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Cipher Pharmaceuticals Inc. v. Actavis Labs. FL, Inc.

United States District Court, D. New Jersey

April 20, 2015

CIPHER PHARMACEUTICALS INC., et al., Plaintiffs,
v.
ACTAVIS LABORATORIES FL, INC., et al., Defendants

Page 509

For Plaintiffs: Theodora McCormick, Esq., EPSTEIN, BECKER & GREEN, P.C., Newark, New Jersey; Leora Ben-Ami, Esq., Jeanna M. Wacker, Esq., Laura A. Keay, Esq., New York, New York.

For Defendants: Liza M. Walsh, Esq., Tricia B. O'Reilly, Esq., Eleonore Ofosu-Antwi, Esq., Roseland, New Jersey; E. Anthony Figg, Esq., C. Nichole Gifford, Esq., Lisa N. Phillips, Esq., Brett A. Postal, Esq., Washington, DC.

Page 510

OPINION

Joseph E. Irenas, Senior United States District Judge:

This is a patent infringement suit. The Court conducted a Markman hearing on April 2, 2015, which included extensive testimony from the parties' expert witnesses. This opinion construes the five remaining disputed terms[1] of the two related patents, the '427 patent[2] and the '102 patent[3], both of which disclose a " pharmaceutical semi-solid composition of isotretinoin," commercially known as the prescription drug Absorica.

I.

According to Plaintiffs, Absorica is an improvement on the well-known acne drug, Accutane, which is another formulation of isotretinoin.[4]

Isotretinoin, a retinoid (related to Vitamin A), is a difficult drug with which to work for three reasons. First, it degrades when exposed to light and air. Second, it

Page 511

is very poorly water soluble. Third, it has a narrow therapeutic window, meaning that there is a small range between the dose at which the drug is effective and the dose at which it is toxic.[5]

Accutane purportedly sought to address at least some of these problems by dissolving isotretinoin in a gelatin capsule (to be taken orally) largely composed of oily, fatty ingredients such as beeswax and vegetable oil. However, when patients ingested Accutane, it did not mix well in the aqueous (watery) environment of the human body, leading to poor bioavailability of the isotretinoin active ingredient. Thus, to boost absorption, patients were instructed to take Accutane with food.

However, this approach, according to Plaintiff, was not ideal. The " food effect" was strong, resulting in radical spikes in absorption and an increased risk of overshooting the therapeutic window. Decreased absorption associated with low food intake was also a problem; it could lead to " re-treatment" which itself carries a risk of toxic exposure simply due to taking the drug for a longer period of time.[6] The absorption problem was magnified by the reality that typical isotretinoin patients are teenagers, who, as a group, are known to be " notoriously non-compliant." (Plaintiffs' tutorial, p. 2)

Absorica allegedly solves the " food effect" absorption problem by creating a novel semi-solid formulation of isotretinoin. Absorica, like Accutane, has an oily vehicle (i.e., oily excipient); but, unlike Accutane, Absorica also has a water-soluble component (i.e., hydrophilic excipient). This new formulation allegedly obviates the need to take the drug with food. Absorica is the only isotretinoin product currently on the market with the dosage instruction that the capsules should be taken " without regard to meals."

The terms to be construed are:

Term 1 : " semi-solid suspension"
Term 2 : " hydrophobic lipidic balance (HLB) value"
Term 3 : " having an HLB value equal to or greater than 10" / " has an HLB value of at least [12, 13]"
Term 4 : " the isotretinoin is partially in suspension and/or partially in solution"
Term 5 : " an amount of about 1 to 10% of at least one additional surfactant" / " about 1 - 10% of an additional surfactant"

II.

Claim construction is a matter of law for the Court to decide. Markman v. Westview Instruments, Inc., 517 U.S. 370, 391, 116 S.Ct. 1384, 134 L.Ed.2d 577 (1996). " It is a 'bedrock principle' of patent law that 'the claims of a patent define the invention to which the patentee is entitled the right to exclude.'" Phillips v. AWH Corp., 415 F.3d 1303, 1319 (Fed. Cir. 2005) (en banc) (quoting Innova/Pure Water, Inc. v. Safari Water Filtration Sys., Inc., 381 F.3d 1111, 1115 (Fed. Cir. 2004)).

The Court begins a claim construction analysis by examining the intrinsic evidence, which includes the claims, the specification, and the prosecution history. Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996). " A claim construction analysis must begin and remain centered on the claim language itself." Innova, 381 F.3d at 1116. There is a

Page 512

heavy presumption that a claim term conveys its ordinary and customary meaning, which " is the meaning that the term would have to a person of ordinary skill in the art in question at the time of the invention." Phillips, 415 F.3d at 1313. But a patentee may overcome this presumption and choose " to be his or her own lexicographer by clearly setting forth an explicit definition for a claim term." Johnson Worldwide Assocs., Inc. v. Zebco Corp., 175 F.3d 985, 990 (Fed. Cir. 1999); see also Schering Corp. v. Amgen Inc., 222 F.3d 1347, 1353 (Fed. Cir. 2000); Markman v. Westview Instruments, Inc., 52 F.3d 967, 979-80 (Fed. Cir. 1995), aff'd 517 U.S. 370, 116 S.Ct. 1384, 134 L.Ed.2d 577 (1996).

The claims themselves and the context in which a term is used within the claims can " provide substantial guidance as to the meaning of particular claim terms." Phillips, 415 F.3d at 1314. In addition, other claims of the patent may be useful in construing a claim term, as " claim terms are normally used consistently throughout the patent." Id. Similarly, claims that differ from each other may provide insight into how a term should be read. Laitram Corp. v. Rexnord, Inc., 939 F.2d 1533, 1538 (Fed. Cir. 1991).

After examining the claims, " it is always necessary to review the specification to determine whether the inventor has used any terms in a manner inconsistent with their ordinary meaning." Vitronics, 90 F.3d at 1582. " For claim construction purposes, the description may act as a sort of dictionary, which explains the invention and may define terms used in the claims." Markman, 52 F.3d at 979. For this reason, " the specification is always highly relevant to the claim construction analysis. Usually, it is dispositive; it is the single best guide to the meaning of a disputed term." Vitronics, 90 F.3d at 1582.

Finally, the Court should also examine the prosecution history, if it is in evidence. Phillips, 415 F.3d at 1317. " The prosecution history can often inform the meaning of the claim language by demonstrating how the inventor understood the invention and whether the inventor limited the invention in the course of prosecution, making the claim scope narrower than it would otherwise be." Id.

" [I]deally there should be no 'ambiguity' in claim language to one of ordinary skill in the art that would require resort to evidence outside the specification and prosecution history." Markman, 52 F.3d at 986. But if the term remains unclear or ambiguous after examining the intrinsic evidence, the Court may turn to extrinsic evidence. Pall Corp. v. Micron Separations, Inc., 66 F.3d 1211, 1216 (Fed. Cir. 1995). " Extrinsic evidence consists of all evidence external to the patent and prosecution history, including expert and inventor testimony, dictionaries, and learned treatises." Markman, 52 F.3d at 980. Although extrinsic evidence is useful in determining how a person of ordinary skill in the art would understand the term, it is less reliable for the purposes of claim construction than the patent and its prosecution history. Phillips, 415 F.3d at 1318-19. Therefore, extrinsic evidence must be viewed within the context of intrinsic evidence. Id. at 1319.

III.

The Court addresses one initial issue before turning to the disputed terms.

A.

Defendants assert that four out of the five disputed claim terms are indefinite. Defendants urge the Court to decide that issue now, at the ...


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