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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