India: United States District Court For The District Of New Jersey Invalidates All Asserted Claims Of US Patent No. 8822438 For Prostate Cancer Drug Zytiga (Abiraterone Acetate)

Last Updated: 30 November 2018
Article by Antony David
Most Read Contributor in India, January 2019

US healthcare giant Johnson & Johnson (J&J) on Oct. 26, 2018 announced that the District Court of New Jersey has issued a ruling that invalidates all the claims of J&J subsidiary Janssen's US Patent No. 8,822,438 for the prostate cancer drug Zytiga® (abiraterone acetate). The patent challenge was brought by generic drug makers who had questioned the validity of the US8822438 patent which is scheduled to expire on August 24, 2027.

The defendants in this case are Amerigen Pharmaceuticals; Amneal Pharmaceuticals; Dr. Reddy's Laboratories; Mylan Pharmaceuticals; Teva Pharmaceuticals USA, Inc. ("Teva'9; West-Ward Pharmaceutical Corporation, and Hikma Pharmaceuticals, LLC ("West-Ward/Hikman"); and Wockhardt. The defendants are generic drug companies who seek to engage in the commercial manufacture, use, offer for sale, or sale of a generic version of the plaintiff's branded drug, ZYTIGA®.

ZYTIGA® (abiraterone acetate) is a prescription medicine that is used along with prednisone. On February 7, 2018, the USFDA approved Zytiga in combination with prednisone for treatment of men with metastatic high-risk castration-sensitive prostate cancer (CSPC). The USFDA initially approved abiraterone acetate with prednisone in 2011 for patients with metastatic castration-resistant prostate cancer (CRPC) who had received prior chemotherapy, and expanded the indication in 2012 for patients with metastatic CRPC. The recommended dose for Zytiga for metastatic CSPC is 1,000 mg orally once daily with prednisone 5 mg orally once daily. Zytiga had sales of $1.4 billion in the first 9 months of 2018 in the US alone.

The plaintiff, i.e. Janssen alleged infringement of claims 4, 8, 11, 19 and 20, all of which rely on claim 1 of the US 8,822,438 patent, based on the defendants' filing of Abbreviated New Drug Applications ("ANDAs"). If defendants' ANDAs are approved, defendants will allegedly induce infringement of the asserted claims of the US 8,822,438 patent under 35 U.S.C. § 27 1(b) and contribute to infringement of the asserted claims under 35 U.S.C. § 27 1(c). Defendants denied infringement and claimed that the patent claims are invalid for obviousness and for lack of a written description.

The US8822438 patent covers method of treatment of a prostate cancer in a human by co-administering Zytiga with steroid prednisone. Independent Claim 1 of the US8822438 patent reads as follows:

"A method for the treatment of a prostate cancer in a human comprising administering to said human a therapeutically effective amount of abiraterone acetate or a pharmaceutically acceptable salt thereof and a therapeutically effective amount of prednisone."

Essentially, the US District Judge McNulty ruled as follows "Like the PTAB, I find that the '438 patent is invalid for obviousness. I find the patent's written description to be adequate, however. In the alternative, and to facilitate appellate review, I have ruled on the infringement issues that were tried. Assuming that the '438 patent is valid, I find based on the proposed generic labels that the ANDA defendants' marketing of abiraterone would infringe, on either an induced infringement or contributory infringement theory".

The US District Judge McNulty found that there was more than sufficient motivation for a person of ordinary skill in the art (POSA) to combine abiraterone with prednisone. The Judge ruled that prednisone's ability to reduce pain and side effects in cancer patients "would furnish a powerful motivation" to combine prednisone with Zytiga's active ingredient and as such: "That road led straight to the practice of the patented method: the target condition would be prostate cancer; the target population would be the subset of patients who had mCRPC; the dosage would be 1000mg of abiraterone and 10mg of prednisone daily; the object would be to slow the spread of the disease by hormone deprivation; the clinical results would be the same, and would be measured by prolongation of life (or, in the interim, by proxy metrics such as reduction of PSA levels)". The judge concluded that "the patented combination here was well foreshadowed in peer-reviewed articles. That factor outweighs the others. Balancing all of the prior art and the other indicia, I find that the evidence favors a conclusion of obviousness. Tokai Corp. u. Easton Enters., 632 F.3d 1358, 1370 (Fed. Cir. 2011) ("However, even assuming the existence of a nexus, we see no error in the district court's determination that Tokai failed to establish 'that any of these secondary factors are significant,' . . . in light of the strong showing of prima facie obviousness.")."

The judge also said that if the US8822438 patent is found to be valid upon appeal, the generic-drug companies would infringe it. The decision has come after a number of generic-drug companies including Teva Pharmaceutical Industries Ltd., Mylan NV, and Amneal Pharmaceuticals Inc submitted Abbreviated New Drug Applications to sell generic versions (250 mg and/or 500 mg tablets) of the drug.

Caroline Pavis, a spokeswoman for J&J's Janssen unit said "We strongly disagree with the court's ruling and will continue to defend the patent." "We plan to appeal the decision."

Previously, on 17 January 2018 the US Patent Trial and Appeal Board (PTAB), in three inter partes proceedings, found the US8822438 patent invalid for being obvious. A motion for reconsideration remains pending.

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