivation" (TSM) test for patent obviousness as a "rigid preventative rule" and instructed lower courts to take a more "expansive and flexible approach," one applying "common sense" and recognizing that the "combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results." The Court also held that when there existed a "design need or market pressure to solve a problem," the pursuit of known options, anticipated to be successful, was likely the product of "ordinary skill and common sense," making the claimed reveal that obviousness remains an important of the prior art; the level of "ordinary skill" invention invalid because it would have been invalidity defense, particularly for generic in the particular field; and the differences "obvious to try." This pronouncement was drug manufacturers.
between the claimed invention and the prior significant, since the Federal Circuit had long KSR has made it more likely to obtain art — are not in dispute. If the prior art clearly chastised obvious-to-try invalidity arguments. summary judgment of patent obviousness teaches the claimed elements of the invention Recent Federal Circuit decisions applying KSR when the central factual issues making up the and no more than ordinary skill or common to cases involving the pharmaceutical arts "prima facie" obviousness case — the teaching sense is required to combine them with the natiOnal law jOurnal the expectation of success, KSR mandates other inactive components of these formula- ingredients, it merely recited well-known a conclusion of obviousness. Indeed, the tions are often well known and described in functions of the ingredients.
Supreme Court in KSR affirmed the district the prior art, obviousness, even in light of Patents claiming improvements in the court's grant of summary judgment of KSR, will continue to involve a highly case- physical form of known drug molecules have obviousness based on the undisputed specific inquiry into the teachings of the prior proven more difficult to defend under KSR. In teachings of the prior art. So, too, did the art and whether an ordinarily skilled arti- Bayer Schering Pharma A.G. v. Barr Laboratories Federal Circuit this year in Tokai Corp. v. Easton san would reasonably expect to achieve the Inc., 575 F.3d 1341 (2009), the Federal Circuit Enterprises, 632 F.3d 1358 (Fed. Cir. 2011).
objectives of the claimed invention through applied KSR's "obvious-to-try" analysis and The Federal Circuit has generally adopted the combination. The proponent of an obvi- invalidated a patent covering micronized a very sophisticated level of skill in the ousness defense must articulate some rea- drospirenone, the progestogenic component pharmaceutical arts. In Unigene Labs Inc. son suggested by the prior art for combining in certain of Bayer's oral-contraceptives. v. Apotex Inc., 2011 U.S. App. Lexis 17762 previously known components to obtain the Drospirenone is relatively insoluble, and (Fed. Cir. Aug. 25, 2011), the court held claimed invention.
Bayer acknowledged that micronization was that a person of ordinary skill would have a well known to increase solubility. Yet, because master's degree or doctorate in a chemical drospirenone was subject to degradation in field and four to eight years of experience acid solutions, Bayer argued that an ordinarily in pharmaceutical liquid-dosage-form skilled artisan would have applied an development. In Daiichi Sankyo Co. v. Apotex Patents claiming enteric coating to prevent exposure to acidic Inc., 501 F.3d 1254 (Fed. Cir. 2007), the court conditions in the stomach. The court rejected in invalidating a patent covering the use of this argument, holding that published results ofloxacin for topical treatment of ear infections for a closely related drug put a hypothetical held that a person having the relevant level are particularly drug developer at a "crossroads" where two of skill was one "engaged in developing options, both with predictable results, were pharmaceutical formulations and treatment susceptible to ‘KSR' presented. This made micronization "obvious methods for the ear, or a specialist in ear treatments." Because the prior art taught the Patents claiming dosage amounts or use of a related antibiotic, ciprofloxacin, such regimens are also more susceptible to KSR a person would understand that ofloxacin challenges. In Tyco Healthcare Group L.P. also would be effective.
v. Mutual Pharm. Co., 642 F.3d 1370 (Fed. In two cases decided earlier this year, Cir. 2011), the Federal Circuit easily the Federal Circuit's approach was slightly affirmed obviousness of a patent claiming different in reaching the same result. The KSR involved a relatively straightforward 7.5-milligram dosing for the sleep-inducing court recognized that the parties disputed the mechanical device, an automated car-braking drug temazepam. Although the marketed hypothetical level of skill, but held that was system. In more technically complicated dis- doses were generally higher, at 10 to 30 not a material dispute precluding summary ciplines such as organic synthesis or phar- milligrams, the court noted that the British judgment, as even a person at the lower skill macology, the Federal Circuit has since cau- National Formulary advised dosages of 5 to level advocated by the patent owner would tioned that KSR's obvious-to-try approach 15 milligrams for elderly patients. Because understand the teaching of the prior art. See must be viewed in light of the complexity of the claimed dosage fell within this range, the Tokai, 632 F.3d at 1369; Duramed Pharm. Inc. the field. In Unigene, the court stated that a court found the claims obvious, a presumption v. Watson Labs. Inc., 413 Fed. Appx. 289, 296 "flexibly viewed and applied" TSM approach unrebutted by any showing that the prior art (Fed. Cir. 2011) (nonprecedential).
"provides the sources of evidence that an taught away from this dosage.
The principles enunciated in KSR should ordinary skilled artisan might have found Proof of patent obviousness requires also be helpful in challenging pharmaceutical and combined at the time of the invention" a thorough examination of the prior art patents claiming new drug compounds, and "remains the primary guarantor against literature to establish a known motive or particularly when the prior art suggests a a non-statutory hindsight analysis." The court reason to try the combination that is claimed "lead compound" that can be modified with held that a nasal-spray composition was not by the asserted patent. Five years after KSR, anticipated success to reach the patented obvious, despite the fact that a component in it is clear that obviousness patent-validity molecule. Yet the burden to successfully the claimed formulation was used in prior art attacks remain extremely viable defenses challenge claims directed to new drugs formulations at the same concentration, but to assert in pharmaceutical and other remains high. As the Federal Circuit stated for a different purpose.
patent cases.
in Takeda Chem. Indus. Ltd. v. Alphapharm Pty. In In re Brimonidine Patent Litig., 643 F.3d Ltd., 492 F.3d 1350, 1357 (Fed. Cir. 2007), 1366, 1372 (Fed. Cir. 2011), the Federal Mark Jansen is a partner, and Byron Chin is an and Altana Pharma A.G. v. Teva Pharmaceuticals Circuit reached a similar conclusion associate, in the San Francisco office of Kilpatrick USA Inc., 566 F.3d 999, 1007 (Fed. Cir. 2009), regarding four related patents that claimed Townsend & Stockton. Their practices focus on when a patent claims a new compound, the ophthalmic solutions. Defendant Apotex patent and complex commercial intellectual property accused infringer must, consistent with KSR, Inc. had advanced an "obvious to try" litigation, with an emphasis on pharmaceutical "identify some reason that would have led a argument, pointing out that all of the patent litigation.
chemist to modify a known compound in a claimed components were known in two particular manner." prior art formulations. The court rejected this Many important patents in the pharma- argument, noting that the prior art failed to ceutical arts are directed to formulations, disclose any indication that the combined Reprinted with permission from the October 17, 2011 edition of THE combinations of active drugs and different components would work together properly. NATIONAL LAW JOURNAL 2011 ALM Media Properties, indications and/or conditions of use such as Yet a fifth patent was found obvious because, LLC. All rights reserved. Further duplication without permission is prohibited. For information, contact 877-257-3382, reprints@alm.
dosing. Although the active ingredients and rather than claiming specific formulation com or visit www.almreprints.com. #005-10-11-19

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