2009-1032 Boehringer Ingelheim v. Barr Labs
D/NJ 05-Cv-700 and 05-Cv-854
Judge Joseph J. Farnan, Jr.
An interesting appeal concerning the interplay of terminal disclaimers, restrictions, and patent extensions. The case involves efforts to market a generic version of pramipexole dihydrochloride, FDA approved for the treatment of idiopathic Parkinson's disease and Restless Leg Syndrome (RLS). Defendants alleged that the asserted '812 patent was invalid for non-statutory double-patenting based on Boehringer's related '086 patent, which expired in 2006.
During trial and just before closing arguments, Boehringer filed a terminal disclaimer for the '812 patent, disclaiming the statutory term after expiration of the '086 patent. It then argued that this not only avoided the double-patenting defense but also that the '812 was still in force due to an extension to that patent's term under § 156. The Court disagreed, finding the terminal disclaimer ineffective and that the asserted claims of the '812 were invalid. Aaron Barkoff at the Orange Book Blog previously wrote about the district court's decision here.
Oral argument is scheduled for Monday, June 1, 2009 at 1:00 P.M., Courtroom 402.
Summary of Argument from plaintiff Boehringer. Bruce M. Wexler, Joseph M. O'malley Jr., Eric W. Dittmann, Angela C. Ni and Stephen B. Kinnaird of Paul, Hastings, Janofsky, & Walker LLP, on brief.
The district court erred in refusing to recognize Boehringer's terminal disclaimer as obviating the double-patenting issue.
First, the court erred in refusing to give effect to the terminal disclaimer because of the timing of its filing. No timing limitation appears in the plain language of 35 U.S.C. § 253. The statute allows terminal disclaimers to be filed as to a “patent,” necessarily recognizing that terminal disclaimers may be filed post-issuance. Further, Congress twice rejected a timing limitation - once when it enacted § 253 and deliberately removed a no “unreasonable delay” requirement that had appeared in predecessor statutes, and again 20 years later when it rejected a proposed revision of § 253 that would have reimported a similar requirement. Consistent with the plain language of § 253 and its legislative history, this Court and others have recognized the ability of a patentee to file a terminal disclaimer during litigation, including after a finding of patent invalidity for double patenting. And here, Boehringer filed a terminal disclaimer before any ruling on the issue of patent validity.
The district court erred in refusing to recognize Boehringer's terminal disclaimer on the ground that it was filed at a time “after the expiration of the earlier '086 patent.” Again, the statute imposes no timing limitation. And the district court failed to recognize that resetting the original ‘812 patent expiration to coincide with the expiration date of ‘086 patent should not prevent the uncontested patent term extension (granted for reasons relating only to FDA delay) from also applying. Consistent with this Court's reasoning in Merck & Co., Inc. v. Hi-Tech Pharmacal Co., Inc., 482 F.3d 1317 (Fed. Cir. 2007), a term ex-tension of a patent subject to a terminal disclaimer does not conflict with the policies underlying double patenting or terminal disclaimers.
Since Boehringer's terminal disclaimer obviated Mylan's double-patenting assertion, the district court's invalidation of the‘812 patent should be reversed. In that event, the Court need not address whether § 121 shields the ‘812 patent from double patenting. To the extent the Court does so, however, the district court's analysis also contains legal error.
Section 121 protects the ‘812 patent from an obviousness-type double-patenting assertion over the ‘086 patent. The plain language of that provision makes clear that it applies if the application that led to the double-patenting “reference” patent - here, the ‘086 divisional application -was filed “as a result of a restriction requirement. Here, the ‘086 application was unquestionably filed as a result of a restriction requirement, and the claims of its divisional, the ‘812 patent, are consonant with that restriction requirement. The district court erred in concluding that there was “tension” between the plain language of the statute and this Court's precedent. As demonstrated below, there is no such tension, and both sources of law result in the same out-come protecting the ‘812 patent.
Even under the district court's erroneous interpretation of § 121, the outcome should be the same. Boehringer originally included the subject matter of the ‘812 patent claims in the ‘374 parent application, but received a restriction requirement man-dating that distinct subject matter be separated out. The ‘812 patent claims invention groups expressly set forth in the ‘374 restriction requirement. But for the restriction requirement, the ‘812 patent would not exist, and the ‘812 divisional application was therefore filed as a result of a restriction requirement. This does not change because one subjective reason for filing that application was to expedite and simplify prosecution in the face of a potential interference. Because § 121 would be satisfied under both the plain language of the statute and the district court's erroneous interpretation of this Court's precedent, the judgment of invalidity should be reversed.
First, the court erred in refusing to give effect to the terminal disclaimer because of the timing of its filing. No timing limitation appears in the plain language of 35 U.S.C. § 253. The statute allows terminal disclaimers to be filed as to a “patent,” necessarily recognizing that terminal disclaimers may be filed post-issuance. Further, Congress twice rejected a timing limitation - once when it enacted § 253 and deliberately removed a no “unreasonable delay” requirement that had appeared in predecessor statutes, and again 20 years later when it rejected a proposed revision of § 253 that would have reimported a similar requirement. Consistent with the plain language of § 253 and its legislative history, this Court and others have recognized the ability of a patentee to file a terminal disclaimer during litigation, including after a finding of patent invalidity for double patenting. And here, Boehringer filed a terminal disclaimer before any ruling on the issue of patent validity.
The district court erred in refusing to recognize Boehringer's terminal disclaimer on the ground that it was filed at a time “after the expiration of the earlier '086 patent.” Again, the statute imposes no timing limitation. And the district court failed to recognize that resetting the original ‘812 patent expiration to coincide with the expiration date of ‘086 patent should not prevent the uncontested patent term extension (granted for reasons relating only to FDA delay) from also applying. Consistent with this Court's reasoning in Merck & Co., Inc. v. Hi-Tech Pharmacal Co., Inc., 482 F.3d 1317 (Fed. Cir. 2007), a term ex-tension of a patent subject to a terminal disclaimer does not conflict with the policies underlying double patenting or terminal disclaimers.
Since Boehringer's terminal disclaimer obviated Mylan's double-patenting assertion, the district court's invalidation of the‘812 patent should be reversed. In that event, the Court need not address whether § 121 shields the ‘812 patent from double patenting. To the extent the Court does so, however, the district court's analysis also contains legal error.
Section 121 protects the ‘812 patent from an obviousness-type double-patenting assertion over the ‘086 patent. The plain language of that provision makes clear that it applies if the application that led to the double-patenting “reference” patent - here, the ‘086 divisional application -was filed “as a result of a restriction requirement. Here, the ‘086 application was unquestionably filed as a result of a restriction requirement, and the claims of its divisional, the ‘812 patent, are consonant with that restriction requirement. The district court erred in concluding that there was “tension” between the plain language of the statute and this Court's precedent. As demonstrated below, there is no such tension, and both sources of law result in the same out-come protecting the ‘812 patent.
Even under the district court's erroneous interpretation of § 121, the outcome should be the same. Boehringer originally included the subject matter of the ‘812 patent claims in the ‘374 parent application, but received a restriction requirement man-dating that distinct subject matter be separated out. The ‘812 patent claims invention groups expressly set forth in the ‘374 restriction requirement. But for the restriction requirement, the ‘812 patent would not exist, and the ‘812 divisional application was therefore filed as a result of a restriction requirement. This does not change because one subjective reason for filing that application was to expedite and simplify prosecution in the face of a potential interference. Because § 121 would be satisfied under both the plain language of the statute and the district court's erroneous interpretation of this Court's precedent, the judgment of invalidity should be reversed.
Summary of Argument from defendant Mylan. David J. Harth and Shannon M. Bloodworth of Perkins Coie, on brief.
Boehringer no longer disputes that the asserted claims of the '812 patent are invalid for double patenting. Instead, Boehringer argues that it can avoid the effect of that finding by filing a last minute terminal disclaimer to a patent that expired almost two years earlier. Alternatively, Boehringer argues that it should be able to avail itself of the “safe harbor” provisions of § 121. Neither argument has merit.
Terminal disclaimers permit a patent holder to avoid double patenting objections by surrendering all rights obtained under the second patent from the date the first patent expires. Section 253, covering terminal disclaimers, allows the patent holder to maintain a patent on an obvious variation of an earlier patent while ensuring that the public will have full access to both the earlier patented discovery and all such variations at the expiration of the first patent. In order to prevent the unlawful extension of the patent monopoly, this Court requires that a patentee file a terminal disclaimer before the expiration of the first patent. Any other rule would allow the patentee to maintain the benefits of a patent that otherwise would be invalid for double patenting.
A patent extension under § 156 cannot supplant these fundamental principles. Section 156 grants pharmaceutical patent holders a limited extension in order to compensate for the delay in obtaining regulatory approval. But Congress strictly limited the scope of extensions under § 156 to the patented product and its approved uses. Boehringer's § 156 extension was limited to the use of pramipexole for the treatment of Parkinsonism. Boehringer's '812 patent, however, covers considerably more than this. Boehringer cannot retroactively swap six months of the '812 patent rights it already enjoyed for six months of future § 156 rights when those future rights are narrower. Indeed, even without the disclaimer, Boehringer has already benefited from an unlawful extension of its monopoly.
Nothing permits Boehringer to unilaterally change the terms and dates of its § 156 extension. When applying for the extension, Boehringer told the PTO that there had been no terminal disclaimer on the '812 patent and that no other patents were relevant to the extension. The PTO relied on those assertions and included them in the public disclosure on the requested extension. Boehringer cannot now alter those terms without approval or a new application for ex-tension.
Nor can Boehringer avail itself of the safe harbor provision of § 121, which protects a divisional application filed as a result of a restriction requirement from a finding of double patenting based on the original application, so long as the divisional application maintains the terms of the restriction. Here, as Boehringer's own patent attorney admitted, the application for the '812 patent was not filed “as the result of” any restriction requirement. While a restriction requirement was imposed on the '812 patent's “grandparent” application, the '812 patent's claims were divided from the “parent” application for tactical reasons, not as a result of the original restriction imposed on the grandparent, nor for any restriction imposed on the parent. Section 121, by its terms, cannot apply here.
Even if § 121 did apply, the '812 patent violated the restriction requirement imposed on the grandparent application. Under this Court's jurisprudence, this lack of “consonance” precludes the application of § 121. The original restric-tion required Boehringer to separate five different groups of benzthiazole compound claims from each other and to keep any claims on methods of using a particular benzthiazole compound together with claims on the compound itself. Boehringer's '812 patent violates both of these requirements because it contains compounds from several different benzthiazole groups and does not contain the related method of use claims. As a result, even if the restriction requirement on the original application somehow applied to the double patenting claims in this case, the lack of con-sonance between the '812 patent and the original restriction would bar the application of § 121.
Terminal disclaimers permit a patent holder to avoid double patenting objections by surrendering all rights obtained under the second patent from the date the first patent expires. Section 253, covering terminal disclaimers, allows the patent holder to maintain a patent on an obvious variation of an earlier patent while ensuring that the public will have full access to both the earlier patented discovery and all such variations at the expiration of the first patent. In order to prevent the unlawful extension of the patent monopoly, this Court requires that a patentee file a terminal disclaimer before the expiration of the first patent. Any other rule would allow the patentee to maintain the benefits of a patent that otherwise would be invalid for double patenting.
A patent extension under § 156 cannot supplant these fundamental principles. Section 156 grants pharmaceutical patent holders a limited extension in order to compensate for the delay in obtaining regulatory approval. But Congress strictly limited the scope of extensions under § 156 to the patented product and its approved uses. Boehringer's § 156 extension was limited to the use of pramipexole for the treatment of Parkinsonism. Boehringer's '812 patent, however, covers considerably more than this. Boehringer cannot retroactively swap six months of the '812 patent rights it already enjoyed for six months of future § 156 rights when those future rights are narrower. Indeed, even without the disclaimer, Boehringer has already benefited from an unlawful extension of its monopoly.
Nothing permits Boehringer to unilaterally change the terms and dates of its § 156 extension. When applying for the extension, Boehringer told the PTO that there had been no terminal disclaimer on the '812 patent and that no other patents were relevant to the extension. The PTO relied on those assertions and included them in the public disclosure on the requested extension. Boehringer cannot now alter those terms without approval or a new application for ex-tension.
Nor can Boehringer avail itself of the safe harbor provision of § 121, which protects a divisional application filed as a result of a restriction requirement from a finding of double patenting based on the original application, so long as the divisional application maintains the terms of the restriction. Here, as Boehringer's own patent attorney admitted, the application for the '812 patent was not filed “as the result of” any restriction requirement. While a restriction requirement was imposed on the '812 patent's “grandparent” application, the '812 patent's claims were divided from the “parent” application for tactical reasons, not as a result of the original restriction imposed on the grandparent, nor for any restriction imposed on the parent. Section 121, by its terms, cannot apply here.
Even if § 121 did apply, the '812 patent violated the restriction requirement imposed on the grandparent application. Under this Court's jurisprudence, this lack of “consonance” precludes the application of § 121. The original restric-tion required Boehringer to separate five different groups of benzthiazole compound claims from each other and to keep any claims on methods of using a particular benzthiazole compound together with claims on the compound itself. Boehringer's '812 patent violates both of these requirements because it contains compounds from several different benzthiazole groups and does not contain the related method of use claims. As a result, even if the restriction requirement on the original application somehow applied to the double patenting claims in this case, the lack of con-sonance between the '812 patent and the original restriction would bar the application of § 121.
PATracer: Copies of the appeal brief are available from Kyle.
I don't understand how Boehringer can be faulted or accused of double patenting (which i assume involves intent) given that:
a) the two patents were approved within 5.5 months of each other
b) the second patent *references* the first
c) the second patent received the above mentioned extension in 1999
all of which, to me, points to boehringer genuinely thinking they were each patentable, and the us patent office *agreeing* that both items were patentable. after all, why on earth have a patent office if it's purpose does not include ensuring that there is no duplication? why have patents at all, if the authority of the office that approves them carries no weight?
seems to me if there is a question of responsibility for the existence of double patents, it should lie with the the entity charged with approving them - am i missing something?
any light you could shed on this for me would be much appreciated. would also be grateful if you could direct me toward any more recent information on this matter.
Posted by: jane | 24 August 2009 at 17:04
Good points jane. I believe that the patent office having an issue in front of should make the patent stronger becuase courts will defer to its decision abssent strong evidence to the contrary. The outcome of the 156 extension issue will also be interesting if necessary.
Posted by: Pittsburgh Patent Lawyer | 03 September 2009 at 22:34