Helsinn Healthcare v. Dr. Reddy’s Laboratories@Palonosetron HCl: Patent Trial and Appeal Board

Patent Trial and Appeal Board (PTAB) accepted Dr.Reddy’s Laboratories Inter Partes Review petitions IPR2015-01550, IPR2015-01551, IPR2015-01553 and IPR2015-01554 against claims 22-27 and 30 of US  patent no. 8,729,094 which is owned by Helsinn Healthcare.

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Palonosetron HCl and its patent litigations:
Palonosetron is a serotonin-3 (5-HT3) receptor antagonist indicated in adults for:
i) Moderately emetogenic cancer chemotherapy prevention of acute and delayed nausea and vomiting associated with initial and repeat courses (1.1);
ii) Highly emetogenic cancer chemotherapy prevention of acute nausea and vomiting associated with initial and repeat courses (1.1);
iii) Prevention of postoperative nausea and vomiting (PONV) for up to 24 hours following surgery.

Helsinn Healthcare received FDA approval on Jul 25, 2003 to market Palonosetron HCl injectable; intravenous (EQ 0.075mg base/1.5ml (EQ 0.05mg base/ml) EQ 0.25mg base/5ml (EQ 0.05mg base/ml)) under the brand name Aloxi.

Palonosetron is patented in US through US 5,202,333 A which is set to expire on Oct 13, 2015 (including PED) which is listed in orange book. Further, there are other patents which claims formulations are also listed in orange book.

ANDA litigations:
Several ANDA’s has been received by FDA which were filed by generic companies for seeking approval to market the generic version of Aloxi. Helsinn sued the ANDA filers. However, Teva, Dr.Reddys and Sandoz has received Tentative Approvals for generic version of Palonosetron HCl.

Helsinn Healthcare v. Dr.Reddy’s labs:
Reddy’s labs filed an ANDA (201533 & 203050) under § 505(j)(2)(A)(vii)(IV). ANDA No. 201533 seeks the FDA approval necessary to engage in the commercial manufacture, use, sale, offer for sale, and/or importation of generic 0.25mg/5mL and 0.075mg/1.5mL Palonosetron HCl intravenous solutions prior to the expiration of the US 7,947,724, US 7,947,725, US 7,960,424, US 8,518,981, US 8,598,218, US 8,598,219, and US 8,729,094 patents. Helsinn sued Reddy’s labs (and also sued other generics like Sandoz and Teva with the same patents) under the infringement of the ’US ‘724, US’725 (3:11-cv-03962), US ‘424 (3:11-cv-05579), US ‘094 (3:14-cv-04274), US ‘218, US ‘219 and US ‘981 (3:13-cv-05815) under 35 U.S.C.§ 271(e)(2)(A). All of these cases are before The Honorable Judge Cooper in the U.S. District Court for the District of New Jersey.

Before PTAB:
The present IPR petitions has been filed against the claims 22-27 and 30 of the US ‘094 patent on the grounds of obviousness.

Claim 22 comprises a method for reducing the likelihood of cancer chemotherapy-induced nausea and vomiting, comprising intravenously administering to a human in need thereof a pharmaceutical single-use, unit-dose formulation comprising a 5 mL sterile aqueous isotonic solution buffered at a pH of about 5.0+0.5, said solution comprising: about 0.05 mg/mL Palonosetron HCl based on the weight of its free base; and a tonicifying effective amount of mannitol; wherein said solution optionally comprises one or a combination of a citrate buffer and a chelating agent, wherein said formulation is stable at 24 months when stored at room temperature, and wherein said intravenous administration to said human occurs before the start of the cancer chemotherapy.

Claims 23-27 and 30 are dependent on claim 22.

Reddy’s argued that the above claims of US ‘094 Patent are taught, either expressly or inherently, in the prior art, or are obvious in view of the prior art.

The following documents have been opted as a prior art in the present case (imp considered):
i) Berger’s U.S. Patent No. 5,202,333 which claims Palonosetron and described the synthesis of the molecule, and various analogs, and it provided some basic information about how Palonosetron could be formulated and used;

ii) Chelly’s Abstracts of Scientific Papers 1996 Annual Meeting, 85 Anesthesiology, No. 34, A21 (Sept. 1996) which discloses results of a completed Phase II clinical study in humans where Palonosetron was administered orally to 351 patients to prevent postoperative nausea and vomiting (“PONV”) following laparoscopic surgery, dosed at 0.3, 1.0, 3.0, 10.0, and 30μg/kg [0.021mg, 0.07mg, 0.21mg, 0.7mg, and 2.1mg] or placebo;

iii) Tang’s The Efficacy of RS-25259, a Long-Acting Selective 5-HT3 Receptor Antagonist, for Preventing Postoperative Nausea and Vomiting After Hysterectomy Procedures, which discloses preliminary efficacy of Palonosetron in a second Phase II clinical study;

iv) Zofran’s In Physician’s Desk Reference 1503-07 (55th ed.);

v) Avis et al., Parental Drug Administration: Routes, Precautions, Problems, complications, and Drug Delivery Systems and etc.,

Reddy’s argued that the invention claimed in claim 22-27 and claim 30 are obvious to a person skilled in the art in view of the combination of the teachings disclosed in the above prior art.

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FDA: Recent Paragraph IV Patent Certifications

August 5, 2015, FDA announced that it received Abbreviated New Drug Application’s (ANDA) containing a “Paragraph IV” patent certification for the following drugs.

Drug Name Dosage Form Strength RLD Date of Submission
Carbidopa and Levodopa Extended-release Capsules 61.25 mg/245 mg Rytary 6/10/2015
Doxycycline Hyclate Delayed-release Tablets 80 mg Doryx 7/1/2015
Fidaxomicin Tablets 200 mg Dificid 5/27/2015
Oseltamivir phosphate Oral Suspension 6 mg/mL Tamiflu 6/18/2015
Phenylephrine and Ketorolac Injection 1%/0.3% Omidria 5/29/2015

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Brief Description of the above Drugs:

i) Carbidopa and Levodopa:
Carbidopa is an aromatic amino acid decarboxylation inhibitor and Levodopa is an aromatic amino acid.

Rytary is a combination of Carbidopa and Levodopa which are approved for the treatment of Parkinson’s disease, post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication or manganese intoxication. Impax Labs Inc is the NDA (N203312) owner for Rytary (23.75MG; 95MG, 36.25MG; 145MG, 48.75MG; 195MG, 61.25MG; 245MG capsule, extended release; oral) which was approved on Jan 7, 2015, and it also received NDF exclusivity which is going to expire on Jan 7, 2018. There are several patents listed for the above combination which are set to expire on Dec 26, 2028.

ii) Doxycycline Hyclate (80 mg):
Doxycycline belongs to tetracycline class of compounds. It is a broad-spectrum antibiotic of the tetracycline class that is useful for the treatment of a number of infections, including bacterial, protozoal and helminth. Doxycycline was developed by Pfizer which first received FDA approval in 1967, pfizer marketed Doxycycline under the brand name Vibramycin.

Doryx Capsules contain specially coated pellets of Doxycycline Hyclate in a delayed-release formulation for oral administration. Mayne Pharma Intl received FDA approval for its NDA 050582 (capsule, delayed release;oral EQ 75MG and 100MG of Doxycycline Hyclate base), in July 22, 1985 which was discontinued later. Further, on May 6, 2005 Mayne Pharma received FDA approval for its NDA 050795 (tablet, delayed release;oral EQ 50, 75, 80, 100, 150, 200mg of Doxycycline Hyclate base). There are 2 patent listed in orange book for DORYX, which are US 6,958,161 (Dec 15, 2022) and US 8,715,724 (Feb 3, 2028).

iii) Fidaxomicin:
Fidaxomicin is a narrow spectrum macrocyclic antibiotic drug. Cubist Pharmaceuticals received FDA approval on May 27, 2011 for its NDA 201699, which is currently marketing Fidaxomicin under the brand name Dificid. There are several patents listed in OB for Dificid which claims polymorphic forms and compositions and etc., NCE is going to expire on May 27, 2016.

iv) Oseltamivir Phosphate:
Oseltamivir Phosphate is an influenza neuraminidase inhibitor indicated for:
a) Treatment of acute, uncomplicated influenza in patients 2 weeks of age and older who have been symptomatic for no more than 2 days. (1.1)
b) Prophylaxis of influenza in patients 1 year and older. (1.2)

Roche received FDA approval to market Oseltamivir Phosphate as capsules containing 30 mg, 45 mg, or 75 mg Oseltamivir for oral use, in the form of Oseltamivir phosphate, and as a powder for oral suspension, which when constituted with water as directed contains 6 mg/mL Oseltamivir base. Tamiflu is the brand name of Oseltamivir Phosphate.

The related patents listed in OB for Tamiflu are going to expire in 2015-2017. Its interesting to see for which patent the paragraph iv has been filed.

v) Phenylephrine and Ketorolac:
Omidria (phenylephrine and ketorolac injection) contains is an alpha 1-adrenergic receptor agonist and nonselective cyclooxygenase inhibitor which are indicated for:
Maintaining pupil size by preventing intraoperative miosis, Reducing postoperative pain

Omidria received FDA approval on May 30, 2014 which is marketed by Omeros.

No Specific Personal Jurisdiction over Zydus in the Case of Novartis v. Zydus Novel Tech Inc

On Aug 07, 2015 The District Court Of Delaware granted Zydus novel tech inc (defendants) motion to dismiss the Novartis (plaintiff) complaint for lack of personal jurisdiction.

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Background:
Novartis (Plaintiff) filed a Hatch-Waxman patent infringement action against defendants Zydus Noveltech, Inc., Zydus Pharmaecuticals (USA) Inc., and Cadila Healthcare Ltd for infringing two patents for the “Exelon” transdermal system, which is used to treat dementia. Immediately after filing this case, Plaintiffs filed a parallel action in the District of New Jersey.

Exelon and its patent Litigation’s:
Exelon (Rivastigmine Tartrate) is an acetylcholinesterase inhibitor indicated for treatment of:
a)
Mild to moderate dementia of the Alzheimer’s type (1.1)
b)
Mild to moderate dementia associated with Parkinson’s disease (1.2).

Rivastigmine is chemically known as (S)-N-Ethyl-N-methyl-3-[1-(dimethyl amino)ethyl]-phenyl carbamate hydrogen-(2R,3R).

Rivastigmine was developed by Marta Weinstock-Rosin of the Department of Pharmacology at the Hebrew University of Jerusalem and sold to Novartis by Yissum for commercial development. It is a semi-synthetic derivative of physostigmine.

Novartis received FDA approval for Rivastigmine Tartrate (EQ 1.5MG, EQ 3MG, EQ 4.5MG and EQ 6MG base) on Apr 21, 2000. Further, it also received approval for its film, extended release;transdermal patch (4.6MG/24HR, 9.5MG/24HR and 13.3MG/24HR).

Several generic companies received FDA approval to sell generic version of Rivastigmine Tartrate Capsule;Oral EQ 1.5MG, EQ 3MG, EQ 4.5MG and EQ 6MG base.

From 2011 Novartis filed several ANDA suits against the generic companies in the court of Delaware:
i) 11-1077-RGA and 11-1112-RGA (Novartis v. Par pharma and Novartis v. Watson);

Present Scenario:
Zydus Noveltech sent its ANDA notice letter on July 16, 2014 to Novartis in Switzerland, Germany, and New Jersey. In return Novartis sued Zydus Noveltech in the court of Delaware for infringing two patents for the “Exelon” transdermal system, which is used to treat dementia.

The patents in suits are U.S. Patent No. 6,335,031 and US 6,316,023 which are set to expire on Jan 8, 2019.

Zydus Noveltech have moved to dismiss the complaint for lack of personal jurisdiction, as the Zydus Noveltech is a New Jersey corporation with a principal place of business in Vermont. Previously defendants Zydus Pharmaceuticals and Cadila also moved to dismiss the complaint for failure to state a claim under Federal Rule of Civil Procedure 12(b)(2), and Cadila moved to dismiss for insufficient service of process under Rule 12(b)(5). The Court granted a stipulation to dismiss the complaint against defendants Zydus Pharmaceuticals and Cadila.

Zydus Pharmaceuticals and Zydus Noveltech are sister companies, and Cadila is their ultimate parent company. The majority shareholder of Zydus Noveltech is Zydus International Private Ltd., a subsidiary of Cadila.

Novartis argued that there is specific jurisdiction over Zydus Noveltech for two reasons:
i) Zydus Noveltech directed its notice of ANDA filing to Novartis Pharmaceuticals, a Delaware corporation; and
ii) Zydus Noveltech will eventually, if authorized by the FDA, sell its generic product in Delaware.

Judge Andrews referred AstraZeneca AB v. Mylan Pharmaceuticals, Acorda Therapeutics, Inc. v. Mylan Pharmaceuticals which are similar type of cases.

After hearing the arguments the judge stated that the submission of the ANDA letter triggered an injury against Plaintiff. It does not follow that that injury should be where the Plaintiff is incorporated, Delaware, rather than where the letter was directed, New Jersey. Defendant directed activity to New Jersey, not Delaware.

Further, the court also stated that the act of filing the ANDA and the paragraph IV notification constitute an injury, neither was directed at Delaware because defendant sent its letter to plaintiffs abroad and in New Jersey. Therefore, this court cannot exercise specific personal jurisdiction over Defendant.

Continuation In Part (or) Divisional: Role of Section 121 Safe Harbor in G.D. Searle LLC v. Lupin Pharmaceuticals, Inc.,

The safe harbor provision of section 121 didn’t help Pfizer to save its reissued U.S. Patent No. RE44,048.

Recently the U.S. Court of Appeals for the Federal Circuit upheld a district court ruling that a reissue patent was invalid for obviousness-type double patenting. Case No. 14-1476.

Background:

Pfizer filed a patent infringement action against Teva Pharmaceuticals in the District Court for the District of New Jersey, wherein the district court held that Teva infringed three patents owned by Pfizer specifically,
i) claims 1-3, 7-9, 11, and 13 of U.S. Patent No. 5,466,823 (“the `823 patent”);
ii) claims 1-5 and 15-18 of U.S. Patent No. 5,563,165 (“the 165 patent”); and
iii) claims 1-4 and 11-17 of U.S. Patent No. 5,760,068 (“the `068 patent”).

The claims of the above patents related to Celecoxib (Celebrex®).

The district court also held that the asserted claims of the three patents were not invalid for a best mode violation and that the asserted claims of the `068 patent were not invalid for obviousness-type double patenting.

Further, Teva appeals the decision to the Federal Circuit which concluded that
i) the asserted claims of the US `068 patent are invalid for double patenting and reverse the district court on that aspect of its judgment;
ii) that claim 9 of the US `823 patent and claim 17 of the US `165 patent are not invalid for a best mode violation;
Finally, it affirm the district court’s judgment of infringement with respect to claim 9 of the `823 patent and claim 17 of the `165 patent.

In the above case Pfizer invoked the so called “safe harbor” provision of section 121 which in certain circumstances protects a patent that issues on a divisional application from invalidation based on a related patent that issued on an application as to which a restriction requirement was made, or on an application filed as a result of such a requirement.

In 2008 Pfizer filed U.S. Patent Application No. 12/205,319 (“the ’319 application”), seeking reissue of the ’068 patent, which sought to correct that alleged error by reissue. Pfizer has made the following changes to the US ‘068 patent (imp are given).
a) it deleted portions of the ’068 patent specification that were not present in the US 5,466,823 patent;
b) it designated the US ‘068 patent as a divisional of the US ‘823 patent and removed the priority claim to the US 5,521,207 patent.

Finally the examiner has allowed some technical errors; and also allowed to make additional changes, including designating the US ’068 patent issued as a divisional of the US ‘823 and removing subject matter not present in the US ‘823 patent. Finally in 2013 USPTO issued reissued patent RE44,048 for US ‘068.

On the day the RE ’048 patent issued, Pfizer filed the instant case against five generic drug manufacturers, alleging infringement of the RE ’048 patent. However, the court found that the RE ’048 patent was not a valid reissue patent, because Pfizer’s asserted error of prosecuting a prior patent application as a continuation-in-part, rather than as a divisional, was not correctable by reissue under section 251. The court further found that the safe harbor provision of 35 U.S.C. § 121 did not apply to the RE ’048 patent, and that the relevant claims of the RE ’048 patent were invalid for obviousness-type double patenting in light of the ’165 patent. A final judgment of invalidity was entered against Pfizer. This appeal followed.

In the Federal Circuit, the parties submitted their arguments. Finally the Federal Circuit concluded that the section 121 safe harbor provision does not apply to the RE ’048 patent, and AFFIRMED the district courts decision.

The following diagram can help to understand the above case.

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Allergan v. Sandoz@Bimatoprost: CAFC

On August 04, 2015 before Circuit Judges LOURIE, LINN, and HUGHES, United States Court of Appeals for the Federal Circuit Affirm the decision of District Court of Eastern District of Texas, which held that the asserted claims of Allergan’s US ’504, ’605, and ’479 are not invalid for obviousness or for lack of an adequate written description and enablement. The decision can be find here.

Background:

Sandoz, Lupin, Hi-Tech, and Watson each submitted an Abbreviated New Drug Application (“ANDA”) to the FDA, seeking approval to engage in the commercial manufacture, use, importation, sale, or offer for sale of generic versions of Lumigan (Bimatoprost) 0.01% prior to the expiration of the US 7,851,504, 8,278,353, 8,299,118, 8,309,605, and 8,338,479 patents. In response, Allergan sued each of the ANDA applicants in the United States District Court for the Eastern District of Texas, asserting that their ANDA filings infringed those patents. The district court consolidated those actions into one case.

About Lumigan:
In 2001, the FDA approved Lumigan® 0.03%, a once daily topical solution developed by Allergan, for treating open angle glaucoma and ocular hypertension. Lumigan 0.03% contains 0.03% by weight of Bimatoprost and 50 parts per million (“ppm”) benzalkonium chloride (“BAK”), among other ingredients.

Although Lumigan 0.03% was effective at lowering IOP, it also caused frequent and severe hyperemia. Many patients thus stopped using it without consulting their physicians, which led to gradual vision loss. To address that problem, Allergan explored a number of alternative formulations of Bimatoprost and surprisingly discovered that increasing the concentration of BAK from 50 ppm to 200 ppm significantly increased the corneal permeability of Bimatoprost. After further research, Allergan developed Lumigan® 0.01% (“Lumigan 0.01%”).

Lumigan® 0.01% contains 0.1 mg/mL of Bimatoprost and benzalkonium chloride 0.2 mg/mL with other excipients. Lumigan is a prostaglandin analog indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension. Lumigan 0.01% is approved (NDA: N022184) to Allergan on Aug 31, 2010. Allergan expects net sales of Lumigan between $590 million and $620 million.

There are several patents listed in Orange Book for Bimatoprost. The patents in lawsuit are US 7,851,504 (Jun 13, 2027), US 8,278,353, US 8,299,118, US 8,309,605 and US 8,338,479 which all are OB listed for Bimatoprost. The above said patents claims various compositions of Bimatoprost.

Allergan (plaintiff) v. Sandoz, Lupin, Hi-Tech Pharmacal CO (Defendants) @Texas:
After Allergan sued Sandoz and others in the district court, the  district court held a five-day bench trial in July 2013 on the issues of obviousness and infringement. The defendants argued that the claims were invalid for lack of written description and enablement in pre- and post-trial briefings.

The defendants argued that Woodward disclosed a formulation comprising 0.001%–1% Bimatoprost and 0–1000 ppm BAK for treating glaucoma, and that the amounts of Bimatoprost and BAK in the claimed formulation fall within those prior art ranges, thus rendering the claims obvious.

The cited prior art is:

1) Woodward’s US 5,688,819; and
2) Lyons’s US 6,933,289.

After going through the factual findings, the district court concluded that the asserted claims would not have been obvious. In reaching that conclusion, the court emphasized that the prior art taught away from the claimed invention because it taught:

1) that Bimatoprost lost efficacy as its concentration decreased;
2) that BAK had no impact on Bimatoprost’s permeability; and
3) that BAK was cytotoxic and could cause corneal disorders.

The district court also rejected the defendants’ invalidity challenges based on the written description and enablement requirements and it states that each of the ANDA products infringed each of the asserted claims.

Further, the defendants timely appealed (2014-1275) the decision to Federal Circuit and Hi-Tech also challenges the district court’s finding that it infringed the claims of the ’504, ’605, and ’479 patents literally and under the doctrine of equivalents.

Hi-Tech argued that it’s ANDA specifies that the proposed product has a pH of 6.8–7.2 during the product’s shelf life. And it also argues that the district court erred in construing a “pH of about 7.3 and also erred in finding that Hi-Tech literally infringed the Group I claims and that prosecution history estoppel did not bar Allergan from relying on the doctrine of equivalents to prove infringement.

Finally, the judges of CAFC reviewed the district court’s decision and its findings, after considering the arguments the Federal Circuit made the following points:

i) Rejected the Appellants’ argument that the unexpected results do not support nonobviousness because they are merely the inherent properties of an otherwise obvious formulation;
ii) The specifications of the asserted patents provide an adequate written description of the invention;
iii) The asserted claims are not invalid for lack of enablement;
iv) The district court did not clearly err in finding that Hi-Tech literally infringed the Group I claims and that Hi-Tech infringed the claims of the US ’504, ’605, and ’479 patents.

FDA: Paragraph IV Patent Certifications

On July 21, 2015 FDA announced that it received Abbreviated New Drug Application’s (ANDA) with a “Paragraph IV” patent certification for the following drugs.

Drug Name Dosage Form Strength RLD Date of Submission
Emtricitabine, Rilpivirine, and Tenofovir Disoproxil Fumarate Tablets 200 mg/25 mg/300 mg Complera 5/20/2015
Memantine HCl Extended-release and Donepezil HCl Capsules 14 mg/10 mg and 28 mg/10 mg Namzaric 5/18/2015

About Complera:

Complera is a combination of two nucleoside analog HIV-1 reverse transcriptase inhibitors (Emtricitabine and Tenofovir Disoproxil Fumarate) and one non-nucleoside reverse transcriptase inhibitor (Rilpivirine), which was approved to Gilead Sciences INC on Aug 10, 2011. The product was approved to treat HIV-1 infection in adult patients with no antiretroviral treatment history and with HIV-1 RNA less than or equal to 100,000 copies/mL at the start of therapy. The combination is protected by related patents which are listed in the OB, NCE is going to expire on May 20, 2016 and NPP is going to expire on Dec 13, 2016.

About Namzaric:

Namzaric is a combination of Memantine HCl extended-release, a NMDA receptor antagonist, and Donepezil HCl, an acetylcholinesterase inhibitor, indicated for the treatment of moderate to severe dementia of the Alzheimer’s type in patients. The combo was approved to Forest Labs LLC on Dec 23, 2014.

US Delaware Court Rejects Glenmark’s Patent Plea for Bayer’s Finacea

On July 27, 2015 the District Court Of Delaware stated that Glenmark’s ANDA for generic azelaic acid hydrogel infringes Bayer’s US ‘070 patent and the claims of the US ‘070 are valid. The order can be find here.

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The above action was arises by the filing of ANDA by Glenmark seeking to market a generic azelaic acid hydrogel, wherein Bayer is the holder of approved New Drug Application 21470 for Finacea® Gel, 15%, indicated for topical treatment of inflammatory papules and pustules of mild to moderate rosacea.

Azelaic acid:

Azelaic acid is a saturated dicarboxylic acid which is being used as topical treatments for various skin disorders, including acne vulgaris, melisma, and rosacea. FDA approved Allergan’s NDA N020428 for 20% Cream; Topical form of Azelaic acid and it is marketed under the brand name AZELEX. Further, FDA also approved Bayer’s N021470 for Finacea® Gel, 15%.

US 6,534,070 is an OB listed patent for Finacea (azelaic acid). which claims composition of azelaic acid and it is set to expire on Nov 18, 2018.

The claim of US ‘070 is

A composition that comprises:
(i) azelaic acid as a therapeutically active ingredient in a concentration of 5 to 20% by weight;
(iii) at least one triacylglyceride in a concentration of 0.5 to 5% by weight;
(iv) propylene glycol; and
(v) at least one polysorbate, in an aqueous phase that further comprises water and salts, and the composition further comprises
(ii) at least one polyacrylic acid; and
(vi) lecithin;
wherein the composition is in the form of a hydrogel.

About Glenmark and its ANDA:
Glenmark Pharmaceuticals is a pharmaceutical company headquartered in Mumbai, India. It manufactures and markets generic formulation products and active pharmaceutical ingredients (API), both in the domestic and international markets. In the formulation business, its business spans segments such as Dermatology, Internal Medicine, Paediatrics, Gynaecology, ENT and Diabetes.

On July 27, 2012, pursuant to 21 U.S.C. § 355(j), Glenmark submitted ANDA No. 204637, seeking approval to commercially manufacture, use, sell, offer for sale and/or import a generic Azelaic Acid Gel, 15% formulation with a paragraph IV certification stating that the ‘070 patent is not infringed and is invalid.

The ANDA product of Glenmark is a composition for topical administration to treat rosacea that contains azelaic acid as the therapeutically active ingredient and the original ANDA seems to be interchanged triglyceride and lecithin with alternate excipients to match with the reference listed drug Finacea® Gel.

                                             Glenmark tried to develop a composition of azelaic acid which doesn’t fall with in the scope of US 070′ claims. And it further showed that the batch 540/03-08/036 (“batch 036”) and batch 540/03-08/041 (“batch 041”) were satisfactory formulations. In batch 036, PPG-20-Methyl glucose ether distearate was substituted for triglyceride and lecithin. In batch 041 – which would later become the accused formulation – isopropyl myristate was substituted for triglyceride and lecithin “to improve the penetration.

Further, Glenmark also argued that the claims of US ‘070 patent are not valid under U.S.C 103 (Obviousness), as the claims of US ‘070 are nothing but a mere optimization of the prior art formulation.

Plaintiffs (Bayer) argue that the patented composition is non-obvious and Glenmark’s ANDA infringes the claims of US ‘070.

Finally the court concluded that defendants (Glenmark) have not met their burden to prove, by clear and convincing evidence, that claims 1-12 of the ‘070 patent are invalid for obviousness and defendants infringe the asserted claims of the ‘070 patent.