Hatch-Waxman at the Federal Circuit: Sustaining validity of formulation patents is no easy task


In the hierarchy of patenting strategies used to protect some of the most valuable pharmaceutical innovations, patents related to formulation innovations have long been relegated to second-class citizenship, especially when compared to the class of patents directed to the molecular structure of the active drug itself. This second-class status is the result of a perception, if not outright truth, that it is more difficult to sustain the validity of formulation patents, whether on appeal or otherwise. A look back at 2013, while limited in sheer number of data points, appears to support this trend. Of the almost ten Hatch-Waxman based cases that made their way to the Federal Circuit in 2013, 50% of those cases resulted in the claims either being affirmed as invalid or a determination that those patents were invalid on appeal. Two other cases resulted in non-infringement findings and one was a mixed result. A chart summarizing the more interesting of these cases is set forth below.




Ruling Below

Federal Circuit Result

AstraZeneca AB v. Hanmi USA, Inc.
2013 WL 6670610Nexium®
Whether the written description of the patents in suit limits “alkaline salt” to certain specifically named salts.The district court construed the term “alkaline salt” and “pharmaceutically acceptable salt” to be limited to the disclosed salts. After this ruling, the parties consented to a final judgment that Hanmi’s proposed product does not infringe the claims of either of the asserted patents.The Federal Circuit agreed with the District Court.Based upon the description of “the present invention” as new salts, the Federal Circuit found disclaimer.

The first sentence of the Detailed Description declares:

The present invention refers to the new Na +, Mg 2+, Li +, K +, Ca 2+ or N + (R)4 salts of the single enantiomers of omeprazole, where R is an alkyl with 1-4 carbon atoms, i.e. Na +, Mg 2+, Li +, K +, Ca 2+ or N +(R)4 salts of (+)-[omeprazole] and (-)-[omeprazole], where R is an alkyl with 1-4 carbon atoms.

Id., col. 2, lines 42-49. That language clearly defines “the present invention” not as salts of omeprazole, or salts of single enantiomers of omeprazole, but as a particular set of “new” salts of enantiomers of omeprazole, limited to the six named cations. The Abstract, though not grammatically a sentence, confirms the limiting disclaimer by identifying what AstraZeneca said was “novel”: “The novel optically pure compounds Na +, Mg 2+, Li +, K +, Ca 2+ or N +(R)4 salts of (+)-[omeprazole] or (-)-[omeprazole], in particular sodium and magnesium salt form thereof …” Id., Abstract.

Those statements clearly confine the invention to the six identified cations, disclaiming anything else. See, e.g., Verizon Servs. Corp. v. Vonage Holdings Corp., 503 F.3d 1295, 1308 (Fed. Cir. 2007); Honeywell Int’l, Inc. v. ITT Indus., 452 F.3d 1312, 1318-19 (Fed. Cir. 2006); SciMed Life Sys., Inc. v. Advanced Cardiovascular Sys., Inc., 242 F.3d 1337, 1340-45 (Fed. Cir. 2001).

2013 WL 6670610 at *3.

Galderma Laboratories, L.P. v. Tolmar, Inc.
2013 WL 6483704Differin® Gel, 0.3%
Whether the asserted claims were obvious over the prior art.After a bench trial, the District Court concluded that the defendants had not shown by clear and convincing evidence that the claims were obvious over the asserted prior art.The Federal Circuit held that the patents, which taught use of active ingredient at 0.3% concentration, were invalid as obvious in light of prior art that disclosed preferred range of 0.01%-1% for that ingredient, with same inactive ingredients.At the heart of the Court’s ruling was the fact that Galderma had not met its burden of production regarding secondary considerations.

The relevant dispute in this case is thus not over whether the prior art discloses all of the claim elements or over the motivation to combine the prior art references. Rather, the dispute is whether there was motivation to select the claimed 0.3% adapalene composition in the disclosed range. In these circumstances, where there is a range disclosed in the prior art, and the claimed invention falls within that range, the burden of production falls upon the patentee to come forward with evidence that (1) the prior art taught away from the claimed invention; (2) there were new and unexpected results relative to the prior art; or (3) there are other pertinent secondary considerations.

2013 WL 6483704 at *4. Judge Newman in dissent argued that this articulation of the standard obviated the presumption of validity.

AstraZeneca LP v. Breath Ltd.
2013 WL 5813759
Whether the District Court correctly concluded that the claims in the patents in suit were not infringed and invalid as anticipated and obvious.The District Court held that the asserted claims of one patent were not infringed and the claims of the other were invalid as anticipated and obvious.The Federal Circuit remanded the case to the District Court to allow the Court to evaluate the merits in light of the correct claim construction and affirmed the District Court’s obviousness determination.
Sunovion Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA, Inc.731 F.3d 1271Lunesta®What “essentially free” meant in the context of the asserted patent.The District Court granted summary judgment based up a claim construction of the term “essentially free.” The Court ruled that, based upon the prosecution history, “essentially free” meant “less than 0.25%.” The defendant’s ANDA called for not more than 0.6%, or in other words, from 0.0% to 0.6%. Based upon a certification from the Defendant that it would not manufacture below 0.3%, the District Court granted summary judgment of non-infringement.While the Federal Circuit affirmed the claim construction, the Court reversed on summary judgment.

What Reddy has asked the FDA to approve as a regulatory matter is the subject matter that determines whether infringement will occur, and the fact that Reddy either tells the court that its manufacturing guidelines will keep it outside the scope of the claims or has even filed a declaration in the court stating that it will stay outside the scope of the claims does not overcome the basic fact that it has asked the FDA to approve, and hopes to receive from the FDA, approval to market a product within the scope of the issued claims.

731 F.3d 1271, 1278.Thus a declaration to the Court the Defendant will not manufacture an infringing product is insufficient.

Pronova Biopharma Norge AS v. Teva Pharmaceuticals USA, Inc.
2013 WL 5345899Lovaza®
Whether the claims were infringed and not invalid.The District Court found that the patents were infringed and not invalid as obvious or anticipated by prior public use.The Federal Circuit concluded that the patent was invalid under the public use bar. After the Court concluded that the “ready for patenting” prong of Pfaff had been satisfied, the sole issue was whether there was public access to the invention. Because samples were sent to a doctor without restriction and that doctor tested those samples, the Court concluded there had been an invalidating public use.
Allergan, Inc. v. Sandoz Inc. 726 F.3d 1286Combigan®Whether claims to a combination therapy were invalid as obvious.After a week-long bench trial, the District Court held that the asserted patents were not invalid as obvious.The Federal Circuit affirmed as to one claim of the asserted patents, concluding that the defendants had failed to prove by clear and convincing evidence that the claim was obvious.The Court reversed as to the other claims, concluding they would have been obvious to one of skill in the art.
Bayer Healthcare Pharmaceuticals, Inc. v. Watson Pharmaceuticals, Inc.713 F.3d 1369Whether patent claims to pharmaceutical formulations and dosing regimens were invalid as obvious.The District Court granted summary judgment at certain claims were not obvious in light of the prior art.Reversed.The case turned on whether one of skill would have been motivated to combine the teachings of the prior art to derive the claimed subject matter.Because the Federal Circuit believed the prior art itself provided such motivation, the asserted claims were found to be obvious.
Cephalon, Inc. v. Watson Pharmaceuticals, Inc. 707 F.3d 1330FENTORA®Whether claims to a sublingual buccal effervescent dosage form were infringed and not invalid.The District Court held that the claims were not infringed and invalid for lack of enablement.The Federal Circuit affirmed that the plaintiffs had failed to prove infringement but reversed on enablement.

What’s your prediction about the number of new Hatch-Waxman litigation cases in 2014? Cast your vote here.