Boehringer Ingelheim Int'l. v. Barr Laboratories, Inc. (Fed. Cir. 2010)

The Metes and Bounds of Obviousness-type Double Patenting

    By Kevin E. Noonan --

Obvious-type double patenting has become an important issue in patent litigation (Amgen Inc. v. F. Hoffman-La Roche Ltd., Pfizer, Inc. v. Teva Pharmaceuticals USA, Inc., Proctor & Gamble Co. v. Teva Pharmaceuticals USA, Inc.) and in the Patent Office (In re Fallaux).  While in many ways an anachronism with the change in U.S. patent term to 20 years from earliest priority date, the doctrine is still viable as a way to prevent third parties from having to defend related patents against different patent assignees, due to the provision that terminally-disclaimed patents be commonly assigned.

The Federal Circuit had occasion to opine on the doctrine once again in Boehringer Ingelheim Int'l. v. Barr Laboratories, Inc.  The patent at issue, U.S. Patent No. 4,866,812, was found invalid by the District Court under the doctrine of obviousness-type double patenting.  This patent claimed priority as a divisional application to U.S. Patent No. 4,843,086, which in turn claimed priority as a divisional application to U.S. Patent No. 4,731,374.  The subject matter was directed to tetrahydrobenzthiazoles, particularly pramipexole, marketed as Mirapex for the treatment of Parkinson's disease.

During prosecution of the grandparent '374 patent, the examiner imposed a restriction requirement listing 10 overlapping groups of 15 originally-filed claims.  These groups comprised product (Groups I-V), "utility" (VIII-X) or process (VI) claims.  The examiner permitted applicant to pick one group from the product and utility groups or the process group, and the applicant picked Group II and IX for prosecution that resulted in the '374 patent.  The first filed divisional application, that resulted in the '086 patent, encompassed claims from Groups VIII, IX and X, but "none of the claims [in this divisional] covered subject matter claimed [in the '374 patent]."  The second-filed divisional application encompassed claims from Groups I, III, IV and V "and [did] not cross the examiner's lines of demarcation with either the claims of the grandparent '947 application (the '374 patent) or those of the parent '197 application (the '086 patent)."  The applications "were therefore divided as between applications along the lines of demarcation drawn by the examiner in the restriction requirement."  The '812 patent received a patent term extension under 35 U.S.C. § 156 of 1,564 days (4 years and about 15 weeks), which extended the expiration date from December 12, 2006 to March 25, 2011.

Litigation ensued as the result of ANDAs being filed by Barr (the original filer) and Mylan, and during the ensuing bench trial Boehringer filed a terminal disclaimer of the '812 patent over the '086 patent (which had expired by that time).  In doing so, "Boehringer sought to disclaim the approximately six months of the '812 patent's original term that extended beyond the term of the '086 patent, and then to apply its 1,564-day extension to this shortened original term."  The District Court held that this terminal disclaimer was ineffective, since the '086 had expired, and also rejected Boehringer's claim that 35 U.S.C. § 121 "safe harbor" precluded application of the '086 patent against the '812 patent for obviousness-type double patenting.

Consequently, the District Court found the patent invalid for obviousness-type double patenting:  "On the merits, the district court concluded that the compound claims of the '812 patent were obvious in view of the method-of-use claims of the '086 patent."

The Federal Circuit reversed and remanded (and awarded costs to Boehringer) in an opinion by Judge Linn, joined by Judge Prost and joined in part by Judge Dyk, who also filed a dissent-in-part.  The Court opined on two issues raised by Boehringer:  Was the terminal disclaimer effective?  Do the safe-harbor provisions of 35 U.S.C. § 121 apply?

As to the first issue, the Court rejected Boehringer's characterization of the District Court's decision, saying that the basis was not that Boehringer attempted to disclaim term during litigation, but that the terminal disclaimer was filed after the expiration of the '086 patent.  The issue was retroactivity -- the opinion "agree[s] with Boehringer . . . that a patentee may file a disclaimer after issuance of the challenged patent or during litigation, even after a finding that the challenged patent is invalid for obviousness-type double patenting."  The problem with permitting such retroactive terminal disclaimers, according to the Court, is that:

[T]he later patent purports to remain in force even after the date on which the patentee no longer has any right to exclude others from practicing the claimed subject matter.  By permitting the later patent to remain in force beyond the date of the earlier patent's expiration, the patentee wrongly purports to inform the public that it is precluded from making, using, selling, offering for sale, or importing the claimed invention during a period after the expiration of the earlier patent.

This constitutes "an unjustified advantage" for the patentee, the Court opined, that cannot be undone by retroactive disclaimer "because it has already enjoyed rights that it seeks to disclaim" (emphasis in original).  For this reason, and that permitting such retroactive terminal disclaimer "would be inconsistent with '[t]he fundamental reason' for obviousness-type double patenting, namely, 'to prevent unjustified timewise extension of the right to exclude'," Boehringer argued that the patent term extension vitiated any such "unjustified advantage" because the '812 patent enjoyed a patent term extension that covered the term after the '086 patent expired.  The Court disagreed, distinguishing "the rights enjoyed by a patentee during the term of a patent" from "the rights enjoyed by a patentee during the term of an extension under § 156."  The Court says these are "not the same" because "the rights of a patentee during a term extension are limited in ways that do not normally apply to granted patents."  In this regard the Court cited the provisions of 35 U.S.C. § 156(d)(5)(F):

The rights derived from any patent the term of which is extended under this paragraph shall, during the period of interim extension --
    (i) in the case of a patent which claims a product, be limited to any use then under regulatory review;
    (ii) in the case of a patent which claims a method of using a product, be limited to any use claimed by the patent then under regulatory review; and
    (iii) in the case of a patent which claims a method of manufacturing a product, be limited to the method of manufacturing as used to make the product then under regulatory review.

(emphases added).  The point is that the claims extended under § 156 are only those claims identified by Boehringer as reading on "the use of pramipexole for the treatment of the 'signs and symptoms of idiopathic Parkinson's disease.'"  Since there were claims (5 and 6) that were not eligible for extension, the pubic would have been misinformed that Boehringer was entitled to exclude the practice of these claims after the '086 patent expired -- constituting an "unjustified advantage":

[A] competitor that performed a patent search on June 28, 2006 would have wrongly been led to believe that the '812 patent continued to cover the specific compounds claimed in claims 5 and 6, and that it precluded use of pramipexole for treatment of conditions beyond those approved by the FDA.  This is precisely the type of "unjustified timewise extension of the right to exclude" that the doctrine of obviousness-type double patenting is designed to prevent.

Turning to the safe-harbor issue, the Court noted that the safe-harbor is available when the claims of a patent are divided by the Patent Office, and "is not lost if an applicant does not file separate divisional applications for every invention or when independent and distinct inventions are prosecuted together" -- it is not limited to filing "only one divisional application":

[W]here the third sentence of § 121 refers to a patent issuing on an application filed as a result of a restriction requirement, it is referring to patents issuing from any number of multiple divisional applications and precludes any one from being used as a reference against any other.

The opinion states that the basis of the District Court's decision (that the safe harbor did not apply) was that the application that resulted in the '812 patent was not filed "as the result of" a restriction requirement in the '086 (parent) patent, but in the '374 (grandparent) patent.  The Federal Circuit characterizes the questions raised regarding the safe harbor as "(1) whether § 121 can ever apply to a divisional of a divisional of the application in which a restriction requirement was entered; and (2) whether the 'as a result of' requirement of § 121 applies to the '812 patent and is satisfied here," which the Court reviewed de novo.

With regard to the first question, the Court construed the safe-harbor provisions of 35 U.S.C. § 121:

A patent issuing on an application with respect to which a requirement for restriction under this section has been made, or on an application filed as a result of such a requirement, shall not be used as a reference either in the Patent and Trademark Office or in the courts against a divisional application or against the original application or any patent issued on either of them, . . .

as meaning that the safe harbor applies "when the PTO issues a restriction requirement that leads to more than two separate applications."  In addition, the Court noted that § 121 refers broadly to "a divisional application," and does not state that the divisional must be a direct divisional of the original application, and that Congress could have worded the statute to be limited to "a divisional application of the original application" if that was its intention.  The Court noted that in other situations the safe harbor has been applied to applications "sharing a common lineage (Geneva Pharms., Inc. v. GlaxoSmithKline PLC, 349 F.3d 1373, 1378 (Fed. Cir. 2003)) or to continuation applications of divisional applications (Amgen Inc. v. F. Hoffman-La Roche Ltd., 580 F.3d 1340, 1354 (Fed. Cir. 2009))."  Thus, the Court held that there is no basis to conclude that the safe harbor does not apply to "a divisional of a divisional" as here.

With regard to the "as a result of" provision of the statute, the Federal Circuit agreed with the District Court that this provision must be satisfied by both the '086 ('reference") and '812 ("challenged") patents, citing Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 1360 (Fed. Cir. 2008).  In this case, the Court agreed with Boehringer that "so long as consonance is met, it makes no difference in terms of compliance with the 'as a result of' requirement whether the applicant responds to the examiner's restriction requirement by filing one or more divisional applications from the original application, or instead files a single divisional application followed by successive additional divisionals," where "consonance" is defined as the situation where "the line of demarcation between the 'independent and distinct inventions' that prompted the restriction requirement be maintained."  Here, Boehringer filed two divisionals encompassing various combinations of claims comprising the "different inventions" set forth as being distinct in the restriction requirement assessed against the (grandparent) '374 application, but not overlapping any of these different classes between the different patents.  In the way Boehringer prosecuted these patents it "neither violated the examiner's restriction requirement nor risked loss of the safe harbor of § 121."  In making this determination, the Court rejected defendant's argument that the safe harbor only applies where an applicant "strictly follow[s] an examiner's election procedure and [does] not overlap claims to independent and distinct inventions in any single divisional application":

An overlap of claims to independent and distinct inventions within a given divisional application is neither contrary to the restriction requirement nor relevant to the requirements of the third sentence of § 121.  Rather, what consonance requires is that the claims prosecuted in two or more applications having common lineage in a divisional chain honor, as between applications, the lines of demarcation drawn by the examiner to what he or she considered independent and distinct inventions in the restriction requirement.

Because "[n]one of the inventions claimed as between the '374 original patent, the '086 division, and the '812 division of the division, crosses the examiner's lines of demarcation of inventions identified in the restriction requirement, . . . consonance is met and the '086 patent cannot be used as a reference against the '812 patent any more than if both patents had issued from direct divisions from the application in which the restriction requirement was made."

While this decision appears to be a straightforward (and sensible) application of the statute (as well as the policy concerns behind the statute and a common-sense approach to how patent prosecution is performed), Judge Dyk (at left) dissented to this aspect of the Court's opinion.  In Judge Dyk's opinion, the majority opinion "significant expands" the scope of the safe harbor.  His interpretation of the safe harbor is as a narrow exception to the general rule precluding unwarranted extension of patent term for closely-related inventions that are obvious variants.  His objection is not that the majority's determination that the safe harbor applies to "later" divisional applications filed as the result of a restriction requirement.  Rather, his dissent is based on consonance, which he defines as requiring a complete adherence with the contours of the restriction.  His reasoning is that Federal Circuit precedent was based on an applicant being "compelled to comply with a restriction requirement" and who "faithfully follows" the requirement.

In Judge Dyk's view, neither the '086 patent nor the '812 patent are consonant with the restriction requirement, because while the claims prosecuted in these patents did not overlap with the claims in the '374 patent or each other, they were not limited to one of the groups of claims set forth in the original restriction.  Rather, each of the '086 and '812 patents contained non-overlapping combinations of claims from several of these groups.  It is not enough that there is no overlap -- Judge Dyk believes that "preserving the lines of demarcation" requires applicants to file divisional applications for each of the groups set forth in the restriction requirement asserted in the grandparent '374 application.  He supports his position by citing several cases that he contends are inconsistent with the majority opinion.  These include Gerber Garment Tec., Inc. v. Lectra Sys. Inc., 916 F.2d 683, 688 (Fed. Cir. 1990); Symbol Techs., Inc. v. Opticon, Inc., 935 F.2d 1569, 1569 (Fed. Cir. 1991); Texas Instruments Inc. v. U.S. International Trade Commission, 988 F.2d 1165 (Fed. Cir. 1993); and Applied Materials, Inc. v. Advanced Semiconductor Materials America, Inc., 98 F.3d 1563 (Fed. Cir. 1996).

Judge Dyk also believes that a proper interpretation of the statute would preclude the '812 (daughter) patent from the benefit of the safe harbor from the '086 (parent) patent regardless of whether the '812 patent was entitled to the benefit of the safe harbor over the '374 (grandparent) application, because the '812 patent was not filed "as the result of" a restriction requirement imposed against the '086 patent.  This portion of his dissent seems to imply that divisional applications would need to be filed on the same date to maintain the safe harbor, and seems to contradict his apparent agreement with the majority that "a divisional of a divisional" was entitled to safe harbor protection.  His rationale is that "the child was not separated from the parent 'as a result of' the restriction requirement, but rather as the result of the applicant's voluntary choice" and "[s]ince the separation was not 'due to the administrative requirements imposed by the Patent and Trademark Office,' . . . the child application should not be afforded the protections of section 121 with respect to the parent application."  This situation would permit a patentee to file successive applications, none of which could be asserted against each other due to the safe harbor, resulting in "multiple unjustified extensions of the patent term."  He characterizes this as "abuse," saying that "[t]he majority's opinion is devoid of any justification for this untenable result.  It hardly requires argument to demonstrate that Congress could not have intended section 121 to operate in this perverse fashion."

Boehringer Ingelheim Int'l. v. Barr Laboratories, Inc. (Fed. Cir. 2010)
Panel:  Circuit Judges Linn, Dyk, and Prost
Opinion by Circuit Judge Linn; opinion dissenting-in-part by Circuit Judge Dyk

Comments

[EG]

Kevin,

Very nice discussion of this case. Boehringer also argued that the "as a result of" requirement should only apply to the original patent (or its progeny) that were the basis for the double patenting issue, not the challenged patent. Reading the literal language of the 3rd sentence of 35 USC 121, I think Boehringer is correct. But from reading the majority's discussion, there appears to be too much precedential baggage to go that way now.

As you astutely point out, the majority opinion, in allowing restricted groups (or a portion thereof) to be collected in one divisional is a very practical result, and certainly consistent with the 3rd sentence of 35 USC 121. It also doesn't violate the spirit of not crossing the "demarcation line" regarding how the examiner restricted the groups in the first place. If the examiner in the divisional wants to further restrict between the collected groups, he/she can still do so.

By contrast, Judge Dyk's dissent simply exalts form over substance (something that SCOTUS does all too often in patent law, the MedImmune decision on DJs being an awful example of this in its effect on patent licensing negotiations). Most importantly for restriction practice, his dissent makes no practical sense to me because it creates all kinds of potentially costly (and complex) issues. For example, Dyk's view would require a separate divisional to be filed for each of the restricted groups. For Boehringer, that would have meant filing potentially 9 separate divisionals, with all the attendant expense and prosecution complexity. And if you fail to file a divisional on one of the restricted groups, you create a potential "disclosed but didn't claim" problem.

[Kevin E. Noonan]

Dear EG:

Yes, but you can see the policy versus practicality dynamic here. Judge Dyk's interpretation will strike anyone who has ever done patent prosecution as being burdensome, but there are some middle grounds. For example, the applicant could inform the "new" examiner (of each of the divisional applications) about which claims fell within which groups in the original restriction requirement, perhaps inviting a similar restriction. But if none were forthcoming, or if the applicant made an argument about why claims from different groups should be examined together (presumably not that they were not patentably-distinct), then there would be an Office determination that could change (or at least vet) the issue.

Since these patents were all granted before the change in the patent term statute, the court properly discussed the traditional rationale for the safe harbor versus terminal disclaimers. Perhaps this is an issue that will fade, but in any event it is good that Judge Dyk's interpretation did not prevail. It reminded me of some of the provisions of the claims and continuation rules.

Thanks for the comment.

[John]

Regarding rights derived during the term of an extension under 35 USC 156, not clear why the court cited 156(d)(5)(F) (page 14 of opinion), which relates to INTERIM extensions (extensions granted while regulatory review is PENDING), instead of 156(b), which relates to extension based on COMPLETED regulatory review. The rights derived under the latter appear to be more expansive than those under the former. Page 6 of the opinion indicates that the rights derived are provided under 156(b).

[John]

Regarding the rights derived during a patent term extension, shouldn't the court have cited 35 USC 156(b) (extensions) rather than 35 USC 156(d) (interim extensions)? These differ substantially.

[Kevin E. Noonan]

Dear John:

Thanks for pointing that out; there were some citation errors in the post that we are fixing.

But the court did cite 156(d)(5)(F) for the proposition, and you are right, it is curious. The extension was granted under Sec. 156(b), but they needed the language from Sec. 156(d)(5)(F) to make their point. Given their ultimate conclusion it doesn't make a difference to the outcome.

Thank you for catching this.

[Sean]

To re-post a question that I posted at Patently-O, can anyone explain why the CAFC feels compelled to decide more than it needs to decide? They could have resolved the safe harbor issue, and determined that the other issue was moot.

The only way they needed to reach both issues is if they were going to affirm the D/Ct. Instead, they issued a "holding" with respect to the terminal disclaimer issue, even though it was not necessary to the outcome of the case.

[Kevin E. Noonan]

Dear Sean:

Hard to know, but maybe they went through the arguments to arrive at the 2-1 split on the consonance issue, and in doing so agreed that filing a terminal disclaimer was not acceptable after a patent had expired. Remember, they affirmed the district court on the terminal disclaimer issue, but reversed on the consonance issue. So it isn't as if they would come to the same decision on each issue.

But that's just a guess. Thanks for the comment.

[Sean]

Hello Mr. Noonan,
Why do you say that obviousness-type double patenting is an anachronism with the current patent term rules? Thank you.

[Sean]

Btw, asking about anachronism - I'm a different Sean. Thanks.

[Kevin E. Noonan]

Dear Different Sean:

In the "old days," the fear was that a patentee would dribble out claims to obvious variants of an invention and get serial 17-year terms for different patents that would encompass (and thus provide infringement liability) to commercial embodiments of the invention, thus inequitably extending the term of exclusivity.

With the advent of the 20-year term from earliest filing date, this can no longer happen - patents claiming the same priority date expire on the same day (providing maintenance fees are paid, there are not differential PTA or PTE terms, etc.). Thus, I think the "main" purpose of the doctrine is not relevant to anything filed since June, 1995.

But the "being sued by different patentholders" rationale remains.

Thanks for the comment.