Earlier today, Judge Garrett Brown of the United States Federal District Court for the District of New Jersey, issued an Order and Findings of Fact and Conclusions of Law in the dispute between between Merck and Teva Pharmaceuticals. Judge Brown found that the patent in question, US Patent No. 5,565,473, was valid and enforceable, and that the Teva’s Abbreviated New Drug Application (“ANDA”) filing infringed the patent. The ‘473 patent specifically relates to montelukast sodium, which is the active ingredient in the Singulair® tablets, Merck’s pharmaceutical product used for treating certain ailments, including asthma and allergic rhinitis. Those familiar with patent law will realize that it is technically not appropriate for a district court to find that a patent is valid, and rather should have declared the patent not invalid, but the point remains that as a result of his 100+ page ruling Judge Brown has handed Merck a large victory and Teva Pharmaceuticals a significant setback.
This dispute originally arose as a result of Merck Sharp & Dohme Pharmaceuticals, SRL alleging that defendants Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries, LTD infringed the ‘473 patent, which is entitled “Unsaturated Hydroxyalkylquinoline Acids as Leukotriene Antagonists.” The act of infringement by Teva was the filing of an ANDA. On February 20, 1998, the use of Singulair® tablets in 10 mg form and 5 mg form for the prophylaxis and chronic treatment of asthma in patients 15 years of age and older and pediatric patients from 6 to 14 years of age, respectively, was approved by the United States Food and Drug Administration (“FDA”). In an effort to get to market prior to the expiration of the ‘473 patent, Teva filed ANDA No. 78-605 with the FDA a paragraph III certification pursuant to 21 U.S.C. § 355(j)(2) on November 13, 2006, seeking approval for generic tablets containing 10 mg of montelukast sodium. On December 22, 2006, Teva USA filed ANDA No. 78-723 as a paragraph III certification pursuant to 21 U.S.C. § 355(j)(2) for generic tablet containing 4 mg and 5 mg of montelukast sodium. Id. at 58; TEX 3004.0001, 0020. No later than February 23, 2007, MSD received notice that Teva revised ANDA No. 78-605 to include a Paragraph IV certification under 21 U.S.C. § 355(j)(2)(A)(vii). Similarly, on or about April 2, 2007 MSD received similar notice that Teva had also revised ANDA No. 78-723 to include a Paragraph IV certification under 21 U.S.C. § 355(j)(2)(A)(vii).
So what does all of this mean? In 1984 Hatch-Waxman Amendments to the Drug Price Competition and Patent Term Restoration Act were enacted by Congress. The purpose of Hatch-Waxman (as it is called) was to make it easier for a generic drug manufacturer to piggy-back on the studies previously submitted by the original inventor of a new drug. In the United States, in order for a new drug to receive market approval a New Drug Application, known as an NDA, must be submitted to the Food and Drug Administration (FDA). To lessen the burden on generics, Hatch-Waxman allowed generic manufacturers to submit Abbreviated New Drug Applications, known as ANDAs. In the event that the generic manufacturer can establish that the drug mentioned in the ANDA is the bioequivalent of a drug approved in a NDA, the generic manufacturer can sail through approval by relying on the costly and time consuming studies previously submitted as a part of the NDA.
An ANDA applicant must make one of four certifications regarding each patent that applies to the drug for which approval is being sought: (I) no such patent information has been submitted to the FDA; (II) the patent has expired; (III) the patent is set to expire on a certain date; or (IV) the patent is in valid or will not be infringed by the drug covered in the ANDA. It is the paragraph IV certifications that are the most interesting because although the ANDA applicant has not made or used the compound thereby creating a literal act of infringement, special legislation interprets the filing of a paragraph IV certification to be an act of infringement that allows the patent owner to file a lawsuit in the federal district court to challenge the would-be generic maker and characterize the filing of the ANDA as an infringement of the underlying patent. For more on this topic see IPWatchdog Hatch-Waxman articles.
Teva admitted that the montelukast sodium tablets that are the subject of its ANDA Nos. 78-605 and 78-723 infringe claims 1, 7, and 18-22 of the ‘473 patent if those claims are upheld as valid and enforceable. However, pursuant to a stipulation entered on February 23, 2009, Merck agreed to dismiss with prejudice its claim of infringement of claims 1 and 7 of the ‘473 patent, leaving claims 18-22 still alleged to be infringed.
A non-jury trial was conducted in the United States Federal District Court for the District of New Jersey from February 23 to February 26, 2009. On the basis of the evidence introduced at trial, Judge Brown concluded that Teva failed to prove either that: (1) MSD acquired the ‘473 patent through inequitable conduct or (2) the ‘473 patent was obvious under 35 U.S.C. § 103 in light of these additional prior arts. As such, he concluded that “the ‘473 patent is valid and enforceable and that Teva’s ANDA Nos. 78-605 and 78-723 infringe claims 18-22 of the ‘473 patent.” This is where patent mavens will realize that what the Judge said is not in keeping with the presumed validity of a patent. Patent claims are not technically supposed to be declared valid, because the law states that they are valid unless and until they are ruled to be invalid. A minor point though, which certainly does not change the importance of the decision or the thoroughness with which Judge Brown wrote his findings of fact and conclusions of law. I merely point it out for those patent attorneys and agents who might otherwise question news reports (including this one) regarding the Court’s ruling. I know when I hear something out of synch like this I always grow suspicious. No need for suspicions though, this is what Judge Brown wrote, and it is a big victory for Merck.
Perhaps of particular interest to some, the arguments made by Teva that relate to invalidity as a result of obviousness were rebutted, in part, through secondary considerations. To be fair, Judge Brown ruled that the claims of the ‘473 patent were not obvious because Teva did not prove the prior art should render the claims obvious, but secondary considerations were also analyzed. Secondary considerations are reality checks for whether it is intellectually honest to say that an invention is obvious. While the Supreme Court has never mandated secondary considerations, choosing rather to say they “may” be helpful, the Federal Circuit has long since mandated that they be considered, and a strong showing of secondary considerations can and will negate an otherwise good obviousness rejection. Here, Judge Brown went through a number of secondary considerations and concluded the following:
- There is sufficient evidence that Singulair® is a commercial success and a ‘nexus’ exists between the ‘473 patent and Singulair®’s commercial success.
- Singulair® met a long-felt but unsolved need in the treatment of asthma and allergic rhinitis, at least in part because the record shows that other drugs available prior to montelukast’s inception showed significant shortcomings.
- Montelukast exhibits superior properties that a person of ordinary skill in the relevant art would have found surprising or unexpected.
- Merck also put forth sufficient evidence of the failed attempts of others to develop a leukotriene antagonist to demonstrate that montelukast is not obvious.
- There was sufficient evidence to demonstrate that Teva is attempting to copy Singulair®’s products and capitalize on these products success.
So at least for now, Singulair® will not be falling into the public domain prior to the expiration of the ‘473 patent. I would bet my last dollar on an appeal to the Federal Circuit though. Teva has come this far and they might as well go to the next step.