I normally try to steer clear of issues raised in Hatch-Waxman litigation between the “innovators” and the “generics,” unless it raises specific points of patent law of general interest – there is just so much of it, and other blogs that are dedicated to following its often double-jointed trail. However, the Supreme Court may well grant cert. within the next few weeks in Caraco Pharm. Labs, Ltd. V. Novo Nordisk, Supreme Ct. 10-844, opinion below, Novo Nordisk A/S v. Caraco Pharm. Labs. Ltd, 601 F.3d 1359 (Fed. Cir. 2010), reh’g den. 615 F.3d. 1374 (2010), evidenced both by the fact that the Solicitor General filed an amicus brief requested by the Court that supported cert., and the Fed. Cir. decision below drew a strong dissent.
There is almost no way to do a short course on the laws, regulations, and strategies employed by holders of NDA-approved drugs (the innovators’ or branded’s drugs) to keep generic competitors out of the market, but I will try to summarize the relevant facts. An innovator will list an FDA approved drug in the “Orange Book” along with a list of patents certified to cover the drug or its method of use in treatment. The innovator also provides a use code for each patent (e.g., U-83 is treatment of seizures, but some use descriptions are very narrow, e.g., Use of drug x with drug y and drug z to improve glycemic control in patients with condition w.) These “use codes” are important because they are supposed to be reflected in the labeling.
If a generic company wants to have an ANDA approved (get on the market), it has to file a certification under 355(j)(2)(A)(vii) – that there are no listed patents, that the patents have expired, that the company will wait to launch until the listed patent(s) have expired or that the patents that are listed are invalid and/or not infringed. The last category—the paragraph IV certification — gives rise to most “Hatch-Waxman litigation.” However, if the Orange Book lists patents that do not cover the drug per se and do not cover all the approved uses for the drug, the generic company can file a para. IV certification (no patents will be infringed) and state that they are seeking approval for a use the patent(s) do not claim (a section viii statement). To determine if this is the case, and whether or not they can approve the ANDA and a label information, the FDA does not analyze the listed patents, but looks to the use code in the Orange Book.
If the method patent claims and use code are both relatively limited – that is, there are two approved uses – such as treating seizures in epilepsy and in narcolepsy, but the listed patent only claims epilepsy seizure treatment, and the generic company only wants approval to treat narcolepsy, it can request a label “carve-out,” and only seek approval of a label directing the treatment of epilepsy. Without the carve-out, the innovator could sue the generic for inducing infringement by directing doctors to practice both the patented and unpatented uses.
Presently, the generic company may “respond with a counterclaim seeking an order requiring the [innovator] to correct or delete the patent information [listed] on the ground that the patent does not claim either – (aa) the drug for which the [NDA] was approved; or (bb) an approved method of using the drug.” However, the generic company cannot seek an order that the use code is overly broad. So even a delisting or correction of the patent list will not clear the way for the FDA to approve a “non-infringement inducing” label. During litigation, Novo had broadened its use code to cover uses Caraco alleged were not within the claims of the listed patents. So the question presented is:
“Whether an ANDA applicant [generic company] may assert a counterclaim under Section 355(j)(5)(c)(ii)(I) by alleging that the brand name manufacturer’s patent information [the use code] does not accurately and precisely describe the method of use claimed by its patent.”
The Fed. Cir. decision below answered this question, “No,” based on the pain language of the statute. However, the dissent wrote: “With the majority’s blessing, pioneering drug manufacturers now have every incentive to follow Novo’s lead and draft exceedingly broad use codes thereby insulating themselves from competition and rendering Section viii a dead letter.” Id. At 1377. For more on the advantages to “patenting the label” please jump back to my post of January 13, 2011.