Each week, we succinctly summarize the preceding week of Federal Circuit precedential patent opinions. We provide the pertinent facts, issues, and holdings. Our Review allows you to keep abreast of the Federal Circuit’s activities – important for everyone concerned with intellectual property. We welcome any feedback you may provide.
– Joe Robinson, Bob Schaffer, Lindsay Henner, Parker Hancock and Tinh Nguyen
Federal Circuit Review – Issue No. 63-03.
Federal Circuit Affirms “Teaching Away” and “Unexpected Results” that Support Non-obviousness
Allergan, Inc. v. Sandoz Inc., No. 2014-1275, 2015 U.S. App. LEXIS 13616 (Fed. Cir. Aug. 4, 2015) (Before Lourie, Linn, and Hughes, J.) (Opinion for the court, Lourie, J.). Click Here for a copy of the opinion.
In 2001, the U.S. Food and Drug Administration (“FDA”) approved Lumigan 0.03%, a once-daily topical solution developed by Allergan for glaucoma and ocular hypertension. The product contains 0.03% by weight of bimatoprost and 50 parts per million (“ppm”) benzalkonium chloride (“BAK”). Bimatoprost can cause hyperemia (excessive blood flow). Allergan later discovered that 200 ppm of BAK increased the corneal permeability of bimatoprost, which led to Lumigan 0.01%. This product contains 0.01% bimatoprost and 200 ppm BAK.
The FDA approved Lumigan 0.01% for the same indications as Lumigan 0.03%. Sandoz, Lupin Pharmaceuticals, Hi-Tech Pharmacal, and others submitted Abbreviated New Drug Applications (“ANDAs”) seeking FDA approval to market generic versions of Lumigan 0.01%. Allergan sued these generic drug companies, asserting that the ANDAs infringed five patents listed for Lumigan 0.01% in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (“Orange Book”).
The asserted patent claims require 0.01% bimatoprost and 200 ppm BAK, plus either (I) “a pH of about 7.3” or (II) a clinical profile that “results in less hyperemia” compared to 0.03% bimatoprost and 50 ppm BAK. After bench trial, the district court held that the asserted claims were not obvious, were adequately described, were enabled, and were infringed. Appellants appealed.
The Federal Circuit affirmed. The asserted claims were not obvious because, although the claimed amounts (0.01% bimatoprost and 200 ppm BAK) fell within the range disclosed in the prior art (0.001-1% bimatoprost and 0-1000 ppm BAK), Allergan “had produced ample evidence of teaching away and unexpected results, and that such evidence fully support[ed] a conclusion of non-obviousness.” For example: (1) BAK is a toxin and “should be minimized in ophthalmic formulations to avoid safety problems,” (2) BAK decreases permeability of bimatoprost, and (3) BAK causes hyperemia at high concentrations. Thus, the prior art “’criticize[d], discredit[ed], or otherwise discourage[d]’ the use of 200 ppm BAK in a bimatoprost formulation.” The Court also rejected the argument that the claims provided “only a difference in degree, not a difference in kind.” Allergan’s patent claims were the opposite of prior art wisdom, and its new 0.01% formulation “unexpectedly maintained the [intraocular pressure]-lowering efficacy of Lumigan 0.03%, while exhibiting reduced incidence and severity of hyperemia.” These results constituted unexpected difference in kind.
The Court also agreed with the district court that the Group II claims for “less hyperemia” satisfied the written description requirement. Although the district court erroneously relied on the undisclosed clinical protocol for its written description determination, the patent specifications nevertheless “specifically describe a formulation comprising 0.01% bimatoprost and 200 ppm BAK as one of the best modes of the invention.” Furthermore, while the clinical efficacy and hyperemia profile of the claimed formulation were not explicitly described, the defendants emphatically argued (for obviousness) that “the inherent properties of a formulation comprising 0.01% bimatoprost and 200 ppm BAK produce the claimed clinical profile.” Because the formulation was adequately described and the recited properties were admittedly inherent, the claims were not invalid as lacking written description.
The Court also rejected a lack enablement challenge, based on arguing that “the specifications contain no actual efficacy and hyperemia data.” According to the Court, “efficacy data are generally not required in a patent application.” Here, the specifications disclosed actual in vivo and in vitro data, “showing that increasing the amount of BAK unexpectedly increased the permeability of bimatoprost across ocular membranes.” The specifications also contained a constructive example, which taught that a formulation comprising 0.015% bimatoprost and 125 ppm BAK was effective in reducing intraocular pressure and also exhibiting less hyperemia than Lumigan 0.03%. Based on these disclosures, the Court concluded that “the skilled artisan would not have questioned the utility of the claimed formulation and would be able to make and use the claimed invention without undue experimentation.”
The Court also rejected the argument that a pH of 6.8-7.2 does not infringe a “pH of about 7.3.” The parties agreed to construe a “pH of about 7.3” as a “pH of approximately 7.3.” Given this claim construction, the Court found no error in encompassing a pH value that differs by only one decimal place.
In sum, the Court affirmed the district court ruling that the patents are valid and were infringed.