Category Archives: Formulations

PTAB Upholds Alcon Patent For Glaucoma Treatment

As reported by Law360 at URL: https://www.law360.com/ip/articles/1085124/ptab-upholds-alcon-patent-for-glaucoma-treatment

The Final Written Decision itself is included below, and can be downloaded by clicking this link:

Argentum-v-Alcon-FWD-IPR2017-01053

The patent may be viewed at the USPTO website at
http://pdfpiw.uspto.gov/.piw?Docid=08268299.

PTAB Upholds Alcon Patent For Glaucoma Treatment

Law360 (September 21, 2018, 8:52 PM EDT) — The Patent Trial and Appeal Board on Thursday upheld the validity of an Alcon patent covering the glaucoma treatment Travatan Z, rejecting arguments by generics maker Argentum that the invention was obvious.

The board held that Argentum Pharmaceuticals LLC failed to establish that a combination of publications and patents that preceded Alcon Research Ltd.’s patent would have made the challenged patent claims obvious for an ordinarily skilled artisan, according to the final written decision. Continue reading

Imprimis Pharmaceuticals: Application published: “Epinephrine-Based Ophthalmic Compositions for Intraocular Administration and Methods for Fabricating Thereof”

March 1, 2018: The USPTO today published a patent application filed by Imprimis Pharmaceuticals of San Diego, CA: U.S. Application Publication No. 2018/0055790, “Epinephrine-Based Ophthalmic Compositions for Intraocular Administration and Methods for Fabricating Thereof”.

According to the published abstract:

Pharmaceutical compositions for intraocular injection are described, the compositions comprise therapeutically effective quantity of lyophilized preservative-free and sulfite-free epinephrine or adrenaline and a metal chelator. Methods for fabricating the compositions and using them for intraocular injections are also described.

Published Claim 1 recites:

1. A method for preparing a pharmaceutical composition, the method comprising:
(a) preparing an aqueous composition consisting of:
(a1) a therapeutically effective quantity of at least one compound selected from the group consisting of epinephrine, phenylephrine, EPI-Shugarcaine and tropicamide;
(a2) at least one metal chelator;
(a3) optionally, at least one anesthetic;
(a4) optionally, at least one non-steroid anti-inflammatory drug; and
(a5) a quantity of sterile water, wherein the composition is optionally free of sulfites and is free of preservatives; and
(b) lyophilizing the aqueous composition, to obtain thereby the lyophilized pharmaceutical composition.

The published application can be viewed at the USPTO website at http://pdfaiw.uspto.gov/.aiw?Docid=20180055790.

Note: A published application is not an issued patent. The USPTO automatically publishes most applications 18 months after filing, and the publication is simply a copy of the as-filed application, without examination.

Allergan obtains patent: “Crystalline forms of bimatoprost acid, methods for preparation, and methods for use thereof”

January 2, 2018: Allergan, Inc. of Irvine, CA, obtained U.S. Patent No. 9,855,232, “Crystalline forms of bimatoprost acid, methods for preparation, and methods for use thereof”.

According to the abstract of the patent:

The invention provides new crystalline forms of 7-[3,5-Dihydroxy-2-(3-hydroxy-5-phenyl-pent-1-enyl)-cyclopentyl]-hept-5-e- noic acid. This compound is commonly referred to as “bimatoprost acid.” The novel crystalline forms are designated forms I, II, and III. The invention crystalline forms are useful for solid ocular implant formulations, utilized in the treatment of various ocular conditions, such as, for example, ocular hypertension. In addition, invention crystalline forms are useful for solid or semisolid dosage formulations used to treat ocular hypertension.

Issued Claim 1 recites:

1. A solid implant formulation, the solid implant formulation comprising a therapeutically effective amount of 7-[3,5-Dihydroxy-2-(3-hydroxy-5-phenyl-pent-1-enyl)-cyclopentyl]-hept-5-e- noic acid in crystalline form II as characterized by X-ray diffraction pattern of about 12.0, 14.2, 16.0, 18.8, 20.6, 22.6, 24.1, 28.1, 35.9 and 36.5.

The patent may be viewed at the USPTO website at http://pdfpiw.uspto.gov/.piw?Docid=09855232.

Allergan obtains patent: “Artificial tears and therapeutic uses”

November 21, 2017: Allergan, Inc. of Irvine, CA, obtained U.S. Patent No. 9,821,020, “Artificial tears and therapeutic uses”.

According to the abstract of the patent:

The present invention provides ophthalmic compositions, e.g. artificial tears, suitable for treating dry eye syndrome in a human or other mammal suffering there from, e.g. a dog or cat, which comprise a mixture of castor oil with another oil, e.g. a food oil, e.g. olive oil, sesame oil, corn oil etc.

Claim 1 of the issued patent recites:

1. A composition for effectively treating dry eye in an animal or human in need thereof, the composition comprising therapeutically effective amounts of:
an oil mixture consisting essentially of linseed oil and castor oil;
carboxymethyl cellulose;
glycerin;
polysorbate 80;
crosslinked copolymers of acrylic acid and C10-C30 alkyl acrylate;
polyoxyl stearate;
carnitine;
erythritol;
boric acid; and
water,
wherein said composition is an emulsion.

The patent may be viewed at the USPTO website at http://pdfpiw.uspto.gov/.piw?Docid=09821020.

Sydnexis obtains patent: “Ophthalmic composition”

September 26, 2017: Sydnexis, Inc. of San Diego, CA, obtained U.S. Patent No. 9,770,447, “Ophthalmic composition”.

According to the abstract of the patent:

Provided herein is an ophthalmic composition. In some embodiments, the ophthalmic composition includes a low concentration of an ophthalmic agent for treatment of an ophthalmic disorder or condition; and an ophthalmically acceptable carrier, wherein the ophthalmic agent is distributed with substantial uniformity throughout the ophthalmically acceptable carrier. Further disclosed herein include an ophthalmic composition including a low concentration of an ophthalmic agent and deuterated water. Also disclosed herein are methods of arresting or preventing myopia development by administering to an eye of an individual in need thereof an effective amount of an ophthalmic composition as described herein.

Claim 1 of the patent reads:

1. An ophthalmic composition, comprising one and no more than one ophthalmic agent, and deuterated water, at a pD of from about 4.2 to about 7.9, wherein the ophthalmic agent consists of atropine, atropine sulfate, or a combination thereof, at a concentration of from about 0.001 wt % to about 0.03 wt %.

The patent may be viewed at the USPTO website at http://pdfpiw.uspto.gov/.piw?Docid=09770447.

Allergan obtains patent: “Pharmaceutical compositions and methods of use of 4-pregenen-11β-17-21-triol-3,20-dione derivatives”

August 1, 2017: Allergan, Inc. of Irvine, CA, obtained U.S. Patent No. 9,717,743, “Pharmaceutical compositions and methods of use of 4-pregenen-11β-17-21-triol-3,20-dione derivatives”.

According to the abstract of the patent:

The present invention relates to pharmaceutical compositions comprising 4-pregenen-11β-17-21-triol-3,20-dione derivatives, and their use as pharmaceuticals as modulators of the glucocorticoid receptors (GR) and/or the mineralocorticoid receptors (MR). The invention relates specifically to the use of these compounds and their pharmaceutical compositions to treat ocular conditions associated with the glucocorticoid receptors (GR) and/or the mineralocorticoid receptors (MR).

The patent may be viewed at the USPTO website at http://pdfpiw.uspto.gov/.piw?Docid=09717743.

Cloudbreak Therapeutics: Application published: “Compositions and Methods for Treating Pterygium”

July 27, 2017: The USPTO today published a patent application filed by Cloudbreak Therapeutics, LLC of Irvine, CA: U.S. Application Publication No. 2017/0209368, “Compositions and Methods for Treating Pterygium”.

According to the published abstract:

Compositions and methods for inducing pterygium regression from visual axis/central cornea, stabilizing pterygium, treating hyperemia and symptoms in pterygium patients, and treating pterygium recurrence following pterygiectomy are disclosed. The methods include administration of a multikinase inhibitor, an antimetabolite or a combination thereof to patients in need thereof.

The published application can be viewed at the USPTO website at http://pdfaiw.uspto.gov/.aiw?Docid=20170209368.

Note: A published application is not an issued patent. The USPTO automatically publishes most applications 18 months after filing, and the publication is simply a copy of the as-filed application, without examination.

Allergan: Application published: “Two Part Formulation System for Ophthalmic Delivery”

July 27, 2017: The USPTO today published a patent application filed by Allergan, Inc. of Irvine, CA: U.S. Application Publication No. 2017/0209532, “Two Part Formulation System for Ophthalmic Delivery”.

According to the published abstract:

Ophthalmic products and related methods are described herein. These methods include a stabilizing composition comprising a therapeutically active agent which is separated from a liquid vehicle composition by a barrier. The barrier may be removed to allow the two compositions to mix to provide an ophthalmically acceptable liquid comprising the therapeutically active agent.

The published application can be viewed at the USPTO website at http://pdfaiw.uspto.gov/.aiw?Docid=20170209532.

Note: A published application is not an issued patent. The USPTO automatically publishes most applications 18 months after filing, and the publication is simply a copy of the as-filed application, without examination.

Allergan: Application published: “Androgen Composition for Treating an Opthalmic [sic] Condition”

July 6, 2017: The USPTO today published a patent application filed by Allergan, Inc. of Irvine, CA: U.S. Application Publication No. 2017/0189412, “Androgen Composition for Treating an Opthalmic [sic] Condition”.

According to the published abstract:

The disclosure provides compositions for treating an ocular condition. The composition comprises a physiologically effective amount of an androgen, wherein the composition is suitable for topical administration to an eye. The disclosure further provides methods for treating an ocular condition with the disclosed compositions.

The published application can be viewed at the USPTO website at http://pdfaiw.uspto.gov/.aiw?Docid=20170189412.

Note: A published application is not an issued patent. The USPTO automatically publishes most applications 18 months after filing, and the publication is simply a copy of the as-filed application, without examination.

Allergan obtains patent: “Ophthalmic compositions and methods for treating eyes”

June 6, 2017: Allergan, Inc. of Irvine, CA, obtained U.S. Patent No. 9,668,997, “Ophthalmic compositions and methods for treating eyes”.

According to the abstract of the patent:

Ophthalmic compositions including compatible solute components and/or polyanionic components are useful in treating eyes, for example, to relieve dry eye syndrome, to protect the eyes against hypertonic insult and/or the adverse effects of cationic species on the ocular surfaces of eyes and/or to facilitate recovery from eye surgery.

The patent may be viewed at the USPTO website at http://pdfpiw.uspto.gov/.piw?Docid=09668997.