Patent Docs

In re Dinsmore (Fed. Cir. 2014)

Court Upholds PTO Determination That Reissue Cannot Cure Improper Terminal Disclaimer

By Kevin E. Noonan --

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 case involved a reissue application filed under 35 U.S.C. § 251 for U.S. Patent No. 7,236,568, having claims directed to "[a m]iniature x-ray source with improved output stability and voltage standoff."  During the original prosecution, applicants had filed a terminal disclaimer over the claims of U.S. Patent No. 6,658,086.  As with all terminal disclaimers, the one at issue attested that the claims of the later '568 patent would be enforceable "only for and during such period" as the earlier '086 and '568 patents were co-owned.  37 C.F.R. § 1.321(c).  This provision is intended to prevent an accused infringer from being sued by separate patent owners having claims that are not patentably distinct.  (This consideration also explains why terminal disclaimer practice survives the change in patent law from the previous regime awarding a 17 year patent term for each patent to the current law, where the term of a granted patent in the U.S. is twenty years from the earliest filing date -- with some not relevant exceptions.  This change voided the alternative purpose of terminal disclaimers, that is to prevent a patentee from extending the statutory patent term by obtaining claims of patentably-indistinct scope having overlapping 17-year terms.)

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).

The Court identified the asserted defect in the terminal disclaimer to be that the patentees could not enforce the patent "themselves" (i.e., absent common ownership with the '086 patent) and that this was not the outcome the patentees desired to achieve.  This is, the panel says, not a basis for reissue but rather "no more than a statement of a now-regretted choice," which was not a proper ground for reissue or "error" as the statue required.  This is because the nexus between the error and the patent defect is that the specification, drawings or claims are defective (or, for the claims, unduly broad) due to the error.  While not stating that defects resulting from "applicant's choices" can never be the basis for a reissue application, the Court does assert that "not every choice that produces inoperativeness or invalidity by reason of a specification, drawing, or claiming problem (within the meaning of section 251) can qualify" but only those based on error.  Drawing on case law, the opinion states that:

[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).

Here, the Court concludes, "the applicants have not identified any deficient understanding as leading to the issuance of [the] original claims with the terminal disclaimer," and hence there was no basis under the statute for a reissue examination.  The Court characterizes the facts as showing that the applicants had the choice of amending the claims to overcome the obviousness-type double patenting rejection, or filing a terminal disclaimer.  Having chosen to do the latter, and without any showing of any misunderstanding regarding what they were doing, or any mistake with regard to the ownership status of the prior patent and their application:

[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.

In re Dinsmore (Fed. Cir. 2014)
Panel: Circuit Judges Taranto, Bryson, and HughesOpinion by Circuit Judge Tarnato

Gilead Sciences, Inc. v. Natco Pharma Ltd. (Fed. Cir. 2014)

By Kevin E. Noonan --

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.

The case involved antiviral drugs and methods directed to influenza virus as claimed in U.S. Patent Nos. 5,763,483 and 5,952,375.  These patents were commonly owned, named the same inventors, and were directed to related subject matter (interference with viruses by "selective interference with certain enzymes"), but did not share any priority relationship and had different filing and expiration dates set forth by the Court as follows:

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.

The question the majority considered was before it was:

Can a patent that issues after but expires before another patent qualify as a double patenting reference for that other patent?

The majority answered this question "yes" under the circumstances of this case.  In a nutshell:

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).

The majority bases its decision that OTDP applies in this situation on the "bedrock principle" that "when a patent expires, the public is free to use not only the same invention claimed in the expired patent but also obvious or patentably indistinct modifications of that invention."  However:

[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).

The panel majority rejected Gilead's argument that extending the term of the '483 patent was not the issue, because that patent issued earlier than the '375 patent.  This argument garnered no traction with the panel majority in view of the policy reasons underlying their decision.  The panel acknowledged disruptions caused by the GATT treaty in the traditional term relationships between patents, stating that "the focus on controlling the patent term of later issued patents in those [earlier] cases [cited by Gilead] makes perfect sense:  before the URAA [GATT}, later issued patents expired later" (emphasis in opinion).  Patent issue dates under the prior regime "served as a reliable stand-in for the date that really mattered" to the panel:  the patent expiration date at which time the invention fell into the public domain.  Doing otherwise would encourage "significant gamesmanship" during prosecution, according to the panel majority, setting out the scenario that:

[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.

Such gamesmanship is illustrated by the change in whether or not OTDP applies based on whether the first filed application granted as a patent one day before or one day after the later-filed application:

versus

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.

Gilead Sciences, Inc. v. Natco Pharma Ltd. (Fed. Cir. 2014)
Panel: Chief Judge Rader and Circuit Judges Prost and Chen
Opinion by Circuit Judge Chen; dissenting opinion by Chief Judge Rader

St. Jude Medical, Inc. v. Access Closure, Inc. (Fed. Cir. 2013)

By Kevin E. Noonan --

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.

The patents in suit, U.S. Patent No. 7,008,439 (Janzen patent; claims 7, 8 and 9); 5,275,616, and 5,716,375 (Fowler patents, claim 14 and claim 21, respectively), were directed to apparatus, methods, or both for sealing vascular puncture that arises, inter alia, when a vein or artery is punctured as part of a medical procedure, and provides an alternative to applying direct pressure to seal the wound.  Regarding the Janzen patent, three claims were asserted below and considered by the Court in its opinion:

U.S. Patent No. 7,008,439:

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).

The following related patents are relevant to the double patenting issues before the Court:

• Grandparent application, USSN 07/746,339, now U.S. Patent No. 5,391,183
• Divisional application USSN 08/318,380, now U.S. Patent No. 5,830,130
• Continuation granted as Janzen patent, second continuation U.S. Patent 5,725,498

The U.S. Patent and Trademark Office imposed a restriction requirement in the '339 application ("the grandparent application), wherein Group I was directed to apparatus claims and Group II directed to method claims.  The Office also imposed an election-of-species requirement between Species A, B, and C:

• Species A:  Claims relating to the apparatus comprising a solid tissue dilator;
• Species B:  Claims relating to the apparatus comprising a hollow dilator and guidewire;
• 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.

The Court reiterated its interpretation of the statute:

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).

The opinion notes the basis in the regulations for election of species requirements (37 C.F.R. § 1.146):

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.

(emphasis added).

The key to the Court's decision in applying the statute in this instance is the italicized phrase "if no claim to the genus is found to be allowable," i.e., there is no generic claim in the grandparent application.  That is the case here, which results in the election of species being a restriction of the claims in the grandparent application for purposes of applying Section 121.  (The opinion notes that the restriction requirement in the grandparent application expressly stated the rule.)  This outcome is a rational one, according to the Court:

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.

ACI also appealed the District Court's determination that the claims of the Fowler patents were not obvious.  The following are the claims that were at issue:

U.S. Patent No. 5,275,616:

14.  A method of sealing an incision formed in the body of a patient wherein the incision extends generally from the skin of the patient; through the lumen of a blood vessel and into the blood vessel of a patient, the method including the steps of:
    forming a vessel plug of a material which is absorbable in the body of the patient and wherein the vessel plug is formed to include distal and proximal ends therein and is dimensioned to be received in the incision; and
    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.

(where the italicized portion of claim 14 recites the limitations of claim 9 from which claim 14 is a dependent claim); and,

U.S. Patent No. 5,716,375:

21.  An insertion assembly for sealing an incision in the body of a patient wherein the incision extends from the skin of the patient into a blood vessel of the patient, said insertion assembly comprising in combination:
    a vessel plug which is constructed of a material that is absorbable within the body of a patient and which seals the incision from the flow of blood therethrough; and
    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."

Judge Lourie provided a concurring opinion, which agreed with the result but rejected the panel's analysis elevating the election of species requirement to a formal restriction.  In Judge Lourie's view:

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.

St. Jude Medical, Inc. v. Access Closure, Inc. (Fed. Cir. 2013)
Panel: Circuit Judges Lourie, Plager, and Wallach
Opinion by Circuit Judge Plager; concurring opinion by Circuit Judge Lourie

In re Hubbell (Fed. Cir. 2013)

By Donald Zuhn --

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.

In 1998, some five years before the '509 application was filed, Dr. Hubbell moved from Caltech to Eidgenössische Technische Hochschule Zürich (ETH Zürich).  In 2002, the application that issued as the '685 patent was filed.  The '685 patent, which is jointly assigned to ETH Zürich and Universitat Zurich, lists Dr. Hubbell, Dr. Schense, and Shelly Sakiyama-Elbert as inventors (Anna Jen is also listed as an inventor on a Certificate of Correction).  Thus, the '509 application and '685 patent do not have common inventive entities or common owners.  Claim 1 of the '685 patent recites:

1. A fusion protein, comprising:
    (i) a first protein domain;
    (ii) a second protein domain; and
    (iii) an enzymatic or hydrolytic cleavage site between the first and the second domains;
    wherein the first domain is a growth factor selected from the group consisting of the platelet derived growth factor superfamily and the transforming growth factor beta (TGFβ) superfamily;
    wherein the second domain is a crosslinking Factor XIIIa substrate domain;
    wherein the enzymatic cleavage site is selected from the group consisting of proteolytic substrates and polysaccharide substrates, and
    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."

The majority also refused to create a new equitable right to resort to terminal disclaimers in cases such as this one.  Finally, with regard to Appellant's argument that the rejected claims should be reconsidered under a two-way obviousness analysis, rather than the standard one-way test, the majority noted that "the two-way test is appropriate only in the 'unusual circumstance' where 'the PTO is solely responsible for the delay in causing the second-filed application to issue prior to the first.'"  In the instant case, Appellants "cannot establish that the PTO is solely responsible for any delays associated with the claims on appeal," because Appellants' counsel before the Board "specifically conceded that Hubbell was partially responsible for the delay that caused the '685 patent to issue before the application claims," and as the majority explained:

[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.

Writing in dissent, Judge Newman begins by pointing out that:

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.

Following a short discussion of the evolution of the law of double patenting, Judge Newman concludes that:

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.

In re Hubbell (Fed. Cir. 2013)
Panel: Circuit Judges Newman, O'Malley, and Wallach
Opinion by Circuit Judge O'Malley; dissenting opinion by Circuit Judge Newman

Eli Lilly & Co. v. Teva Parenteral Medicines, Inc. (Fed. Cir. 2012)

By Kevin E. Noonan --

A three judge Federal Circuit panel went a long way towards disentangling its jurisprudence on the question of obviousness-type double patenting, in affirming a District Court finding that the doctrine did not apply to the patent claims at issue in Eli Lilly & Co. v. Teva.  In what seems to becoming a penchant of this Court (see "Momenta Pharmaceuticals Inc. v. Amphastar Pharmaceuticals, Inc.: 'The Rest of the Story'"), the panel distinguished its decision rather than simply finding the Court's most recent spate of decisions to have gone astray (see "Cert. Denied in Eli Lilly v. Sun Pharmaceuticals").

The present case concerns pemetrexed, a folate metabolism inhibitor synthesized by Professor Ed Taylor at Princeton University and developed by Eli Lilly & Co., sold as the anticancer drug Alimta® for treating mesothelioma and small cell lung cancer.  Pemetrexed's biological activity, as with earlier folate inhibitors like methotrexate, is understood to result from its structural similarity to naturally occurring folic acid, which is needed for DNA and RNA synthesis:

Earlier embodiments of folate inhibitors, like methotrexate, were disadvantageous because their effects on nucleic acid metabolism were felt by non-cancerous as well as cancer cells, due to their ability to inhibit cellular enzymes like dihydrofolate reductase (DHFR) that were needed for both DNA and RNA production.  Pemetrexed was able to specifically inhibit DNA synthesis by virtue of its specificity for enzymes such as thymidylate synthetase (because the nucleotide thymidine is incorporated into DNA but not RNA).

Princeton University obtained (and Eli Lilly licensed) three patents related to pemetrexed:  U.S. Patent No. 5,344,932 (the patent-in-suit); U.S. Patent No. 5,028,608 and U.S. Patent No. 5,248,775.  The '608 patent disclosed and claimed a related but structurally distinct antifolate compound, and the '775 patent disclosed a "family of chemical intermediates that can be used to make a variety of antifolates"; important for the issues on appeal, the '775 patent disclosed an intermediate in antifolate synthesis that can be used to make pemetrexed (along with a variety of other antifolate molecules).  The '608 and '775 patents expired prior to the instant suit, while expiration of the '932 patent was delayed until July 14, 2016 pursuant to patent term extension under 35 U.S.C. § 156.

Eli Lilly sued Teva, Barr Laboratories and APP Pharmaceuticals after each filed an ANDA, pursuant to 35 U.S.C. § 271(e)(2), asserting claims 1, 2, 3 and 7 of the '932 patent.  At the district court, the defendants asserted as a defense that the claims of the '932 patent were invalid under the judicially established doctrine of obviousness-type double patenting over claim 3 of the '608 patent (claiming a related but structurally distinct antifolate molecule) and claim 7 of the 775 patent (that claims the intermediate).  With regard to the '608 patent, Teva contended at trial that pemetrexed was related to the compound claimed by claim 3 of the '608 patent by substitution of a thienyl group with a phenyl group, something Teva asserted was "consistent with 'conventional wisdom' in the field [of the pharmaceutical arts]" and thus rendered the claims invalid.  As for the '775 patent, Teva's argument was that the pemetrexed compounds claimed in the '932 patent were a "use" of the intermediate compound disclosed in the '775 patent, and were invalid for double patenting under a line of Federal Circuit cases, the most recent of which was Sun Pharmaceuticals Industries, Ltd. v. Eli Lilly & Co.  In the alternative, Teva argued that pemetrexed was merely an obvious end product for the '775 patent intermediate.

The District Court found none of these arguments persuasive.  The Court rejected Teva's "focus" on the particular portion of pemetrexed that differed from the compound disclosed in the '608 patent, saying that the weight of the evidence was that the skilled worker would have "pursued changes outside of the aryl region to improve TS inhibition and would have avoided introducing a phenyl group into the '608 Compound based on previous reports of toxicity with analogous antifolate structures."  The basis for the District Court's rejection of Teva's obviousness-type double patenting argument over the disclosure of the '775 patent intermediate was that the intermediate was not claimed ("so the teachings from the '775 patent's specification were inapplicable to its obviousness-type double patenting analysis") and that there were many possible end products that could have been produced from the '775 patent intermediate and no reasoned basis for the skilled worker to have produced pemetrexed as the end product.

The Federal Circuit agreed, in an opinion by Judge Lourie joined by Judges Dyk and Wallach.  The panel rejected Teva's argument on appeal, that Federal Circuit precedent (specifically, Amgen Inc. v. Hoffmann-La Roche Ltd., 580 F.3d 1340 (Fed. Cir. 2009)), mandated that a court look only at the differences between the claims at issue and the earlier claims, "so that any features held in common between the claims -- in this case, all but the aryl regions of the '608 Compound and pemetrexed -- would be excluded from consideration."  The panel acknowledged that Amgen directs a court to identify the differences, but asserts that Amgen then requires that the claims at issue be considered "as a whole" and not "the differences [] in isolation."  The basis for this analytical framework is the rubric reasserted in Amgen that obviousness-type double patenting is assessed "analogous to an obviousness analysis under 35 U.S.C. §103."  And as in a § 103 analysis, claims must be considered "as a whole" in an obviousness-type double patenting analysis says the panel, citing General Foods Corp. v. Studiengesellschaft Kohle mbH, 972 F.2d 1272 (Fed. Cir. 1992).  "On the merits," the panel found no basis for finding clear error in the District Court's factual determinations underlying its judgment, and "absent any motivation to derive pemetrexed from the '608 Compound or reason to expect success in doing so," the panel concluded that the District Court had not erred in finding against Teva that the asserted claims of the '932 patent were not invalid for obviousness-type double patenting over the claims of the '608 patent.

Turning to Teva's obviousness-type double patenting arguments based on the teachings of the '775 patent, the panel noted that these argument's were rooted in earlier precedent, specifically citing In re Byck, 48 F.2d 665 (CCPA 1931), and Sun Pharmaceutical Industries, Ltd. v. Eli Lilly & Co., 611 F.3d 1381 (Fed. Cir. 2010).  But the panel found this reliance on these cases "unsound" and proceeded to distinguish this case from that precedent.  The panel began by citing the "general rule" that obviousness-type double patenting depends on a comparison with what is claimed in an earlier patent, "with the earlier patent's written description considered only to the extent necessary to construe its claims," citing In re Avery, 518 F.2d 1228, 1232 (CCPA 1975).  The panel then further reaffirmed the fundamental principles that the doctrine of obviousness-type double patenting is concerned with what is claimed, not what is disclosed, because the goal of the doctrine is to prevent separate patenting of merely obvious variants of a previously patented invention.

The opinion then characterized the line of cases relied upon by Teva as "a limited exception" to this rule.  The basis for this exception was set forth in Byck, wherein:

It would shock one's sense of justice if an inventor could receive a patent upon a composition of matter, setting out at length in the specification the useful purposes of such composition, manufacture and sell it to the public, and then prevent the public from making any beneficial use of such product by securing patents upon each of the uses to which it may be adapted.

Next, the Court turned to a "trio" of recent cases:  Sun Pharma, Geneva Pharm., Inc. v. GlaxoSmithKline PLC, 349 F.3d 1373 (Fed. Cir. 2003), and Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353 (Fed. Cir. 2008).  Each of these cases, according to the panel, resulted from situations where the second patent claimed a use of a composition claimed in an earlier patent that disclosed the later-claimed use.  According to the opinion, these cases each "address the situation in which an earlier patent claims a compound, disclosing the utility of that compound in the specification, and a later patent claims a method of using that compound for a particular use described in the specification of the earlier patent," citing Sun Pharma, and that in each case the later application (or patent) claimed "a, or the" disclosed use of the composition claimed in the earlier patent.  This analysis was enough by itself to distinguish the claims at issue here, because it was not disputed that the intermediate compound disclosed in the '775 patent (and the compound claimed in the '608 patent) were not the same compound claimed in the '932 patent, i.e., pemetrexed.  Under these circumstances, "[t]he particular concerns motivating our prior decisions are [] absent here" because the claims of the '932 patent were "wholly independent" of the claims of the '775 patent, according to the opinion.  And "[p]utting aside the teachings in the '775 patent's specification, Teva's double patenting contentions evaporate."  In addition, the panel noted that it had no basis for finding error in the District Court's conclusion that there was "no reason" the skilled worker would have chosen to make pemetrexed from the '775 patent intermediate, noting in passing that while not controlling, this conclusion was consistent with the provisions of the Manual of Patent Examining Procedure that states that:

[A]n intermediate product and a final product can be shown to be distinct inventions if the intermediate and final products are mutually exclusive inventions (not overlapping in scope) that are not obvious variants, and the intermediate product as claimed is useful to make other than the final product as claimed.  §806.05(j).

Finally, the panel found that the District Court had erred by refusing to consider so-called "secondary" considerations of non-obviousness, on the grounds that these considerations were not to be applied in an obviousness-type double patenting assessment (on the contrary, the opinion asserts that they must be considered).  But this was harmless error because the District Court had reached the correct conclusion in rejecting Teva's invalidity arguments based on obviousness-type double patenting.

The panel's opinion and discussion of the reasoning behind it appears to have cabined to a narrow category of facts the trio of decisions that applied the disclosure, as opposed to just the claims, of an earlier patent to make an obviousness-type double patenting determination on later-filed claims.  Under the revised interpretation of the obviousness-type double patenting standard enunciated by the Lilly court here, the claims of an earlier patent alone are to be considered for determining obviousness-type double patenting, except insofar as the disclosure of the earlier patent is necessary to construe the scope of the earlier claims, or unless the later application claims a use for a composition claimed in an earlier patent wherein the use itself is disclosed but not claimed in the earlier patent.  If this view is not further distinguished by a future panel, the Court may have brought some certainty to the application of the obviousness-type double patenting doctrine, consistent with their mandate from Congress to harmonize and clarify U.S. patent law.

Eli Lilly & Co. v. Teva Parenteral Medicines, Inc. (Fed. Cir. 2012)
Panel: Circuit Judges Lourie, Dyk, and Wallach
Opinion by Circuit Judge Lourie

Otsuka Pharmaceutical Co. v. Sandoz, Inc. (Fed. Cir. 2012)

By Andrew Williams --

On Monday, in Otsuka Pharmaceutical Co. v. Sandoz, Inc., the Federal Circuit clarified the differences between obviousness and obviousness-type double patenting for a chemical composition-of-matter invention.  Specifically, a new chemical compound is prima facie obvious if (1) a chemist of ordinary skill would have selected prior art compounds as a lead compounds, and (2) a reason or motivation for modifying the lead compounds to make the claimed compound with a reasonable expectation of success can be found in the prior art.  On the other hand, for obviousness-type double patenting, the lead compound is the previously claimed compound, so the first inquiry is not necessary.  However, the reason or motivation for modifying that previously claimed compound still needs to be found in the prior art.

The compound at issue in this case is aripiprazole, the active ingredient of Abilify®:

This compound is a "carbostyril derivative."  For the purposes of the appeal, the significant features of the compound included (1) the two hydrogen atoms connected at the 3 and 4 positions of the carbostyril ring, instead of the double bond between the 3 and 4 carbon atoms as found in the carbostyril moiety, (2) the butoxy linker at the 7-position of the ring, which has four methylene units as opposed to three found in a propoxy linker, and (3) the terminal phenyl ring is 2,3-dichloro substituted (because of the chlorine atoms connected to the 2 and 3 positions of this ring).  There were three asserted prior art "lead compounds" in this appeal.  The first was the "unsubstituted butoxy" as disclosed and claimed in an earlier Otsuka patent:

This compound differs from aripiprazole because it doesn't have the two chlorine substituents on the phenyl ring.  The second asserted lead compound was the "2,3-dichloro propoxy" compound:

This compound was disclosed in prior art foreign counterpart patents of Otsuka, and differs from aripiprazole because it has a propoxy linker at the 7-position of the carbostyril ring.  The final asserted lead compound was OPC-4392, an Otsuka development compound that had been tested in humans as a potential antipsychotic:

There are a few differences between this compound and aripiprazole:  OPC-4392 has a 2,3-dimethyl substituted phenyl ring, a propoxy linker, and the carbostyril ring contains a double bind at the 3,4-position.

Abilify® is marketed for the treatment of schizophrenia, bipolar disorder, irritability associated with autistic disorder in pediatric patients, and as an add-on treatment for depression.  The first drug for the treatment of schizophrenia, chlorpromazine, was discovered in the early 1950s.  It was found that this antipsychotic drug treated the "positive" symptoms of schizophrenia, including hallucinations and delusions (clearly "positive" in this case does not necessarily mean "desirable").  However, the "negative" symptoms of schizophrenia, such as flat affect, poverty of speech, inability to experience pleasure, lack of desire to form relationships, and lack of motivation, were not treated by the "typical" antipsychotics.  The first "atypical" antipsychotic, clozapine, was discovered in the early 1960s, and treated both the positive and negative symptoms of schizophrenia.  However, this drug had serious potential side effects.  In 1994, the FDA approved the first post-clozapine atypical antipsychotic, risperidone, and since then, the FDA has approved seven others, including aripiprazole in 2002.  However, aripiprazole is the only such compound that doesn't have a chemical structure related to either clozapine or risperidone.

Otsuka is the assignee of the patent at issue in this case, which claims aripiprazole, pharmaceutical compositions for treating schizophrenia, and methods of treating schizophrenia.  The Defendants in this case, Sandoz et al., Apotex Inc. and Apotex Corp., and Teva et al., all filed ANDAs to market generic versions of aripiprazole products.  These cases were consolidated, and reduced to a validity determination of the asserted patent after the Defendants conceded infringement.  The U.S. District Court for the District of New Jersey held a bench trial, and concluded that the Defendants failed to prove by clear and convincing evidence that the asserted claims would have been obvious to one of skill in the art, or that they were invalid for nonstatutory double patenting.  The Defendants appealed.

Obviousness of New Chemical Compounds

The Federal Circuit first considered whether aripiprazole was obvious over the three asserted lead compounds.  As indicated above, the first step of this inquiry is whether an asserted compound is, in fact, a lead compound, or in other words, whether the compound is "a natural choice for further development efforts," citing Altana Pharma AG v. Teva Pharm. USA, Inc., 566 F.3d 999 (Fed. Cir. 2009).  However, mere structural similarity between two compounds is not sufficient to establish that a prior art compound would have been a "lead" compound; rather there must be evidence of a compound's pertinent properties that would have provided a reason or motivation to select it.  Without such evidence, the analysis in no more than ex post reasoning.  The second step is determining if the reason or motivation for modifying the lead compound can be found in the prior art.  The Federal Circuit approved of the lower court's statement of the inquiry as:

The hypothetical person of skill in the art's identification of a lead compound, structural differences between the proposed lead compound and the claimed invention, motivation or teaching in the prior art to make the necessary changes to arrive at the claimed invention, and whether the person of skill in the art would have a reasonable expectation of success in making such structural changes.

The Court first considered whether the unsubstituted butoxy compound was a lead compound.  This compound is disclosed and claimed U.S. Patent No. 4,734,416 ("the '416 patent").  Generally, the '416 patent taught a genus with about nine trillion compounds, and explained that the compounds have antihistaminic action and central nervous controlling action.  However, Dr. Bryan Roth explained to the lower court that a skilled artisan would not have understood that all compounds in the genus would have potential antipsychotic activity.  The unsubstituted butoxy compound was also disclosed in the "Nakagawa declaration," submitted by one of the co-inventors in the prosecution of the '416 patent.  This declaration disclosed three sets of test data, the third of which was for "inhibiting jumping behavior in mouse induced by Methamphetamine and L-DOPA."  Even though schizophrenia and antipsychotic activity were not mentioned in the declaration, evidence was presented that such data could be indicative of such activity to a skilled artisan.  Nevertheless, out of the nine carbostyril derivatives tested, the two most potent had a 5-propoxy linker instead of a 7-butoxy linker.  The unsubstituted butoxy compound was of only middling potency.  At best, the Nakagawa declaration would have suggested that one of the two potent propoxy compounds would have been a potential lead compound.  Because these were not suggested as lead compounds for the development of aripiprazole, neither the '416 patent nor the Nakagawa declaration supported the selection of the unsubstituted butoxy compound as a lead compound.

The Federal Circuit also determined that the Defendants failed to prove that aripiprazole would have been obvious over the 2,3-dichloro propoxy.  It is true that this compound was disclosed in a foreign application.  However, the compound was disclosed "as one among hundreds of examples that may be useful for an extensive list of potential central nervous system controlling activities."  Without a teaching that would tie the 2,3-dichloro propoxy to any meaningful suggestion of antipsychotic activity, this compound could not be considered a lead compound.  The Court distinguished Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348 (Fed. Cir. 2007), because in that case the prior art reference not only provided ample motivation to narrow the prior art genus, it also predicted the results.  There was no such analogous showing in this case.

The Court similarly concluded that with respect to the final prior art compound, OPC-4392, it was not shown that it would have been selected as a lead compound because none of the evidence was sufficient to demonstrate this.  For example, the Defendants alleged that a Murasaki 1987 reference disclosed that the compound was an anti-psychotic drug, but that reference instead taught that the anti-psychotic action of OPC-4392 was not very strong.  Moreover, even if OPC-4392 was selected as a lead compound, there was no proof that the prior art taught or provided the motivation to modify this compound in the three specific ways required to arrive at aripiprazole.  The Court rejected the argument that Otsuka took a very small amount of time to develop aripiprazole from OPC-4392 as evidence of its obviousness, because an inventor's own path can never lead to a conclusion of obviousness.  Without the prima facia case of obviousness in view of these asserted three lead compounds, the Federal Circuit did not address the objective evidence of nonobviousness.

Obviousness-type Double Patenting of Chemical Compounds

The Federal Circuit agreed with the District Court that the claims to aripiprazole were not invalid for nonstatutory double patenting over claims to the unsubstituted butoxy compound claimed in the '416 patent.  In doing so, the Federal Circuit clarified what the analysis is for chemical compounds.  First, even though the determination for obviousness-type double patenting is analogous to the 35 U.S.C. § 103 analysis, there are potential differences.  For example, for chemical compounds, the initial inquiry as to whether a compound is a "lead compound" is unnecessary, because the compound is explicitly set forth by the asserted claim.  Nevertheless, even though there are differences between the two inquiries, one commonality is that it is still necessary to establish that the prior art would have supplied the motivation to modify the earlier compound with a reasonable expectation of success.  Because this motivation was not established, the Federal Circuit concluded that the claims were not invalid.

Otsuka Pharmaceutical Co. v. Sandoz, Inc. (Fed. Cir. 2012)
Panel: Circuit Judges Lourie, Moore, and Reyna
Opinion by Circuit Judge Lourie

Cert. Denied in Eli Lilly v. Sun Pharmaceuticals

By Kevin E. Noonan --

The Supreme Court refused today to grant certiorari in Eli Lilly & Co. v. Sun Pharmaceutical Industries, Ltd. on the question of obviousness-type double patenting.  In doing so, the Court let stand precedent that seriously expands the scope of the obviousness-type double patenting standard, turning a legal principle that was "clear" to one "distorted by divergent statements[] leading to [a] flawed ruling," according to Judge Newman (joined by Judges Lourie and Linn and Chief Judge Rader) in dissent from denial of Eli Lilly's petition for rehearing en banc.

To recap, a Federal Circuit panel (opinion by Judge Prost, joined by Judges Gajarsa and Bryson) affirmed the District Court judgment that claims of Eli Lilly's U.S. Patent No. 5,464,826 ("the '826 patent) were invalid for obviousness-type double patenting over another Lilly patent, U.S. Patent No. 4,808,614 ("the '614 patent") (see Patent Docs report).  The '614 patent claims gemcitabine, and methods of using gemcitabine to treat viral infections, while the '826 patent claims methods of using gemcitabine for treating cancer.  Eli Lilly markets the drug GEMZAR®, which contains gemcitabine as the active ingredient, for the treatment of various forms of cancer.  Accordingly, both the '614 and '826 patents were listed in the Orange Book with respect to GEMZAR®.  Sun filed an ANDA in 2006 to market a generic version of GEMZAR®, and filed a declaratory judgment action in 2007, asserting, among other things, that the '826 patent was invalid.  The U.S. District Court for the Eastern District of Michigan granted Sun's motion for partial summary judgment that the asserted claims of the '826 were invalid based on obviousness-type double patenting.

The history of these patents and their interrelationship were important factors leading to the panel decision.  The '614 patent was a continuation-in-part of a priority patent that disclosed gemcitabine and its antiviral activity.  The application that eventually gave rise to the '614 patent contained additional disclosure regarding the anticancer activities of gemcitabine but contained no claims to this activity.  The '826 patent, in an application filed on the same day as the application that resulted in the '614 patent, both disclosed and claimed this activity and methods for exploiting the anticancer properties of gemcitabine in methods for treating cancer with the drug.  Thus, the '614 patent was entitled to the priority claim to the original patent while the '826 patent was not.

The panel opinion relied on two earlier cases, Geneva Pharm., Inc. v. GlaxoSmithKline PLC, 349 F.3d 1373 (Fed. Cir. 2003), and Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353 (Fed. Cir. 2008) in deciding that the '826 claims were invalid over the '614 patent in obviousness-type double patenting grounds.  These cases can be distinguished, however, since in both cases the specifications disclosed one and only one activity (or use) for the claimed compound, not (as here) an additional, new use.  Also, the panel used what was disclosed, rather than just what was claimed in the '614 patent in making its obviousness-type double patenting rejection of the '826 patent, and this is where the opinion veered significantly from prior precedent.  In doing so, the panel created a per se rule of obviousness-type double patenting that, while promoting certainty also "upsets the settled expectations of the patenting community" by significantly expanding the scope of the obviousness-type double patenting doctrine.

Specifically, under the rule established by the panel opinion, if the earlier of two co-owned patents includes claims to a compound and discloses one or more uses for the compound in the specification, under the Federal Circuit's ruling any claim(s) in a later patent to any method of use disclosed (but not claimed) in the specification of the earlier patent are per se invalid based on obviousness-type double patenting.  This rule is contrary to prior case law, both in removing flexibility in considering the effect of the later patent on "improperly extending 'protection, beyond the date of expiration of the [earlier] patent, of the very same invention claimed therein . . . or of a mere variation of that invention which would have been obvious to those of ordinary skill in the relevant art,'" In re Kaplan, 789 F.2d 1574, 1579-80 (Fed. Cir. 1986), but also by collapsing the obviousness-type double patenting analysis into obviousness under 35 U.S.C. § 103 (using the patentee's own prior patent as if it were prior art under 35 U.S.C. § 102).  This constitutes a new, non-statutory type of prior art, a patentee's own prior patent application that was not "by another" and did not constitute a statutory bar (i.e., the patentee's own earlier work disclosed more than a year before the later application's filing date).  This is expressly contrary to the Federal Circuit's earlier precedent, e.g., General Foods Corp. v. Studiengesellschaft Kohle mbH, 972 F.2d 1272 (Fed. Cir. 1992), that a commonly owned, prior patent disclosure cited in support of a double patenting rejection cannot be used as though it were prior art.  Specifically, the earlier-filed patent disclosure is not to be considered in making an obviousness-type double patenting rejection.  In re Kaplan, 789 F.2d 1574 (Fed. Cir. 1986).

Despite this disjunction between prior precedent and the panel opinion, the Federal Circuit declined to rehear the case en banc, in a 5-4 ruling from a diminished number of active judges.  Thus, Eli Lilly's only recourse was to appeal to the Supreme Court; however, consideration by the Court was unlikely, for several reasons.  First, the Supreme Court is a generalist court interested in the more significant, "high profile" cases that have characterized the Court's patent jurisprudence for the past decade (including KSR Int'l Co. v. Teleflex Inc., eBay Inc. v. MercExchange, LLC, Quanta Computer, Inc. v. LG Electronics, Inc., Microsoft Corp. v. AT&T Corp., Dickinson v. Zurko).  The obviousness-type double patenting doctrine lies deep in the minutiae of patent law and was unlikely to attract the Court's attention.  The Court also takes interest in patent law questions from the Federal Circuit where the court seems divided (such as Warner-Jenkinson Co. v. Hilton Davis Chemical Co. and Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co.).  This question was important (for the pharmaceutical industry in general) but it will take the Federal Circuit in its entirety to choose a case where the irregularities introduced into this important patent law doctrine will be set straight.

Patent Docs filed an amicus case in support of certiorari in this case.

Washington Legal Foundation Files Amicus Brief in Sun Pharmaceutical Industries, Ltd. v. Eli Lilly & Co.

By Kevin E. Noonan --

The Washington Legal Foundation (WLF), a self-styled "non-profit public interest law and policy center that regularly appears before federal and state courts to promote economic liberty, free enterprise, and a limited and accountable government," filed an amicus curiae brief on September 8th, urging the Federal Circuit to rehear en banc Eli Lilly's appeal of the Court's affirmance of an invalidity finding of U.S. Patent 5,464,826.  The Federal Circuit affirmed a District Court determination that the claims of the '826 patent were invalid over the claims of Lilly's U.S. Patent No. 4,808,614 under the judicially-created doctrine of obviousness-type double patenting.  The '826 patent claimed methods for using gemcitabine (sold by Lilly under the name GEMZAR®) for treating cancer, and the earlier '614 patent disclosed but did not claim this use.  The lawsuit between the parties arose after Sun filed an ANDA for generic gemcitabine, and Sun Pharmaceuticals filed a declaratory judgment action that the '614 and '826 patents (both of which were listed in the FDA's Orange Book) were invalid.

The Federal Circuit in its panel decision based affirmance on its earlier decisions in Geneva Pharm., Inc. v. GlaxoSmithKline PLC, 349 F.3d 1373 (Fed. Cir. 2003), and Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353 (Fed. Cir. 2008), that the only type of applications that qualify for the "safe harbor" provisions of 35 U.S.C. § 121 were divisional applications, i.e., applications filed in response to a Patent Office-promulgated restriction requirement.  Restriction is proper if the Office determines that an application claims more than one patentably-distinct invention, and the safe harbor protects applicants from inconsistent determinations from the Office that the claims are patentably-distinct for restriction purposes but fall within the scope of the obviousness-type double patenting doctrine.

Here, the '614 patent was a continuation-in-part of an earlier-filed application whose description of methods of using gemcitabine were limited to the compound's antiviral activities.  The '826 patent, which arose from an application filed on the same day as the '614 patent, claimed the use of gemcitabine for treating cancer.  The District Court's obviouness-type double patenting determination as well as the Federal Circuit's affirmance were ultimately grounded in the policy considerations enunciated in Pfizer and Geneva Pharm.:

It would shock one's sense of justice if an inventor could receive a patent upon a composition of matter, setting out at length in the specification the useful purposes of such composition, . . . and then prevent the public from making any beneficial use of such product by securing patent upon each of the uses to which it may be adapted.

Pfizer, 518 F.3d at 1368 n.8; Geneva Pharm., 349 F.3d at 1386.

The WLF objects to this "expansion" of the obviousness-type double patenting doctrine in its amicus brief.  The group argues that the Court's decisions threaten to lower the incentive to innovate by limiting a patentee's ability to protect improvements in their inventions.  Citing Miller v. Eagle Mfg. Co., 151 U.S. 186, 198 (1894), the brief argues that it is settled law that "an inventor may obtain 'a separate patent' for a 'new improvement on his own invention.'"  Id. at 199.  Indeed, the brief argues that "[h]ad anyone other than Eli Lilly discovered this method of treating cancer with gemcitabine, quite clearly they would have been entitled to a patent," citing Lilly's brief in support of its petition for rehearing en banc.  WLF's brief also argues that "Miller specifically precludes the possibility that a patent that merely describes a separately patentable invention renders another patent claiming that invention invalid under the doctrine of double patenting." 151 U.S. at 198, an interpretation directly contrary to the panel decision here.

The brief recognizes that the panel believes that its decision was consistent with the Geneva Pharm. decision, but distinguished this case by characterizing the panel decision here as "extending" the holding in Geneva Pharm -- specifically, asserting that in that case, a compound and its "only" use were not patentably distinct, whereas gemcitabine had "two separate methods of use," making Takeda v. Doll, 561 F.3d 1372 (Fed. Cir. 2009), the appropriate prior precedent.  In the Takeda case, the Court held that a later-claimed method of making a claimed pharmaceutical was patentably distinct provided that "a second method of making the same pharmaceutical was discovered before the filing of the application that led to the second patent."  Id. at 1377.  Since the application leading to the '826 patent was filed on the same day as the invalidating '614 patent, "the new method necessarily was discovered prior to the filing of either patent" (emphasis in original).  Thus, the brief concludes, "discovery of the second method of using the compound should have rendered both the new method and the older method patentably distinct from the compound."

The brief also notes that the Court's decision here is contrary to Patent Office restriction practice, which "categorically barred an applicant from presenting claims to a compound and two distinct methods of using that compound.  37 C.F.R. §§ 1.141(a)-(b) (1984)."  Had Lilly presented claims to both methods of use in the same patent, the brief argues that the application would have been subject to a restriction requirement, which would have forced these claims to be pursued in two separate patents.  This part of the brief implies strongly that it is equally "a shock to a sense of justice" to have substantive rights so influenced by procedural details of whether the claims are presented in the same or separate applications (an argument that depends on the unique facts here that the '614 and '826 application were effectively filed on the same day), in view of these established rules of practice.  The brief argues that the en banc Court should solicit the PTO's views on this question.

Eli Lilly & Co. v. Teva Pharmaceuticals USA, Inc. (Fed. Cir. 2010)

By Kevin E. Noonan --

The old proverb "success has many fathers, while failure is an orphan" comes to mind when considering the Federal Circuit's decision in Eli Lilly & Co. v. Teva Pharmaceuticals USA, Inc.  In the Court's decision, repeated failures, even by Lilly scientists in developing its osteoporosis drug Evista® (raloxifene hydrochloride), were sufficient to defeat Teva's counterclaim that patent claims related to methods of use were obvious.

The action arose following Teva's ANDA filing containing a Paragraph IV certification that the patents-in-suit were invalid (there was no discussion in the opinion of any inequitable conduct allegations below).  The patents fell within three broad categories, and included the Bone Loss patents (U.S. Patent No. 6,906,086 and Reissue Patents Nos. RE39,049; and RE38,968), the Low Dose patent (Reissue Patent No. RE39,050) and the Particle Size patents (U.S. Patents Nos. 6,458,811 and 6,894,064).  Specific claims representative of the patents-in-suit include the following:

Claim 1 of the '086 patent (Bone Loss patent):

A method of inhibiting post-menopausal bone loss in a post-menopausal woman in need of treatment to prevent or treat post-menopausal osteoporosis comprising administering a single daily oral dose to said woman of an effective amount of [raloxifene] hydrochloride.

Claim 14 of the '050 reissue patent (Low Dose patent):

A method of preventing post-menopausal osteoporosis in a post-menopausal woman in need of treatment to prevent post-menopausal osteoporosis comprising administering to said woman a hydrochloride salt of . . . [raloxifene] in an amount of 60 mg/day.

Claim 1 of the '811 patent (Particle Size patent; emphasis added):

A compound of formula I . . . [raloxifene] and pharmaceutically acceptable salts and solvates thereof, characterized in that the compound is in particulate form, said particles having a mean particle size of less than about 25 microns, at least about 90% of said particles have a size of less than about 50 microns.

The District Court (Judge Sarah Evans Parker) found the Bone Loss and Low Dose patents not invalid under §§ 103 and 112, 1st paragraph (enablement), but that the Particle patents were invalid for failing to satisfy the written description requirement under 112, 1st paragraph, and granted a permanent injunction keeping generic raloxifene hydrochloride off the market until Lilly's patents expire.

Relevant to the Federal Circuit's analysis was the developmental history of raloxifene.  Originally pursued as an "antiestrogen" breast cancer treatment (similar in mode of action to tamoxifen), clinical experience with the drug showed low bioavailability in humans (despite significant bioavailability in experimental animals).  This result appeared to be related to the presence of free hydroxyl groups in raloxifene that were modified by conjugation with glucaronide as part of the detoxification and elimination pathways in humans.  The Court cited several prior art references disclosing low bioavailability and that raloxifene underwent "rapid metabolic conversion."  These included the Buzdar reference (1988) that disclosed results showing that raloxifene elicited no complete or partial responses for breast cancer patients resistant to tamoxifen (although the reference did not directly attribute these results to low bioavailability).  These bioavailability concerns regarding raloxifene were an express ground for the District Court to find that Lilly's claims for its Bone Loss and Low Dose patents were non-obvious, since the known low bioavailability for raloxifene would have precluded the skilled worker from having a reasonable expectation that the drug would be clinically useful for treating osteoporosis.

In its opinion, written by Chief Judge Rader joined by Judge Linn and Judge Prost, the Court affirmed the District Court's determination that Teva had not provided clear and convincing evidence that the claims of the Bone Loss or Low Dose patents were obvious.  On appeal, Teva argued three prior art references in support of its obviousness arguments.  U.S. Patent No. 5,075,321 (Schreiber patent) disclosed the use of raloxifene for treating autoimmune disorders (and according to the opinion was the basis for Lilly reissuing three of the patents-in-suit).  The Court found that this reference did not provide clear and convincing evidence of obviousness, because osteoporosis is not an autoimmune disease, and the evidence suggested different mechanisms of action.  "Without a closer relationship, Teva cannot show that an ordinarily skilled artisan would have expected Dr. Schrieber's article to have relevance for the treatment of postmenopausal osteoporosis," the Court said.  The opinion also rejected Teva's argument that the reference is relevant for showing clinically-significant bioavailability for raloxifene, based on the different uses (osteoporosis versus autoimmune disorders) as well as the fact that what was prior art in the Schrieber reference was based on animal studies that did not address the bioavailability issue in humans.

The second reference, a scientific journal article by Jordan, disclosed rat studies on the effects of tamoxifen and raloxifene on bone density.  According to the Court's opinion, "Dr. Jordan concluded that these results 'may have important implications for the clinical [human] applications of antiestrogens'" and that "'[i]t is possible . . . that in the future, tamoxifen could be considered to be used as a substitute for estrogen [for the prevention of osteoporosis in postmenopausal women]'" (emphasis added).  The reference also contained an assertion calling for clinical investigation of the use of tamoxifen for treating osteoporosis.  Unfortunately for Teva's argument, the Federal Circuit did not consider these teachings relevant for the use of raloxifene, because the reference suggested that tamoxifen, not raloxifene, be explored for use as an osteoporosis treatment.  In addition, not only was the reference silent as to the bioavailability issue, but the opinion cited the District Court's reasoning that the Jordan reference "exemplified" the bioavailability concerns with raloxifene and that the skilled worker "'would not have had a reasonable expectation of success in using raloxifene to treat human postmenopausal osteoporosis.'"  The Federal Circuit particularly faulted the portion of Teva's arguments relying on how Lilly scientists interpreted the Jordan results in support of its case for obviousness, since these inventors have greater than ordinary skill.  In addition, the Lilly scientists possessed internal information relating to the capacity for conjugation of raloxifene to be reversed in vivo (resulting in improved bioavailability), but this knowledge was also unavailing in support of Teva's arguments the court held, relying on KSR Int'l. Co. v. Teleflex Inc. ("The question is not whether the combination was obvious to the patentee but whether the combination was obvious to a person of ordinary skill in the art.")  Not expressly stated in the Court's opinion was the extent to which its determination was affected by Lilly scientists possessing information not within the knowledge of the worker of ordinary skill.

Finally, with regard to the Jones patent (which disclosed raloxifene), the opinion relied on this patent having been filed before any of the bioavailability results were obtained or concerns were raised, and that "[t]he record does not contain any reason that a person of ordinary skill would have ignored those later publications."  The Court also said that further evidence, specifically the results of the "failed" Buzdar study, would have precluded the skilled worker from having a reasonable expectation of success using raloxifene.  The Court rejected Teva's arguments that the Buzdar reference did not attribute its results to bioavailability issues, saying the skilled worker could draw that inference.

The Court came to the same conclusions and affirmed the lower court's non-obviousness determination for the claims of the Low Dose patent.  On appeal, Teva also argued that these claims were invalid under the doctrine of obviousness-type double patenting, based in part on the District Court's finding that the nature of the experiments to determine a clinically-effective low dose were routine (in its analysis addressing Teva's enablement challenge to these claims).  The Federal Circuit noted that this challenge was not raised below, and that the "record is insufficiently clear for it to conclude that the proper resolution is beyond any doubt."  Possibly significant (in view of the several recent instances of claims being invalidated for obviousness-type double patenting), the Court expressly stated that the policy rationales raised by Teva (that these patents extended Lilly's exclusivity term for Evista®) were not great enough to overcome the procedural deficiencies.

Teva also challenged the Bone Loss and Low Dose patents in the District Court on enablement grounds, and the Federal Circuit also affirmed the District Court's determination that the claims of these patents were enabled.  Teva's enablement challenge sounded in operability under 35 U.S.C. § 112, 1st paragraph (which the Court has held has its own utility requirement distinct from the utility requirement under § 101; In re Brana).  Here, the opinion cites the Manual of Patent Examining Procedure for its provisions relating to the effect of human clinical trials on the question of operability raised under 35 U.S.C. § 112, 1st paragraph (i.e., that having an on-going clinical trial is evidence that the invention is sufficiently operable for patenting purposes):

Before a drug can enter human clinical trials, the sponsor, often the applicant, must provide a convincing rationale to those especially skilled in the art (e.g., the Food and Drug Administration) that the investigation may be successful.  Such a rational would provide a basis for the sponsor's expectation that the investigation may be successful.  In order to determine a protocol for phase I testing, the first phase of the clinical investigation, some credible rationale of how the drug might be effective or could be effective would be necessary.  Thus, as a general rule, if an applicant has initiated human clinical trials for a therapeutic product or process, Office personnel should presume that the applicant has established that the subject matter of that trial is reasonably predictive of having the asserted therapeutic utility.  MPEP (2008) § 2107.03 at IV (emphasis added).

The Court's opinion recognized that Teva's arguments relate to an inherent "Catch 22" regarding the relationship between the enablement requirement and the lack of a reasonable expectation of success in an obviousness determination:

To the extent that Teva revisits this [obviousness] argument in the enablement context, it appears to contend that Lilly's actions provide circumstantial evidence that an ordinarily skilled artisan would not have found helpful the facts on which the district court relied to hold that the patents are enabled.  This court rejects that argument as well, and for essentially the same reason:  it conflates the expertise of Lilly scientists with the knowledge of one of ordinary skill in the art.  . . .  Indeed, Lilly appears to have had many advantages that a person of ordinary skill would not have had, not the least of which was the FDA's prior approval of Lilly's IND application.  Lilly's reliance on those advantages rather than its knowledge of Black's conjugate studies [relating to greater than expected bioavailability] to proceed with human trials does not create clear and convincing evidence that a person of ordinary skill would fail to find comfort in the latter.

The Federal Circuit also affirmed the District Court's finding that the asserted claims of the Particle Size patents were invalid for failure to satisfy the written description requirement of 35 U.S.C. § 112, 1st paragraph.  These patents disclosed a range of particle sizes that increased bioavailability, wherein "within the claimed particle size range, the raloxifene particles provide 'surprisingly consistent in vivo absorption/bioavailability characteristics.'"  The District Court construed the relevant claim language, "in particulate form," to include the size of the particles either in the pure active pharmaceutical ingredient (API) or in the tablet after formulation (which construction benefited Lilly's contention that the API had been prepared with easily-dissociated particles so that the API, but not the formulated tablet, would fall outside the scope of the Particle Size patent claims).  Unfortunately for Lilly, however, the District Court found that the patent specifications did not disclose or describe determining particle size in the formulated tablet, and the Federal Circuit agreed:

[A]fter reading the patent, a person of ordinary skill in the art would not understand how to extract raloxifene particles from a formulation in order to determine whether they fall within the claimed particle size range and, in fact, would have no indication that size measurements on anything other than unformulated raloxifene would bear any relevance to the invention.

The Court affirmed, because since satisfaction of the written description requirement is a question of fact, it could not find that the District Court's decision was clearly erroneous, in particular due to admissions by Lilly's own expert regarding whether these embodiments were disclosed.

Since the Federal Circuit affirmed the District Court's decision that neither the Bone Loss nor the Low Dose patents are invalid, the injunction preventing Teva from providing generic raloxifene hydrochloride stands until expiration of the last expiring of these patents (March 2, 2014).

Eli Lilly & Co. v. Teva Pharmaceuticals USA, Inc. (Fed. Cir. 2010)
Panel:  Chief Judge Rader and Circuit Judges Linn and Prost
Opinion by Chief Judge Rader

Sun Pharmaceutical Industries, Ltd. v. Eli Lilly & Co. (Fed. Cir. 2010)

By Andrew Williams --

On Wednesday, in Sun Pharm. Indus., Ltd. v. Eli Lilly & Co., the Federal Circuit affirmed a finding that claims of Lilly's U.S. Patent No. 5,464,826 ("the '826 patent) were invalid for obviousness-type double patenting over U.S. Patent No. 4,808,614 ("the '614 patent").  The '614 patent claims gemcitabine, and methods of using gemcitabine to treat viral infections, while the '826 patent claims methods of using gemcitabine for treating cancer.  Lilly markets the drug GEMZAR, which contains gemcitabine as the active ingredient, for the treatment of various forms of cancer.  Correspondingly, both the '614 patent and the '826 patent were listed in the Orange Book with respect to GEMZAR.  Sun filed an ANDA in 2006 to market a generic version of GEMZAR, and filed a declaratory judgment action in 2007, asserting, among other things, that the '826 patent was invalid.  Ultimately, the U.S. District Court for the Eastern District of Michigan granted Sun's motion for partial summary judgment because the asserted claims of the '826 were invalid based on obviousness-type double patenting.

Lilly's '614 patent was a continuation-in-part ("CIP") application of U.S. Application No. 06/473,883 ("the '833 application").  The original '833 application only described gemcitabine's antiviral activity.  However, when the CIP application was filed, the specification was amended to include the observation that "certain compounds of the present invention have also demonstrated excellent oncolytic activity in standard cancer screens" ('614 patent, col. 17, ln. 54-56).  Nevertheless, the '614 patent did not claim any methods of treating cancer.  In fact, Sun and Lilly did not dispute that the '614 patent was entitled to the benefit of the '833 application filing date.  On the same date that Lilly filed the application that resulted in the '614 patent, it also filed an application that gave rise to the '826 patent.  Because both of these applications were filed prior to 1995 (December 4, 1984 to be exact), the patent term was calculated based on the issue date.  Lilly obtained patent term extension for the '614 patent, and as a result, the patent expired on May 15, 2010.  The '826 patent was set to expire two-and-a-half years later, on November 7, 2012.  Lilly did not file a terminal disclaimer.

The Federal Circuit agreed with the District Court in finding that this case was analogous to the prior decisions in Geneva Pharm., Inc. v. GlaxoSmithKline PLC, 349 F.3d 1373 (Fed. Cir. 2003), and Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353 (Fed. Cir. 2008).  In Geneva Pharm., an earlier patent claimed the compound potassium clavulanate, and the specification disclosed its utility in inhibiting B-lactamase, while a later patent claimed the method of using the compound to inhibit B-lactamase.  Because the second patent did no more than claim the previously disclosed utility of a previously claimed compound, the two patents were not patentably distinct.  In Pfizer, an earlier patent claimed several COX-2 inhibitors, and disclosed that they could be used to treat both inflammation and inflammation-associated disorders.  A later patent claimed these previously disclosed methods of use.  Again, the Court found that these two patents were not patentably distinct.

Lilly asserted two reasons why the present case was different from both Geneva Pharm. and Pfizer.  First, Lilly pointed out that in the earlier cases, there was only one disclosed utility -- the methods of use that were claimed in the later patents.  In contrast, Lilly's earlier patent disclosed more than one utility -- treating viral infections and cancer.  Because the treatment of cancer was not the "essential utility," Lilly argued, the two patents were patentably distinct.  The Court rejected this argument because the Pfizer case, in fact, did involve more than one essential utility -- the treatment of inflammation, and the treatment of inflammation-associated disorders.  Of course, the Court does not address whether these were results of the same utility, namely, whether the treatment of the inflammation-associated disorders would flow naturally from the treatment of the inflammation.  But, on the other hand, it is not clear from the discussion whether the anti-cancer properties of gemcitabine would not naturally result from the treatment of the viral infections.  Nevertheless, the Court determined that the holdings of Geneva Pharm. and Pfizer extend to any and all uses disclosed in the earlier specification.

The Federal Circuit also rejected Lilly's second argument that the trial court erred in consulting the specification of the issued patent instead of the specification of the priority document, the '833 application.  In support of this argument, Lilly relied on claim construction concepts as articulated in Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005).  Specifically, Lilly argued that a claim term should be given its ordinary and customary meaning as understood by one of ordinary skill in the art at the time of invention.  Gemcitabine's anti-cancer properties were unknown at the time the '614 patent was invented.  However, the Federal Circuit pointed out that its claim construction precedent establishes that claim terms must be construed in light of the entire issued patent, and therefore found no support for Lilly's argument.

Ultimately, the Federal Circuit appears to justify its decision on the policy considerations as articulated in both Pfizer and Geneva Pharm.:

It would shock one's sense of justice if an inventor could receive a patent upon a composition of matter, setting out at length in the specification the useful purposes of such composition, . . . and then prevent the public from making any beneficial use of such product by securing patent upon each of the uses to which it may be adapted.

Pfizer, 518 F.3d at 1368 n.8; Geneva Pharm., 349 F.3d at 1386.

Sun Pharmaceutical Industries, Ltd. v. Eli Lilly & Co. (Fed. Cir. 2010)
Panel: Circuit Judges Bryson, Gajarsa, and Prost
Opinion by Circuit Judge Prost

Re-examination Ordered on "Expired" Harvard Oncomouse Patent

    By Kevin E. Noonan --

On Monday, the U.S. Patent and Trademark Office granted an ex parte reexamination request for U.S. Patent No. 5,925,803, the latest-filed and last-granted member of the Harvard Oncomouse patent family.  Remarkable about the petition is that the third party requester (TPR), Ellen Gonzales of Gonzales Patent Services, contends that the '803 patent has expired by operation of a terminal disclaimer filed in an earlier-filed application, but maintains that despite the putative expiration, the Office retains jurisdiction to consider the re-examination request.

There are three claims in the '803 patent, all directed to methods for testing a compound suspected to be a carcinogen:

1.  A method of testing a material suspected of being a carcinogen, comprising exposing a transgenic mouse to said material and detecting neoplasms as an indication of carcinogenicity, wherein the germ cells and somatic cells of said mouse contain an activated oncogene sequence introduced into said mouse, or an ancestor of said mouse, at an embryonic stage.

2.  A method of testing a material suspected of conferring protection against the development of neoplasms, said method comprising
    (1) providing a first and a second transgenic mouse, the germ cells and somatic cells of which contain an activated oncogene sequence introduced into said mice, or an ancestor of said mice, at an embryonic stage,
    (2) treating said first mouse with said material, and
    (3) detecting, as an indication of said protection, a reduced incidence of development of neoplasms in said first mouse, compared to the incidence in said second mouse, which is not so treated.

3.  The method of claim 1, further comprising exposing said first and second mice to a carcinogen prior to, after, or simultaneously with treating said first mouse with said material.

The TPR asserted six substantial new questions (SNQ) of patentability against these claims:

• SNQ1:  Claim 1 of the '803 Subject Patent is obvious in view of Claims 1, 11, and 12 of [grandparent U.S. Patent No. 4,736,866] in view of Ward et al. or Schach et al. under the doctrine of judicially-created obviousness-type double patenting.

• SNQ2:  Claims 1-3 of the '803 Subject Patent are unpatentable in view of the Claims 1-12 of the '866 Grandparent Patent under the doctrine of judicially-created obviousness-type double patenting.

• SNQ3:  Claims 2-3 of the '803 Subject Patent are obvious in view of the claims of the '866 Grandparent Patent in view of the Proctor Patent, under the doctrine of judicially-created obviousness-type double patenting.

• SNQ4:  Claims 1-3 of the '803 Subject Patent are obvious under 35 U.S.C. 103(a) in view of Schwab et al.

• SNQ5:  Claims 2-3 of the '803 Subject Patent are obvious under 35 U.S.C. 103(a) over Jaenisch et al. in view of the Proctor patent.

• SNQ6:  Claim 1 of the '803 Subject Patent is obvious under 35 U.S.C. 103(a) over Jaenisch et al. in view of the either Ward et al. or Schach et al.

TPR contends that the following describes the priority chain and the relationship between the grandparent '866 patent, parent U.S. Patent No. 5,087,571, and the '803 patent.  The '866 patent, according to the TPR, contained claims 1-12 directed to the Harvard oncomouse; claims 13-19 directed to methods for testing a compound suspected of being a carcinogen; and claims 20-22 directed to plasmid constructs; claim 1 is representative:

1.  A transgenic non-human mammal all of whose germ cells and somatic cells contain a recombinant activated oncogene sequence introduced into said mammal, or an ancestor of said mammal, at an embryonic stage.

The TPR contends in her request that the applicant cancelled the claims to the testing methods and let claims to the Harvard Oncomouse proceed to grant as the '866 patent.

The application that gave rise to the parent '571 patent, the TPR contends, was improperly designated as a "divisional application," despite the fact that no restriction requirement was raised against any of the claims of the '866 patent and that the patentee voluntarily cancelled the testing method claims in the '866 patent as part of their patenting strategy.  This application was filed initially with original claims 13-24 that had been cancelled during prosecution of the '866 patent.  Prosecution of the '571 patent resulted in two granted claims:

1.  A method of providing a cell culture comprising
    (1) providing a transgenic non-human mammal, all of whose germ cells and somatic cells contain a recombinant activated oncogene sequence introduced into said mammal, or an ancestor of said mammal, at an embryonic stage; and
    (2) culturing one or more of said somatic cells.

2.  A cell derived from a somatic cell obtained from a transgenic non-human mammal, all of whose germ cells and somatic cells contain a recombinant activated oncogene sequence introduced into said mammal, or an ancestor of said mammal, at an embryonic stage which cell contains said recombinant activated oncogene sequence.

Significantly, applicants filed a terminal disclaimer over the claims of the '866 patent in order to overcome an obviousness-type double patenting rejection raised against these claims.  The following language in the terminal disclaimer is important for the arguments successfully raised in the request (with emphasis added):

Your petitioner, President and Fellows of Harvard College, hereby disclaims any portion of an patent granted on the above-identified application or on any application which is entitled to the benefit of the filing date of this application under 35 U.S.C. 120 not extending the term of any patent granted on that application beyond the term of issued U.S. Patent No. 4,736,866 issued April 12, 1988.

The TPR contended that this language was not required in a terminal disclaimer and the patentees were bound by it (i.e., that it cannot be rescinded by certificate of correction, reissue, or reexamination, even if it was filed in error).  As in the '866 patent, patentees cancelled the testing method claims in the application that granted as the '571 patent.

The application that granted as the '803 patent was the first member of the priority chain having a restriction requirement, which was filed with claims 1-13 and 15-24 of the grandparent application.  This restriction requirement identified three groups:  claims 1-12 and 15-17, directed to a transgenic animal and methods for producing such an animal; claims 13, 18 and 19, drawn to suspected carcinogen testing methods; and claims 20-24 being drawn to plasmids; applicants elected to prosecute the testing method claims.  During prosecution the applicants overcame an obviousness rejection based on the '866 patent and the Ward and Schah references on the grounds that 35 U.S.C. § 121 "prohibits the USPTO from rejecting a later divisional application 'where (as here) the divisional application is filed as the result of a restriction requirement in the original case.'"  The TPR contended that this statement is inaccurate, insofar as there was no restriction requirement issued during prosecution of either the grandparent '866 patent or the '571 patent.

The TPR argued in the request that the '803 patent expired by operation of the terminal disclaimer filed in the '571 patent on July 12, 2005, the expiration date of the '866 patent.  Reexamination is still proper, she contended, because a reexamination "may be declared for an expired patent at any time during the enforceability of the patent" (emphasis in original), which will run until July 12, 2011 (i.e., six years after the patents expiration date; M.P.E.P. § 2211).  Moreover, a question arising as a result of obviousness-type double patenting is appropriate for raising a substantial new question of patentability in a reexamination (M.P.E.P. § 2217).  Finally, the TPR argued that public policy concerns supported the Office granting her request for reexamination:

TPR respectfully requests that a Reexamination nonetheless be declared to serve the public notice function of Reexaminations (i.e., to make it clear on the record that the '803 Subject Patent is only avoiding the double-patenting rejections because of the terminal disclaimer in the '571 Parent Patent, which likewise informs the public that the patent expired on July 12, 2005).  In such a case, even if a Reexamination is not declared, to serve the public notice function, TPR respectfully requests that the Patent Office indicate in writing that the terminal disclaimer in the '571 Parent Patent application insulates the '803 Subject Patent from obviousness type double patenting rejections, and further, affirmatively state that the '803 Subject Patent therefore expired on July 12, 2005.  This public notice function is particularly important in this case as the Patentee is publicly advertising that the '803 Subject Patent does not expire until July of 2016, which is 11 years past the actual expiration date.

The Office agreed.  As set forth under Reexamination Control No. 90/010,955, the Office granted the reexamination based on all six substantial new questions of patentability.  Although the paper granting the request cited revisions to the reexamination statute (35 U.S.C. § 301 et seq.) enacted by Congress in 2002 in response to the Federal Circuit's decision in the In re Portola Packaging case, which permit a reexamination request to be granted on art considered by the Office during ex parte prosecution provided that a substantial new question of patentability is raised, the paper also notes that all of the art cited by the TPR (except for the Ward reference) had not been considered by the examiner during prosecution of the '803 patent.  Moreover, the Office did not separately address the standing issue raised by the TPR, apparently agreeing that a reexamination is properly granted on an expired patent during the period where the patent right can be enforced.

The reexamination will be considered by Primary Examiners Brenda Brumback, Padmashri Ponnaluri, and SPE Deborah Jones.

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

The Metes and Bounds of Obviousness-type Double Patenting

    By Kevin E. Noonan --

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Obviousness-type Double Patenting after Amgen v. F. Hoffmann-La Roche

    By Kevin E. Noonan --

Although Amgen's erythropoietin franchise has weathered its most recent challenge by F. Hoffmann-La Roche's pegylated EPO analog, Mircera® (see Amgen Inc. v. F. Hoffman-La Roche Ltd. (Fed. Cir. 2009)), the victory was not absolute.  The status of three of the patents-in-suit -- U.S. Patent Nos. 5,547,933 (the '933 patent), 5,955,422 (the '422 patent, claim 1) and 5,756,349 (the '349 patent, claim 7) -- were put in jeopardy by the Federal Circuit's reversal of summary judgment and remand to the District Court on the question of whether these patents are invalid for obviousness-type double patenting.  If the District Court were to make a determination that they are invalid, Amgen's EPO patent estate will expire almost two years earlier than expected, with loss of at least a portion of the company's significant revenues from its flagship product.  The likelihood of this outcome will depend on the parties' reaction to the latest installment of Federal Circuit jurisprudence on obviousness-type double patenting following its decision last year in Pfizer, Inc. v. Teva Pharmaceuticals USA, Inc.

The ultimate parent application, which matured into U.S. Patent No. 4,703,008, was subject to a restriction requirement identifying the following groups of claims:

I.  Claims 1–13, 16, 39–41, 47–54, and 59, drawn to polypeptide, classified in Class 260, subclass 112.
II.  Claims 14, 15, 17–36, 58, and 61–72, drawn to DNA, classified in Class 536, subclass 27.
III.  Claims 37–38, drawn to plasmid, classified in Class 435, subclass 317.
IV.  Claims 42–46, drawn to cells, classified in Class 435, subclass 240.
V.  Claims 55–57, drawn to pharmaceutical composition, classified in Class 435, subclass 177.
VI.  Claim 60, drawn to assay, classified in Class 435, subclass 6.

Pursuant to the restriction requirement, each of these claim groupings defined an independently-patentable invention, and as such would entitle Amgen to a separate patent unfettered by obviousness-type double patenting.  It is undisputed that Amgen prosecuted the claims of Group II in the '008 patent.  Thereafter, Amgen filed two applications claiming priority to the '008 patent, the '178 application and the '179 application; these applications are related to the patents-in-suit according to the following schematic diagram:

The Court characterized "in broad strokes" the claims of the three patents under consideration:

[T]he '933 patent claims recombinant EPO, a pharmaceutical composition comprising recombinant EPO, and methods of treating kidney dialysis patients by administering pharmaceutical compositions comprising recombinant EPO . . . .  The '422 patent claims a pharmaceutical composition comprising recombinant EPO . . . .  The '349 patent claims the process of producing recombinant EPO in vertebrate cells capable of producing EPO at a specific rate.

At first blush, the claims of the '933 patent would appear to correspond to Groups I and V from the '008 restriction requirement, and the claims of the '422 patent correspond to Group V.  Two other patents-in-suit -- U.S. Patent Nos. 5,441,868 (the '868 patent) and 5,618,698 (the '698 patent) -- recite claims for methods of making EPO.

Roche's position, unpersuasive at the District Court, was that the claims of the '933, '422, and '394 patents were invalid for obviousness-type double patenting over the claims of the '868 and '698 patents, and in turn the claims of the '868 and '698 patents were invalid for obviousness-type double patenting over the claims of the '008 patent.  This question depends on the meaning of 35 U.S.C. § 121, which sets forth a "safe harbor" provision protecting claims subject to a restriction requirement (and thus determined by the Patent Office to define separately-patentable inventions) from a determination of obviousness-type double patenting:

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.

35 U.S.C. § 121, third sentence; see also Applied Materials, Inc. v. Advanced Semiconductor Materials Am., Inc., 98 F.3d 1563 (Fed. Cir. 1996), cited in the Court's opinion.  The District Court held that the '933, '422, and '349 patents were immunized from obviousness-type double patenting, since they had issued from applications in the chain back to the '178 and '179 applications, which were filed pursuant to a Patent Office-imposed restriction requirement.  However, these applications when filed were not designated as "divisional applications," the language of the statute, but rather as "continuation applications," and Roche argued that this difference precluded the '933, '422, and '349 patents from the § 121 safe harbor.

The Federal Circuit agreed, to the extent that summary judgment and JMOL granted by the District Court was improper.  In its opinion, by Judge Schall and joined by Judges Mayer and Clevenger, the CAFC granted no deference to the District Court's decision, first applying its own standard of review regarding summary judgment, next using the 1st Circuit's standard of review for JMOL, and last for the substantive question of obviousness-type double patenting, which it interpreted as being analogous to claim construction, as a "matter of what is claimed" and thus subject to the Federal Circuit's de novo review precedent.  Using these standards, the Federal Circuit held that the '933, '422, and '349 patents were not entitled to the § 121 safe harbor because the '178 and '179 applications were filed as continuation applications and not divisional applications.  In interpreting the statute so literally, the CAFC noted that, unlike the claims in the Pfizer case that arose from a continuation-in-part application, each of the '933, '422, and '349 patents may have satisfied the substantive requirements for divisional application status -- being limited to the subject matter disclosed in the prior parent application, reciting claims determined to define a patentably-distinct invention, and being filed during the pendency of the earlier-filed parent application.  Nonetheless, the Court held that "[t]his distinction . . . does not justify departing from a strict application of the plain language of §121, which affords its [safe harbor] benefits to 'divisional applications.'"  In making this decision, the CAFC distinguished both its Applied Materials and Symbol Technologies, Inc. v. Opticon, Inc., 935 F.2d 1569 (Fed. Cir. 1991) precedent, because in those cases the "continuation" application was filed ultimately from a properly-designated divisional application.

The CAFC reached a different conclusion with regard to the '868 and '698 patents, because the parties litigated the obviousness-type double patenting question on the merits before the District Court.  As characterized in the Federal Circuit's opinion, the claims of the '008 patent recite a recombinant cell that expresses human EPO, and the claims of the '868 and '698 patents recite methods of producing recombinant EPO using such cells, either in vitro or in vivo.  The District Court distinguished the method claims of the '868 and '698 patents and the recombinant cell (product or composition) claims of the '008 patent because:

none of the '008 claims require:  (1) that the recited host cell actually express any EPO polypeptide; (2) that the recited host cell actually express a glycosylated EPO polypeptide; (3) that the host cell be capable of producing an isolatable amount of a glycosylated EPO polypeptide; and (4) that any glycosylated EPO isolated from cells grown in culture have the stated in vivo function.

The District Court relied on expert testimony for the proposition that, even if in possession of the recombinant cell disclosed in the '008 patent, at the priority date claims to methods for making EPO were novel, useful, and non-obvious.  (The lower court also noted that the Patent Office had found these claims to be patentably-distinct.)  The Federal Circuit agreed with this distinction, that while the recombinant cells claimed in the '008 patent might be "capable of producing" recombinant EPO having in vivo biological function, the claim did not recite a limitation that such cells actually produce functional EPO.  This requirement is affirmatively found in the '868 and '698 patent claims, rendering them patentably distinct.

In making this determination, the Federal Circuit invoked a number of recent, post-KSR decisions on obviousness under 35 U.S.C. § 103, the standard used without using the '008 patent as prior art, including In re Kubin, In re O'Farrell (where the application, not the case, is recent), and Pharmastem Therapeutics, Inc. v. Viacell Inc.  The CAFC opined that the skilled artisan would not have reasonably expected to produce recombinant, glycosylated EPO having the properties -- biological activity, post-translational modifications and amount -- required by the claims of the '868 and '698 patents at the time of the invention.  In making this determination, the Federal Circuit rejected Roche's argument that the capacity for making recombinant EPO was inherent in the claimed cells (and did not address the issue of whether the claims of the expired '008 patent would have satisfied the utility or enablement requirements if the claimed cells did not inherently produce functional recombinant EPO).  The CAFC applied the Supreme Court's KSR warning against hindsight in refusing to consider the actuality that the cells claimed in the '008 patent produced biologically-active EPO in determining whether the skilled worker would have had an expectation that they would do so.

Finally, the Federal Circuit clarified the application of the principles it enunciated in Takeda Pharmaceutical Co. v.  Doll regarding the availability of later-disclosed (or discovered) methods to overcome obviousness-type double patenting invalidation of a process claim over an earlier-issued product claim.  In Takeda, the Federal Circuit held that art used by a patentee to support patentable distinctiveness of process claims filed after grant of product claims was limited to art-recognized processes known at the time the later (or "secondary" in the Takeda court's parlance) patent application was filed.  Roche argued that Amgen should not be permitted to introduce evidence relating to processes for producing recombinant EPO after the 1984 filing date of the '008 patent where Roche was precluded from asserting art available after the 1984 priority date.

Here, the Federal Circuit held that Roche's arguments "collide" with 35 U.S.C. § 120, wherein Amgen's later-filed applications are entitled to the benefit of priority to the '008 patent.  The CAFC found that interpreting its Takeda precedent as Roche advocated would "violate the plain language" of § 120, which entitles all of Amgen's patents-in-suit to the priority benefit of the '008 patent and accordingly prevents any of Amgen's patents-in-suit from being invalidated based on art available after the November 30, 1984 priority date of the '008 patent.  The Court's opinion acknowledged (and asserted that the Takeda court recognized) that this rule "could 'provide the patentee with the best of both worlds:  the applicant can use the filing date as a shield, enjoying the earlier priority date in order to avoid prior art, and rely on later-developed alternative processes as a sword to defeat double patenting challenges.'"  Nonetheless, the Federal Circuit characterized this seeming one-sidedness as being limited and hence not inequitable.  However, the CAFC noted that the '349 patent could not benefit from the application of the principles in the Takeda opinion, since it (unlike the '933 and '422 patents) recited claims to methods and not products.  Thus:

Takeda will permit Amgen, if it wishes to do so, to rely on alternative processes for making the products claimed in the '933 and '422 patents up to their filing dates to prove that the claims of those patents and the claims of the '868 and '698 patents are patentably distinct.  If Amgen pursues that course, Roche will be free to rely on subsequent developments in the art up to the filing dates of the '933 and '422 patents to prove that any alternative processes put forth by Amgen do not render the claims of the '933 and '422 patents and the claims of the '868 and '698 patents patentably distinct.

Unless the parties settle, on remand it can be expected that the District Court will be compelled to find the asserted claims of the '933, '422, and '349 patents invalid for obviousness-type double patenting, unless Amgen can establish patentable distinctiveness on the merits (i.e., outside the § 121 safe harbor).  Until such time (including any further appeals to the Federal Circuit or the Supreme Court), the significant holding in this decision is that whether a claim is entitled to the § 121 safe harbor depends, in the first instance, on whether the application reciting that claim is designated as a "divisional" and not a "continuation" application.  (Such claims must also satisfy the requirements for divisional applications.)  The Federal Circuit's opinion is stringent, harsh, and unyielding, and provides another "trap for the unwary" for which patent law is infamous.  It also raises the specter of malpractice liability in designating follow-on applications accurately, a practice tip that the patent bar ignores at its peril.

Amgen Inc. v. F. Hoffman-La Roche Ltd. (Fed. Cir. 2009)

Something for Everyone, but the Injunction Stands

 

    By Kevin E. Noonan --

Amgen has several times successfully defended its erythropoietin (EPO) franchise, the company's first commercial success and in many ways the crown jewel of its (or anyone's) biologics drug pipeline.  That string of successes continued today with a decision by the Federal Circuit against its latest challenger, Hoffman-La Roche.  But the decision also put several of the patents protecting Amgen's EPO at risk, making this a mixed victory at best for the biotechnology company.

The case involved the most recent challenge, Roche's Mircera® product, a pegylated derivative of human EPO.  Amgen sued Roche in a declaratory judgment action in Massachusetts asserting six patents:  U.S. Patent Nos. 5,547,933 (the '933 patent), 5,441,868 (the '868 patent), and 5,618,698 (the '698 patent), U.S. Patent Nos. 5,955,422 (the '422 patent, claim 1) and 5,756,349 (the '349 patent, claim 7) and U.S. Patent No. 5,621,080 (the '080 patent).  On October 23, 2007, a jury found that Mircera® infringed the '933 patent, the '868 patent and the '698 patent, and that these patents as well as the '422 patent and the '349 patent were not invalid.  (The jury reached neither infringement nor validity of the '080 patent).  Specifically, the jury found that Roche's Mircera® infringed claims 3, 7, and 8 of the '933 patent (claim 12 was found not to be literally infringed but infringed under the Doctrine of Equivalents); claims 1 and 2 of the '868 patent; and claims 6 through 9 of the '698 patent.  On October 1, 2008, Massachusetts District Court Judge William Young ruled (in Amgen's favor for each) on several post-trial motions, including:  1) affirming the jury's infringement decision by denying Roche's motion for judgment as a matter of law (JMOL); 2) reaffirming its pretrial decision to grant summary judgment regarding infringement of claim 1 of the '422 patent; 3) "explaining" its reasoning for ruling, also pretrial, that the claims of Amgen's patents-in-suit are not invalid for obviousness-type double patenting (despite the intervening Federal Circuit decision in Pfizer, Inc. v. Teva Pharmaceuticals USA, Inc.); 4) denying Roche's motion for JMOL that claim 1 of the '422 patent and claims 3, 7, and 9 of the '933 patent are not invalid for indefiniteness for reciting the term "human erythropoietin"; and 5) granting Amgen a permanent injunction barring "Roche, its agents, servants, employees, counsel, and all persons and entities acting in concert therewith" from infringing the claims of the patents-in-suit for the remaining life of those patents.

The Federal Circuit's decision, written by Judge Schall and joined by Judges Mayer and Clevenger, affirmed most of the determinations by the District Court and the jury.  These will be discussed more extensively in future posts, but can be summarized simply here:  the panel vacated Judge Young's decision on whether the '933 (claims 3, 7, and 8), '349 (claim 7) and '422 (claim 1) patents are not invalid under obviousness-type double patenting and remanded this issue to the trial court; vacated the judgment that claim 7 of the '349 patent was not infringed and remanded for a new trial on that issue; affirmed the judgments that the asserted claims of the '868 patent (claims 1 and 2) and the '698 patent (claims 6-9) are not invalid and were infringed, and that claims 3, 7, and 8 of the '933 patent and claim 1 of the '422 patent were infringed; and finally that claims 9, 11, 12, and 14 of the '933 patent are not infringed by Mircera®.

Because of the number claims asserted and the status of these various claims under the CAFC's opinion, a scorecard seems in order:

The following claims of the '933 patent are infringed but may be invalidated by the trial court for obviousness-type double patenting:

3.  A non-naturally occurring glycoprotein product of the expression in a mammalian host cell of an exogenous DNA sequence comprising a DNA sequence encoding human erythropoietin said product possessing the in vivo biological property of causing bone marrow cells to increase production of reticulocytes and red blood cells.

7.  The glycoprotein product according to claim 3 . . . wherein the host cell is a non-human mammalian cell.

8.  The glycoprotein product according to claim 7 wherein the non-human mammalian cell is a CHO cell.

The following claim is infringed by Mircera® under the doctrine of equivalents, but its status with regard to the obviousness-type double patenting question is uncertain (it does not fall within the CAFC's remand):

12.  A pharmaceutical composition comprising an effective amount of a glycoprotein product effective for erythropoietin therapy according to claim 7 and a pharmaceutically acceptable diluent, adjuvant or carrier.  [Infringed under the doctrine of equivalents.]

The following claims of the '868 patent are both not invalid and are infringed:

1.  A process for the production of a glycosylated erythropoietin polypeptide having the in vivo biological property of causing bone marrow cells to increase production of reticulocytes and red blood cells comprising the steps of:
    (a)  growing, under suitable nutrient conditions, mammalian host cells transformed or transfected with an isolated DNA sequence encoding human erythropoietin; and
    (b)  isolating said glycosylated erythropoietin polypeptide therefrom.

2.  The process according to claim 1 wherein said host cells are CHO cells.

The following claims of the '698 patent are not invalid and are infringed:

6.  A process for the production of a glycosylated erythropoietin polypeptide having the in vivo biological property of causing bone marrow cells to increase production of reticulocytes and red blood cells comprising the steps of:
    a) growing, under suitable nutrient conditions, vertebrate cells comprising amplified DNA encoding the mature erythropoietin amino acid sequence of FIG. 6; and
    b) isolating said glycosylated erythropoietin polypeptide expressed by said cells.

7.  The process of claim 6 wherein said vertebrate cells further comprise amplified marker gene DNA.

8.  The process of claim 7 wherein said amplified marker gene DNA is Dihydrofolate reductase (DHFR) gene DNA.

9.  The process according to claims 2, 4 and 6 wherein said cells are mammalian cells.

Claim 1 of the '422 patent is infringed but may be invalidated for obviousness-type double patenting:

1.  A pharmaceutical composition comprising a therapeutically effective amount of human erythropoietin and a pharmaceutically acceptable diluent, adjuvant or carrier, wherein said erythropoietin is purified from mammalian cells grown in culture.

Finally, infringement of claim 7 of the '349 patent will be decided in a new trial, but may be invalid under obviousness-type double patenting:

7.  A process for producing erythropoietin comprising the step of culturing, under suitable nutrient conditions, vertebrate cells according to claim 1, 2, 3, 4, 5 or 6.

Wherein claims 1 through 6 of the '349 patent related to vertebrate cells encoding recombinant EPO:

1.  Vertebrate cells which can be propagated in vitro and which are capable upon growth in culture of producing erythropoietin in the medium of their growth in excess of 100 U of erythropoietin per 10⁶ cells in 48 hours as determined by radioimmunoassay, said cells comprising non-human DNA sequences which control transcription of DNA encoding human erythropoietin.

The significance of the Federal Circuit's decision, and the consequences of an adverse decision on remand for the '933, '349 and '422 patents are illustrated by the respective expiration dates of the five patents at issue in the litigation:

*term shortened by terminal disclaimer

Thus, invalidation of the '933, '349 and '422 patents would reduce Amgen's patent protection on its various EPO products (including Aranesp® and Epogen®) from May 2015 to August 2012 (more than 3 years), which would have a significant (negative) effect on the corporate bottom line.  Accordingly, Amgen can be expected to continue this litigation.

The CAFC's opinion did not disturb the permanent injunction imposed by Judge Young, preventing Roche from marketing Mircera® in the U.S. despite obtaining FDA approval in November, 2007, giving Roche more than sufficient incentive to continue as well.

The substance of the Federal Circuit's opinion, including its reasoning on the standards for obviousness type double patenting, will be the subject of later posts.     

Amgen Inc. v. F. Hoffman-La Roche Ltd. (Fed. Cir. 2009)
Panel: Circuit Judges Mayer, Clevenger, and Schall
Opinion by Circuit Judge Schall