By Jody Coultas, J.D.
Dr. Reddy’s Laboratories, Ltd., Dr. Reddy’s Laboratories, Inc., Teva Pharmaceuticals USA, Inc., and Teva Pharmaceutical Industries, Ltd. failed to prove that three patents held by Helsinn Healthcare S.A. were invalid under the pre-America Invents Act (AIA) on-sale bar rule or that a fourth patent was invalid under the post-AIA on-sale bar, according to the federal district court in Trenton, New Jersey (Helsinn Healthcare S.A. v. Dr. Reddy’s Laboratories, Ltd., March 3, 2016, Cooper, M.). The court also found that the patents were valid and that three of four of Teva’s generic products would infringe those patents.
Helsinn and Roche are assignees of U.S. Patents Nos. 7,947,724 (the ‘724 patent), 7,947,725 (the ‘725 patent), 7,960,424 (the ‘424 patent), and 8,598,219 (the ‘219 patent), which cover Aloxi®, an intravenous solution with approved indications for preventing or treating cancer chemotherapy-induced nausea and vomiting. Dr. Reddy’s and Teva filed Abbreviated New Drug Applications for generic versions of Aloxi.
On November 13, 2015, the court issued a Memorandum Opinion holding that: (1) the asserted claims of the ‘724, ‘725, and ‘424 patents are valid and were infringed by both Teva’s proposed 0.25 mg and 0.075 mg generic products; (2) the asserted claims of the ‘219 patent were valid and are infringed by Teva’s proposed 0.25 mg generic product; and (3) the asserted claims of the ‘219 patent were valid and are not infringed by Teva’s proposed 0.075 mg generic product. The court issued this supplemental order stating its findings of fact and conclusions of law.
Pre- AIA on-sale bar. The ‘724, ‘725, and ‘424 patents were subject to the pre-AIA on-sale bar. Historically, a secret sale or offer for sale of a claimed invention precluded patentability under the on-sale bar. Two license and supply agreements, both effective on April 6, 2001, were signed by Helsinn and MGI Pharma, Inc. The MGI Supply Agreement constituted a sale because it was a contract for a future commercial product. Because the sale was made more than one year prior to the application date of the patents-in-suit, the MGI Agreement satisfied the pre-AIA sale prong. The fact that the clearly-described “products” had not yet received FDA approval at the time of the contracting did not change this conclusion.
Helsinn’s agreements, entered into for the purpose of pursuing FDA approval, which included, analytical development, formulation development, batches preparation for clinical trials, and stability data generation were not sales or offers for sale under the pre-AIA on-sale bar, according to the court. Helsinn argued that agreements with Oread, Inc. and SP Pharmaceuticals, LLC were service contracts, in which Oread and SP provided services like manufacturing, formulation development, and analytical development to Helsinn. Helsinn also argued that the Oread and SP Agreements were for developmental batches of its product, thus falling outside the “commercial sale” scope of the on-sale bar. The issue of what constitutes a commercial sale under the pre-AIA on-sale bar remains in flux at this time. While the on-sale bar is intended to prevent the commercial exploitation of a patent prior to its critical date, the court did not see how supply agreements for developmental batches can reasonably be considered commercial exploitation when, particularly in the pharmaceutical field, the developmental batches are critical to pre-commercialization steps, like clinical trials, formulation development, and manufacturing quality requirements.
Post-AIA on-sale bar. The court, having considered the parties’ arguments on the plain language meaning of Section 102(a)(1), the USPTO’s guidelines, an AIA Committee Report, and the public policy considerations underlying the passage of the AIA, held that Section 102(a)(1) of the Patent Act requires a public sale or offer for sale of the claimed invention. Section 102 of the Patent Act states that: A person shall be entitled to a patent unless the invention was patented or described in a printed publication, in public use, or on sale in this country, more than one year prior to the date of the patent application. The court’s noted that its conclusion that the on-sale bar apply to public sales comported with the plain language meaning of the amended section, the USPTO’s interpretation of the amendment, the AIA Committee Report, and Congress’s overarching goal to modernize and streamline the United States patent system.
The post-AIA on-sale bar did not apply to the MGI Agreement because the sale or offer or sale did not make Helsinn’s claimed invention available to the public one year prior to the critical date, according to the court. Helsinn argued that the on-sale bar did not apply because the product defined in the MGI Agreement was indefinite or uncertain because it had not yet received FDA approval. The sale prong of the on-sale bar is satisfied if an agreement between parties is for a commercial purpose and contains contractual language. The MGI Supply Agreement contained contractual terms relating to Helsinn’s product, the quantity of product that would be sold to MGI, and at which price. Also, the MGI Agreement did not make the claimed invention available to the public.
Readiness for patenting. Having considered the “sale” prong of the on-sale bar under both pre- AIA and post-AIA standards, will now consider whether the patents-in-suit were ready for patenting by the critical date of January 30, 2002. To show that an invention is ready for patenting requires proof of reduction to practice before the critical date or proof that prior to the critical date, the inventor had prepared drawings or other descriptions of the invention that were sufficiently specific to enable a person skilled in the art to practice the invention.
There was not clear and convincing evidence to establish the readiness for patenting prong of the on-sale bar test for patent invalidity, according to the court. The issue was whether a person skilled in the art would likely know that the claimed intravenous pharmaceutical formulation containing palonosetron was effective for reducing the likelihood of emesis or CINV in a human as of the critical date of January 30, 2002. Based on the facts presented, Dr. Reddy’s failed to show that as of January 30, 2002, the inventor had determined that the invention would work for its intended purpose. Helsinn’s Phase II study data showed no statistical significance in the stated primary endpoint of complete control for 24 hours for any dosage below 2 mg. That study also lacked the scope and controls that would make it a valid prediction of efficacy at any dose.
Written description. The court found that the specification of the ‘219 patent provided an adequate written description of the efficacy of the invention claimed. Teva argued that if the court found that fully complete Phase III data would be required as claim support in order for the ‘219 patent to be “ready for patenting” under the on-sale bar, then that patent is invalid for lack of written description because there was no Phase III data, or any preclinical or clinical efficacy data, in the specification. The specification disclosed the claimed formulations, and as of the provisional application date of January 30, 2003, a skilled artisan would immediately understand the claimed formulation in the disclosure. A skilled artisan would have knowledge that the inventors were in possession of the invention at the time of the patent application, and that there is no clear and convincing evidence to the contrary.
Infringement. Teva’s 0.075 mg/1.5 ml product did not infringe the asserted claims of the ‘219 patent, according to the court. Under the Hatch-Waxman framework, the filing of an ANDA constitutes an artificial act of infringement. Courts must then compare the asserted patent claims against the product that is likely to be sold following ANDA approval to determine whether there was actual infringement. The burden to prove infringement falls squarely on the patent holder. Teva filed one consolidated ANDA, seeking approval for products at two different dose levels (0.25 mg and 0.075 mg), and two different treatment indications (chemotherapy-induced nausea and vomiting (“CINV”) for the 0.25 mg dose, and post-operative nausea and vomiting (“PONV”) for the 0.075 mg dose). Teva conceded that its 0.25 mg/5 ml CINV dosage strength product met the limitations of the asserted claims of the ‘219 patent. However, the burden remained with Helsinn to prove that Teva’s PONV dosage strength product infringed the ‘219 patent by a preponderance of the evidence. Helsinn failed to do so.
Because the court found that the ‘724, ‘725, and ‘424 patents were valid, the court agreed with the parties’ stipulation that both the 0.075 mg dose and the 0.25 mg dose generic product specified in Teva’s ANDA will infringe those three patents.
The case is No. 11-3962 (MLC).
Attorneys: Charles Michael Lizza (Saul Ewing, LLP) for Helsinn Healthcare SA and Roche Palo Alto LLC. Mayra Velez Tarantino (Patunas Tarantino LLC) for Teva Pharmaceutical USA, Inc.
Companies: Helsinn Healthcare SA; Roche Palo Alto LLC; Teva Pharmaceuticals USA, Inc.; Dr. Reddy’s Laboratories, Ltd.; Dr. Reddy’s Laboratories, Inc.; MGI Pharma, Inc.
MainStory: TopStory Patent NewJerseyNews
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