Federal Circuit Affirms ‘Teaching Away’ and ‘Unexpected Results’ that Support Non-obviousness

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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.

 

The Author

Joseph Robinson

Joseph Robinson has over 20 years of experience in all aspects of intellectual property law. He focuses his practice in the pharmaceutical, life sciences, biotechnology, and medical device fields. His practice encompasses litigation, including Hatch-Waxman litigation; licensing; counseling; due diligence; and patent and trademark prosecution. He has served as litigation counsel in a variety of patent and trademark disputes in many different jurisdictions, and has also served as appellate counsel before the Court of Appeals for the Federal Circuit. Joe also focuses on complex inter partes matters before the U.S Patent and Trademark Office, inventorship disputes, reexaminations and reissues. His experience includes numerous interferences, a particular advantage in new U.S. Patent and Trademark Office post-grant proceedings. He also counsels on patent–related U.S. Food and Drug Administration issues, including citizen petitions, Orange Book listing, and trademark issues. For more information and to contact Joe please visit his profile page at the Troutman Sanders website.

Joseph Robinson

Robert Schaffer is an intellectual property partner at Troutman Sanders. Bob applies more than 30 years of experience to IP counseling and litigation. His work includes patent procurement, strategic planning and transactional advice, due diligence investigations, district court patent cases, and Federal Circuit appeals. He regularly handles complex and high-profile domestic and international patent portfolios, intellectual property agreements and licensing, IP evaluations for collaborations, mergers, and acquisitions. In disputed court cases Bob’s work includes representing and counseling client in ANDA litigations, complex patent infringement cases and appeals, and multidistrict and international cases. In disputed Patent Office matters his work includes representing and counseling clients in interferences, reexaminations, reissues, post-grant proceedings, and in European Oppositions. For more information and to contact Bob please visit his profile page at the Troutman Sanders website.

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Discuss this

There are currently 1 Comment comments.

  1. Anon August 15, 2015 7:00 am

    Was “obvious to try” explored?

    Given the known propensity for multi-component (chemical) items to sometimes (often) act counter to the teachings of single component items, does not the entire branch of chemistry/pharmacy/compositions “fall” into “standard” practices?

    Please pardon the excursion and seeming conflation of 103 and 101. But the emerging treatment of standard practices would appear to make the attempted pass over of 103 into a guaranteed fail-trap of 101. After all, as I point out, it is common knowledge (common sense?) that the teachings of single items often do not apply when items are combined. That’s why the common practice of development pays no heed to such “teachings away” – it is now well-known standard practice to try combinations of items that are singularly “taught away.”

    Since all of pharma and all of the chemical arts know this and incorporate this into standard practices, is not the bar raised for “something more?”

    If Flash of Genius is being resurrected for other arts, it cannot be sequestered from these arts. If “standard practices” will be the norm imported into 101 (in addition to 103), does not the exception swallow the rule, and is that not rather obvious for this art field?

    Is this a case of “Congratulations, you have successfully jumped out of the frying pan. My condolences for landing in the fire.”…?