Source: https://www.patentdocs.org/double-patenting/
Timestamp: 2019-04-18 10:51:22+00:00

Document:
On Friday, December 7th, the Federal Circuit handed down two opinions concerning the proper application of the judicially created doctrine of obviousness-type double patenting (OTDP). The first, Novartis AG v. Ezra Ventures LLC (Fed. Cir. 2018), set forth the narrow, albeit important, holding that a terminal disclaimer, or loss of term for a later-expiring patent based on an earlier-expiring patent in relation to which the later-expiring patent recited patentably indistinct claims, did not include extension of term pursuant to the provisions of 35 U.S.C § 156. The Court held that, insofar as patent term extension under § 156 was a statutory grant, and loss of term under OTDP was a judicially created doctrine, the statutory grant was not trumped by OTDP.
The second case decided by the Federal Circuit that day, Novartis Pharmaceuticals Corp. v. Breckenridge Pharmaceutical Inc., provided the Court with the opportunity to decide whether the operation of the OTDP doctrine was the same for two patents that were granted under U.S. patent law after the term of a U.S. patent was changed from 17 years from the grant date to 20 years from the earliest claimed priority date under the Uruguay Round Agreements Act of 1994 (URAA), compared with circumstances where one patent is subject to pre-URAA term and the other to the post-URAA term.
Despite these differences, the District Court, relying on the rubric from Gilead that "a later-filed but earlier-expiring patent can serve as a double patenting reference for an earlier-filed but later-expiring patent," invalidated the '772 patent claims under OTDP over the '990 patent claims. As explained in the opinion, the District Court also relied on decisions by district courts following Gilead, including Janssen Biotech Inc. v. Celltrion Healthcare Co., 210 F. Supp. 3d 278 (D. Mass. 2016); MLC Intellectual Property, LLC v. Micron Technology, Inc., 2016 WL 4192009 (N.D. Cal. Aug. 9, 2016); and DDB Technologies, LLC v. Fox Sports Interactive Media, LLC, 2014 WL 12167628 (W.D. Tex. May 15, 2014), in support of its decision. The District Court rejected four arguments asserted by Novartis attempting to distinguish Gilead. First, that grant of the '990 patent did not affect the expiration date of the '772 patent; the Court held that "it was Novartis's choice to file the '990 patent, and the harm to the public lies in the inability to practice the invention claimed in the '990 patent once it expired." Second, that Novartis had not engaged in any gamesmanship which was the basis for the Gilead court's concerns; the Court held that gamesmanship was not required to violate proscription against OTDP under Gilead (or AbbVie, Inc. v. Mathilda & Terence Kennedy Institute of Rheumatology Trust, 764 F.3d 1366 (Fed. Cir. 2014)). Third, that allowing the earlier-expiring, post-URAA patent to be an OTDP reference against a later-expiring, pre-URAA patent would impermissibly shorten the statutorily mandated 17-year term of the pre-URAA patent; the Court found that Novartis had courted that risk by filing the earlier-expiring patent having patentably indistinct claims. Finally, that the patent term extension Novartis had obtained for the '772 patent "immunized" the patent from a double patenting challenge; the Court found no precedent for this contention and noted that the question was not at issue. The parties having stipulated to infringement and that the '772 patent claims would be invalid for OTDP if the '990 was a proper OTDP reference, the District Court entered judgment that the '772 patent was invalid and this appeal followed.
[T]he correct framework here is to apply the traditional obviousness-type double patenting practices extant in the pre-URAA era to the pre-URAA '772 patent and look to the '772 patent's issuance date as the reference point for obviousness-type double patenting.
Under their analysis, "because a change in patent term law should not truncate the term statutorily assigned to the pre-URAA '772 patent," the '990 patent "cannot properly be used as an OTDP reference."
[T]hat the change in patent term law under the URAA altered the analytical inquiry for double patenting; issuance dates of post-URAA patents did not serve as reliable stand-ins for the expiration date of the patent as is true for pre-URAA patents, and the proper reference point for an obviousness-type double patenting inquiry is the expiration date of the patent in question.
The circumstances before the Court here are not the same and Gilead does not control, according to the opinion ("Gilead addressed a question that is not applicable here"). And the opinion characterizes the Court's Gilead opinion as being dependent upon the changes that arose post-URAA, because patent issue dates no longer "served as a reliable stand-in for the date that really mattered -- patent expiration." This is because, as in the Gilead case, "a patent that issues first does not [necessarily] expire first." The relationship of the earlier- and later-expiring patents before the Court here also does not have the potential negative consequences the Court cautioned against in Gilead, such as the opportunity for patentees to engage in gamesmanship regarding patent application and issue dates, and the potential that a difference of even one day in issue date could change the relationship in an OTDP-determining way.
The AbbVie situation is "a prime example of the post-URAA scenario [the Court] contemplated in Gilead," according to the opinion (noting that, as in Gilead, the effective filing date (EFD) of the '422 patent represents applicant choice, because it did not have the same EFD of the '766 patent). That factor was not at play regarding the Novartis patents and thus AbbVie does not control the outcome here.
The key purpose of obviousness-type double patenting is to prevent a patent owner from extending the exclusivity rights over his invention beyond a full patent term. We saw this impermissible practice in Gilead and in AbbVie, where the patent owners claimed different effective filing dates for different patents to extend the life of patent exclusivity. Gilead[.] Here, critically, Novartis did not seek to extend its patent rights over its everolimus invention beyond one patent term, in this case, 17 years from issuance of the '772 patent. Had the law not changed, regardless of whether Novartis obtained the '990 patent, the '772 patent would have expired on September 9, 2014 (September 9, 2019 with the patent term extension). The fact that the law for the term of a patent changed, resulting in the later-issued '990 patent having an earlier expiration date than it would have pre-URAA should not affect the '772 patent's statutorily-granted 17-year patent term. Rather than Novartis receiving a windfall with a 17-year term for its '772 patent, its '990 patent's term was truncated by the intervening change in law. To find that obviousness-type double patenting applies here because a post-URAA patent expires earlier would abrogate Novartis's right to enjoy one full patent term on its invention (citations omitted).
In Novartis AG v. Ezra Ventures LLC, the Federal Circuit addressed a narrow but important question regarding its jurisprudence on the issue of obviousness-type double patenting (OTPD). That question was whether its decision in Gilead Sciences Inc. v. Natco Pharma Ltd., which established that a first patent filed earlier than a second patent but that issued later, could be used to invalidate the second patent on OTDP grounds, if the reason the later-expiring patent was later-expiring was due to Patent Term Extension under 35 U.S.C. § 156.
In rendering its decision, the Gilead panel held that the intervening change in U.S. patent term occasioned by ratification of the GATT-TRIPS agreement did not influence its decision. Rather, the panel grounded its decision on the "bedrock" principle that the public had a right to practice an invention (and its obvious variants) once a patent on that invention had expired. Important to the instant Novartis decision, the Gilead panel also voiced its concern that holding to the contrary in that case could raise the possibility of "significant gamesmanship" regarding patent term depending on when related applications were filed and when they were allowed to issue. The Gilead decision has been applied to mean that the relevant dates for considering OTDP are the expiration dates of the later and earlier-expiring patents, and whether the claims in the later-expiring patent were mere obvious variants of the earlier-expiring claims.
The Novartis case arose in ANDA litigation brought by Novartis against Ezra Ventures over its multiple sclerosis drug Gilenya® over Orange Book-listed U.S. Patent No. 5,604,229. As explained in the opinion, claims of the '229 patent encompassed fingolimod, the active ingredient in Gilenya®. The '229 patent was filed prior to the GATT-TRIPS changes in U.S. patent law, and thus had a patent term calculated as 17 years after issuance (in this case, corresponding to February 18, 2014). In addition, Novartis had been granted five years of Patent Term Extension under § 156, thus expiring on February 18, 2019.
Before the District Court, Ezra Ventures filed a motion to dismiss (that the Court denied) under Fed. R. Civ. Pro. 12(c) for judgment on the pleadings, on three grounds. First, that extension of the '229 patent "de facto also extends the life of the '565 patent, and thereby violates § 156(c)(4)'s requirement that only 'one patent be extended.'" Second, that this extension "violates the 'bedrock principle' that the public may practice an expired patent." And third, that the '565 patent "renders the '229 patent invalid for statutory- and obviousness-type double patenting because Novartis's '229 patent claims are not patentably distinct from its '565 patent claims." With regard to the argument that this is an impermissible extension in violation of § 156(c)(4), the District Court held that "de facto" extension as argued here was inconsistent with the meaning of the extension statute. In addition, the lower court relied on the Federal Circuit's decision in Merck & Co. v. Hi-Tech Pharmacal Co., 482 F.3d 1317 (Fed. Cir. 2007), that the term of a terminally disclaimed patent can be extended under § 156, which "de facto" extends the term of that patent over the term of the patent over which it has been terminally disclaimed. Thereafter, Ezra Ventures stipulated infringement and withdrew its defenses, and the District Court entered final judgment against Ezra Ventures, clearing the procedural path for this appeal.
The Federal Circuit affirmed, in an opinion by Judge Chen joined by Judges Moore and Hughes. The panel first addressed Ezra Venture's argument that extension of the '229 patent by Patent Term Extension also (improperly) extended the term of the '565 patent. As an initial matter, the opinion notes that "nothing in the statute restricts the patent owner's choice for patent term extension among those patents whose terms have been partially consumed by the regulatory review process," despite it not being uncommon for a patented drug to also be the subject of patents on "a product, a method of using that product, and/or a method of manufacturing the product." The panel agreed with the District Court that Congress did not choose language that would preclude extension of a patent on a drug product because it also "effectively" extends the patent, for example, on a method of using that drug product. Here, only one patent term was extended -- the '229 patent -- and this satisfies the statutory mandate and does not violate § 156(c)(4).
Next the Federal Circuit considered the "interaction" between § 156 and OTDP. In what the panel states is "a logical extension" of its holding in Merck & Co. v. Hi-Tech Pharmacal Co., the Court held here that OTDP does not invalidate extension of the patent term under § 156. After explicating the Court's basis for its Merck opinion (inter alia, the plain meaning of the § 156 and the differences in statutory language between § 156 and § 154, the patent term adjustment statute, which cannot extend the term of a terminally disclaimed patent) the opinion notes that the Merck decision involved just the issue raised here: that a terminally disclaimed patent can still receive the benefit of a patent term extension under § 156. Accordingly, extension of the term of the '229 patent past the expiration date of the '565 patent was not improper.
It is when the opinion turns to "Ezra's policy concerns" that the panel took the opportunity to set forth its reasoning on the question of the function of the OTDP doctrine. Citing Proctor & Gamble Co. v. Teva Pharm. USA, Inc., 566 F.3d 989, 999 (Fed. Cir. 2009), the opinion states that the instant situation "does not raise the traditional concern with obviousness-type double patenting of a patent owner 'extending his exclusive rights to an invention through claims in a later-filed patent that are not patentably distinct from claims in the earlier filed patent.'" The opinion then distinguishes the policy considerations at play here with more recent OTDP decisions of the Court, particularly Gilead Sciences, Inc. v. Natco Pharma Ltd., specifically referring to that Court's concerns with gamesmanship not present here.
The other distinction between the situation in Gilead and the one here is whether the differences in the relationship between the patents (patents filed pre- and post-URAA here, in contrast to having two post-URAA patents in Gilead) are addressed in the opinion accompanying this one, Novartis Pharmaceuticals Corp. v. Breckenridge Pharmaceutical. That case will be the subject of a later post.
Last week, the Federal Circuit affirmed the rejection by the U.S. Patent and Trademark Office's Patent Trial and Appeal Board of claims 1-7 of U.S. Patent No. 6,284,471 as being unpatentable under the doctrine of obviousness-type double patenting. Janssen Biotech, Inc. and New York University ("Janssen"), co-assignees of the '471 patent, argued on appeal that obviousness-type double patenting was not applicable because the safe-harbor provision of 35 U.S.C. § 121 protected the '471 patent claims. In affirming the Board's decision, however, the Federal Circuit determined that the '471 patent was not entitled to safe-harbor protections.
The '471 patent issued from U.S. Application No. 08/192,093, which was filed as a continuation-in-part application of U.S. Application Nos. 08/013,413 and 08/010,406. On the same day that the '093 application was filed, Janssen also filed U.S. Application No. 08/192,102, which was also filed as a continuation-in-part application of the '413 and '406 applications, and which later issued as U.S. Patent No. 5,656,272. Janssen subsequently filed U.S. Application No. 08/324,799, which was filed as a continuation-in-part of the '093 and '102 applications, and which later issued as U.S. Patent No. 5,698,185. The relationships of the above applications and patents is shown in the chart below, which is reproduced from the Federal Circuit's opinion.
During prosecution of the '413 application, which relates to antibodies specific to human tumor necrosis factor alpha and included claims directed to a chimeric antibody and methods of treatment, a restriction requirement was issued in which Group I was directed to antibodies, pharmaceutical compositions, and assay methods, and Group IV was directed to methods for treating an animal by administering a pharmaceutical composition containing an antibody. Instead of replying to the restriction requirement, Janssen expressly abandoned the '413 application and filed the '093 and '102 applications as continuation-in-part applications of the '413 and '406 applications.
The '093 application disclosed and claimed subject matter from both the '413 and '406 applications (the '406 application relates to immunoreceptor molecules that are specific for TNF alpha or beta). After the '093 application was filed, Janssen allowed the '406 application to go abandoned. Janssen then filed a preliminary amendment in the '093 application, cancelling method claims designated as the invention of Group IV in the restriction requirement issued in the '413 application. However, Janssen did not limit the claimed subject matter to only that claimed and disclosed in the '413 application, as the '093 application still included claims directed to chimeric antibodies (based on the '413 application) and immunoreceptor molecules (based on the '406 application), and also retained language regarding binding to the TNF genus generally as opposed to the species of TNF alpha. In an Office action issued during prosecution of the '093 application, the claims were provisionally rejected on obviousness-type double patenting grounds over the '799 application. Janssen responded by amending the claims, including limiting claim 1 to TNF alpha. Janssen also filed preliminary amendments in both the '799 and '102 applications, replacing the pending claims of the '799 application with claims directed to methods of treating rheumatoid arthritis, and the pending claims of the '102 application with claims directed to methods of treating Crohn's disease.
Following the issuance of another Office action in the '093 application, in which the double patenting rejection was maintained, Janssen responded by arguing for withdrawal of the rejection in view of the amendment of the claims of the '799 application to recite methods of treating rheumatoid arthritis and by pointing to the restriction requirement issued in the '413 application, which Janssen argued precluded an obviousness-type double patenting rejection in the '093 application. The Examiner withdrew the double patenting rejection, and the '093 application eventually issued as the '471 patent, with claims directed to a chimeric antibody specific for TNF alpha (claims 1, 3, and 5–6), immunoassay methods for detecting human TNF (claims 2 and 4), and polypeptides of particular amino acid sequences that bind to human TNF alpha (claims 8 and 9).
Twelve years after the '471 patent issued, the USPTO instituted a reexamination of the patent (in response to a third-party request) on double patenting grounds over three patents including the '272 and '195 patents. During the reexamination, Janssen cancelled claims 8 and 9; requested that the benefit claim to the '406 application be deleted; sought amendment of the specification, abstract, and drawings to delete portions that were not in the '413 application; and requested that the application be designated as a divisional of the '413 application. The Examiner, however, maintained the double patenting rejections on the basis that the safe harbor did not apply, noting that more than thirty-two issued patents "reached through the '471 patent for benefit of a prior filing date" and that the "patentability of those claims . . . cannot be determined without reopening examination of those patents in view of the deletion of the subject matter in the '471 patent." The Examiner also determined that the one-way test for double patenting applied because the PTO was not "solely responsible" for the '471 patent's later issuance, and that the claims of the '471 patent were unpatentable under that test. The Board subsequently affirmed the Examiner's determination, and Janssen appealed the Board's decision to the Federal Circuit.
[P]atents issued on CIP applications are not within the scope of § 121. [Pfizer, 518 F.3d] at 1362. Nor are patents issued on continuation applications. [Amgen Inc. v. F. Hoffman-La Roche Ltd., 580 F.3d 1340, 1354 (Fed. Cir. 2009)]. Our precedent is clear: aside from the original application and the original patent, the protection afforded by § 121 is limited to divisional applications and patents issued on divisional applications. Pfizer, 518 F.3d at 1362.
The panel noted that in G.D. Searle LLC v. Lupin Pharm., Inc., 790 F.3d 1349 (Fed. Cir. 2015), the question of whether a patent owner can retroactively bring a challenged patent, issued from a CIP application, within the scope of the § 121 safe harbor by amending the CIP application after issuance to redesignate the application as a divisional application was answered by the Federal Circuit in the reissue context, where the Court determined that the patent owner could not take advantage of the safe-harbor provision simply by designating the CIP as a divisional application. Applying Searle to the instant case, the panel indicated that it was "persuaded by the reasoning in Searle that a patent owner cannot retroactively bring its challenged patent within the scope of the safe-harbor provision by amendment in a reexamination proceeding," stating that "once the '471 patent issued on the '093 application—which, like the application in Searle, at the time of issuance included new matter not disclosed in the original application and so was a properly designated CIP—the '471 patent was barred from safe-harbor protections."
The panel pointed out that "[t]he '471 patent cannot retroactively become, for the purposes of § 121, a 'patent issued on' a divisional application after it already issued on a CIP application; not even if that CIP application is effectively redesignated as a divisional application during reexamination," and noted that "[f]or a challenged patent to receive safe-harbor protections, the application must be properly designated as a divisional application, at the very latest, by the time the challenged patent issues on that application." In response to Janssen's argument that it had not enjoyed a benefit from having filed the '093 application as a CIP of the '413 and '406 applications because no issued claims in the '471 patent relied upon the new matter in the '093 application, the panel disagreed, explaining that "the examiner found that Janssen had benefitted because more than thirty patents issued to Janssen claiming priority to the '471 patent and/or the '093 application as a CIP of both the '406 and '413 applications."
[W]e do not decide whether such filing practices or amendments made prior to issuance—wherein an application is designated as a divisional application by the time the challenged patent issues on that application—would be sufficient to bring the challenged patent within the scope of the safe-harbor protections.
The opinion concludes with the panel finding to be unpersuasive Janssen's argument that the Board erred by failing to apply a two-way test for double patenting. Instead, the panel concluded that Janssen failed to establish that the PTO is "solely responsible" for any alleged delay associated with the issuance of the '471 patent. Finding that the '471 patent was not entitled to safe-harbor protections, and that the Board did not err in applying the one-way test for double patenting, the Federal Circuit affirmed the Board's rejection of claims 1–7 of the '471 patent as being unpatentable under the doctrine of obviousness-type double patenting.
The U.S. Patent and Trademark Office has now filed its response brief in In re: Janssen Biotech, Inc., New York University, No. 2017-1257 (Fed. Cir.), the Federal Circuit appeal involving U.S. Patent No. 6,284,471/Reexamination Control No. 90/012,851 ("Reexam appeal"). This is a parallel appeal to Janssen's appeal from its District Court action against Celltrion involving the '471 patent, Janssen Biotech, Inc. v. Celltrion Healthcare Co., Ltd., No. 2017-1120 (Fed. Cir.) ("Janssen v. Celltrion"). Notably, however, Janssen (and New York University) previously argued in the parallel Janssen v. Celltrion appeal that this PTO appeal controlled: "Because the '471 Patent was amended in reexamination, a decision favorable to Janssen in the co-pending appeal would supersede the district court's ruling, which was based on the un-amended form of the '471 Patent." As such, this Reexam appeal is the one to watch.
At issue in both of these appeals is (1) whether the claims of the '471 patent (as amended in the reexamination) are subject to the "safe harbor" of 35 U.S.C. § 121 to avoid the ODP issue altogether, and (2) if not, how the test for ODP should be applied, either under a "one-way test," or a "two-way test."
Under the "safe harbor" provision of 35 U.S.C. § 121, a restriction requirement from the PTO acts as a sort of estoppel with respect to a divisional application filed in response to that requirement: neither of the patents that result directly from the restriction requirement can be used as an ODP reference against the other patent.
If the safe harbor does not apply, then the PTO and courts must apply either a one-way test or two-way test for ODP. In the one-way test, the only question is whether the claimed subject matter in the later-expiring patent is obvious over that of the earlier-expiring patent. In the two-way test, the examiner (or patent challenger) must show that the subject matter of the claims of both patents would be obvious over the other, and thus is a much more difficult obstacle for the examiner (or patent challenger) to overcome. Although there are a number of pitfalls, the two-way test applies if (i) the later-expiring patent was filed before the earlier-expiring patent and (ii) the applicant could not avoid separate filings (by filing conflicting claims in the earlier-filed application) and (iii) the PTO was solely responsible for the delay in prosecution of the later-expiring patent. If all three are true, the two-way test applies; if any one is false, then the one-way test applies.
In its briefs in both appeals, Janssen made many of the same arguments supporting reversal of the District Court and the PTO decisions. There are two significant differences in the two appeals, however. First, the PTO has argued an alternative ground for rejecting the § 121 safe harbor, specifically the lack of "consonance." Second, and perhaps more damning, Janssen has to contend in this Reexam appeal with the PTO's finding that the PTO was not solely responsible for the delay in prosecution of the '471 patent. In the District Court decision on appeal in Janssen v. Celltrion, Judge Wolf did not rule on this last issue, finding a potential issue of fact.
The PTO's brief relied heavily on three facts, the first two of which are undisputed: (1) that the applicant filed the '093 application, which issued as the '471 patent, as a CIP application, not a divisional application (although they tried to fix this retroactively); (2) that claim 1 of the '471 patent is not patentably distinct from the claims of appellees' '272 and '195 reference patents; and (3) that the PTO had found that Janssen was partially responsible for the delay caused in the '903 application prosecution which caused the '471 patent to issue after its siblings, the '272 and '195 patents. PTO Response Brief, Slip op. at 18-19, 23 (note that the page numbering used here is the court's page numbering at the top of the page in the slip opinion, rather than the brief's page numbering at the bottom).
With respect to the § 121 safe harbor issue, the PTO followed a long line of cases -- Pfizer, Inc. v. Teva Pharms. USA, Inc., 518 F.3d 1353 (Fed. Cir. 2008); Amgen Inc. v. F. Hoffman-LaRoche Ltd., 580 F.3d 1340 (Fed. Cir. 2009); Amgen v. HLR, and G.D. Searle LLC v. Lupin Pharms., Inc., 790 F.3d 1349 (Fed. Cir. 2015) (id. at 29-34), and a long-standing PTO practice (id. at 34-38), in holding that because the applicants filed the '093 application as a CIP application, not a divisional application, the '471 patent was not entitled to § 121's safe harbor. Indeed, the single largest chunk of the PTO's argument is directed to reminding the Federal Circuit of what exactly it held in those three decisions. That is, under these prior decisions, applicants' belated attempt to re-cast the filing as a divisional is too little, too late. As Searle made clear, "Janssen cannot 'retroactively alter the nature' of the original '093 CIP application" to make it a divisional application after-the fact. Id. at 20. Because Janssen filed the '093 application as a CIP of two applications, and included subject matter and claims not supported by the disclosure of the '413 application where the restriction requirement was made, "there is no way that the '093 application can be considered a divisional of the '413 application in 'form' or in 'substance.'" Id. at 20.
A second, alternative argument that the PTO made for denying appellees the § 121 safe harbor was that the claims at issue in the ODP rejection did not maintain "consonance." That is, issued claims in the three patents involved in the ODP rejection are not consonant with the restricted claims in the '413 application because they did not maintain the independent and distinct inventions that prompted the restriction requirement. The PTO provided several reasons, including: (a) the issued claims in the '195 patent and '272 patent are not limited to TNF-α, whereas claims that were the subject of the restriction requirement were limited to TNF-α; and (b) claims 1 and 9 of the '471 patent are not only broader than the original Group I claims of the restriction requirement but they are also directed to subject matter not disclosed in the '413 application where the restriction was made.
Notably, for Janssen to prevail on the § 121 safe harbor issue it must establish that the PTO erred on both of these two grounds. It appears unlikely to succeed with either.
Regarding the § 121 safe harbor argument, Janssen argued a number of equities that the PTO's brief dismissed. With respect to Janssen's argument that its added disclosure -- disclosed but not eventually claimed -- in the '093 application benefited the public, for example, the PTO noted that Janssen could have filed both a CIP and a divisional application and given the same benefit without losing its divisional designation. With respect to Janssen's argument that it relied to its detriment on the Examiner's withdrawal of an ODP objection, because it could have filed a divisional while the parent application was still pending, the PTO argued that the timing is unlikely because Janssen did not file a divisional application during the two years that the examiner's ODP objection was pending. And with respect to Janssen's argument that it relied on a non-precedential decision in a reexamination, the PTO noted that the decision was both not binding and in any event preceded Searle. Id. at 45-47.
With respect to the second issue on appeal, the PTO argued that Janssen was not entitled to the two-way ODP test because (a) the application that led to the '471 and '272 patents were filed on the same day, and the MPEP clearly states that where "both applications are filed on the same day, only a one-way determination of distinctness is needed" and (b) Janssen was partially responsible for the "delay" that caused the '471 patent to issue after the '272 and '195 reference patents. These examples of delay cited by the PTO included (i) the applicant waited ten months to file a preliminary amendment that included immunoreceptor claims from the other parent application (not supported by the '413 application where the original restriction requirement was made) -- which then prompted a further restriction requirement; (ii) that, by contrast, Janssen took specific steps in the '195 and '272 applications explicitly designed to expedite prosecution; (iii) after receiving a final rejection in May, 1996, Janssen waited six months, until October, 1996 to file a Notice of Appeal; and then (iv) Janssen waited another six months, until May, 1997 to reopen prosecution by filing a 37 C.F.R. § 1.129(a) amendment. Id. at 52-54.
If there are points for brevity, the PTO got all this done in only 10,627 of the 14,000 words allotted.
From the nadir of the Supreme Court's allegations that the Federal Circuit "fundamentally misunderstood" the law of inducing infringement in Limelight Networks, Inc. v. Akamai Technologies, Inc., the nation's specialized patent appellate court has crafted a two-prong test for assessing when the actions of more than a single actor amount to literal infringement sufficient to support a determination of inducement. Akamai Technologies, Inc. v. Limelight Networks, Inc. (Fed. Cir. 2015) (en banc).
1. A method of administering pemetrexed disodium to a patient in need thereof comprising administering an effective amount of folic acid and an effective amount of a methylmalonic acid lowering agent followed by administering an effective amount of pemetrexed disodium, wherein the methylmalonic acid lowering agent is selected from the group consisting of vitamin B12, hydroxycobalamin, cyano-10-chlorocobalamin, aquocobalamin perchlorate, aquo-10-cobalamin perchlorate, azidocobalamin, cobalamin, cyanoco- balamin, or chlorocobalamin.
(Where the italicized limitations were specifically at issue.) Here, the patient practices the step of the claim involving administering folic acid (which is available as a pill), and the physician administers B12 and pemetrexed by injection. The question of whether the existence of two actors (patients and physicians) practicing the claims creates a divided infringement situation that would vitiate literal infringement was clearly contemplated throughout the litigation, during the course of which the Federal Circuit and Supreme Court were considering the question. That both actors performed their individual steps of the claimed method was not disputed, but its effects on infringement liability, and whether Teva could be liable for inducing infringement was central to the dispute between the parties.
As the litigation progressed, defendants conditionally stipulated to induced infringement subject to being able to litigate the issue if (as it turned out) the Supreme Court reversed the Federal Circuit's contemporaneous standard. The District Court proceeded on the invalidity issues and held Eli Lilly's claims not to be invalid on obviousness and obviousness-type double patenting grounds nor were indefinite. After the Supreme Court's Akamai decision, the parties relitigated the infringement issues. The District Court used the label as evidence of infringement, wherein under FDA regulations Teva's label comprising instruction for administration of the drug would be identical to Eli Lilly's label. Based on this determination, the District Court found defendants had induced infringement, and this appeal followed.
The Federal Circuit affirmed, in an opinion by Chief Judge Prost joined by Judges Newman and Dyk. The opinion recognized the Supreme Court's overriding teaching that induced infringement requires a finding that literal infringement had occurred. Moreover, inducement also requires an intent to induce, which requires that the alleged infringer "knew or should have known" that her actions would induce infringement. In order for more than one actor to practice the steps of a claimed method and for literal infringement to lie, the Supreme Court-approved standard is that either one of the actors works at the "direction or control" of the other actor, or the actors form a joint enterprise. With regard to the question of "direction or control," the panel set forth the revised Akamai standard operationalized as a two-prong test. The first prong of that test is whether one actor "'conditions participation in an activity or receipt of a benefit' upon anothers' performance of one or more steps of a patented method," and the second prong is whether that actor "'establishes the manner or timing of that performance,'" citing the Court's Akamai decision following remand from the Supreme Court (italics in opinion). The District Court held that the first prong was satisfied because folate administration was a precondition for the physician administering B12 and the drug, and that the second prong was satisfied because the physician prescribed the dose and administration schedule to the patient.
What is relevant is whether the physician sufficiently directs or controls the acts of the patients in such a manner as to condition participation in an activity or receipt of a benefit—in this case, treatment with pemetrexed in the manner that reduces toxicities—upon the performance of a step of the patented method and establishes the manner and timing of the performance [italics in opinion].
The panel also noted that the District Court's conclusions on this point were supported by the Physician Prescribing Information and Patient Information comprising the FDA-approved label as well as expert testimony (wherein both parties' experts agreed on the importance of folate pre-administration). Finally on this point, the panel stated that such "conditioning" did not require that a legal obligation be imposed on one of the parties or that the step comprise an "unavoidable technological prerequisite to participation."
With regard to the second prong, the District Court and the panel relied upon the product label. This information comports with the dosage amounts and frequencies encompassed by the asserted claims. Expert testimony supported the finding that it was the physician who prescribed folate (in administered amount and frequency) to the patient.
Taken as a whole, the panel found no reversible error in the District Court's factual determinations.
The panel then turned to whether Eli Lilly had established that defendants exhibited the requisite intent to induce infringement, which required evidence of specific intention and acts and not mere knowledge of the patent in suit. The District Court once more relied on the generic product label (identical to Eli Lilly's label). The District Court and the Federal Circuit rejected Teva's argument that the label was not sufficient to provide specific evidence of inducement, because it purportedly did not show how physicians (the direct infringer) do act rather than as they may act. The panel's reaction to that argument was that "[t]he question is not just whether [those] instructions describ[e] the infringing mode, . . . but whether the instructions teach an infringing use such that we are willing to infer from those instructions an affirmative intent to infringe the patent," citing Takeda Pharm. USA, Inc. v. West-Ward Pharm. Corp. and that "it is irrelevant that some users may ignore the warnings in the proposed label," citing AstraZeneca LP v. Apotex, Inc. Also relevant to the panel's decision was that the label (in both the Physician Prescribing Information and Patient Information) emphasized how important folate administration was for reducing toxicity associated with administration of the drug. This portion of the opinion concludes "[i]n sum, evidence that the product labeling that Defendants seek would inevitably lead some physicians to infringe establishes the requisite intent for inducement."
With regard to the invalidity issues, the opinion first considered Teva's indefiniteness contentions. The factual basis for these were that the term "vitamin B12" was indefinite, because there were various species of the vitamin (claimed as vitamin B12, hydroxycobalamin, cyano-10-chlorocobalamin, aquocobalamin perchlorate, aquo-10-cobalamin perchlorate, azidocobalamin, cobalamin, cyanocobalamin, or chlorocobalamin); the District Court found that the term meant cyanocobalamin based on expert testimony. The panel noted that it does not defer to this expert testimony because satisfaction of the statute is a question of law. But the opinion does note that the question of how the skilled worker would understand the term is a question of fact reviewable for clear error, and found no such error in the District Court's finding (a definition that was supported even by defendant's expert). Upon consideration of how the term was used in the claims, and despite some apparent inconsistency in claim language, the Federal Circuit agreed that the skilled worker would have understood the meaning of the term.
With regarding to obviousness, the panel referenced the District Court's "thorough opinion" that the prior art did not motivate the skilled worker to practice the claimed method, and specifically that the skilled artisan would not have been motivated to "(1) use folic acid pretreatment with pemetrexed; (2) use vitamin B12 pretreatment with pemetrexed; or (3) use the claimed doses and schedules of folic acid and vitamin B12 pretreatments with pemetrexed." The focus of these determinations was that the art did not show any correlation between pemetrexed toxicity and vitamin B12 deficiency (although there was evidence of a correlation with folate deficiency). Expert testimony from both sides established that there was no recognition in the art that vitamin B12 deficiencies were associated with cancer treatment with antifolate compounds. Nor was there evidence from the art that B12 would have been routinely administered (or that its administration schedules would have been routine) in cancer treatment. The panel made similar determinations in affirming the District Court's finding that the claims of the '209 patent were not invalid under the obviousness-type double patenting doctrine.
Eli Lilly benefited in this case by having prevailed at the District Court, in large part due to the burden of finding clear error to overcome the District Court's decision. But the opinion does set forth an affirmation of the Court's two-prong test for finding that more than one actor can perform the steps in a claimed method sufficient to satisfy the unitary standard for finding literal infringement.
Over seven years ago, the Federal Circuit delivered a mixed ruling against Pfizer in litigation against Teva) relating to the pain medication Celebrex® (celocoxib) (where "celocoxib" is 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl]benzenesulfonamide). In that case, Pfizer, Inc. v. Teva Pharmaceuticals USA, Inc. (Fed. Cir. 2008), the Court upheld a District Court determination that Teva was liable for infringing a trio of Pfizer patents (U.S. Patent Nos. 5,466,823; 5,563,165; and 5,760,068) but reversed the District Court's determination that the claims of the '068 patent were not invalid for obviousness-type double patenting. Pfizer took steps to remedy the deficiency of the claims of the '068 patent by reissue, but those efforts were deemed insufficient in a decision handed down today in G.D. Searle LLC v. Lupin Pharmaceuticals Inc. et al.
This case involved ANDA litigation against five generic defendants (Lupin, Teva Pharmaceuticals USA Inc., Mylan Pharmaceuticals Inc., Watson Laboratories, Inc., Apotex Inc. and Apotex Corp.), again related to generic Celebrex. The basis for the Court's earlier determination that the '068 patent was invalid for obviousness-type double patenting was that the designation of this patent as a "continuation-in-part" was not merely semantic but had substantive repercussions regarding whether the '068 claims were entitled to the "safe harbor" provisions of 35 U.S.C. § 121. These provisions entitle a divisional application filed as the result of a restriction requirement (a Patent Office determination that an applicant has filed claims directed to more than one invention) to be exempt from obviousness-type double patenting, and illustrate Congressional intent (from the legislative history of the 1952 Patent Act) to prevent the unfairness of forcing an applicant to be required to file a divisional application based on claiming "independent inventions" through restriction while permitting the original application to be used as "prior art" in a obviousness-type double patenting rejection. The Federal Circuit considered it also Congress's intent to restrict the safe harbor to divisional applications (which have an identical specification to the originally-filed application) and keep any claims in such a divisional application strictly within the bounds of what had been determined to be a separate invention. This meant, for example, that an applicant would not be able to include claims in a divisional that were within the scope of any claims previously elected for examination. In this way applicants would be precluded from inequitably increasing patent term while not being penalized for electing one invention and pursuing additional inventions in divisional applications.
The lineage of the '068 patent began with U.S. patent application No. 08/160,594 in which the U.S. Patent and Trademark Office imposed a three-way restriction requirement: to the claimed compounds per se, compositions of said compounds and methods of use for treating inflammation and resulting pain without the side effects of conventional non-steroidal anti-inflammatory compounds. The compound claims were elected and granted as U.S. Patent No. 5,466,823 and the composition claims pursued in a divisional application (Serial No. 08/457,059) that issued as U.S. Patent No. 5,563,165. Both the '823 and '165 patents have expired.
Pfizer did not pursue the method of treatment claims in a divisional application but instead filed a continuation-in-part application that contained additional disclosure (including previously undisclosed compounds) as well as claims to the three classes of inventions that were subject to restriction in the '594 application. The U.S. application issued as U.S. Patent No. 5,521,207 and is also expired. However, this application was the priority document for a PCT (International) Application that entered the national phase in the U.S. as Serial No. 08/648,113. In that application the PTO imposed a unity of invention/restriction requirement along exactly the same lines as in the '594 application, requiring the applicant to choose between claims to the compounds, compositions, and method of treatment claims. Pfizer chose to pursue the method of treatment claims and these claims ultimately granted in the '068 patent.
In the earlier litigation, the Federal Circuit found that the claims of the '068 patent did not fall within the safe harbor because it was a continuation-in-part application, not a divisional. Such a "CIP" application by definition contains some of the disclosure of an earlier-filed application in addition to new disclosure. Because of this distinction, the Federal Circuit found that CIP applications could not fall within the safe harbor because they could encompass additional information (and patentable inventions) that were not a part of the original, restricted claims.
(1) it deleted portions of the '068 patent specification that were not present in the '594 application; (2) it designated the '113 application as a divisional of the '594 application and removed the priority claim to the '629 application; (3) it amended claim 1 to be a method claim using only the compounds originally disclosed in the '594 application; (4) it canceled claims 2-12, which were method claims using compounds that were not present in the '594 application; (5) it canceled claim 18 (reciting a method of preventing colorectal cancer), which was not found in the '594 application; and (6) it added new method claims 19-23, which recited the use of the method disclosed in claim 1 to treat five specific types of inflammation-associated disorders.
Initially the PTO rejected the reissue application on the grounds that these changes were not the types of error intended to be remedied by reissue; in response Pfizer amended its amendment to assert "various technical errors" that Pfizer contended rendered the claims indefinite, and on that basis the reissue application was permitted to continue. Pfizer then made the changes in the original version of the application and the application granted as RE44,048.
The District Court held that these corrections were not correctable under the reissue statute, and that the claims in the '048 reissue patent were not entitled to the safe harbor under 35 U.S.C. § 121 and thus were invalid for obviousness-type double patenting.
The Federal Circuit affirmed, in an opinion by Judge Bryson joined by Chief Judge Prost and Judge Hughes. The opinion recognized the question of the propriety of the reissue application under § 251 but was content to limit the decision to the absence of the safe harbor under § 121 for the reissue claims. The panel expressly rejected Pfizer's argument that the restriction requirement from the '594 application extended to the national phase of the PCT application, despite the similarities in the nature of three classes of claims in each. The panel reasoned that this cannot be the case because the national phase '113 application contained new matter not contained in the '594 application and thus was properly treated as a continuation-in-part (the earlier case had expressly held that CIPs were not entitled to the safe harbor provisions of § 121). In this regard the panel rejected the changes in the reissue application, stating that "[s]imply deleting that new matter from the reissue patent does not retroactively alter the nature of the '113 application."
Moreover, when the '113 application issued as the '068 patent in June 1998, Pfizer obtained patent protection for the new matter that was not present in the '594 application. For years thereafter, the public was not free to practice that new matter (e.g., the now cancelled claims 2-12 and 18 of the '068 patent) because of that patent protection. Pfizer cannot now identify the '113 application as a divisional of the '594 application (for purposes of section 121) and retroactively relinquish the new matter in the '113 application, after having enjoyed years of patent protection for it. See In re Harita, 847 F.2d 801, 809 (Fed. Cir. 1988) ("In any given case, the [reissue] statute should be so applied to the facts that justice will be done both to the patentee and the public."); see also In re Serenkin, 479 F.3d 1359, 1362 (Fed. Cir. 2007) ("[Section] 251 is based on fundamental principles of equity and fairness[.]"). Fairness to the public does not permit Pfizer to convert the '113 application into a division of the original '594 application, and thereby take advantage of the safe harbor provision, simply by designating it as a divisional application years after the fact.
When separate restriction requirements are imposed on separate applications and the record does not show that any of the various restriction requirements carried forward from one application to the next, the earlier restriction requirement cannot be viewed as having continued in effect with respect to the later-filed application [citing Bristol-Myers Squibb Co. v. Pharmachemie B.V., 361 F.3d 1343, 1349-50 (Fed. Cir. 2004)].
The record here was that there were two separate restriction requirements asserted in two related but distinct (regarding the disclosure in the specification and the subject matter of the claims) applications, and that these differences precluded the restriction requirement imposed in the '594 application from having "carried over" to the '113 application (and the panel noted there was no evidence that the '113 application examiner referenced or was even aware of the restriction in the '594 application). And the Court expressly rejected Pfizer's "but for" argument with regard to the requirement imposed in the '594 application (that "but for" that restriction the method of treatment claims would have been prosecuted in the '594 application).
While this decision is entirely consistent with the Court's earlier Pfizer decision, it does illustrate how stringently the Court has and intends to apply the law of obviousness-type double patenting for pharmaceutical patents.
After reflecting upon the events of the past twelve months, Patent Docs presents its eighth annual list of top patent stories. For 2014, we identified eighteen stories that were covered on Patent Docs last year that we believe had (or are likely to have) the greatest impact on patent practitioners and applicants. Yesterday, we counted down stories #18 to #15, and today we count down stories #14 to #11 as we work our way towards the top three stories of 2014. As with our other lists (2013, 2012, 2011, 2010, 2009, 2008, and 2007), links to our coverage of these stories (as well as a few links to articles on related topics) have been provided in case you missed the articles the first time around or wish to go back and have another look. As always, we love to hear from Patent Docs readers, so if you think we left something off the list or disagree with anything we included, please let us know. In addition, we will be offering a live webinar on the "Top Patent Law Stories of 2014" on January 20, 2015 from 10:00 am to 11:15 am (CT). Details regarding the webinar can be found here.
In March, the Supreme Court granted certiorari in Teva Pharmaceuticals USA, Inc. v. Sandoz Inc. to resolve the question of "[w]hether a district court's factual finding in support of its construction of a patent claim term may be reviewed de novo, as the Federal Circuit requires (and as the panel explicitly did in this case), or only for clear error, as Rule 52(a) requires." In October, the Court heard oral argument in the case. 2015 will bring a decision from the Court as to whether appellate courts should afford any deference to a trial court's claim construction determination, and regardless of the Court's decision, Teva v. Sandoz will likely make a return trip to our top stories list (although coming in perhaps a little higher than #14 on next year's list).
In January, the Federal Circuit affirmed a determination by the District Court for the District of Columbia that challenges of patent term adjustment (PTA) determinations by the U.S. Patent and Trademark Office for fifteen Novartis patents were untimely asserted, and with respect to three other Novartis patents, reversed the District Court's ruling that the Patent Office's interpretation of 35 U.S.C. § 154(b)(1)(B) was contrary to law. With respect to the first fifteen patents, the Court noted that Novartis did not file suit within 180 days of denial of reconsideration of the Office's PTA determination, and that Novartis had failed to demonstrate why the 180-day rule should be equitably tolled. The three other patents at issue involved the impact of an RCE filing on the calculation of B Delay. For these patents, the Federal Circuit agreed with the Office that no PTA time is available for any time in continued examination, even if the continued examination was initiated more than three calendar years after the application's filing (in other words, for an RCE filed more than three years after the application filing date). The Court, however, agreed with Novartis that the"time consumed by continued examination should be limited to the time before allowance, as long as no later examination actually occurs. In June, the U.S. Patent and Trademark Office published a notice of proposed rulemaking to implement the Federal Circuit's decision in Novartis v. Lee.
In January, the Supreme Court held in Medtronic, Inc. v. Mirowski Family Ventures, LLC that when a licensee seeks a declaratory judgment against a patentee to establish that there is no infringement, the burden of proving infringement remains with the patentee. The decision by the Supreme Court reversed a Federal Circuit decision from 2012. As we noted in our summary of the Medtronic decision, the case potentially disrupts the balance of power between a patent holder and a licensee. In particular, we suggested that licensees may be emboldened to force patent holders to prove that licensed products or processes infringe the patents at issue, noting that a licensee would have little risk in doing so because a patent holder would not be able to assert counterclaims. Therefore, the best that can be hoped for from the patentee's point of view would be to maintain the status quo, which could end up creating a disincentive for patent holders from entering into licensee agreements.
The Federal Circuit issued two opinions in 2014 that address the judicially created doctrine of obviousness-type double patenting. In April, the Court decided in Gilead Sciences Inc. v. Natco Pharma Ltd. that a patent (in this case Gilead's U.S. Patent No. 5,763,483) that issues after but expires before another patent (Gilead's U.S. Patent No. 5,952,375) can qualify as a double patenting reference for the other patent. Instead of focusing on the issue date, as Gilead argued it should do, the panel majority in Gilead v. Natco focused on the date at which time the invention fell into the public domain. The majority argued that doing otherwise would encourage "significant gamesmanship" during prosecution, explaining that "if the double patenting inquiry was limited by issuance date, inventors could routinely orchestrate patent term extensions by (1) filing serial applications on obvious modifications of an invention, (2) claiming priority to different applications in each, and then (3) arranging for the application claiming the latest filing date to issue first." Thus, in Gilead, the majority fashioned a rule that "the earliest expiration date of all the patents an inventor has on his invention and its obvious variants" should be used for an obviousness-type double patenting analysis. In September, in AbbVie Inc. v. Mathilda & Terence Kennedy Institute of Rheumatology Trust, the Federal Circuit rejected the Kennedy Trust's argument that because of the Uruguay Round Agreement Act (URAA), which implemented a 20-year patent term, the statutory and policy rationales underlying the obviousness-type double patenting doctrine no longer exist. Instead, the Court noted that the doctrine also serves to prevent an inventor from securing a second, later expiring patent for the same invention, and that patents claiming overlapping subject matter that were filed at the same time still can have different patent terms due to examination delays at the USPTO.
After reflecting upon the events of the past twelve months, Patent Docs presents its eighth annual list of top patent stories. For 2014, we identified eighteen stories that were covered on Patent Docs last year that we believe had (or are likely to have) the greatest impact on patent practitioners and applicants. Today, we count down stories #18 to #15, and then over the next few days, we will work our way towards the top stories of 2014. As with our other lists (2013, 2012, 2011, 2010, 2009, 2008, and 2007), links to our coverage of these stories (as well as a few links to articles on related topics) have been provided in case you missed the articles the first time around or wish to go back and have another look. As always, we love to hear from Patent Docs readers, so if you think we left something off the list or disagree with anything we included, please let us know. In addition, we will be offering a live webinar on the "Top Patent Law Stories of 2014" on January 20, 2015 from 10:00 am to 11:15 am (CT). Details regarding the webinar can be found here.
18. White House Begins to Implement Initiatives to "Foster innovation"
In June of 2013, the White House released a Fact Sheet on the Administration's task force on high-tech patent issues providing seven different legislative recommendations and five executive actions (see "'When the Patent System is Attacked!' -- The White House Task Force on High-Tech Patent Issues"). In 2014, the White House took the first steps toward implementing the executive actions. The step that attracted the most attention was the U.S. Patent and Trademark Office's publication of a notice of proposed rulemaking in which the Office proposed changes to the rules of practice that it claimed would "facilitate the examination of patent applications and . . . provide greater transparency concerning the ownership of patent applications and patents." The proposed changes to the rules would require that the "attributable owner" be identified at the time an application is filed (or shortly thereafter), during the pendency of an application when there is a change in the attributable owner (within three months of such change), at the time the issue fee is paid, when maintenance fee payments are made, and if a patent becomes involved in supplemental examination, ex parte reexamination, or a trial proceeding before the Patent Trial and Appeal Board. In February, the White House provided an update on the five executive actions, "announcing major progress" on the initiatives that the Administration declared would help combat so-called "patent trolls." One of the initiatives involved the launching of a new "on-line toolkit" "[t]o help level the playing field and ensure individuals and businesses know their rights and are aware of available resources before entering into costly litigation or settlements." With respect to the White House's initiative to promote transparency concerning patent ownership, Hal Wegner stated in his e-mail newsletter in February that while "attempts to minimize comment [on the proposed rulemaking regarding attributable owner identification] have involved suppression of existing comments as if this will perhaps lead to the public falling asleep at the comment switch," "the leadership of the Patent Office has been sheltered from questioning by the public, while the Administration’s lobbyist group, 'Business Forward', continues to have access to PTO leadership" (emphasis in original).
In June, the Federal Circuit dismissed an appeal by Consumer Watchdog from a decision of the Patent Trial and Appeal Board affirming the patentability of claims 1-4 of the Wisconsin Alumni Research Foundation's U.S. Patent No. 7,029,913, which is directed to a replicating in vitro cell culture of pluripotent human embryonic stem cells derived from a pre-implantation embryo. In dismissing the appeal, the Federal Circuit determined that Consumer Watchdog had failed to establish an injury in fact sufficient to confer Article III standing because it had failed to identify any alleged injury aside from the Board denying Consumer Watchdog the particular outcome it desired in the reexamination of the '913 patent. Given that Consumer Watchdog had been seeking to invalidate the patent as being invalid for encompassing ineligible subject matter, but for the dismissal for lack of standing, the appeal might have helped elucidate how the Federal Circuit viewed the patent eligibility of subject matter other than nucleic acids after The Supreme Court's decision in Association for Molecular Pathology v. Myriad Genetics, Inc.
Two decisions by the Federal Circuit in June and December served as a reminder to applicants and practitioners that patent law remains "full of traps for the unwary." In Dinsmore, the Court affirmed a final rejection by the U.S. Patent and Trademark Office, which had refused to accept a reissue declaration in which the patentee indicated that the "error" in the patent that made it defective was the inadvertent filing of a terminal disclaimer. In Japanese Foundation for Cancer Research, the Federal Circuit reversed a District Court determination ordering the U.S. Patent and Trademark Office to withdraw an improperly filed terminal disclaimer. In distinguishing the facts of the instant case from the Court's earlier decision in Carnegie Mellon Univ. v. Schwartz, the Court indicated that Carnegie Mellon had intended to file a terminal disclaimer but had erred in identifying the correct patent serial number, whereas here the issue was whether the Office could withdraw a disclaimer that was intentionally filed (in the correct patent), i.e. where there was not the kind of error in Carnegie Mellon that justified the contrary results.
In the context of the controversy caused by the U.S. Patent and Trademark Office's Myriad/Mayo guidance, the Ariosa Diagnostics v. Sequenom case worked its way through the appeal process with oral argument before the Federal Circuit taking place in November. A little more than a year earlier, the Northern District of California had granted summary judgment for declaratory judgment plaintiff Ariosa Disgnostocs, finding that Sequenom's claimed method for detecting a paternally inherited nucleic acid of fetal origin was not patent eligible. Among the controversial aspects of the case, was the District Court's determination that Sequenom's argument that there were alternative methods of detecting cffDNA available was unpersuasive because "Sequenom has failed to present any evidence showing that any of these alternative methods are practical and commercially viable" (emphasis added). Regardless of where the Federal Circuit comes down on this case, it will likely make a return visit to next year's list of top stories and likely impact future iterations of the USPTO's guidance on subject matter eligibility.
Last month, in AbbVie Inc. v. Mathilda & Terence Kennedy Institute of Rheumatology Trust, the Federal Circuit affirmed a determination by the District Court for the Southern District of New York that U.S. Patent No. 7,846,442, which is owned by the Mathilda & Terence Kennedy Institute of Rheumatology Trust ("Kennedy Trust"), was invalid under the doctrine of obviousness-type double patenting in view of the Kennedy Trust's U.S. Patent No. 6,270,766.
8. A method of treating rheumatoid arthritis in an individual in need thereof comprising co-administering methotrexate and an [anti-TNFα] antibody or an antigen-binding fragment thereof to the individual, in therapeutically effective amounts.
1. A method of treating an individual suffering from rheumatoid arthritis whose active disease is incompletely controlled despite already receiving methotrexate comprising adjunctively administering with methotrexate therapy a different composition comprising an anti-human [TNFα] antibody or a human [TNFα] binding fragment thereof to the individual, wherein the anti-human [TNFα] or fragment thereof (a) binds to an epitope on human [TNFα], (b) inhibits binding of human [TNFα] to human [TNFα] cell surface receptors and (c) is administered at a dosage of 0.01-100 mg/kg, and wherein such administration reduces or eliminates signs and symptoms associated with rheumatoid arthritis.
The relevant differences between the two representative claims are as follows: (1) while the '766 method is directed towards any "individual in need," the '442 method is directed towards individuals with "active disease"; (2) while the '766 method recites "co-administering" methotrexate and an anti-TNFα antibody, the '442 method recites "adjunctively administering" an anti-TNFα antibody with methotrexate.
The '766 patent application, which was filed on August 1, 1996, claimed the benefit of an application that was filed on October 8, 1992. After the '766 patent issued in 2001, the Kennedy Trust filed the '442 patent application. Although the specification of the '442 patent is identical to that of the '766 patent, the '442 patent only claims the benefit of the '766 patent's August 1, 1996 filing date. As a result, while the '766 patent expired on October 8, 2012, the '442 patent does not expire until August 21, 2018.
As the opinion notes, AbbVie, Inc. and AbbVie Biotechnology Ltd. ("AbbVie"), which license the '766 patent but not the '442 patent, paid the Kennedy Trust more than $100 million in royalties in order to sell its anti-TNFα antibody, Humira, in combination with methotrexate for the treatment of rheumatoid arthritis. However, when the '442 patent issued in 2010 and the Kennedy Trust sought an additional license from AbbVie, AbbVie instead filed a declaratory judgment action seeking a determination that the '442 patent was invalid for obviousness-type double patenting.
At trial, the Kennedy Trust contended that the '442 patent was patentable over the '766 patent because the latter claims a broad genus of methods for treating rheumatoid arthritis, and the former claims a narrower species of those treatment methods having unexpected results. The District Court, however, determined that the claims of the '442 patent that were at issue in the declaratory judgment action were invalid over certain claims of the '766 patent. In reaching that decision, the District Court determined that the adjunctive administration of the '442 method was one of three forms of co-administration covered by the '766 patent, and that the term "active disease" as recited in the '442 method covered all patients suffering from rheumatoid arthritis and requiring treatment. Thus, the District Court determined that the '442 patent covered the same invention as the '766 patent, and as a result that the asserted claims of the '442 patent were invalid over the asserted claims of the '766 patent for obviousness-type double patenting.
[T]he statutory and policy rationales underlying the obviousness-type double patenting doctrine no longer exist and the doctrine should be discarded. More specifically, [the] Kennedy [Trust] contends that the Uruguay Round Agreement Act (URAA), Pub. L. 103-465, 108 Stat. 4809, effective June 8, 1995, and its implementation of a 20-year period of patent protection that runs from a patent's earliest claimed priority date, eliminated the need for the obviousness-type double patenting doctrine. . . . Now that the patent term is measured from the earliest claimed priority date, as opposed to the date of issuance, [the] Kennedy [Trust] contends that the submarine patent problem no longer exists and that the URAA amendment vitiated the policy basis for the doctrine of obviousness-type double patenting.
[T]his argument ignores another crucial purpose of the doctrine: It is designed to prevent an inventor from securing a second, later expiring patent for the same invention. . . . That problem still exists. Patents claiming overlapping subject matter that were filed at the same time still can have different patent terms due to examination delays at the PTO.
As a result, the Court determined that "the doctrine of obviousness-type double patenting continues to apply where two patents that claim the same invention have different expiration dates." With respect to the dispute between AbbVie and the Kennedy Trust, the Court stated that the Kennedy Trust was "not entitled to an extra six years of monopoly solely because it filed a separate application unless the two inventions are patentably distinct."
Before reaching a decision on whether the differences between the '766 and '442 patents rendered their claims patentably distinct, the Court addressed the disputed terms of "co-administering" and "active disease." With respect to the first term, the Kennedy Trust argued that the District Court's construction excluded a fourth form of co-administration, namely, administration of the anti-TNFα antibody antibody alone after discontinuing the administration of methotrexate. The Court, however, noted that "[t]he '766 patent's specification confirms the correctness of the district court's claim construction," in that "[t]he specification never uses the term 'co-administering' to refer to patients who only received the antibody after discontinuing treatment with methotrexate."
With respect to the second term, the Kennedy Trust argued that the prosecution history revealed that a more specific definition of "active disease" (i.e., particularly sick patients) was critical to the Examiner's allowance of the '442 patent claims. "[A]ssum[ing], without deciding, that [the Kennedy Trust's] proposed construction of 'active disease' was correct," the Court noted that "[t]he consequence is the genus claimed in the '766 patent (treating all patients in need thereof) is broader than the species claimed in the '442 patent (treating patients with 'active disease,' i.e., particularly sick patients)." As a result, the Court stated that it "must decide whether a patent that claims to treat a subset of patients with more severe rheumatoid arthritis (the '442 patent) is an obvious variant of a patent that claims treatment of rheumatoid arthritis patients generally (the '766 patent)."
While noting that "[i]t is well-settled that a narrow species can be non-obvious and patent eligible despite a patent on its genus," the opinion points out that "species are unpatentable when prior art disclosures describe the genus containing those species such that a person of ordinary skill in the art would be able to envision every member of the class." In the instant case, the opinion stated that "it is clear that a reader of the '766 patent could have easily envisioned a species limited to sicker patients," and determined that the District Court was correct in concluding that the species of the '442 patent was not patentably distinct from the genus of the '766 patent.
As for the Kennedy Trust's argument that the species of the '442 patent showed unexpected results, the Court found that argument to be unsupported. Looking to the specification to assess what results were expected at the time the '766 patent application was filed (which the Court stated was permissible), the Court determined that "the '442 patent merely claims the known utility of the '766 patent and does not claim a species with unexpected results." The Court therefore concluded that the '442 patent was invalid for obviousness-type double patenting in light of the '766 patent.
Despite thirty years of efforts by the Federal Circuit to bring consistency and transparency to patent law (and the last dozen years of the Supreme Court's efforts to the contrary), in many respects patent law remains "full of traps for the unwary." A recent Federal Circuit decision, affirming final rejection by the U.S. Patent and Trademark Office in a narrowing reissue application illustrates one such trap (and a particular type of unwariness).
The reason patentees filed the reissue application was that the two patents were not and never were co-owned. As part of the reissue procedure, the inventors filed a "reissue declaration," purporting to set forth an "error" in the patent that made it defective and that was to be cured by reissue, said error being the filing of the terminal disclaimer (as set forth in the opinion, in this first declaration the applicants stated that they "inadvertently and without deceptive intent filed a Terminal Disclaimer over [the '086 patent], which was not commonly owned by the owners of [the '568 patent] currently at issue." There was no offer to file a "corrected" terminal disclaimer. This assertion was insufficient, the examiner deciding that it was "not an error upon which a reissue can be based." In response to rejection by the examiner, applicants filed a petition with the Commissioner for Patents to permit them to replace the terminal disclaimer of record with one identical in all respects except that the replacement did not contain the provision (as noted, required by PTO regulations) that the '568 patent would be enforceable only during such time that it was commonly owned with the '086 patent. The Office denied this petition a total of three times, each time on the grounds that the statement was required in a valid terminal disclaimer.
In response to PTO rejection of the reissue as being unsupported by a proper declaration, applicants submitted a substitute, setting forth as the defect allowance of the '568 patent claims in the first place, due to the defective terminal disclaimer. In their response, applicants cancelled several of the granted claims and submitted substitute claims, which were not accepted, and after additional submissions during prosecution finally submitted narrower claims amended to overcome the asserted obviousness-type double patenting grounds (as well as another attempt to file a terminal disclaimer lacking the "co-owned" language), illustrating the pitfall here: wherein such claims in a co-pending continuation application or that had been granted in a patent defective on other grounds might have been considered; here, applicants could not satisfy the predicate grounds for permitting them to file a reissue application in the first place. This last attempt was also unsuccessful; the examiner rejected the proffered claims on the grounds that the alleged "defect" (the terminal disclaimer) was not a proper basis for filing a reissue application. This rejection was affirmed by the Patent Trial and Appeal Board (in a decision that emphasized the "voluntary and intentional" aspects of a terminal disclaimer filing) and appeal to the Federal Circuit followed.
The Federal Circuit affirmed, in an opinion by Judge Taranto joined by Judges Bryson and Hughes. Starting with the text of the statute, the opinion grounds its decision to affirm on the panel's determination that the asserted basis for error, that the terminal disclaimer was "ineffective or invalid" is "simply incorrect in the most straightforward sense," i.e., because any defect could be "cured" by having the two patents be co-owned. The Court also found the terminal disclaimer to be valid, insofar as it contained all the required assertions and averments necessary to be given effect by the PTO to overcome the asserted obviousness-type double patenting rejection. In addition, the terminal disclaimer fulfilled the policy objective of preventing third party accused infringers from being subject to "multiple infringement suits by different assignees asserting essentially the same patented invention," citing In re Hubbell, 709 F.3d 1140, 1145 (Fed. Cir. 2013).
[F]or purposes of narrowing re-issue-qualifying choices to those involving "error," it is important whether deficient understandings, by the applicants or their agents, gave rise to the patenting choice that reissue is being invoked to correct. In the authorities that the applicants here feature, false or inadequate understandings about then-existing facts or law evidently underlay the aspects of the original patent sought to be altered by reissue.
The Court has previously held that reissue was unavailable for an applicant had not been able to identify any "deficient understanding" behind the error; "[i]n such cases, the reissue application was held inadequate as being no more than an effort to reverse a later-regretted choice made in obtaining the original patent," citing Miller v. Bridgeport Brass Co., 104 U.S. 350, 355 (1881); In re Serenkin, 479 F.3d 1359, 1364 (Fed. Cir. 2007); In re Mead, 581 F.2d 251, 257 (CCPA 1978); and In re Orita, 550 F.2d 1277, 1280 (CCPA 1977).
[T]he applicants -- knowing that the patents were not commonly owned -- intentionally surrendered a possible right (the ability to obtain all or some of the '568 patent claims in a form enforceable independently of the '086 patent) in exchange for a benefit (overcoming an obviousness-type double-patenting rejection of several of the proposed claims).
All the patentees are trying to do here is "simply to revise a choice they have made," and, without more, this is not an "error" that the reissue statute was enacted to remedy.
The Federal Circuit extended the scope of the judicially created doctrine of obviousness-type double patenting (OTDP) in a split decision rendered in Gilead Sciences Inc. v. Natco Pharma Ltd. In doing so, the panel majority applied what it viewed as the important policy motivations for the doctrine, a rationale unpersuasive to the Chief Judge in dissent.
As shown, the later-filed application expires after the earlier-filed application.
The lawsuit arose under the provisions of 35 U.S.C. § 271(e)(2) upon filing of Natco's Abbreviated New Drug Application (ANDA). Gilead sued, the parties stipulated infringement, and the issue before the District Court was whether Gilead's '483 patent was invalid for OTDP in view of the earlier-filed '375 patent. Gilead filed a terminal disclaimer in the '375 patent with regard to the '483 patent (something that the Court noted was unnecessary because "the '375 patent's expiration date is before the '483 patent's expiration date" absent abandonment), but no terminal disclaimer was filed in the '483 patent, and separate examiners were not informed of the existence of the other application otherwise. According to the opinion, Gilead "crafted a separate 'chain' of applications having a later priority date than the '375 patent family," which provides a hint early in the opinion that the panel majority was attempting to prevent Gilead from strategucally avoiding OTDP. The District Court determined that the extensions in patent term were "not a result of gamesmanship, but instead were a result of changes to [the] patent laws" attendant upon ratification of the GATT treaty.
The Federal Circuit vacated the District Court's judgment of infringement and remanded for reconsideration of Natco's invalidity contentions; notably, the opinion states that "[f]or purposes of this appeal, we assume that the '483 patent claims a mere obvious variant of the invention claimed in the '375 patent" because the District Court did not reach the merits. The decision for the majority was penned by Judge Chen joined by Judge Prost, with Chief Judge Rader dissenting.
Can a patent that issues after but expires before another patent qualify as a double patenting reference for that other patent?
Because the obviousness-type double patenting doctrine prohibits an inventor from extending his right to exclude through claims in a later-expiring patent that are not patentably distinct from the claims of the inventor's earlier-expiring patent, we agree with Natco that the '375 patent qualifies as an obviousness-type double patenting reference for the '483 patent.
The panel majority began its analysis by citing several Supreme Court cases (Miller v. Eagle Mfg. Co., 151 U.S. 186, 197-98, 202 (1894); Suffolk Co. v. Hayden, 70 U.S. 315, 317 (1865), and particularly Justice Story riding the First Circuit at Odiorne v. Amesbury Nail Factory, 18 Fed. Cas. 578, 579 (C.C.D. Mass. 1819)) for the proposition that the patent grant is balanced by the invention falling into the public domain once the patent expires, which implicates judicial prohibitions against extending the patent term that the OTDP prohibition is intended to impose. This included not only serial patents on the same invention but also a prohibition on patents reciting patentably indistinct inventions, i.e., ones that claimed only an "obvious modification" of a patented invention. The majority cited 35 U.S.C. § 253 as changing the scope of the OTDP doctrine, permitting separate patents provided that the patentee disclaimed later term, citing Application of Robeson, 331 F.2d 610, 614 (CCPA 1964), which is "tantamount for all practical purposes to having all the claims in one patent." Application of Braithwaite, 379 F.2d 594, 601 (CCPA 1967).
[T]hat principle is violated when a patent expires and the public is nevertheless barred from practicing obvious modifications of the invention claimed in that patent because the inventor holds another later-expiring patent with claims for obvious modifications of the invention. Such is the case here.
Because the panel majority believes that the claims of the '483 patent are mere obvious variants of the claims in the '375 patent, they held that, if the claims of the '483 patent are patentably indistinct from the claims of the '375 patent, then the term of the '483 patent should end on the same date as the '375 patent expires (keeping in mind that neither the District Court nor the majority have yet made that determination).
[I]f the double patenting inquiry was limited by issuance date, inventors could routinely orchestrate patent term extensions by (1) filing serial applications on obvious modifications of an invention, (2) claiming priority to different applications in each, and then (3) arranging for the application claiming the latest filing date to issue first. If that were to occur, inventors could potentially obtain additional patent term exclusivity for obvious variants of their inventions while also exploring the value of an earlier priority date during prosecution.
These differences are "simply too arbitrary, uncertain, and prone to gamesmanship" in the panel majority's view, and the majority opined that "Congress could not have intended to inject the potential to disturb the consistent application of the doctrine of double patenting by passing the URAA."
Thus, the majority fashioned a rule that "the earliest expiration date of all the patents an inventor has on his invention and its obvious variants" should be used for the District Court's OTDP analysis, saying that "[p]ermitting any earlier expiring patent to serve as a double patenting reference for a patent subject to the URAA guarantees a stable benchmark that preserves the public's right to use the invention (and its obvious variants) that are claimed in a patent when that patent expires."
Chief Judge Rader dissented in an opinion where he characterized the majority's decision as unnecessarily "expand[ing] the judicially-created doctrine of OTDP." While agreeing with the majority that "the doctrine has served a useful purpose over the years" under U.S. patent law prescribing a patent term of 17 years from patent grant date, under current law the Chief does not apprehend that the rationale behind the OTDP doctrine still exists. In his view, "a primary motivation behind the doctrine -- preventing the effective extension of patent term -- is largely no longer applicable." The Chief Judge does recognize what he terms "a second underlying policy concern -- preventing multiple infringement suits by different assignees asserting essentially the same patented invention." But he does not believe this concern is implicated in this case, either.
In his dissent the Chief Judge notes a logical inconsistency in the majority's argument, that if the '375 patent had never issued, Gilead would have been entitled to the full extent of the '483 patent term. Thus, the issue can be considered not as the majority has, that the term of the '483 patent is improperly extended past the expiration date of the earlier-filed '375 patent, but rather whether an earlier-issued patent's term can be cut short by later grant of an earlier-filed application (which the majority sanctioned here). And he noted that Gilead conformed to the statutory regime regarding priority and did not claim priority in the later-filed '483 patent to the related disclosure (and priority date) of the earlier-filed '375 patent. In doing so, Gilead "forfeit[ed] its earlier claim to priority and subject[ed] any new patent to intervening prior art," perhaps the antithesis of gamesmanship (giving up about 10 months of priority according to the Chief).
With regard to the majority's stated view, he recited what he believes to be "the flawed assumption that upon the expiration of a patent, the public obtains an absolute right to use the previously-claimed subject matter." The Chief Judge noted that "even a patentee [does not] have the affirmative right to use its claimed subject matter," citing Spindelfabrik Suessen-Schurr, Stahlecker & Grill GmbH v. Schubert & Salzer Maschinefabrik Aktiengesellschaft, 829 F.2d 1075, 1081 (Fed. Cir. 1987). In addition, he argued, this assumption "ignores the possible existence of overlapping patents" (such as a first patent to a genus and a later patent to a species; this argument ignores the requirement that said later species be patentably distinct from the genus). In addition to generally counseling his brethren that judicial restraint in extending judicially created patent doctrines is the more prudent path, the Chief Judge also noted the potential for unforeseen effects of the majority's decision on filing behavior under the "first-inventor-to-file" provisions of the America Invents Act.
The Federal Circuit revisited the extent of the safe harbor from the judicially created doctrine of obviousness-type double patenting carved out by 35 U.S.C. § 121 in St. Jude Medical, Inc. v. Access Closure Inc. Unlike earlier decisions regarding whether continuation or continuation-in-part applications could benefit from the safe harbor, here the Court considered the effects of election-of-species requirements on whether there is consonance between claims in one patent over those on a related patent in which such a requirement is imposed.
7. A device for closing a puncture in a wall of an artery comprising: an elongated member having a distal end, said elongated member sized to be fitted through a passageway leading to said puncture so that said distal end is disposed near said puncture in said artery, separable plug means for plugging said puncture being disposed in said elongated member, movable guide means extending longitudinally through said elongated member and said plug means for extension through said puncture for guiding said plug means to said puncture, and means for ejecting said plug means from said distal end of said elongated member so as to place said plug means in blocking relation with said puncture, so as to seal said puncture [A device as claimed in claim 1], wherein said plug means includes an orifice therethrough, said guide means being disposed through said orifice, said orifice automatically closing when said guide means is removed therefrom.
8. A device for closing a puncture in a wall of an artery comprising: an elongated member having a distal end, said elongated member sized to be fitted through a passageway leading to said puncture so that said distal end is disposed near said puncture in said artery, a separable plug member for plugging said puncture being disposed in said elongated member, a movable guide element extending longitudinally through said elongated member and said plug member for extension through said puncture for guiding said plug member to said puncture, and an ejecting mechanism for ejecting said plug member from said distal end of said elongated member so as to place said plug member in blocking relation with said puncture, so as to seal said puncture.
9. A method of closing a puncture in a wall of an artery made for the purpose of moving an elongated cardiac catheter into the artery in which an exterior guide tube is extended through a passage leading to the puncture and through the puncture in the wall of the artery and into the artery so a to enable the catheter to be guidingly moved through the guide tube and into the artery, the method comprising the steps of: withdrawing the cardiac catheter and moving the guide tube outwardly so that it no longer extends within the puncture, extending a plug having a removable guide wire extending longitudinally therethrough so that the guide wire extends from the plug through said puncture, moving the plug inwardly along the guide wire into blocking relation with said puncture, and withdrawing the guide wire from the plug so as to leave the plug sealed in blocking relation with said puncture.
(where the italicized portion of claim 7 recites the limitations of claim 1 from which claim 7 is a dependent claim).
• Species C: Claims relating to the apparatus comprising a guidewire and no dilator.
In the '339 application, the Applicant elected Group I, Species B, and claims to these embodiments granted in the '183 patent. In the first divisional application (the '380 application), the examiner imposed a similar restriction requirement and applicant elected claims of Group I, Species B that granted in the '130 patent. The '439 patent-in-suit (the Janzen application) contains claims to both Group I and Group II, each electing Species C. And a second continuation (that granted as the '498 patent) contained claims to Group II but without election of any particular species.
The District Court held that the safe harbor provisions of 35 U.S.C. § 121 protected the claims of the Janzen patent from invalidity under obviousness-type double patenting. The Federal Circuit reversed, in an opinion by Judge Plager, joined by Judges Lourie and Wallach, with a concurring opinion by Judge Lourie.
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 if the divisional application is filed before the issuance of the patent on the other application.
(which it opined is "not a model of clarity") that what is required is "consonance," i.e., later-filed applications must conform to the "lines of demarcation" set up by a restriction requirement, citing Gerber Garment Tech., Inc. v. Lectra Sys., Inc., 916 F.2d 683, 688 (Fed. Cir. 1990). It is not a violation of consonance if two or more non-elected inventions are pursued in a subsequent application, the Court noted, citing Boehringer Ingelheim Int'l GmbH v. Barr Labs, Inc., 592 F.3d 1340, 1350 (Fed. Cir. 2010), but "a divisional application filed as a result of a restriction requirement may not contain claims drawn to the invention set forth in the claims elected and prosecuted to patent in the parent application."
As the opinion sets out, the consonance requirement is applied to the patent "challenged for double patenting" as well as the reference patent. And here, the panel states that consonance "requires that the challenged (Janzen) patent, the reference patent, and the patent in which the restriction requirement was imposed (the restricted patent, i.e. the '183 grandparent patent) do not claim any of the same inventions identified by the examiner. In this case, the question of whether the requirement is fulfilled depends on the effect of the election of species requirement. ACI contended below that the election was irrelevant to the consonance question, while St. Jude argued that the election of species must be considered in determining whether consonance was satisfied. The Court held that not only was the election of species relevant but that the result of the combination of restriction and election was the identification of six separate, patentably distinct inventions: Group I, Species A; Group I, Species B; Group I, Species C; Group II, Species A; Group II, Species B; and Group II, Species C. Under this standard, the grandparent patent contained claims to one invention (Group I, Species C) and the Janzen patent contained claims to two other inventions (Group I, Species B and Group II, Species B).
In the first action on an application containing a generic claim to a generic invention (genus) and claims to more than one patentably distinct species embraced thereby, the examiner may require the applicant in the reply to that action to elect a species of his or her invention to which his or her claim will be restricted if no claim to the genus is found to be allowable.
It makes logical sense that the election of species affected the line of demarcation when no claim was generic. If the election of species did not affect the line, double patenting would have prevented the Janzen applicant from obtaining valid claims directed to non-elected species. This result would be unfair since it was the examiner, not the applicant, who created the further division of the application with the election of species, and the examiner already stated on the record that the non-elected species were patentably distinct from the elected species. The unfairness of the result would violate the purpose of the safe harbor.
Having established the parameters of the restriction the Court then assessed whether there was consonance. While the difference in elected species distinguished the Janzen patent from the grandparent '339 application, the panel found no such distinction with the claims of the second continuation (the '498 patent), which contained claims directed to Group II without any limitations as to species. Accordingly, the claims of this second continuation were not consonant with the claims of the Janzen patent, which are directed, inter alia, to inventions of Group II, Species C. The claims of the Janzen patent were thus not patentably distinct from the claims of the second continuation and the Court found them invalid for obviousness-type double patenting.
positioning the vessel plug in the incision such that the distal end of the vessel plug is located proximally of the blood vessel to seal the incision from the flow of blood passing through the blood vessel, [The method of claim 9] further including the step of inflating a member on an insertion member to identify the location of the blood vessel adjacent to the incision.
an elongate positioning member having a passage way therein for the receipt of said vessel plug therein, and at least a portion of said positioning member is expandable so that it has an outer diameter in use which is greater than the diameter of the incision to position said vessel plug in the incision proximally of the blood vessel such that said vessel plug obstructs the flow of blood through the incision without extending into the blood vessel.
ACI argued that these claims were obvious over two prior art references: a 1988 scientific journal article to Takayasu, which disclosed a method and apparatus for sealing punctures in a liver vein using "a compressed 'gelfoam stick'"; and a 1971 scientific journal article to Smiley, which disclosed using a balloon catheter. ACI argued that these references demonstrated that the problem the Fowler's patents addressed -- how to restore hemostatis to a punctured blood vessel -- was known and that these references disclosed methods for solving the problem. The skilled worker would have had a reasonable expectation of achieving the claimed invention by combining the Takayasu and Smiley references and thus were obvious under 35 U.S.C. § 103.
The Federal Circuit agreed with St. Jude's argument that their claimed invention contained limitations and features not disclosed in the cited prior art that distinguished their claims from the hypothetical combination of the teachings of the Takayasu and Smiley references. Rather than combining the references, the Court held that the disclosed elements useful for stemming blood flow from a puncture -– a gelfoam stick or a balloon -– would be considered alternatives and the skilled worker would not combine the references. Nor was the panel convinced that the skilled worker would use an "invasive" balloon rather than non-invasive methods (x-ray or ultrasound) used in the art to check the position of the gelfoam in the wound. The Court characterized as "a logical chasm" the differences between the art and the invention, and further noted that "[e]ven under our "expansive and flexible" obviousness analysis (see KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415, (2007)), we must guard against "hindsight bias" and "ex post reasoning," which "compels [the Court] to reject ACI's argument."
In a nutshell, this case is resolved by the failure of the granted Janzen and '498 (sibling) patents to maintain consonance with the original restriction requirement. The accompanying requirement for election of species, which perhaps raises an issue of first impression, is a complication that should not come into play in deciding the appeal.
According to Judge Lourie, the presence of both method and apparatus claims in the Janzen patent is enough to vitiate consonance with the grandparent application, which contains claims to apparatus ("It is the opposite of consonant.") That is enough to reach the conclusion announced in the panel decision, and thus while Judge Lourie believed that "the majority opinion overcomplicates the analysis of this appeal and improperly commingles restriction practice with election of species practice," he concurred with the decision.
In a 2-1 decision issued earlier today, the Federal Circuit affirmed a determination by the Board of Patent Appeals and Interferences upholding the rejection of the claims of U.S. Application No. 10/650,509 for obviousness-type double patenting over U.S. Patent No. 7,601,685. The '509 application, which is assigned to the California Institute of Technology (Caltech), is directed to matrices containing bidomain peptides or proteins. Claim 18 of the '509 application recites "[a] bidomain protein or peptide comprising a transglutaminase substrate domain and a polypeptide growth factor." The named inventors on the '509 application are Jeffrey Hubbell, Jason Schense, Andreas Zich, and Heike Hall, all of whom were affiliated with Caltech at the time the claimed invention of the '509 application was made.
wherein the hydrolytic cleavage site comprises a substrate with a linkage which undergoes hydrolysis by an acid or a base catalyzed reaction.
During prosecution, the Examiner rejected the claims of the '509 application for obviousness-type double patenting over, inter alia, the application that issued as the '685 patent. In particular, the Examiner determined that the conflicting claims in the '685 patent were directed to species of the claimed invention of the '509 application and therefore anticipated the claimed invention of the '509 application. On appeal, the Board affirmed the Examiner's obviousness-type double patenting rejection over the '685 patent, determining that claim 1 of the '685 patent recites a protein that contains both of the features required in rejected claim 18, and that claim 18's use of the term "comprising" allowed for inclusion of the additional elements recited in claim 1 of the '685 patent. The Board also rejected Appellants' argument that common ownership was a requirement for obviousness-type double patenting, citing MPEP § 804(I)(A), which states that "[d]ouble patenting may exist between an issued patent and an application filed by the same inventive entity, or by a different inventive entity having a common inventor, and/or by a common assignee/owner." Appellants appealed the Board's affirmance of the Examiner's rejection to the Federal Circuit.
On appeal before the Federal Circuit, Appellants argued that obviousness-type double patenting should not apply where an application and a conflicting patent share common inventors but do not have identical inventive entities, were never commonly owned, and are not subject to a joint research agreement. Alternatively, Appellants argued that they should be allowed to file a terminal disclaimer as an equitable measure, or that the Court should employ a two-way obviousness analysis for the rejected claims. The U.S. Patent and Trademark Office countered that (1) whether the '509 application and '685 patent were ever commonly owned was immaterial to the policy of preventing harassment by multiple assignees; (2) identity of inventors is not required where there is an overlap in the inventors; (3) Appellants had not established any grounds upon which they should be allowed to file a terminal disclaimer; and (4) Appellants were not entitled to a two-way obviousness analysis because they admitted to being partially responsible for the delay that caused the '685 patent claims to issue first.
Noting that the Board's affirmance was based in part on § 804(I)(A) of the MPEP, Judge O'Malley, writing for the majority, indicated that "the MPEP standard is consistent with the rationale we have used to support application of obviousness-type double patenting rejections." The rationale being the concern over potential harassment of an infringer by multiple assignees asserting essentially the same patented invention (as well as preventing unjustified extension of the right to exclude). Judge O'Malley also noted that it had previously rejected Appellants' argument that obviousness-type double patenting should never be applied in the absence of common ownership in two other cases: In re Van Ornum, 686 F.2d 937 (CCPA 1982), where an obviousness-type double patenting rejection over a patent with a common inventor but no common ownership was affirmed, and In re Fallaux, 564 F.3d 1313 (Fed. Cir. 2009), where the reference patents and application at issue were related only by way of a single common inventor. Although Appellants argued that Van Ornum and Fallaux were distinguishable because in those cases the applications at issue were once commonly owned, the majority noted that "the potential for harassment by multiple assignees would [still] exist," and therefore "[Appellants'] distinction does not alleviate the underlying harassment concerns here." The majority also refused Appellants' invitation to create a specific exception barring application of obviousness-type double patenting in instances where the conflicting claims share only common inventors, rather than common ownership, declaring that "[w]e too can find no reasoned basis to differentiate between cases involving identical 'inventive entities' and those where the inventive entities are almost identical when assessing obviousness-type double patenting rejections."
[T]he record reveals that, in June 2003, the examiner allowed claims very similar to those at issue on appeal. Rather than permitting those claims to issue, [Appellants] failed to pay the issue fee, let the '918 application claims go abandoned, and filed the '509 application in August 2003. These prosecution choices resulted in the foreseeable consequence that the '685 patent issued before the application claims on appeal.
In accordance with the law of double patenting, double patenting does not apply when the application and patent are of separate ownership and have separate inventive entities. In such situation the appropriate examination path is on the merits of the invention, or through the interference or derivation procedures, or other standard protocol as may apply in the particular situation. . . . This court need not create a new protocol wherein the contributions of distinct entities and separate ownership are rejected for "double patenting" instead of examined under the established rules.
The court today not only finds "double patenting" when there is neither common inventorship nor common ownership, but having so found withholds the standard remedy of the terminal disclaimer, and simply denies the application. This novel ruling is contrary to statute and precedent, with no policy justification for changing the law.
The panel majority does not dispute that these are different inventive entities and that there is not common ownership. However, the court rules that obviousness-type double patenting applies. If there indeed is obviousness-type double patenting, then a terminal disclaimer is necessarily available. However, the court rules that a terminal disclaimer is not available because there is not common ownership. Yet if there is not common ownership or common inventorship, there cannot be double patenting. On this circularity, the court denies the CalTech application on the ground of double patenting.
Noting that there was "no suggestion of any attempt to 'game' the system," Judge Newman ends her dissent by noting that unlike the majority, she would not have foreclosed Caltech's request for equitable relief in the form of authorization to file a terminal disclaimer.

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