Soft Gel Technologies, Inc. v. Jarrow Formulas, Inc.

864 F.3d 1334, 123 U.S.P.Q. 2d (BNA) 1419, 2017 WL 3160480, 2017 U.S. App. LEXIS 13501
Court of Appeals for the Federal Circuit·Decided July 26, 2017·No. 2016-1814; 2016-1815; 2017-1051·Published·Cited by 5 cases

Opinion

BRYSON, Circuit Judge.

Soft Gel Technologies, Inc., appeals from three inter partes reexamination decisions of the Patent Trial and Appeal Board. The Board’s decisions invalidated numerous claims in each of three related Soft Gel patents for obviousness. We affirm.

I

A

Soft Gel is the named assignee of U.S. Patent Nos. 8,124,072 (“the ’072 patent”), 8,105,583 (“the ’583 patent”), and 8,147,826 (“the ’826 patent”). The ’583 patent issued from a continuation-in-part, and ’826 patent issued from a continuation, of the ’072 patent. The ’072 patent issued on February 28, 2012; the ’583 patent issued on January 31, 2012; and the ’826 patent issued oh April 3, 2012.

The specifications of the three patents describe a method for dissolving a substance commonly referred to as CoQlO in solvents known as monoterpenes. ’072 patent, col. 2, 11. 46-48.1 The patented inven[1336] tions include a composition, a-soft gelatin capsule, and a method of making such -a soft gelatin capsule, each involving a solution of CoQlO dissolved in a monoterpene.

CoQlO, also known as ubiquinone, is a coenzyme, i.e., a chemical compound that is required for the biological .activity of certain proteins. ’072 patent, col. 1, 11 16-25. It “affects the function of almost all cells in the'body, making it essential for the health of all human tissues and organs.” Id., col. 1,11. 39-41.

CoQlO is necessary for certain metabolic processes and for the production of cellular energy; it has a secondary role as an antioxidant. ’072 patent, col. 1,11. 18-24, 37-38. It is particularly important in “the .cells that are the most metabolieally active: heart, immune system, gingiva, and gastric mucosa.” Id,, col. 1, 11. 22-24, 41-43. In clinical trials, CoQlO has been shown to be effective in regulating blood pressure, and cholesterol levels, improving cardiovascular health, and “thwarting various diseases such as certain types of cancers.” Id., col. 1, 11. 44-49; see also id., col. 7, 11. 11-21 (noting that CoQlO has been used in the treatment of cardiovascular conditions, periodontal diseases, mitochondrial-related diseases and disorders, and neurological disorders);

Although CoQlO is synthesized by the body, the body may require more than it can synthesize or obtain through normal dietary intake. ’072 patent, col. 1,11. 26-28. Oral supplementation can compensate for á CoQlO deficiency. Id., col. 1, 11. 29-31.

Unfortunately, CoQlO is “sparingly soluble in hydrophilic solvents such as water.” ’072 patent, col. 1,11. 51-52. According to the Soft Gel patents, at the time of the inventions most solvents that were used to administer CoQlO in liquid form could dissolve, at most, only about 5 to 10 percent of the CoQlO. Id., col. 1, 11. 64-67; id., col. 2, 11. 59-61. For that reason, CoQlO was generally administered in solid form, such as in,a tablet or powder. Id., col. 1, 11. 52-53; id., col. 2, 11. 63-64. CoQlO could also be administered as a suspension, in which the Co.QlO is partially dissolved in a solvent. Id,, col. 1,11. 52-53; id., col. 3,11. 21-23. But those delivery methods limited the bioavailability of the CoQlO, as only a small .fraction of the CoQlO would enter the bloodstream. Id., col. 1, 11. 53-55; id., col, 3,11. 23-24. The Soft,Gel patents state that there was “a need in the art for an improved methodology to deliver increased amount[s] of bioavailable CoQ-10 to an individual in need thereof.” Id., col. 1, 11. 56-58.

The patents describe the discovery of monoterpenes as a solvent for CoQlO. ’072 patent, col. i, .11, 62—64; id., col, 2,11. 46-48; see also id., col. 3,11. 24-26. Monoterpenes are a class of compounds that have a ten-carbon skeleton and consist of “two iso-prene units connected in a head-to-end manner.” Id., col. 3, 11. 31-34., “Suitable examples of monoterpenes include, but are not limited to, limonene, .., caryone, .,. and derivatives thereof.” Id., col. 3, 11. 49-53; see also id,, col. 3, 11. 59-63 (listing, “[i]n particular,” a number of “suitable li-monene derivatives”).

Unlike aqueous solvents, monoterpenes can dissolve significant amounts of CoQlO. “Generally, about 30 to about 45% of the CoQ-10 (by weight [relative to that of the monoterpene]) is solubilized [dissolved] in the monoterpene.” ’072 patent, col. 2, 11. 11-12; see also, e.g., id., col. 2, line 65, through col, 3, line 11 (noting that up to about 60% by weight of CoQlO may be dissolved in monoterpene, and describing other “aspects” of the invention in which the weight of solubilized CoQlO relative to monoterpene is “about 0.1 percent ... to about 45 percent,” “about 5 to about 50 percent,” “about 16 to about 40 percent,” and “about 20 to about 35 percent”). The solution of CoQlO dissolved in monoter-[1337] pene may then be formulated as a caplet or soft gelatin- capsule containing the solution. Id., col. 3, line 64, through col. 4, line 1. Formulations- of that solution of CoQlO dissolved in a monoterpene “provid[e] increased bioavailability in delivery,” id:, col. 1, 11. 10-12, because “the solvated [dissolved] coenzyme can more easily pass into cells[,] ,.. delivering increased amounts of the coenzyme into an individual’s physiological makeup,” ’583 patent, col. 7,11. 4-7.

The claims of the Soft Gel patents focus on solutions of CoQlO and a monoterpene called limonene. Limonene is a compound that can have one of two different three-dimensional physical structures, labeled =d-limonene and 1-limonene, The claims of the three Soft Gel patents were amended to cover only solutions of CoQlO and d-limo-nene.

Claim 1 of each patent is representative for purposes of the respective appeal.

Claim 1 of the ’072 patent, as amended, recites as follows:

1. A -soft gelatin capsule, comprising coenzyme Q-10 solubilized in a sufficient quantity of d-limonene- suitable to solubi-lize said coenzyme Q-10 to form a solution, wherein the amount of coenzyme Q-10 in said solution is about 15 percent up to about 60 percent coenzyme Q-10 by weight, with the proviso that the coenzyme Q-10 solubilized in the d-limo-nene is not in an emulsion, suspension, or elixir.

Claim 1 of the ’583 patent, as amended, recites as follows:

1. A solubilized coenzyme Q-10 composition comprising:' -

coenzyme Q-10;

a sufficient quantity of d-limonene suitable to solubilize said coenzyme Q-10 thereby providing a solution in which the coenzyme Q-10 remains solubi- ■ lized, with the proviso that said solution is not part of an emulsion; suspension, or elixir.

Claim 1 of- the ’826 patent, as amended, recites as-follows: ■ ■

1.' A method of preparing a soft gel capsule, comprising the steps of:'
(a) mixing coenzyme Q-10 with a suffi.cient quantity of d-limonene suitable to dissolve said coenzyme Q-10 and form a solution, with the proviso that said solution, is not part of - an emulsion, suspension, or elixir; wherein the amount of coenzyme Q-10 in said solution is about 15% up to about 60% coenzyme Q-10 by weight;

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Soft Gel Technologies, Inc. v. Jarrow Formulas, Inc., 864 F.3d 1334, 123 U.S.P.Q. 2d (BNA) 1419, 2017 WL 3160480, 2017 U.S. App. LEXIS 13501 (Fed. Cir. 2017).

864 F.3d 1334 (Soft Gel Technologies, Inc. v. Jarrow Formulas, Inc.) — published by Counsel Stack Legal Research, free access to 12M+ legal documents.

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