Boehringer Ingelheim v. Barr Laboratories and Mylan Laboratories (Delaware 05-700-JJF)

4,843,086, parent of divisional 4,886,812, expired shortly after Boehringer asserted it.

The original claims of '812 had met a double patenting rejection, but amended claims were allowed without a terminal disclaimer. Boehringer belated filed a terminal disclaimer during trial, after parent '086 expired, awarding itself 1,564 days past expiration of its parent, owing to 35 U.S.C. §156.

Section 156 allows the term of a patent covering a new drug to be extended for a period of up to five years to compensate the patent holder for time consumed by the regulatory drug approval process which would otherwise deprive the patent holder of the full benefit of the patent's term. As a result of this patent term extension, the original expiration date of the '812 patent, December 12, 2006, was extended to March 25, 2011. By its Terminal Disclaimer, Boehringer disclaimed five and a half months of its term extension. This five and a half months is the period of time between the expiration date of the '086 patent on June 27, 2006, and the original expiration date of the '812 patent, December 12, 2006.

Not good enough, defendants cried.

In response, Defendants contend that the Terminal Disclaimer cannot cure the double patenting issue presented in this case because the '086 patent has already expired. According to Defendants, the disclaimer cannot "remedy the double patenting problem because the '812 patent became incurably invalid when the '086 patent expired and Boehringer continued to prevent the public from freely practicing that invention with a longer patent term." D.I. 211 at 16.

Judge Farnan contemplated lack of clear ruling precedent.

Terminal disclaimers allow a patentee or applicant to "disclaim or dedicate to the public the entire term, or any terminal part of the term, of the patent granted or to be granted." 35 U.S.C. § 253. Terminal disclaimers can be used to cure nonstatutory double patenting problems that arise both before the PTO and/or after issuance of the patent. 3A Donald S. Chism, Chism on Patents § 9.04 [4] [a] - [b] (2005) i see e.g., Ventana Med. Sys., Inc. v. Biogenex Labs, Inc., 473 F.3d 1173, 1184 n.4 (Fed. Cir. 2006) i Perricone v. Medicis Pharm. Corp., 432 F.3d 1368, 1375 (Fed. Cir. 2005). Specifically, a terminal disclaimer operates to "tie[] the affected patents together" such that they expire on the same date and are enforceable only during the time period in which they share the same owner. Chism, supra § 9.04[5] at 9-115. The filing of a terminal disclaimer is not a concession that the later filed patent is invalid for obviousness-type or nonstatutory double patenting. See e.g., Motionless Keyboard Co. v. Microsoft Corp., 486 F.3d 1376, 1385 (Fed. Cir. 2007); Ortho Pharm. Corp. v. Smith, 959 F.2d 936 (Fed. Cir. 1992); Quad Environmental Techs. Corp. v. Union Sanitary Dist., 20 U.S.P.Q.2d 1392, 1394-1395 (Fed. Cir. 1991).

Section 253 does not state a time period for the filing of a terminal disclaimer, and the case law has not provided a clear answer to this question. Chism, supra § 9.04[4] [b] at 9-113. In fact, no Federal Circuit decision has squarely determined whether a terminal disclaimer entered after the issuance of the second patent will cure double patenting. Id.

In this case, a dual problem is presented in that the terminal disclaimer was not only filed at or near the conclusion of trial in this action, but it was also filed after the expiration of the earlier '086 patent. 6 Though not clear holdings, the Federal Circuit has at least suggested in dicta, that for a terminal disclaimer to be effective the earlier filed patent must not have expired at the time of the filing of the disclaimer. In re Lonardo, 119 F.3d 960, 965 (Fed. Cir. 1997) ("With obviousness-type double patenting, however, a terminal disclaimer may overcome that basis for unpatentability, assuming that the first patent has not expired.") (emphasis added); Eli Lilly and Co. v. Barr Laboratories, Inc., 251 F.3d 955, 967 n.5 (Fed. Cir. 2001) (recognizing that a terminal disclaimer could not cure nonstatutory double patenting where earlier patent had already been disclaimed, and therefore, had no remaining patent term) .

Boehringer argued Merck v. Hi-Tech Pharmacal, but Judge Farnan didn't buy it.

The Court does not read Merck to be dispositive of the issue here. In Merck, the earlier patent was not expired at the time the terminal disclaimer was filed, and the later patent was first disclaimed and then extended. In this case, the earlier '086 patent expired well before the disclaimer on the '812 patent was filed, and the '812 patent was extended before the disclaimer was filed.

Accordingly, the Court concludes that the terminal disclaimer filed by Boehringer is ineffective to moot the double patenting issue raised in this case.

Then came the issue of whether the parent counted as prior art to the child, application of 35 U.S.C. § 121, for divisionals, which is "strictly applied."

Defendants contend that Section 121 does not apply in this case for three reasons. First, the '671 application which resulted in the '812 patent was not filed "as a result of" a restriction requirement. Second, the '671 application was filed after the issuance of the '374 patent which was the original patent that was subject to the restriction requirement during its prosecution. Third, the claims of the '812 patent are not consonant with the restriction requirement.

[T]he Federal Circuit explained that a patentee "is entitled to invoke the statutory prohibition against the use of the [earlier] patent 'as a reference' against the divisional application that resulted in the [later] patent only if the divisional application was filed as a result of a restriction requirement and is consonant with that restriction requirement." Bristol-Myers Squibb Co. v. Pharmachemie B.V., 361 F.3d 1343, 1347-1348 (Fed. Cir. 2004) (emphasis added); see also Gerber Garment Tech., Inc. v. Lectra Sys., Inc., 916 F.2d 683, 687 (Fed. Cir. 1990) ("The prohibition against use of a parent application 'as a reference' against a divisional application applies only to the divisional applications that are 'filed as a result of' a restriction requirement.").

In this case, the record suggests that the claims in the '086 patent which were divided out and placed into the '671 application/'812 patent were not divided so as to adhere to a restriction requirement, but to address concerns related to the Lilly patent and hasten the approval of the '086 patent in light of those concerns. Accordingly, the Court concludes that Boehringer has not satisfied its burden of demonstrating that Section 121 applies to preclude the use of the '086 patent as an invalidating reference.

Background on double patenting -

The basic premise of double patenting is that the same invention cannot be patented twice. The proscription against double patenting takes two forms: statutory double patenting and nonstatutory double patenting. Statutory double patenting is rooted in the language of 35 U.S.C. § 101, which provides that "an inventor is entitled to a single patent for an invention." Although Section 101 precludes an inventor from obtaining more than one patent on the same invention, it only prohibits a second patent on subject matter which is identical to that claimed in the earlier patent. Robert L. Harmon, Patents and the Federal Circuit at 1148 (8th ed. 2007). Nonstatutory double patenting, also known as obviousness-type double patenting, is a judicially created doctrine designed "to prevent claims in separate applications or patents that do not recite the 'same' invention, but nonetheless claim inventions so alike that granting both exclusive rights would effectively extend the life of patent protection." Perricone v. Medicis Pharmaceutical Corp., 432 F.3d 1368, 1371 (Fed. Cir. 2005). In this regard, nonstatutory double patenting prevents inventors from obtaining unearned, extended patent protection by drafting claims that vary only slightly from the earlier patent. These principles are consistent with the purpose of patent protection, to protect and reward true innovation.

"Double patenting is altogether a matter of what is claimed." General Foods Corp. v. Studiengesellschaft Kohle mbH, 972 F.2d 1272, 1277 (1992). Claims must be read as a whole in analyzing questions of nonstatutory double patenting. Id.

Importantly, the earlier filed patent is not to be treated as a prior art reference. In other words, the earlier patent's disclosure cannot be used to show nonstatutory or obviousness type double patenting. In re Metoprolol Succinate Patent Litig., 494 F.3d l0ll, 1018 (Fed. Cir. 2007). Herein lies the primary distinction between obviousness and obviousness-type double patenting. Obviousness relates to what is disclosed, regardless of whether or not it is actually claimed, whereas obviousnesstype double patenting focuses solely on that which is claimed. Id.; Geneva, 349 F.3d at 1378 n.1.

The differences in the claims between the two patents must be "patentably distinct." Boehringer's claims in the '812 divisional were of slightly different compounds using the methods claimed in '086.

In Geneva, the Federal Circuit concluded that two sets of claims were not patentably distinct where the earlier claims were directed to a compound and the earlier patent disclosed a utility for the compound, and the later claims claimed that utility as a method of using the compound.

In sum, the Court concludes that the '812 patent which claims tetrahydrobenzthiazoles is obvious in light of the '086 patent, which claims methods of using tetrahydrobenzthiazoles for the treatment of certain illnesses. Accordingly, the Court concludes that Defendants have established by clear and convincing evidence that the '812 patent is invalid on the grounds of nonstatutory double patenting.