Patent Docs

Immunex Corp. v. Sandoz Inc. (Fed. Cir. 2020)

By Kevin E. Noonan --

The Federal Circuit held recently that the "all substantive rights" test, used heretofore to determine the identity of the "patentee" for purposes of satisfying 35 U.S.C. § 281, should be the standard for determining common ownership in applying the judicially created doctrine of obviousness-type double patenting (ODP), in Immunex Corp. v. Sandoz Inc.  This decision may serve to complicate the legal landscape for patent licensees when addressing a common ownership question.  As in the St Regis Mohawk Tribe v. Mylan decision, ultimately contract law, not patent law, provides the basis for the Court's decision in this case.

The case arose in litigation under the Biologics Price Competition and Innovation Act (BPCIA, relevant provisions codified under 42 U.S.C. § 262(l)) over Sandoz' biosimilar application for its product Erelzi, a generic form of Enbrel® (etanercept), which is used for reducing the signs and symptoms of moderately to severely active rheumatoid arthritis.  Etanercept is a fusion protein "made by combining a portion of a 75 kilodalton human tumor necrosis factor receptor protein (the extracellular portion) with a portion of immunoglobulin G1 (IgG1), specifically, the portion including the hinge region, CH2 and CH3 domains."  Immunex is the exclusive licensee of Hoffmann-La Roche for U.S. Patent Nos. 8,063,182 (to the etanercept composition of matter) and 8,163,522 (methods for making etanercept).

Immunex received FDA approval for Enbrel® and entered into a royalty-bearing license agreement for Roche for patents and applications that contained claims relevant to this product (including the '182 and '522 patents).  Amgen later acquired Immunex and entered into an "Accord and Satisfaction" agreement with Roche, the purpose of which was "to eliminate the continuing obligations to pay royalties to Roche."  The terms of this agreement gave Immunex a "paid-up, irrevocable, exclusive license to the U.S. patent family for the patents-in-suit."  Relevant to the Federal Circuit's decision, the Agreement gave Immunex "the sole right to grant sublicenses, to make, have made, use, sell, offer for sale and import products covered by the patent family" and "the exclusive right to prosecute patent applications in the U.S. patent family."  Immunex also received the right to enforce the patents in the first instance, Roche reserving the right to sue (and retain all damages received) upon Immunex' notice that it would not bring suit.  Also, Roche can practice the claimed invention only for internal, research purposes under the terms of the agreement.

Sandoz stipulated to Infringement and trial was held on patent validity.  The District Court held that Sandoz had not established by clear and convincing evidence that the claims were invalid for obviousness, failure to satisfy the written description requirement nor obviousness-type double patenting.  With regard to the OPD issue, the District Court set forth the following reasons why Sandoz' arguments were not persuasive:

(1) that Sandoz's proposed test for common-ownership does not apply;
(2) even if that test applies, the patents-in-suit and the asserted double-patenting reference patents are not commonly owned;
(3) even if they are commonly owned, the two-way, rather than the one-way test for obviousness-type double patenting applies as to some of the double-patenting references; and
(4) the patents-in-suit are patentably distinct from each of the asserted double patenting references.

Sandoz appealed.

The Federal Circuit affirmed, in an opinion by Judge O'Malley joined by Judge Chen; Judge Reyna filed a dissenting opinion directed to the ODP issue.  The opinion characterized Sandoz' common ownership argument as "novel," in that although the patents in suit are owned by Roche they are "effectively" owned by Immunex under the Accord & Satisfaction agreement.  This amounted to an application of the "all substantial rights" test used to determine standing to sue under 35 U.S.C. § 281.  The majority agreed that this test can be "informative" in determining common ownership but Sandoz has not done so here because "the agreement at issue here did not transfer all substantial rights from the assignee, Roche, to the exclusive licensee, Immunex."  Further:

Under Sandoz's theory of common ownership, if a party is the effective patentee for purposes of the ability to bring an infringement suit, then it is also an effective patentee for purposes of obviousness-type double patenting," according to Sandoz and if the rule were contrary an assignment can be turned into a license.  In particular, "if a party acquires all substantial rights in a patent application, including the right to control prosecution, then obviousness-type double patenting should apply to prohibit issuance of claims that are not patentably distinct from claims in patents already owned by that party.

The majority expressly rejected Immunex' position, that common ownership arises only when "the relevant inventions were owned by the same entity at the time of the invention," citing MPEP § 804.03(II) for its analysis of 35 U.S.C. 102(b)(2)(C) or pre-AIA 35 U.S.C. 103(c)(1).  The majority further rejected Immunex' historical argument that revisions to the patent statute in 1984 created a "gap" that ODP was intended to fill to prevent two patents arising on obvious variants of a patented invention, citing In re Longi, 759 F.2d 887, 893 (Fed. Cir. 1985) (the opinion noting that the Court had more recently rejected this interpretation in Geneva Pharm., Inc. v. GlaxoSmithKline PLC, 349 F.3d 1373, 1377, 1386 (Fed. Cir. 2003), as has the PTO in Ex Parte Maurice, No. 2005-2463, 2005 WL 4779419, at *2 (B.P.A.I. Sept. 19, 2005)).

The Federal Circuit agreed with Sandoz that the interpretation that the "all substantial rights" test was an appropriate measure for common ownership was more consistent with the purpose of the ODP doctrine, but refused to "import into this judicially-created doctrine the entirety of our body of law analyzing who is a statutory 'patentee' pursuant to 35 U.S.C. § 281," making the distinction:

We conclude only that where one of the rights transferred is the right to prosecute the patent at issue, identification of the effective "patentee" is informative in evaluating whether the patents are "commonly owned" for purposes of obviousness-type double patenting.

Here, the Accord and Satisfaction agreement did not satisfy this test, according to the panel majority.  While there are many factors that can be assessed for this determination, the panel focused on two:  "enforcement and alienation," and "the scope of the licensee's right to sublicense, the nature of license provisions regarding reversion of rights, the duration of the license grant, and the nature of any limits on the licensee's right to assign its interests in the patent," citing Alfred E. Mann Found. v. Cochlear Corp., 604 F.3d 1354, 1360-1 (2010).  Under Delaware law, the majority applied the de novo standard of review regarding interpreting the District Court's construction of the terms of the contract and clear error for parole evidence of the parties' intent (although in view of the express terms of the agreement the Federal Circuit found no need to resort to parole evidence).

With regard to the parties' intent, the District Court found, and the Federal Circuit agreed, that the parties "specifically intended for the Accord & Satisfaction to be a license such that Roche would remain the owner of the patents-in-suit."  This determination was supported in the District Court by the express language of the agreement (wherein it was termed a "license") as well as testimony from an Amgen witness.  This portion of the District Court's opinion came in for criticism by the panel opinion, the majority stating that "we have clarified that 'whether a transfer of a particular right or interest under a patent is an assignment or a license does not depend upon the name by which it calls itself, but upon the legal effect of its provisions,'" citing Lone Star Silicon Innovations LLC v. Nanya Tech. Corp., 925 F.3d 1225, 1230 (Fed. Cir. 2019) (emphasis in original) (quoting Waterman v. Mackenzie, 138 U.S. 252, 256 (1891)).

But the panel opinion is intentionally parsimonious in instructing that rather than "import[ing] into [the] judicially created doctrine [of obviousness-type double patenting] the entirety of our body of law analyzing who is a statutory 'patentee' pursuant to 35 U.S.C. § 281," rather setting forth the principle that "only that where one of the rights transferred is the right to prosecute the patent at issue, identification of the effective 'patentee' is informative in evaluating whether the patents are 'commonly owned' for purposes of obviousness-type double patenting" (emphasis in opinion).  The panel opinion held that the party having the right to control prosecution satisfies the "all substantial rules" test, and as a result "prevent[s] the unjustifiable issuance of claims that are patentably indistinct from claims already owned by that party."  Perhaps most importantly, "looking to the 'all substantial rights' test achieves the proper balance between deterring gamesmanship in prosecution, on the one hand, and avoiding any chilling effect on routine collaborations and licensing between parties working in the same field of research, on the other."

Applying these principles to this case, the panel majority held that Roche had not transferred all substantial rights to Immunex and thus the patents were not commonly owned because the license was not substantially an assignment, as Sandoz had argued.  Considering the enforcement and alienation provisions of the agreement the Federal Circuit majority held that it is "clear" that Roche did not transfer all its substantive rights in the patents.  For the panel majority, retention by Roche of the "secondary" right to sue for infringement was dispositive, saying it was "thoroughly inconsistent" with a conclusion that the license was effectively an assignment.

The opinion expressly distinguished the Court's earlier decision in Speedplay, Inc. v. Bebop, Inc., 211 F.3d 1245 (Fed. Cir. 2000), because there the licensee could frustrate the licensor's secondary right to sue by offering putative infringers a license, whereas here Immunex could not do so once Roche's secondary right has been triggered by Immunex's decision not to bring suit.

The panel also considered Roche retaining the right to veto any assignment by Immunex to a third party to be inconsistent with transfer of all substantial rights in the license.

The majority also affirmed the District Court's decision that Sandoz had not established by clear and convincing evidence that the claims were invalid for obviousness or failure to satisfy the written description requirement (Judge Reyna did not dissent from this part of the opinion).  Regarding written description, the panel affirmed the District Court's decision that the existence of the full-length p75 amino acid sequence in the prior art adequately supported claims directed to a fusion protein between full-length p75 and the F_c portion of IgG, even though the specification only disclosed such a fusion protein comprising a truncated p75 sequence, on the grounds that "[i]t is well-established that a patent specification need not re-describe known prior art concepts," citing Capon v. Eshhar, 418 F.3d 1349, 1357 (Fed. Cir. 2005) (these sequences were also available to the public from deposited materials).  In addition, the panel credited the District Court's reliance on expert witness testimony, wherein the lower court was due deference under the clear error standard of review.

Regarding obviousness, the panel found unpersuasive Sandoz' arguments regarding motivation to combine and secondary indicia.  The panel found Sandoz' own arguments at trial and in post-trial motions regarding the relationship between motivation to combine and use of etanercept for treating inflammatory disorders contradicted its position.  For the relevant objective indicia (clinical success, long-felt need, and failure of others) the panel held that the District Court had properly concluded that Immunex had demonstrated the required nexus between the claims and the etanercept product.  As stated in the opinion, "Sandoz's arguments regarding objective indicia are merely disagreements with the district court's weighing of the evidence," which is not clear error.

Judge Reyna's dissent on the ODP question amounted to his disagreement with the majority's application of the "all substantial rights" standard to the Accord and Satisfaction agreement between the parties; he discerned "gamesmanship" in the course of prosecuting the patents-in-suit.  On substantive law, Judge Reyna also opined that the "one-way" test for obviousness-type double patenting should be applied to this situation.  His reasoning was that because the District Court found that both the Patent Office and Roche were responsible for the delay in prosecution leading to the later-filed application granting first as a patent, the situation did not satisfy the requirement for applying the two-way test that the Patent Office be solely responsible for the delay.

Immunex Corp. v. Sandoz Inc. (Fed. Cir. 2020)
Panel: Circuit Judges O'Malley, Reyna, and Chen
Opinion by Circuit Judge O'Malley; dissenting opinion by Circuit Judge Reyna

Boehringer Ingelheim Pharmaceuticals Inc. v. Mylan Pharmaceuticals Inc. (Fed. Cir. 2020)

By Donald Zuhn –-

Last month, in Boehringer Ingelheim Pharmaceuticals Inc. v. Mylan Pharmaceuticals Inc., the Federal Circuit reversed a decision by the U.S. District Court for the District of New Jersey finding certain claims of U.S. Patent No. 8,853,156 to be directed to ineligible subject matter under 35 U.S.C. § 101, and remanded for further proceedings.  The Federal Circuit also affirmed the District Court's finding that the asserted claims of U.S. Patent Nos. 9,173,859 and 8,673,927 were invalid for obviousness and obviousness-type double patenting.

Plaintiffs-Appellants Boehringer Ingelheim Pharmaceuticals, Inc.; Boehringer Ingelheim International GmbH; Boehringer Ingelheim Corp.; and Boehringer Ingelheim Pharma GmgH & Co. KG ("Boehringer") filed suit against Defendants-Appellees Mylan Pharmaceuticals Inc.; Mylan Inc.; Mylan Laboratories, Ltd.; Aurobindo Pharma Ltd.; and Aurobindo Pharma USA, Inc. ("Mylan") for infringement of the '156, '859, and '927 patents.  The asserted patents relate to the treatment of type 2 diabetes mellitus with DPP-IV inhibitors such as linagliptin.  Mylan moved for partial summary judgment on the pleadings, alleging that claims 10-17, 24, and 25 of the '156 patent are directed to ineligible subject matter under 35 U.S.C. § 101.  The District Court granted Mylan's motion, finding that claims 10-17, 24, and 25 of the '156 patent are directed to the "abstract idea" of "administering the DPP-IV inhibitor to the targeted patient population," and that these claims fail to recite an inventive concept.

At trial, the District Court determined that claims 1, 14, 15, 20, and 21 of the '859 patent and claims 7, 9, 15, 17, 19, 25, and 26 of the '927 patent are invalid for obviousness-type double patenting in view of the claims of U.S. Patent No. 8,178,541, and invalid as obvious in view of U.S. Patent Application Publication No. 2004/0097510.  In particular, the District Court determined that because the claimed invention's doses of linagliptin in 2.5 mg and 5 mg fall within the '510 publication's disclosed range of 1–100 mg, there is a presumption of obviousness.  The District Court alternatively found that a person of ordinary skill in the art would have obtained the claimed dosages through routine experimentation.

In an opinion by Judge Moore, joined by Judges Dyk and Hughes, the Federal Circuit concluded that claims 10–17, 24 and 25 of the '156 patent are directed to patent eligible subject matter.  The opinion notes that the '156 patent relates to the treatment and/or prevention of metabolic diseases such as type 2 diabetes mellitus with DPP-IV inhibitors such as linagliptin in patients for whom normal metformin therapy is not appropriate, setting forth claims 1 and 10 of the '156 patent:

1.  A method of treating and/or preventing metabolic diseases in a patient for whom metformin therapy is inappropriate due to at least one contraindication against metformin comprising orally ad-ministering to the patient a DPP-IV inhibitor wherein the contraindication is selected from the group consisting of: renal disease, renal impairment or renal dysfunction, unstable or acute congestive heart failure, acute or chronic metabolic acidosis, and hereditary galactose intolerance.

10.  The method according to claim 1 wherein the metabolic disorder is type 2 diabetes mellitus and wherein the contraindication is renal disease, renal impairment or renal dysfunction, and wherein said DPP-4 inhibitor is used for said patient in the same dose as for a patient with normal renal function.

On appeal, Boehringer argued, echoing language from Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals International Ltd., 887 F.3d 1117 (Fed. Cir. 2018), that the claims are directed to a "method of treating a specific disease ([type 2 diabetes mellitus]) for specific patients (with renal impairment) using a specific compound (linagliptin) at specific doses (same dose in patients with renal impairment as in patients with normal renal function) to achieve a specific outcome."  Mylan argued that the claims are directed to the natural law that "certain DPP-IV inhibitors (including linagliptin) are metabolized by the liver rather than the kidney."

In finding claims 10–17, 24 and 25 of the '156 patent  to be patent eligible, the Federal Circuit determined that "consistent with this court's decision in Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals International Ltd., 887 F.3d 1117 (Fed. Cir. 2018), the claims are directed to a particular method of treatment under step one and are therefore patent eligible."  The Court explained that even though "certain DPP-IV inhibitors (including linagliptin) are metabolized by the liver rather than the kidney," this "does not make the claim 'directed to' that natural ability."  The panel also noted that because the claims are directed to a method of treatment at step one, the Court could "conclude [that] the claims are patent eligible and need not reach step two" under the two-step framework of Alice Corporation Pty. Ltd. v. CLS Bank International, 573 U.S. 208 (2014).  The Federal Circuit therefore reversed the District Court's grant of judgment on the pleadings of patent ineligibility and remanded to the District Court for further proceedings.

Turning to the District Court's finding that claims 1, 14, 15, 20, and 21 of the '859 patent and claims 7, 9, 15, 17, 19, 25, and 26 of the '927 patent were invalid for obviousness-type double patenting and invalid as obvious in view of the prior art, the opinion notes that the claims at issue relate to the treatment of type 2 diabetes mellitus with linagliptin in 2.5 or 5 mg doses, setting forth claim 14 of the '859 patent:

14.  An oral tablet formulation comprising 1-[(4-me-thyl-quinazolin-2-yl)methyl]-3-methyl-7-(2-butyn-1-yl)-8-(3-(R)-amino-piperidin-1-yl)-xanthine in an amount of 2.5 mg or 5 mg optionally in combination with metformin, and a pharmaceutically acceptable carrier or diluent.

and claim 7, which depends from claim 1, of the '927 patent as illustrative:

1.  A method of treating type II diabetes mellitus comprising administering to a patient in need thereof a pharmaceutically effective oral amount of 1-[(4-methyl-quinazolin-2-yl)-methyl]-3-methyl-7-(2-butyn-1-yl)-8-(3-(R)-amino-piperidin-1-yl)-xanthine, and a pharmaceutically effective amount of metformin, which is from 300 mg to 1000 mg once or twice a day, or delayed-release metformin in a dose of 500 mg to 1000 mg once or twice a day or 500 mg to 2000 mg once a day.

7.  The method according to claim 1, wherein the 1-[(4-methyl-quinazolin-2-yl)methyl]-3-methyl-7-(2-butyn-1-yl)-8-(3-(R)-amino-piperidin-1-yl)-xanthine is administered in an oral dosage of 2.5 mg or 5 mg.

On appeal, Boehringer argued that the District Court's conclusions of invalidity for obviousness-type double patenting and obviousness depended on its determination that the claimed dosages would have been obvious.  In affirming the District Court's findings of invalidity for obviousness-type double patenting and obviousness, the Federal Circuit concluded that the District Court's alternative finding (i.e., that a person of ordinary skill in the art would have obtained the claimed dosages through routine experimentation) is not clearly erroneous.  The Court therefore did not need to decide whether the District Court's presumption determination of obvious was correct.  The Federal Circuit thus affirmed the District Court's decision finding the asserted claims of the '859 and '927 patents to be invalid for obviousness and obviousness-type double patenting.

Boehringer Ingelheim Pharmaceuticals Inc. v. Mylan Pharmaceuticals Inc. (Fed. Cir. 2020)
Nonprecedential disposition
Panel: Circuit Judges Dyk, Moore, and Hughes
Opinion by Circuit Judge Moore

Top Stories of 2018: #11 to #15

By Donald Zuhn –-

After reflecting upon the events of the past twelve months, Patent Docs presents its 12th annual list of top patent stories.  For 2018, we identified fifteen stories that were covered on Patent Docs last year that we believe had (or are likely to have) a significant impact on patent practitioners and applicants.  Today, we count down stories #15 to #11, and in the coming week, we will work our way towards the top stories of 2018.  As with our other lists (2017, 2016, 2015, 2014, 2013, 2012, 2011, 2010, 2009, 2008, and 2007), links to our coverage of these stories (as well as a few links to articles on related topics) have been provided in case you missed the articles the first time around or wish to go back and have another look.  As always, we love to hear from Patent Docs readers, so if you think we left something off the list or disagree with anything we included, please let us know.  In addition, we will be offering a live webinar on the "Top Patent Law Stories of 2018" on January 16, 2019 from 10:00 am to 11:15 am (CT).  Details regarding the webinar, which will focus on a handful of the most important stories on this year's list, can be found here.

15.  USPTO Implements New Authentication System

In October, the U.S. Patent and Trademark Office announced the implementation of a new authentication method for signing into the EFS-Web and Private PAIR, which will replace the use of PKI certificates, and which constitutes a major change in the way stakeholders interact with the USPTO's Patent Electronic Business Center (EBC).  The Office has indicated that the new method will provide users with access to the EFS-Web and Private PAIR until the full release of Patent Center, which is scheduled to replace the EFS-Web and Private PAIR, in 2020.  When announcing the new authentication system, the Office cautioned practitioners that migration to link USPTO.gov accounts to PKI certificates should be completed by the end of October (using the Office's migration tool), sponsorship of support staff should be completed by the end of November (using the Office's sponsorship tool), and that PKI certificates would be phased out on December 31, 2018.  While implementation of the new authentication system has been a fairly straightforward process for many stakeholders, many others were happy to receive an early holiday gift from the USPTO on December 21, when the Office announced that it was delaying the date on which PKI certificates would be retired.  The Office's latest word on PKI certificate retirement is that "EFS-Web and Private PAIR users will no longer be able to authenticate using PKI certificates as of February 15."

For information regarding this and other related topics, please see:

• "USPTO Delays PKI Certificate Termination Date," December 23, 2018
• "USPTO Director Issues Notice on New Authentication System for EFS-Web and Private PAIR," December 3, 2018
• "USPTO News Briefs," October 25, 2018
• "USPTO Moving to New Authentication System for EFS-Web and Private PAIR," October 4, 2018

14.  Federal Circuit Affirms PTAB Decision Finding No Interference in CRISPR Dispute

CRISPR (an acronym for Clustered Regularly lnterspaced Short Palindromic Repeats), which is part of a system for altering chromosomal sequences in situ in a cell in combination with a bacterially derived protein called Cas9, was hailed as a "Breakthrough of the Year" for 2015.  CRISPR provides a mechanism for inserting or deleting specific DNA sequences using CRISPR-associate targeting RNAs and the Cas9 RNA-guided DNA endonuclease enzyme.  Given the commercial potential of this method, patenting was an obvious concern and, as it turned out, more than one group of inventors filed patent applications on the reagents, methods, and cells produced or used to produce CRISPR modifications.  Because these applications were filed prior to March 16, 2013, the dispute regarding who was the first to invent had to be resolved via an interference.  In 2016, the USPTO declared Interference No. 106,048, naming Feng Zhang and his colleagues, the named inventor of the Broad Institute/MIT's patents, as the Junior Party, and Jennifer Doudna and her colleagues at UC/Berkeley as Senior Party.  In February of 2017, the Patent Trial and Appeal Board handed down its decision, finding no interference-in-fact between several patents and patent applications owned by The Broad Institute and applications owned by the Regents of the University of California, Berkeley.  The decision ended the interference and allowed both parties to license (and assert) their patents to (or against) any third party.  The basis for the decision was that UC's claims would not anticipate Broad's claims-in-interference because all of Broad's claims contained the affirmative limitation that the CRISPR technology be operative in eukaryotic cells, and the UC's claims were devoid of any limitation regarding the context in which CRISPR was applied.  In September, the Federal Circuit affirmed the PTAB's decision that there is no interference-in-fact between the Broad's twelve patents and one application-in-interference and the University of California/Berkeley's pending application, thereby concluding the interference between the parties.  This marks the third consecutive appearance – and perhaps the last -- on our Top Stories list for the CRISPR dispute (the dispute was #19 in 2017 and #18 in 2016).

For information regarding this and other related topics, please see:

• "Whither CRISPR? University of California/Berkeley Granted Another CRISPR Patent," October 30, 2018
• "Regents of the University of California v. Broad Institute, Inc. (Fed. Cir. 2018)," September 10, 2018
• "The CRISPR Chronicles -- Broad Institute Wins One and Loses One," January 24, 2018

13.  Federal Circuit Defines Contours of Obviousness-type Double Patenting Doctrine

Four years after issuing decisions in AbbVie Inc. v. Mathilda & Terence Kennedy Institute of Rheumatology Trust and Gilead Sciences, Inc. v. Natco Pharma Ltd., the Federal Circuit again handed down opinions concerning the proper application of the judicially created doctrine of obviousness-type double patenting (OTDP).  In January, in In re Janssen Biotech, Inc., the Federal Circuit affirmed a rejection by the Patent Trial and Appeal Board of certain claims of U.S. Patent No. 6,284,471 for OTDP.  The co-assignees of the '471 patent argued on appeal that OTDP was not applicable because the safe-harbor provision of 35 U.S.C. § 121 protected the '471 patent claims.  The Federal Circuit determined, however, that the '471 patent was not entitled to safe-harbor protections because the '471 patent had issued from a CIP application (even though the co-assignees sought to re-designate the application as a divisional during a reexamination twelve years after the '471 patent issued).  In December, the Federal Circuit issued two more decisions that help define the contours of the OTDP doctrine.  In Novartis AG v. Ezra Ventures LLC, the Court addressed a narrow but important question regarding its OTDP jurisprudence:  whether a first patent filed earlier than a second patent, but that issued later, could be used to invalidate the second patent on OTDP grounds if the reason the later-expiring patent was later expiring was due to Patent Term Extension (PTE) awarded under 35 U.S.C. § 156.  The Federal Circuit affirmed the District Court's determination that OTDP does not invalidate an otherwise validly obtained PTE under § 156.  In Novartis Pharmaceuticals Corp. v. Breckenridge Pharmaceutical Inc., the Federal Circuit was provided with an opportunity to decide whether the operation of the OTDP doctrine was the same for (a) two patents granted after the Uruguay Round Agreements Act of 1994 (URAA) changed the term of U.S. patents from 17 years from the grant date to 20 years from the earliest claimed priority date, and (b) circumstances in which one patent is subject to the pre-URAA term and the other to the post-URAA term.  In reversing the District Court, the Federal Circuit determined that its decision in Gilead Sciences, Inc. v. Natco Pharma Ltd. did not control in this instance, because the difference between how the patents were related to one another with respect to their expiration dates made a difference in how the doctrine of OTDP should be applied.  The Court noted that "because a change in patent term law should not truncate the term statutorily assigned to the pre-URAA '772 patent," the '990 patent "cannot properly be used as an OTDP reference."

For information regarding this and other related topics, please see:

• "Novartis Pharmaceuticals Corp. v. Breckenridge Pharmaceutical Inc. (Fed. Cir. 2018)," December 11, 2018
• "Novartis AG v. Ezra Ventures LLC (Fed. Cir. 2018)," December 9, 2018
• "In re Janssen Biotech, Inc. (Fed. Cir. 2018)," January 29, 2018

12.  Federal Circuit Finds Method of Treatment Claims Patent Eligible

Although there were several interesting decisions issued in 2018 that addressed the issue of subject matter eligibility in the context of life sciences inventions (see list below), the most interesting of these decisions to most life sciences practitioners and applicants is likely one issued by the Federal Circuit in April.  In Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals, the Federal Circuit affirmed a District Court decision finding, inter alia, that the claims of U.S. Patent No. 8,586,610, which are directed to methods of treating a patient suffering from schizophrenia with iloperidone, were not invalid under 35 U.S.C. § 101.  Two months after that decision, the U.S. Patent and Trademark Office distributed a memorandum to the patent examining corps that addressed the impact of the Vanda decision.  The memorandum explains that in Vanda, the Federal Circuit determined that the claims at issue are "patent eligible under 35 U.S.C. § 101 because they are not 'directed to' a judicial exception" (emphasis in memorandum).  The memorandum also states that (with emphasis in memorandum):

The USPTO's current subject matter eligibility guidance and training examples are consistent with the Federal Circuit's decision in Vanda, with the understanding that: (1) "method of treatment" claims that practically apply natural relationships should be considered patent eligible under Step 2A of the USPTO's subject matter eligibility guidance; and (2) it is not necessary for "method of treatment" claims that practically apply natural relationships to include nonroutine or unconventional steps to be considered patent eligible under 35 U.S .C. § 101.  For example, claims 5 and 6 of USPTO Example 29 (Diagnosing and Treating Julitis) should be considered patent eligible under Step 2A of the USPTO's subject matter eligibility guidance in light of the Federal Circuit decision in Vanda.

Last week, Hikma Pharmaceuticals and West-Ward Pharmaceuticals filed a Petition for a Writ of Certiorari for Supreme Court review of the Federal Circuit's decision.

For information regarding this and other related topics, please see:

• "Illumina, Inc. v. Ariosa Diagnostics, Inc. (N.D. Cal. 2018)," December 27, 2018
• "A Glimmer of an Idea on an Experimental Use Exemption," November 7, 2018
• "Roche Molecular Systems, Inc. v. Cepheid (Fed. Cir. 2018)," October 10, 2018
• "Ex parte Galloway (PTAB 2018)," July 26, 2018
• "Illumina, Inc. v. Natera, Inc. (N.D. Cal. 2018)," July 11, 2018
• "USPTO Issues Memorandum on Vanda Pharmaceuticals v. West-Ward Pharmaceuticals," July 9, 2018
• "Supreme Court Denies Certiorari Again in Patent Eligibility and Safe Harbor Cases," June 20, 2018
• "Pernix Ireland Pain DAC v. Alvogen Malta Operations Ltd. (D. Del. 2018)," June 12, 2018
• "Genetic Veterinary Sciences, Inc. v. LABOklin GmbH (E.D. Va. 2018)," May 22, 2018
• "Exergen Corp. v. Kaz USA, Inc. (Fed. Cir. 2018)," March 11, 2018
• "Ex parte Kotanko (PTAB 2018)," February 12, 2018

11.  Supreme Court: Patentees Can Recover Lost Foreign Profits

In June, in WesternGeco LLC v. ION Geophysical Corp., the Supreme Court determined that, based on the "focus" of 35 U.S.C. § 284 of the Patent Act (the general damages provision) when read in light of domestic infringement under 35 U.S.C. § 271(f)(2) (barring exportation of components specifically adapted for a patented invention), a patent owner could recover lost foreign profits.  The decision overruled the Federal Circuit's general practice of interpreting damages under § 271(f)(2) in the same fashion as § 271(a) (the general infringement provision, which does not allow patent owners to recover lost foreign profits).  Justice Thomas, joined by Chief Justice Roberts and Justices Kennedy, Ginsburg, Alito, Sotomayor, and Kagan, determined that despite the "presumption against extraterritoriality" in the enforcement of federal statutes, foreign lost profits due to domestic acts of infringement under § 271(f)(2) should not be categorically barred.  The majority reiterated the facts presented and that "the focus of § 284, in a case involving infringement under § 271(f)(2), is on the act of exporting components from the United States."  In this context, because the infringing act happens domestically, any lost profits (foreign or otherwise) based on that domestic infringement were merely a domestic application of § 284.  The dissent (Justices Gorsuch and Breyer) takes issue with the majority's decision permitting a patentee to be sued for damages for the use abroad of a patented article infringed under the provisions of 35 U.S.C. § 271(f)(2), arguing that "[p]ermitting damages of this sort would effectively allow U. S. patent owners to use American courts to extend their monopolies to foreign markets," and that this "would invite other countries to use their own patent laws and courts to assert control over our economy."

For information regarding this and other related topics, please see:

• "WesternGeco LLC v. ION Geophysical Corp. (2018)," June 24, 2018

Novartis Pharmaceuticals Corp. v. Breckenridge Pharmaceutical Inc. (Fed. Cir. 2018)

By Kevin E. Noonan --

On Friday, December 7th, the Federal Circuit handed down two opinions concerning the proper application of the judicially created doctrine of obviousness-type double patenting (OTDP).  The first, Novartis AG v. Ezra Ventures LLC (Fed. Cir. 2018), set forth the narrow, albeit important, holding that a terminal disclaimer, or loss of term for a later-expiring patent based on an earlier-expiring patent in relation to which the later-expiring patent recited patentably indistinct claims, did not include extension of term pursuant to the provisions of 35 U.S.C § 156.  The Court held that, insofar as patent term extension under § 156 was a statutory grant, and loss of term under OTDP was a judicially created doctrine, the statutory grant was not trumped by OTDP.

The second case decided by the Federal Circuit that day, Novartis Pharmaceuticals Corp. v. Breckenridge Pharmaceutical Inc., provided the Court with the opportunity to decide whether the operation of the OTDP doctrine was the same for two patents that were granted under U.S. patent law after the term of a U.S. patent was changed from 17 years from the grant date to 20 years from the earliest claimed priority date under the Uruguay Round Agreements Act of 1994 (URAA), compared with circumstances where one patent is subject to pre-URAA term and the other to the post-URAA term.

The case arose in ANDA litigation concerning Novartis's Zortress® and Afinitor® drugs (active ingredient: everolimus), used to treat cancer and prevent rejection in kidney and liver transplantations.  Before the District Court, Breckenridge Pharmaceutical challenged the validity of Orange Book-listed patent in suit (to the compound), U.S. Patent No. 5,665,772, based on obviousness-type double patenting.  The invalidating reference, Novartis's U.S. Patent No. 6,440,990 (directed to methods of treatment using pharmaceutical compositions of the claimed compound), was filed after but issued before the '772 patent (a fact pattern akin to that before the Court in Gilead Sciences Inc. v. Natco Pharma Ltd.); the relationship between the two Novartis patents is illustrated below:

This pattern is in contrast to the relationship between the two patents in the Gilead decision, a difference important to the Federal Circuit's decision here:

Despite these differences, the District Court, relying on the rubric from Gilead that "a later-filed but earlier-expiring patent can serve as a double patenting reference for an earlier-filed but later-expiring patent," invalidated the '772 patent claims under OTDP over the '990 patent claims.  As explained in the opinion, the District Court also relied on decisions by district courts following Gilead, including Janssen Biotech Inc. v. Celltrion Healthcare Co., 210 F. Supp. 3d 278 (D. Mass. 2016); MLC Intellectual Property, LLC v. Micron Technology, Inc., 2016 WL 4192009 (N.D. Cal. Aug. 9, 2016); and DDB Technologies, LLC v. Fox Sports Interactive Media, LLC, 2014 WL 12167628 (W.D. Tex. May 15, 2014), in support of its decision.  The District Court rejected four arguments asserted by Novartis attempting to distinguish Gilead.  First, that grant of the '990 patent did not affect the expiration date of the '772 patent; the Court held that "it was Novartis's choice to file the '990 patent, and the harm to the public lies in the inability to practice the invention claimed in the '990 patent once it expired."  Second, that Novartis had not engaged in any gamesmanship which was the basis for the Gilead court's concerns; the Court held that gamesmanship was not required to violate proscription against OTDP under Gilead (or AbbVie, Inc. v. Mathilda & Terence Kennedy Institute of Rheumatology Trust, 764 F.3d 1366 (Fed. Cir. 2014)).  Third, that allowing the earlier-expiring, post-URAA patent to be an OTDP reference against a later-expiring, pre-URAA patent would impermissibly shorten the statutorily mandated 17-year term of the pre-URAA patent; the Court found that Novartis had courted that risk by filing the earlier-expiring patent having patentably indistinct claims.  Finally, that the patent term extension Novartis had obtained for the '772 patent "immunized" the patent from a double patenting challenge; the Court found no precedent for this contention and noted that the question was not at issue.  The parties having stipulated to infringement and that the '772 patent claims would be invalid for OTDP if the '990 was a proper OTDP reference, the District Court entered judgment that the '772 patent was invalid and this appeal followed.

The Federal Circuit reversed, in an opinion by Judge Chen joined by Chief Judge Prost and Judge Wallach.  The panel held that their decision in Gilead did not control in this instance, because the difference between how the patents were related to one another with respect to whether their expiration dates made a difference in how the doctrine of OTDP should be applied.  According to the opinion:

[T]he correct framework here is to apply the traditional obviousness-type double patenting practices extant in the pre-URAA era to the pre-URAA '772 patent and look to the '772 patent's issuance date as the reference point for obviousness-type double patenting.

Under their analysis, "because a change in patent term law should not truncate the term statutorily assigned to the pre-URAA '772 patent," the '990 patent "cannot properly be used as an OTDP reference."

One aspect of this decision useful for the bar is the careful explication of how courts have "applied the principles of obviousness-type double patenting for over a century to restrict a patent owner's patents on an invention and obvious variants to one 17-year patent term," particularly with regard to the issuance dates of earlier- and later-expiring patents.  Gilead, according to the opinion, represents a realization by the Court:

[T]hat the change in patent term law under the URAA altered the analytical inquiry for double patenting; issuance dates of post-URAA patents did not serve as reliable stand-ins for the expiration date of the patent as is true for pre-URAA patents, and the proper reference point for an obviousness-type double patenting inquiry is the expiration date of the patent in question.

The circumstances before the Court here are not the same and Gilead does not control, according to the opinion ("Gilead addressed a question that is not applicable here").  And the opinion characterizes the Court's Gilead opinion as being dependent upon the changes that arose post-URAA, because patent issue dates no longer "served as a reliable stand-in for the date that really mattered -- patent expiration."  This is because, as in the Gilead case, "a patent that issues first does not [necessarily] expire first."  The relationship of the earlier- and later-expiring patents before the Court here also does not have the potential negative consequences the Court cautioned against in Gilead, such as the opportunity for patentees to engage in gamesmanship regarding patent application and issue dates, and the potential that a difference of even one day in issue date could change the relationship in an OTDP-determining way.

The panel also concluded that the Court's AbbVie decision did not control the outcome.  The relationship of the earlier- (U.S. Patent No. 7,846,422) and later- (U.S. Patent No. 6,270,766) expiring patents (both having post-URAA filing dates) in that case was as follows:

The AbbVie situation is "a prime example of the post-URAA scenario [the Court] contemplated in Gilead," according to the opinion (noting that, as in Gilead, the effective filing date (EFD) of the '422 patent represents applicant choice, because it did not have the same EFD of the '766 patent).  That factor was not at play regarding the Novartis patents and thus AbbVie does not control the outcome here.

The Federal Circuit also found support (and solace) for its decision in the choice Congress made in the URAA transition statute, which gave applicants a patent term that was "the greater of" 17 years from issue date or 20 years from the effective filing date.  Thus evinced a choice by Congress for patentees "to enjoy the maximum possible term available for their resulting patents under either patent term regime."  Breckenridge's position, that OTDP could be used to "truncate any portion of the statutorily assigned term of a pre-URAA patent that extends beyond the term of a post-URAA patent would be inconsistent" with this Congressional choice.  The panel also believes the outcome here is consistent with the "core principle underlying the double patenting doctrine:  giving one invention and nonobvious variants of that invention the same patent term."  Stating its rationale succinctly, the Court said:

The key purpose of obviousness-type double patenting is to prevent a patent owner from extending the exclusivity rights over his invention beyond a full patent term.  We saw this impermissible practice in Gilead and in AbbVie, where the patent owners claimed different effective filing dates for different patents to extend the life of patent exclusivity.  Gilead[.]  Here, critically, Novartis did not seek to extend its patent rights over its everolimus invention beyond one patent term, in this case, 17 years from issuance of the '772 patent.  Had the law not changed, regardless of whether Novartis obtained the '990 patent, the '772 patent would have expired on September 9, 2014 (September 9, 2019 with the patent term extension).  The fact that the law for the term of a patent changed, resulting in the later-issued '990 patent having an earlier expiration date than it would have pre-URAA should not affect the '772 patent's statutorily-granted 17-year patent term.  Rather than Novartis receiving a windfall with a 17-year term for its '772 patent, its '990 patent's term was truncated by the intervening change in law.  To find that obviousness-type double patenting applies here because a post-URAA patent expires earlier would abrogate Novartis's right to enjoy one full patent term on its invention (citations omitted).

Novartis Pharmaceuticals Corp. v. Breckenridge Pharmaceutical Inc. (Fed. Cir. 2018)
Panel: Chief Judge Prost and Circuit Judges Wallach and Chen
Opinion by Circuit Judge Chen

Novartis AG v. Ezra Ventures LLC (Fed. Cir. 2018)

By Kevin E. Noonan --

In Novartis AG v. Ezra Ventures LLC, the Federal Circuit addressed a narrow but important question regarding its jurisprudence on the issue of obviousness-type double patenting (OTPD).  That question was whether its decision in Gilead Sciences Inc. v. Natco Pharma Ltd., which established that a first patent filed earlier than a second patent but that issued later, could be used to invalidate the second patent on OTDP grounds, if the reason the later-expiring patent was later-expiring was due to Patent Term Extension under 35 U.S.C. § 156.

To recap, the Gilead Court decided that a later-issued but earlier-expiring patent could be used to establish OTDP over the later-expiring patent, as illustrated here:

In rendering its decision, the Gilead panel held that the intervening change in U.S. patent term occasioned by ratification of the GATT-TRIPS agreement did not influence its decision.  Rather, the panel grounded its decision on the "bedrock" principle that the public had a right to practice an invention (and its obvious variants) once a patent on that invention had expired.  Important to the instant Novartis decision, the Gilead panel also voiced its concern that holding to the contrary in that case could raise the possibility of "significant gamesmanship" regarding patent term depending on when related applications were filed and when they were allowed to issue.  The Gilead decision has been applied to mean that the relevant dates for considering OTDP are the expiration dates of the later and earlier-expiring patents, and whether the claims in the later-expiring patent were mere obvious variants of the earlier-expiring claims.

The Novartis case arose in ANDA litigation brought by Novartis against Ezra Ventures over its multiple sclerosis drug Gilenya^® over Orange Book-listed U.S. Patent No. 5,604,229.  As explained in the opinion, claims of the '229 patent encompassed fingolimod, the active ingredient in Gilenya^®.  The '229 patent was filed prior to the GATT-TRIPS changes in U.S. patent law, and thus had a patent term calculated as 17 years after issuance (in this case, corresponding to February 18, 2014).  In addition, Novartis had been granted five years of Patent Term Extension under § 156, thus expiring on February 18, 2019.

Novartis owned another patent, U.S. Patent No. 6,004,565 that claims methods for administering fingolimod; this patent was filed after the U.S. changed how patent term was calculated under the GATT-TRIPS agreement and thus expired September 23, 2017 (20 years from its filing date).  The filing and expiration dates of the '229 and '565 patents are related as illustrated below:

Before the District Court, Ezra Ventures filed a motion to dismiss (that the Court denied) under Fed. R. Civ. Pro. 12(c) for judgment on the pleadings, on three grounds.  First, that extension of the '229 patent "de facto also extends the life of the '565 patent, and thereby violates § 156(c)(4)'s requirement that only 'one patent be extended.'"  Second, that this extension "violates the 'bedrock principle' that the public may practice an expired patent."  And third, that the '565 patent "renders the '229 patent invalid for statutory- and obviousness-type double patenting because Novartis's '229 patent claims are not patentably distinct from its '565 patent claims."  With regard to the argument that this is an impermissible extension in violation of § 156(c)(4), the District Court held that "de facto" extension as argued here was inconsistent with the meaning of the extension statute.  In addition, the lower court relied on the Federal Circuit's decision in Merck & Co. v. Hi-Tech Pharmacal Co., 482 F.3d 1317 (Fed. Cir. 2007), that the term of a terminally disclaimed patent can be extended under § 156, which "de facto" extends the term of that patent over the term of the patent over which it has been terminally disclaimed.  Thereafter, Ezra Ventures stipulated infringement and withdrew its defenses, and the District Court entered final judgment against Ezra Ventures, clearing the procedural path for this appeal.

The Federal Circuit affirmed, in an opinion by Judge Chen joined by Judges Moore and Hughes.  The panel first addressed Ezra Venture's argument that extension of the '229 patent by Patent Term Extension also (improperly) extended the term of the '565 patent.  As an initial matter, the opinion notes that "nothing in the statute restricts the patent owner's choice for patent term extension among those patents whose terms have been partially consumed by the regulatory review process," despite it not being uncommon for a patented drug to also be the subject of patents on "a product, a method of using that product, and/or a method of manufacturing the product."  The panel agreed with the District Court that Congress did not choose language that would preclude extension of a patent on a drug product because it also "effectively" extends the patent, for example, on a method of using that drug product.  Here, only one patent term was extended -- the '229 patent -- and this satisfies the statutory mandate and does not violate § 156(c)(4).

Next the Federal Circuit considered the "interaction" between § 156 and OTDP.  In what the panel states is "a logical extension" of its holding in Merck & Co. v. Hi-Tech Pharmacal Co., the Court held here that OTDP does not invalidate extension of the patent term under § 156.  After explicating the Court's basis for its Merck opinion (inter alia, the plain meaning of the § 156 and the differences in statutory language between § 156 and § 154, the patent term adjustment statute, which cannot extend the term of a terminally disclaimed patent) the opinion notes that the Merck decision involved just the issue raised here:  that a terminally disclaimed patent can still receive the benefit of a patent term extension under § 156.  Accordingly, extension of the term of the '229 patent past the expiration date of the '565 patent was not improper.

It is when the opinion turns to "Ezra's policy concerns" that the panel took the opportunity to set forth its reasoning on the question of the function of the OTDP doctrine.  Citing Proctor & Gamble Co. v. Teva Pharm. USA, Inc., 566 F.3d 989, 999 (Fed. Cir. 2009), the opinion states that the instant situation "does not raise the traditional concern with obviousness-type double patenting of a patent owner 'extending his exclusive rights to an invention through claims in a later-filed patent that are not patentably distinct from claims in the earlier filed patent.'"  The opinion then distinguishes the policy considerations at play here with more recent OTDP decisions of the Court, particularly Gilead Sciences, Inc. v. Natco Pharma Ltd., specifically referring to that Court's concerns with gamesmanship not present here.

The other distinction between the situation in Gilead and the one here is whether the differences in the relationship between the patents (patents filed pre- and post-URAA here, in contrast to having two post-URAA patents in Gilead) are addressed in the opinion accompanying this one, Novartis Pharmaceuticals Corp. v. Breckenridge Pharmaceutical.  That case will be the subject of a later post.

Novartis AG v. Ezra Ventures LLC (Fed. Cir. 2018)
Panel: Circuit Judges Moore, Chen, and Hughes
Opinion by Circuit Judge Chen

In re Janssen Biotech, Inc. (Fed. Cir. 2018)

By Donald Zuhn –-

Last week, the Federal Circuit affirmed the rejection by the U.S. Patent and Trademark Office's Patent Trial and Appeal Board of claims 1-7 of U.S. Patent No. 6,284,471 as being unpatentable under the doctrine of obviousness-type double patenting.  Janssen Biotech, Inc. and New York University ("Janssen"), co-assignees of the '471 patent, argued on appeal that obviousness-type double patenting was not applicable because the safe-harbor provision of 35 U.S.C. § 121 protected the '471 patent claims.  In affirming the Board's decision, however, the Federal Circuit determined that the '471 patent was not entitled to safe-harbor protections.

The '471 patent issued from U.S. Application No. 08/192,093, which was filed as a continuation-in-part application of U.S. Application Nos. 08/013,413 and 08/010,406.  On the same day that the '093 application was filed, Janssen also filed U.S. Application No. 08/192,102, which was also filed as a continuation-in-part application of the '413 and '406 applications, and which later issued as U.S. Patent No. 5,656,272.  Janssen subsequently filed U.S. Application No. 08/324,799, which was filed as a continuation-in-part of the '093 and '102 applications, and which later issued as U.S. Patent No. 5,698,185.  The relationships of the above applications and patents is shown in the chart below, which is reproduced from the Federal Circuit's opinion.

During prosecution of the '413 application, which relates to antibodies specific to human tumor necrosis factor alpha and included claims directed to a chimeric antibody and methods of treatment, a restriction requirement was issued in which Group I was directed to antibodies, pharmaceutical compositions, and assay methods, and Group IV was directed to methods for treating an animal by administering a pharmaceutical composition containing an antibody. Instead of replying to the restriction requirement, Janssen expressly abandoned the '413 application and filed the '093 and '102 applications as continuation-in-part applications of the '413 and '406 applications.

The '093 application disclosed and claimed subject matter from both the '413 and '406 applications (the '406 application relates to immunoreceptor molecules that are specific for TNF alpha or beta).  After the '093 application was filed, Janssen allowed the '406 application to go abandoned.  Janssen then filed a preliminary amendment in the '093 application, cancelling method claims designated as the invention of Group IV in the restriction requirement issued in the '413 application.  However, Janssen did not limit the claimed subject matter to only that claimed and disclosed in the '413 application, as the '093 application still included claims directed to chimeric antibodies (based on the '413 application) and immunoreceptor molecules (based on the '406 application), and also retained language regarding binding to the TNF genus generally as opposed to the species of TNF alpha.  In an Office action issued during prosecution of the '093 application, the claims were provisionally rejected on obviousness-type double patenting grounds over the '799 application.  Janssen responded by amending the claims, including limiting claim 1 to TNF alpha.  Janssen also filed preliminary amendments in both the '799 and '102 applications, replacing the pending claims of the '799 application with claims directed to methods of treating rheumatoid arthritis, and the pending claims of the '102 application with claims directed to methods of treating Crohn's disease.

Following the issuance of another Office action in the '093 application, in which the double patenting rejection was maintained, Janssen responded by arguing for withdrawal of the rejection in view of the amendment of the claims of the '799 application to recite methods of treating rheumatoid arthritis and by pointing to the restriction requirement issued in the '413 application, which Janssen argued precluded an obviousness-type double patenting rejection in the '093 application.  The Examiner withdrew the double patenting rejection, and the '093 application eventually issued as the '471 patent, with claims directed to a chimeric antibody specific for TNF alpha (claims 1, 3, and 5–6), immunoassay methods for detecting human TNF (claims 2 and 4), and polypeptides of particular amino acid sequences that bind to human TNF alpha (claims 8 and 9).

Twelve years after the '471 patent issued, the USPTO instituted a reexamination of the patent (in response to a third-party request) on double patenting grounds over three patents including the '272 and '195 patents.  During the reexamination, Janssen cancelled claims 8 and 9; requested that the benefit claim to the '406 application be deleted; sought amendment of the specification, abstract, and drawings to delete portions that were not in the '413 application; and requested that the application be designated as a divisional of the '413 application.  The Examiner, however, maintained the double patenting rejections on the basis that the safe harbor did not apply, noting that more than thirty-two issued patents "reached through the '471 patent for benefit of a prior filing date" and that the "patentability of those claims . . . cannot be determined without reopening examination of those patents in view of the deletion of the subject matter in the '471 patent."  The Examiner also determined that the one-way test for double patenting applied because the PTO was not "solely responsible" for the '471 patent's later issuance, and that the claims of the '471 patent were unpatentable under that test.  The Board subsequently affirmed the Examiner's determination, and Janssen appealed the Board's decision to the Federal Circuit.

In an opinion authored by Chief Judge Prost, and joined by Circuit Judges Reyna and Wallach, the Federal Circuit noted that "[t]he main issue on appeal is whether the safe-harbor provision of 35 U.S.C. § 121 applies to the '471 patent and protects it from invalidation based on the '272 and '195 reference patents."  The opinion also noted that "[t]he § 121 safe harbor, 'by its literal terms, protects only divisional applications (or the original application) and patents issued on such applications,'" quoting Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 1360 (Fed. Cir. 2008), and explained that:

[P]atents issued on CIP applications are not within the scope of § 121.  [Pfizer, 518 F.3d] at 1362.  Nor are patents issued on continuation applications.  [Amgen Inc. v. F. Hoffman-La Roche Ltd., 580 F.3d 1340, 1354 (Fed. Cir. 2009)].  Our precedent is clear: aside from the original application and the original patent, the protection afforded by § 121 is limited to divisional applications and patents issued on divisional applications.  Pfizer, 518 F.3d at 1362.

The panel noted that in G.D. Searle LLC v. Lupin Pharm., Inc., 790 F.3d 1349 (Fed. Cir. 2015), the question of whether a patent owner can retroactively bring a challenged patent, issued from a CIP application, within the scope of the § 121 safe harbor by amending the CIP application after issuance to redesignate the application as a divisional application was answered by the Federal Circuit in the reissue context, where the Court determined that the patent owner could not take advantage of the safe-harbor provision simply by designating the CIP as a divisional application.  Applying Searle to the instant case, the panel indicated that it was "persuaded by the reasoning in Searle that a patent owner cannot retroactively bring its challenged patent within the scope of the safe-harbor provision by amendment in a reexamination proceeding," stating that "once the '471 patent issued on the '093 application—which, like the application in Searle, at the time of issuance included new matter not disclosed in the original application and so was a properly designated CIP—the '471 patent was barred from safe-harbor protections."

The panel pointed out that "[t]he '471 patent cannot retroactively become, for the purposes of § 121, a 'patent issued on' a divisional application after it already issued on a CIP application; not even if that CIP application is effectively redesignated as a divisional application during reexamination," and noted that "[f]or a challenged patent to receive safe-harbor protections, the application must be properly designated as a divisional application, at the very latest, by the time the challenged patent issues on that application."  In response to Janssen's argument that it had not enjoyed a benefit from having filed the '093 application as a CIP of the '413 and '406 applications because no issued claims in the '471 patent relied upon the new matter in the '093 application, the panel disagreed, explaining that "the examiner found that Janssen had benefitted because more than thirty patents issued to Janssen claiming priority to the '471 patent and/or the '093 application as a CIP of both the '406 and '413 applications."

The opinion notes that given the panel's determination that once the '471 patent had issued on a CIP application, it was not entitled to safe-harbor protections of § 121, the panel did not need to consider the USPTO's alternative argument that § 121 does not apply because the '471 patent and the reference patents did not maintain consonance with the restriction requirement made in the '413 application.  In addition, in response to Janssen's argument that the Federal Circuit's holding "creates a rigid 'divisional as filed' test," and ignores longstanding USPTO rules and practices that permit applicants to amend the disclosure and claims of an application after it is filed and to change an application's relationship to a prior-filed application, the panel noted that "[t]hese practices, whether or not they are widely practiced or even permitted under PTO rules, have no relevance here because Janssen did not follow them."  The panel also explained that:

[W]e do not decide whether such filing practices or amendments made prior to issuance—wherein an application is designated as a divisional application by the time the challenged patent issues on that application—would be sufficient to bring the challenged patent within the scope of the safe-harbor protections.

The opinion concludes with the panel finding to be unpersuasive Janssen's argument that the Board erred by failing to apply a two-way test for double patenting.  Instead, the panel concluded that Janssen failed to establish that the PTO is "solely responsible" for any alleged delay associated with the issuance of the '471 patent.  Finding that the '471 patent was not entitled to safe-harbor protections, and that the Board did not err in applying the one-way test for double patenting, the Federal Circuit affirmed the Board's rejection of claims 1–7 of the '471 patent as being unpatentable under the doctrine of obviousness-type double patenting.

In re Janssen Biotech, Inc. (Fed. Cir. 2018)
Panel: Chief Judge Prost and Circuit Judges Reyna and Wallach
Opinion by Chief Judge Prost

USPTO Files Response Brief in In re Janssen Biotech, Inc. & New York University

By Grantland Drutchas --

The U.S. Patent and Trademark Office has now filed its response brief in In re: Janssen Biotech, Inc., New York University, No. 2017-1257 (Fed. Cir.), the Federal Circuit appeal involving U.S. Patent No. 6,284,471/Reexamination Control No. 90/012,851 ("Reexam appeal").  This is a parallel appeal to Janssen's appeal from its District Court action against Celltrion involving the '471 patent, Janssen Biotech, Inc. v. Celltrion Healthcare Co., Ltd., No. 2017-1120 (Fed. Cir.) ("Janssen v. Celltrion").  Notably, however, Janssen (and New York University) previously argued in the parallel Janssen v. Celltrion appeal that this PTO appeal controlled:  "Because the '471 Patent was amended in reexamination, a decision favorable to Janssen in the co-pending appeal would supersede the district court's ruling, which was based on the un-amended form of the '471 Patent."  As such, this Reexam appeal is the one to watch.

Both this appeal and the Janssen v. Celltrion appeal involve obviousness-type double patenting (or "ODP"), an issue which presents real risks for pharmaceutical manufacturers who have sought to broaden their patent estates to cover all possible uses of patented compositions.  The ODP doctrine is an attempt to enforce the quid pro quo that is at the core of the patent system:  that, in exchange for a patent, an inventor must fully disclose his invention and promise to permit free use of it at the end of his patent term.  Gilead Sciences, Inc. v. Natco Pharma Ltd., 753 F. 3d 1208, 1212 (Fed. Cir. 2014).  The ODP doctrine prevents an applicant from obtaining several sequential patents on the same invention, including obvious modifications of the invention.  In such cases, a terminal disclaimer should be used to preserve the validity of the later-expiring patent by aligning its expiration date with that of the earlier-expiring patent.  Id. at 1217

At issue in both of these appeals is (1) whether the claims of the '471 patent (as amended in the reexamination) are subject to the "safe harbor" of 35 U.S.C. § 121 to avoid the ODP issue altogether, and (2) if not, how the test for ODP should be applied, either under a "one-way test," or a "two-way test."

Under the "safe harbor" provision of 35 U.S.C. § 121, a restriction requirement from the PTO acts as a sort of estoppel with respect to a divisional application filed in response to that requirement:  neither of the patents that result directly from the restriction requirement can be used as an ODP reference against the other patent.

If the safe harbor does not apply, then the PTO and courts must apply either a one-way test or two-way test for ODP.  In the one-way test, the only question is whether the claimed subject matter in the later-expiring patent is obvious over that of the earlier-expiring patent.  In the two-way test, the examiner (or patent challenger) must show that the subject matter of the claims of both patents would be obvious over the other, and thus is a much more difficult obstacle for the examiner (or patent challenger) to overcome.  Although there are a number of pitfalls, the two-way test applies if (i) the later-expiring patent was filed before the earlier-expiring patent and (ii) the applicant could not avoid separate filings (by filing conflicting claims in the earlier-filed application) and (iii) the PTO was solely responsible for the delay in prosecution of the later-expiring patent.  If all three are true, the two-way test applies; if any one is false, then the one-way test applies.

In its briefs in both appeals, Janssen made many of the same arguments supporting reversal of the District Court and the PTO decisions.  There are two significant differences in the two appeals, however.  First, the PTO has argued an alternative ground for rejecting the § 121 safe harbor, specifically the lack of "consonance."  Second, and perhaps more damning, Janssen has to contend in this Reexam appeal with the PTO's finding that the PTO was not solely responsible for the delay in prosecution of the '471 patent.  In the District Court decision on appeal in Janssen v. Celltrion, Judge Wolf did not rule on this last issue, finding a potential issue of fact.

The PTO's brief relied heavily on three facts, the first two of which are undisputed:  (1) that the applicant filed the '093 application, which issued as the '471 patent, as a CIP application, not a divisional application (although they tried to fix this retroactively); (2) that claim 1 of the '471 patent is not patentably distinct from the claims of appellees' '272 and '195 reference patents; and (3) that the PTO had found that Janssen was partially responsible for the delay caused in the '903 application prosecution which caused the '471 patent to issue after its siblings, the '272 and '195 patents.  PTO Response Brief, Slip op. at 18-19, 23 (note that the page numbering used here is the court's page numbering at the top of the page in the slip opinion, rather than the brief's page numbering at the bottom).

With respect to the § 121 safe harbor issue, the PTO followed a long line of cases -- Pfizer, Inc. v. Teva Pharms. USA, Inc., 518 F.3d 1353 (Fed. Cir. 2008); Amgen Inc. v. F. Hoffman-LaRoche Ltd., 580 F.3d 1340 (Fed. Cir. 2009); Amgen v. HLR, and G.D. Searle LLC v. Lupin Pharms., Inc., 790 F.3d 1349 (Fed. Cir. 2015) (id. at 29-34), and a long-standing PTO practice (id.  at 34-38), in holding that because the applicants filed the '093 application as a CIP application, not a divisional application, the '471 patent was not entitled to § 121's safe harbor.  Indeed, the single largest chunk of the PTO's argument is directed to reminding the Federal Circuit of what exactly it held in those three decisions.  That is, under these prior decisions, applicants' belated attempt to re-cast the filing as a divisional is too little, too late.  As Searle made clear, "Janssen cannot 'retroactively alter the nature' of the original '093 CIP application" to make it a divisional application after-the fact.  Id. at 20.  Because Janssen filed the '093 application as a CIP of two applications, and included subject matter and claims not supported by the disclosure of the '413 application where the restriction requirement was made, "there is no way that the '093 application can be considered a divisional of the '413 application in 'form' or in 'substance.'"  Id. at 20.

A second, alternative argument that the PTO made for denying appellees the § 121 safe harbor was that the claims at issue in the ODP rejection did not maintain "consonance."  That is, issued claims in the three patents involved in the ODP rejection are not consonant with the restricted claims in the '413 application because they did not maintain the independent and distinct inventions that prompted the restriction requirement.  The PTO provided several reasons, including:  (a) the issued claims in the '195 patent and '272 patent are not limited to TNF-α, whereas claims that were the subject of the restriction requirement were limited to TNF-α; and (b) claims 1 and 9 of the '471 patent are not only broader than the original Group I claims of the restriction requirement but they are also directed to subject matter not disclosed in the '413 application where the restriction was made. 

Notably, for Janssen to prevail on the § 121 safe harbor issue it must establish that the PTO erred on both of these two grounds.  It appears unlikely to succeed with either.

Regarding the § 121 safe harbor argument, Janssen argued a number of equities that the PTO's brief dismissed.  With respect to Janssen's argument that its added disclosure -- disclosed but not eventually claimed -- in the '093 application benefited the public, for example, the PTO noted that Janssen could have filed both a CIP and a divisional application and given the same benefit without losing its divisional designation.  With respect to Janssen's argument that it relied to its detriment on the Examiner's withdrawal of an ODP objection, because it could have filed a divisional while the parent application was still pending, the PTO argued that the timing is unlikely because Janssen did not file a divisional application during the two years that the examiner's ODP objection was pending.  And with respect to Janssen's argument that it relied on a non-precedential decision in a reexamination, the PTO noted that the decision was both not binding and in any event preceded Searle.  Id. at 45-47.

With respect to the second issue on appeal, the PTO argued that Janssen was not entitled to the two-way ODP test because (a) the application that led to the '471 and '272 patents were filed on the same day, and the MPEP clearly states that where "both applications are filed on the same day, only a one-way determination of distinctness is needed" and (b) Janssen was partially responsible for the "delay" that caused the '471 patent to issue after the '272 and '195 reference patents.  These examples of delay cited by the PTO included (i) the applicant waited ten months to file a preliminary amendment that included immunoreceptor claims from the other parent application (not supported by the '413 application where the original restriction requirement was made) -- which then prompted a further restriction requirement; (ii) that, by contrast, Janssen took specific steps in the '195 and '272 applications explicitly designed to expedite prosecution; (iii) after receiving a final rejection in May, 1996, Janssen waited six months, until October, 1996 to file a Notice of Appeal; and then (iv) Janssen waited another six months, until May, 1997 to reopen prosecution by filing a 37 C.F.R. § 1.129(a) amendment.  Id. at 52-54.

If there are points for brevity, the PTO got all this done in only 10,627 of the 14,000 words allotted.

• Brief for Appellee - Director of the United States Patent and Trademark Office
• Opening Brief for Janssen Biotech Inc. and New York University

Eli Lilly & Co. v. Teva Parenteral Medicines, Inc. (Fed. Cir. 2017)

By Kevin E. Noonan --

From the nadir of the Supreme Court's allegations that the Federal Circuit "fundamentally misunderstood" the law of inducing infringement in Limelight Networks, Inc. v. Akamai Technologies, Inc., the nation's specialized patent appellate court has crafted a two-prong test for assessing when the actions of more than a single actor amount to literal infringement sufficient to support a determination of inducement.  Akamai Technologies, Inc. v. Limelight Networks, Inc. (Fed. Cir. 2015) (en banc).

The case came to the Court from ANDA litigation between Eli Lilly and Teva and other ANDA filers over infringement under 35 U.S.C. § 271(e)(2) of U.S. Patent No. 7,772,209.  The claims were directed to methods for administering pemetrexed disodium (sold by Eli Lilly as Alimta^®) after pretreatment with folic acid and vitamin B12.  Claims 1 and 12 are representative as set forth in the opinion:

1.  A method of administering pemetrexed disodium to a patient in need thereof comprising administering an effective amount of folic acid and an effective amount of a methylmalonic acid lowering agent followed by administering an effective amount of pemetrexed disodium, wherein the methylmalonic acid lowering agent is selected from the group consisting of vitamin B12, hydroxycobalamin, cyano-10-chlorocobalamin, aquocobalamin perchlorate, aquo-10-cobalamin perchlorate, azidocobalamin, cobalamin, cyanoco- balamin, or chlorocobalamin.

12.  An improved method for administering pemetrexed disodium to a patient in need of chemotherapeutic treatment, wherein the improvement comprises:
    a)  administration of between about 350 μg and about 1000 μg of folic acid prior to the first administration of pemetrexed disodium;
    b)  administration of about 500 μg to about 1500 μg of vitamin B12, prior to the first administration of pemetrexed disodium; and
    c) administration of pemetrexed disodium.

(Where the italicized limitations were specifically at issue.)  Here, the patient practices the step of the claim involving administering folic acid (which is available as a pill), and the physician administers B12 and pemetrexed by injection.  The question of whether the existence of two actors (patients and physicians) practicing the claims creates a divided infringement situation that would vitiate literal infringement was clearly contemplated throughout the litigation, during the course of which the Federal Circuit and Supreme Court were considering the question.  That both actors performed their individual steps of the claimed method was not disputed, but its effects on infringement liability, and whether Teva could be liable for inducing infringement was central to the dispute between the parties.

As the litigation progressed, defendants conditionally stipulated to induced infringement subject to being able to litigate the issue if (as it turned out) the Supreme Court reversed the Federal Circuit's contemporaneous standard.  The District Court proceeded on the invalidity issues and held Eli Lilly's claims not to be invalid on obviousness and obviousness-type double patenting grounds nor were indefinite.  After the Supreme Court's Akamai decision, the parties relitigated the infringement issues.  The District Court used the label as evidence of infringement, wherein under FDA regulations Teva's label comprising instruction for administration of the drug would be identical to Eli Lilly's label.  Based on this determination, the District Court found defendants had induced infringement, and this appeal followed.

The Federal Circuit affirmed, in an opinion by Chief Judge Prost joined by Judges Newman and Dyk.  The opinion recognized the Supreme Court's overriding teaching that induced infringement requires a finding that literal infringement had occurred.  Moreover, inducement also requires an intent to induce, which requires that the alleged infringer "knew or should have known" that her actions would induce infringement.  In order for more than one actor to practice the steps of a claimed method and for literal infringement to lie, the Supreme Court-approved standard is that either one of the actors works at the "direction or control" of the other actor, or the actors form a joint enterprise.  With regard to the question of "direction or control," the panel set forth the revised Akamai standard operationalized as a two-prong test.  The first prong of that test is whether one actor "'conditions participation in an activity or receipt of a benefit' upon anothers' performance of one or more steps of a patented method," and the second prong is whether that actor "'establishes the manner or timing of that performance,'" citing the Court's Akamai decision following remand from the Supreme Court (italics in opinion).  The District Court held that the first prong was satisfied because folate administration was a precondition for the physician administering B12 and the drug, and that the second prong was satisfied because the physician prescribed the dose and administration schedule to the patient.

With regard to the District Court's decision on the first prong, the Federal Circuit held that this determination was supported by the evidence of record.  Contrary to Teva's argument that reduction of toxicity was not conditioned by a patient taking folate, the opinion states that what was conditioned was whether the physician administered the drug to the patient (i.e., a physician would only administer the drug if a patient had taken the prescribed amount of folate at the proper schedule):

What is relevant is whether the physician sufficiently directs or controls the acts of the patients in such a manner as to condition participation in an activity or receipt of a benefit—in this case, treatment with pemetrexed in the manner that reduces toxicities—upon the performance of a step of the patented method and establishes the manner and timing of the performance [italics in opinion].

The panel also noted that the District Court's conclusions on this point were supported by the Physician Prescribing Information and Patient Information comprising the FDA-approved label as well as expert testimony (wherein both parties' experts agreed on the importance of folate pre-administration).  Finally on this point, the panel stated that such "conditioning" did not require that a legal obligation be imposed on one of the parties or that the step comprise an "unavoidable technological prerequisite to participation."

With regard to the second prong, the District Court and the panel relied upon the product label.  This information comports with the dosage amounts and frequencies encompassed by the asserted claims.  Expert testimony supported the finding that it was the physician who prescribed folate (in administered amount and frequency) to the patient.

Taken as a whole, the panel found no reversible error in the District Court's factual determinations.

The panel then turned to whether Eli Lilly had established that defendants exhibited the requisite intent to induce infringement, which required evidence of specific intention and acts and not mere knowledge of the patent in suit.  The District Court once more relied on the generic product label (identical to Eli Lilly's label).  The District Court and the Federal Circuit rejected Teva's argument that the label was not sufficient to provide specific evidence of inducement, because it purportedly did not show how physicians (the direct infringer) do act rather than as they may act.  The panel's reaction to that argument was that "[t]he question is not just whether [those] instructions describ[e] the infringing mode, . . . but whether the instructions teach an infringing use such that we are willing to infer from those instructions an affirmative intent to infringe the patent," citing Takeda Pharm. USA, Inc. v. West-Ward Pharm. Corp. and that "it is irrelevant that some users may ignore the warnings in the proposed label," citing AstraZeneca LP v. Apotex, Inc.  Also relevant to the panel's decision was that the label (in both the Physician Prescribing Information and Patient Information) emphasized how important folate administration was for reducing toxicity associated with administration of the drug.  This portion of the opinion concludes "[i]n sum, evidence that the product labeling that Defendants seek would inevitably lead some physicians to infringe establishes the requisite intent for inducement."

With regard to the invalidity issues, the opinion first considered Teva's indefiniteness contentions.  The factual basis for these were that the term "vitamin B12" was indefinite, because there were various species of the vitamin (claimed as vitamin B12, hydroxycobalamin, cyano-10-chlorocobalamin, aquocobalamin perchlorate, aquo-10-cobalamin perchlorate, azidocobalamin, cobalamin, cyanocobalamin, or chlorocobalamin); the District Court found that the term meant cyanocobalamin based on expert testimony.  The panel noted that it does not defer to this expert testimony because satisfaction of the statute is a question of law.  But the opinion does note that the question of how the skilled worker would understand the term is a question of fact reviewable for clear error, and found no such error in the District Court's finding (a definition that was supported even by defendant's expert).  Upon consideration of how the term was used in the claims, and despite some apparent inconsistency in claim language, the Federal Circuit agreed that the skilled worker would have understood the meaning of the term.

With regarding to obviousness, the panel referenced the District Court's "thorough opinion" that the prior art did not motivate the skilled worker to practice the claimed method, and specifically that the skilled artisan would not have been motivated to "(1) use folic acid pretreatment with pemetrexed; (2) use vitamin B12 pretreatment with pemetrexed; or (3) use the claimed doses and schedules of folic acid and vitamin B12 pretreatments with pemetrexed."  The focus of these determinations was that the art did not show any correlation between pemetrexed toxicity and vitamin B12 deficiency (although there was evidence of a correlation with folate deficiency).  Expert testimony from both sides established that there was no recognition in the art that vitamin B12 deficiencies were associated with cancer treatment with antifolate compounds.  Nor was there evidence from the art that B12 would have been routinely administered (or that its administration schedules would have been routine) in cancer treatment.  The panel made similar determinations in affirming the District Court's finding that the claims of the '209 patent were not invalid under the obviousness-type double patenting doctrine.

Eli Lilly benefited in this case by having prevailed at the District Court, in large part due to the burden of finding clear error to overcome the District Court's decision.  But the opinion does set forth an affirmation of the Court's two-prong test for finding that more than one actor can perform the steps in a claimed method sufficient to satisfy the unitary standard for finding literal infringement.

Eli Lilly & Co. v. Teva Parenteral Medicines, Inc. (Fed. Cir. 2017)
Panel:  Chief Judge Prost and Circuit Judges Newman and Dyk
Opinion by Chief Judge Prost

G.D. Searle LLC v. Lupin Pharmaceuticals, Inc. (Fed. Cir. 2015)

By Kevin E. Noonan --

Over seven years ago, the Federal Circuit delivered a mixed ruling against Pfizer in litigation against Teva) relating to the pain medication Celebrex® (celocoxib) (where "celocoxib" is 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl]benzenesulfonamide).  In that case, Pfizer, Inc. v. Teva Pharmaceuticals USA, Inc. (Fed. Cir. 2008), the Court upheld a District Court determination that Teva was liable for infringing a trio of Pfizer patents (U.S. Patent Nos. 5,466,823; 5,563,165; and 5,760,068) but reversed the District Court's determination that the claims of the '068 patent were not invalid for obviousness-type double patenting.  Pfizer took steps to remedy the deficiency of the claims of the '068 patent by reissue, but those efforts were deemed insufficient in a decision handed down today in G.D. Searle LLC v. Lupin Pharmaceuticals Inc. et al.

This case involved ANDA litigation against five generic defendants (Lupin, Teva Pharmaceuticals USA Inc., Mylan Pharmaceuticals Inc., Watson Laboratories, Inc., Apotex Inc. and Apotex Corp.), again related to generic Celebrex.  The basis for the Court's earlier determination that the '068 patent was invalid for obviousness-type double patenting was that the designation of this patent as a "continuation-in-part" was not merely semantic but had substantive repercussions regarding whether the '068 claims were entitled to the "safe harbor" provisions of 35 U.S.C. § 121.  These provisions entitle a divisional application filed as the result of a restriction requirement (a Patent Office determination that an applicant has filed claims directed to more than one invention) to be exempt from obviousness-type double patenting, and illustrate Congressional intent (from the legislative history of the 1952 Patent Act) to prevent the unfairness of forcing an applicant to be required to file a divisional application based on claiming "independent inventions" through restriction while permitting the original application to be used as "prior art" in a obviousness-type double patenting rejection.  The Federal Circuit considered it also Congress's intent to restrict the safe harbor to divisional applications (which have an identical specification to the originally-filed application) and keep any claims in such a divisional application strictly within the bounds of what had been determined to be a separate invention.  This meant, for example, that an applicant would not be able to include claims in a divisional that were within the scope of any claims previously elected for examination.  In this way applicants would be precluded from inequitably increasing patent term while not being penalized for electing one invention and pursuing additional inventions in divisional applications.

The lineage of the '068 patent began with U.S. patent application No. 08/160,594 in which the U.S. Patent and Trademark Office imposed a three-way restriction requirement:  to the claimed compounds per se, compositions of said compounds and methods of use for treating inflammation and resulting pain without the side effects of conventional non-steroidal anti-inflammatory compounds.  The compound claims were elected and granted as U.S. Patent No. 5,466,823 and the composition claims pursued in a divisional application (Serial No. 08/457,059) that issued as U.S. Patent No. 5,563,165.  Both the '823 and '165 patents have expired.

Pfizer did not pursue the method of treatment claims in a divisional application but instead filed a continuation-in-part application that contained additional disclosure (including previously undisclosed compounds) as well as claims to the three classes of inventions that were subject to restriction in the '594 application.  The U.S. application issued as U.S. Patent No. 5,521,207 and is also expired.  However, this application was the priority document for a PCT (International) Application that entered the national phase in the U.S. as Serial No. 08/648,113.  In that application the PTO imposed a unity of invention/restriction requirement along exactly the same lines as in the '594 application, requiring the applicant to choose between claims to the compounds, compositions, and method of treatment claims.  Pfizer chose to pursue the method of treatment claims and these claims ultimately granted in the '068 patent.

In the earlier litigation, the Federal Circuit found that the claims of the '068 patent did not fall within the safe harbor because it was a continuation-in-part application, not a divisional.  Such a "CIP" application by definition contains some of the disclosure of an earlier-filed application in addition to new disclosure.  Because of this distinction, the Federal Circuit found that CIP applications could not fall within the safe harbor because they could encompass additional information (and patentable inventions) that were not a part of the original, restricted claims.

After receiving this decision, Pfizer filed reissue application No. 12/205,319 under 35 U.S.C. § 251 seeking to amend the '068 patent to conform to the requirements for a divisional application.  According to the panel decision today, in its reissue declaration "Pfizer asserted that it had erred in prosecuting the application leading up to the '068 patent as a continuation-in-part, rather than as a divisional application, and that the error had resulted in invalidating the relevant claims of the '068 patent for obviousness-type double patenting."  Pfizer filed a preliminary amendment wherein:

(1) it deleted portions of the '068 patent specification that were not present in the '594 application; (2) it designated the '113 application as a divisional of the '594 application and removed the priority claim to the '629 application; (3) it amended claim 1 to be a method claim using only the compounds originally disclosed in the '594 application; (4) it canceled claims 2-12, which were method claims using compounds that were not present in the '594 application; (5) it canceled claim 18 (reciting a method of preventing colorectal cancer), which was not found in the '594 application; and (6) it added new method claims 19-23, which recited the use of the method disclosed in claim 1 to treat five specific types of inflammation-associated disorders.

Initially the PTO rejected the reissue application on the grounds that these changes were not the types of error intended to be remedied by reissue; in response Pfizer amended its amendment to assert "various technical errors" that Pfizer contended rendered the claims indefinite, and on that basis the reissue application was permitted to continue.  Pfizer then made the changes in the original version of the application and the application granted as RE44,048.

The District Court held that these corrections were not correctable under the reissue statute, and that the claims in the '048 reissue patent were not entitled to the safe harbor under 35 U.S.C. § 121 and thus were invalid for obviousness-type double patenting.

The Federal Circuit affirmed, in an opinion by Judge Bryson joined by Chief Judge Prost and Judge Hughes.  The opinion recognized the question of the propriety of the reissue application under § 251 but was content to limit the decision to the absence of the safe harbor under § 121 for the reissue claims.  The panel expressly rejected Pfizer's argument that the restriction requirement from the '594 application extended to the national phase of the PCT application, despite the similarities in the nature of three classes of claims in each.  The panel reasoned that this cannot be the case because the national phase '113 application contained new matter not contained in the '594 application and thus was properly treated as a continuation-in-part (the earlier case had expressly held that CIPs were not entitled to the safe harbor provisions of § 121).  In this regard the panel rejected the changes in the reissue application, stating that "[s]imply deleting that new matter from the reissue patent does not retroactively alter the nature of the '113 application."

The opinion also raises the equities (between Pfizer and the public) involved:

Moreover, when the '113 application issued as the '068 patent in June 1998, Pfizer obtained patent protection for the new matter that was not present in the '594 application.  For years thereafter, the public was not free to practice that new matter (e.g., the now cancelled claims 2-12 and 18 of the '068 patent) because of that patent protection.  Pfizer cannot now identify the '113 application as a divisional of the '594 application (for purposes of section 121) and retroactively relinquish the new matter in the '113 application, after having enjoyed years of patent protection for it.  See In re Harita, 847 F.2d 801, 809 (Fed. Cir. 1988) ("In any given case, the [reissue] statute should be so applied to the facts that justice will be done both to the patentee and the public."); see also In re Serenkin, 479 F.3d 1359, 1362 (Fed. Cir. 2007) ("[Section] 251 is based on fundamental principles of equity and fairness[.]").  Fairness to the public does not permit Pfizer to convert the '113 application into a division of the original '594 application, and thereby take advantage of the safe harbor provision, simply by designating it as a divisional application years after the fact.

(This rationale also applies to the foreign patents arising from the PCT application, whose status has not changed.)

The opinion also sets forth as a basis for its decision its determination that the restriction requirement in the '113 application is not the same as the restriction requirement in the '594 application (despite their similarities).  The panel states that the claims in divisional applications must be "derived from the same restriction requirement," citing its earlier opinion regarding this patent family and also Boehringer Ingelheim Int'l GmbH v. Barr Labs., Inc., 592 F.3d 1340, 1354 (Fed. Cir. 2010), stating:

When separate restriction requirements are imposed on separate applications and the record does not show that any of the various restriction requirements carried forward from one application to the next, the earlier restriction requirement cannot be viewed as having continued in effect with respect to the later-filed application [citing Bristol-Myers Squibb Co. v. Pharmachemie B.V., 361 F.3d 1343, 1349-50 (Fed. Cir. 2004)].

The record here was that there were two separate restriction requirements asserted in two related but distinct (regarding the disclosure in the specification and the subject matter of the claims) applications, and that these differences precluded the restriction requirement imposed in the '594 application from having "carried over" to the '113 application (and the panel noted there was no evidence that the '113 application examiner referenced or was even aware of the restriction in the '594 application).  And the Court expressly rejected Pfizer's "but for" argument with regard to the requirement imposed in the '594 application (that "but for" that restriction the method of treatment claims would have been prosecuted in the '594 application).

While this decision is entirely consistent with the Court's earlier Pfizer decision, it does illustrate how stringently the Court has and intends to apply the law of obviousness-type double patenting for pharmaceutical patents.

G.D. Searle LLC v. Lupin Pharmaceuticals, Inc. (Fed. Cir. 2015)
Panel:  Chef Judge Prost and Circuit Judges Bryson and Hughes
Opinion by Circuit Judge Bryson

Top Stories of 2014: #14 to #11

By Donald Zuhn --

After reflecting upon the events of the past twelve months, Patent Docs presents its eighth annual list of top patent stories.  For 2014, we identified eighteen stories that were covered on Patent Docs last year that we believe had (or are likely to have) the greatest impact on patent practitioners and applicants.  Yesterday, we counted down stories #18 to #15, and today we count down stories #14 to #11 as we work our way towards the top three stories of 2014.  As with our other lists (2013, 2012, 2011, 2010, 2009, 2008, and 2007), links to our coverage of these stories (as well as a few links to articles on related topics) have been provided in case you missed the articles the first time around or wish to go back and have another look.  As always, we love to hear from Patent Docs readers, so if you think we left something off the list or disagree with anything we included, please let us know.  In addition, we will be offering a live webinar on the "Top Patent Law Stories of 2014" on January 20, 2015 from 10:00 am to 11:15 am (CT).  Details regarding the webinar can be found here.

14.  Supreme Court Hears Oral Argument in Teva v. Sandoz -- Will Decide Deference for Claim Construction Determinations

In March, the Supreme Court granted certiorari in Teva Pharmaceuticals USA, Inc. v. Sandoz Inc. to resolve the question of "[w]hether a district court's factual finding in support of its construction of a patent claim term may be reviewed de novo, as the Federal Circuit requires (and as the panel explicitly did in this case), or only for clear error, as Rule 52(a) requires."  In October, the Court heard oral argument in the case.  2015 will bring a decision from the Court as to whether appellate courts should afford any deference to a trial court's claim construction determination, and regardless of the Court's decision, Teva v. Sandoz will likely make a return trip to our top stories list (although coming in perhaps a little higher than #14 on next year's list).

For information regarding this and other related topics, please see:

• "Teva v. Sandoz -- Is Deferential Review a Boon for Patent Trolls?" October 14, 2014
• "Teva v. Sandoz -- Supreme Court Preview," October 9, 2014
• "Supreme Court Preview -- Teva Pharmaceuticals USA, Inc. v. Sandoz Inc. -- The End of Cybor Corp.?" September 29, 2014
• "Supreme Court Grants Certiorari in Teva Pharmaceuticals v. Sandoz," March 31, 2014

13.  Federal Circuit Decides Novartis v. Lee -- RCE Tolls B Delay Clock Regardless of When Filed

In January, the Federal Circuit affirmed a determination by the District Court for the District of Columbia that challenges of patent term adjustment (PTA) determinations by the U.S. Patent and Trademark Office for fifteen Novartis patents were untimely asserted, and with respect to three other Novartis patents, reversed the District Court's ruling that the Patent Office's interpretation of 35 U.S.C. § 154(b)(1)(B) was contrary to law.  With respect to the first fifteen patents, the Court noted that Novartis did not file suit within 180 days of denial of reconsideration of the Office's PTA determination, and that Novartis had failed to demonstrate why the 180-day rule should be equitably tolled.  The three other patents at issue involved the impact of an RCE filing on the calculation of B Delay.  For these patents, the Federal Circuit agreed with the Office that no PTA time is available for any time in continued examination, even if the continued examination was initiated more than three calendar years after the application's filing (in other words, for an RCE filed more than three years after the application filing date).  The Court, however, agreed with Novartis that the"time consumed by continued examination should be limited to the time before allowance, as long as no later examination actually occurs.  In June, the U.S. Patent and Trademark Office published a notice of proposed rulemaking to implement the Federal Circuit's decision in Novartis v. Lee.

For information regarding this and other related topics, please see:

• "USPTO Proposes Rules Changes in View of Novartis v. Lee," July 16, 2014
• "Novartis AG v. Lee (Fed. Cir. 2014)," January 15, 2014

12.  Supreme Court Decision Impacts Patentees in License Agreements

In January, the Supreme Court held in Medtronic, Inc. v. Mirowski Family Ventures, LLC that when a licensee seeks a declaratory judgment against a patentee to establish that there is no infringement, the burden of proving infringement remains with the patentee.  The decision by the Supreme Court reversed a Federal Circuit decision from 2012.  As we noted in our summary of the Medtronic decision, the case potentially disrupts the balance of power between a patent holder and a licensee.  In particular, we suggested that licensees may be emboldened to force patent holders to prove that licensed products or processes infringe the patents at issue, noting that a licensee would have little risk in doing so because a patent holder would not be able to assert counterclaims.  Therefore, the best that can be hoped for from the patentee's point of view would be to maintain the status quo, which could end up creating a disincentive for patent holders from entering into licensee agreements.

For information regarding this and other related topics, please see:

• "Medtronic, Inc. v. Mirowski Family Ventures, LCC (2014)," January 22, 2014

11.  Federal Circuit Extends Scope of Obviousness-type Double Patenting and Reaffirms Doctrine's Continued Application

The Federal Circuit issued two opinions in 2014 that address the judicially created doctrine of obviousness-type double patenting.  In April, the Court decided in Gilead Sciences Inc. v. Natco Pharma Ltd. that a patent (in this case Gilead's U.S. Patent No. 5,763,483) that issues after but expires before another patent (Gilead's U.S. Patent No. 5,952,375) can qualify as a double patenting reference for the other patent.  Instead of focusing on the issue date, as Gilead argued it should do, the panel majority in Gilead v. Natco focused on the date at which time the invention fell into the public domain.  The majority argued that doing otherwise would encourage "significant gamesmanship" during prosecution, explaining that "if the double patenting inquiry was limited by issuance date, inventors could routinely orchestrate patent term extensions by (1) filing serial applications on obvious modifications of an invention, (2) claiming priority to different applications in each, and then (3) arranging for the application claiming the latest filing date to issue first."  Thus, in Gilead, the majority fashioned a rule that "the earliest expiration date of all the patents an inventor has on his invention and its obvious variants" should be used for an obviousness-type double patenting analysis.  In September, in AbbVie Inc. v. Mathilda & Terence Kennedy Institute of Rheumatology Trust, the Federal Circuit rejected the Kennedy Trust's argument that because of the Uruguay Round Agreement Act (URAA), which implemented a 20-year patent term, the statutory and policy rationales underlying the obviousness-type double patenting doctrine no longer exist.  Instead, the Court noted that the doctrine also serves to prevent an inventor from securing a second, later expiring patent for the same invention, and that patents claiming overlapping subject matter that were filed at the same time still can have different patent terms due to examination delays at the USPTO.

For information regarding this and other related topics, please see:

• "AbbVie Inc. v. Mathilda & Terence Kennedy Institute of Rheumatology Trust (Fed. Cir. 2014)," September 4, 2014
• "Gilead Sciences, Inc. v. Natco Pharma Ltd. (Fed. Cir. 2014)," April 8, 2014

Top Stories of 2014: #15 to #18

By Donald Zuhn --

After reflecting upon the events of the past twelve months, Patent Docs presents its eighth annual list of top patent stories.  For 2014, we identified eighteen stories that were covered on Patent Docs last year that we believe had (or are likely to have) the greatest impact on patent practitioners and applicants.  Today, we count down stories #18 to #15, and then over the next few days, we will work our way towards the top stories of 2014.  As with our other lists (2013, 2012, 2011, 2010, 2009, 2008, and 2007), links to our coverage of these stories (as well as a few links to articles on related topics) have been provided in case you missed the articles the first time around or wish to go back and have another look.  As always, we love to hear from Patent Docs readers, so if you think we left something off the list or disagree with anything we included, please let us know.  In addition, we will be offering a live webinar on the "Top Patent Law Stories of 2014" on January 20, 2015 from 10:00 am to 11:15 am (CT).  Details regarding the webinar can be found here.

18.  White House Begins to Implement Initiatives to "Foster innovation"

In June of 2013, the White House released a Fact Sheet on the Administration's task force on high-tech patent issues providing seven different legislative recommendations and five executive actions (see "'When the Patent System is Attacked!' -- The White House Task Force on High-Tech Patent Issues").  In 2014, the White House took the first steps toward implementing the executive actions.  The step that attracted the most attention was the U.S. Patent and Trademark Office's publication of a notice of proposed rulemaking in which the Office proposed changes to the rules of practice that it claimed would "facilitate the examination of patent applications and . . . provide greater transparency concerning the ownership of patent applications and patents."  The proposed changes to the rules would require that the "attributable owner" be identified at the time an application is filed (or shortly thereafter), during the pendency of an application when there is a change in the attributable owner (within three months of such change), at the time the issue fee is paid, when maintenance fee payments are made, and if a patent becomes involved in supplemental examination, ex parte reexamination, or a trial proceeding before the Patent Trial and Appeal Board.  In February, the White House provided an update on the five executive actions, "announcing major progress" on the initiatives that the Administration declared would help combat so-called "patent trolls."  One of the initiatives involved the launching of a new "on-line toolkit" "[t]o help level the playing field and ensure individuals and businesses know their rights and are aware of available resources before entering into costly litigation or settlements."  With respect to the White House's initiative to promote transparency concerning patent ownership, Hal Wegner stated in his e-mail newsletter in February that while "attempts to minimize comment [on the proposed rulemaking regarding attributable owner identification] have involved suppression of existing comments as if this will perhaps lead to the public falling asleep at the comment switch," "the leadership of the Patent Office has been sheltered from questioning by the public, while the Administration’s lobbyist group, 'Business Forward', continues to have access to PTO leadership" (emphasis in original).

For information regarding this and other related topics, please see:

• "White House Seeks to Promote Transparency Concerning Patent Ownership," February 24, 2014
• "The White House Releases Update on "Protecting American Inventors and Innovators"," February 20, 2014
• "USPTO Proposes Rules Changes to Require Identification in Applications and Patents of Attributable Owners," January 28, 2014

17.  Federal Circuit Dismisses Consumer Watchdog Appeal for Lack of Standing

In June, the Federal Circuit dismissed an appeal by Consumer Watchdog from a decision of the Patent Trial and Appeal Board affirming the patentability of claims 1-4 of the Wisconsin Alumni Research Foundation's U.S. Patent No. 7,029,913, which is directed to a replicating in vitro cell culture of pluripotent human embryonic stem cells derived from a pre-implantation embryo.  In dismissing the appeal, the Federal Circuit determined that Consumer Watchdog had failed to establish an injury in fact sufficient to confer Article III standing because it had failed to identify any alleged injury aside from the Board denying Consumer Watchdog the particular outcome it desired in the reexamination of the '913 patent.  Given that Consumer Watchdog had been seeking to invalidate the patent as being invalid for encompassing ineligible subject matter, but for the dismissal for lack of standing, the appeal might have helped elucidate how the Federal Circuit viewed the patent eligibility of subject matter other than nucleic acids after The Supreme Court's decision in Association for Molecular Pathology v. Myriad Genetics, Inc.

For information regarding this and other related topics, please see:

• "Consumer Watchdog v. Wisconsin Alumni Research Foundation (Fed. Cir. 2014)," June 5, 2014
• "Consumer Watchdog Replies to United States Brief on Standing Issue," February 11, 2014
• "United States Argues That Consumer Watchdog Lacks Standing to Appeal Board Decision on WARF Patent," February 6, 2014

16.  Federal Circuit Decisions in Terminal Disclaimer Cases Serve as Reminder of Traps for the Unwary

Two decisions by the Federal Circuit in June and December served as a reminder to applicants and practitioners that patent law remains "full of traps for the unwary."  In Dinsmore, the Court affirmed a final rejection by the U.S. Patent and Trademark Office, which had refused to accept a reissue declaration in which the patentee indicated that the "error" in the patent that made it defective was the inadvertent filing of a terminal disclaimer.  In Japanese Foundation for Cancer Research, the Federal Circuit reversed a District Court determination ordering the U.S. Patent and Trademark Office to withdraw an improperly filed terminal disclaimer.  In distinguishing the facts of the instant case from the Court's earlier decision in Carnegie Mellon Univ. v. Schwartz, the Court indicated that Carnegie Mellon had intended to file a terminal disclaimer but had erred in identifying the correct patent serial number, whereas here the issue was whether the Office could withdraw a disclaimer that was intentionally filed (in the correct patent), i.e. where there was not the kind of error in Carnegie Mellon that justified the contrary results.

For information regarding this and other related topics, please see:

• "Japanese Foundation for Cancer Research v. Lee (Fed. Cir. 2014)," December 11, 2014
• "In re Dinsmore (Fed. Cir. 2014)," June 10, 2014

15.  Federal Circuit Hears Oral Argument in Ariosa v. Sequenom

In the context of the controversy caused by the U.S. Patent and Trademark Office's Myriad/Mayo guidance, the Ariosa Diagnostics v. Sequenom case worked its way through the appeal process with oral argument before the Federal Circuit taking place in November.  A little more than a year earlier, the Northern District of California had granted summary judgment for declaratory judgment plaintiff Ariosa Disgnostocs, finding that Sequenom's claimed method for detecting a paternally inherited nucleic acid of fetal origin was not patent eligible.  Among the controversial aspects of the case, was the District Court's determination that Sequenom's argument that there were alternative methods of detecting cffDNA available was unpersuasive because "Sequenom has failed to present any evidence showing that any of these alternative methods are practical and commercially viable" (emphasis added).  Regardless of where the Federal Circuit comes down on this case, it will likely make a return visit to next year's list of top stories and likely impact future iterations of the USPTO's guidance on subject matter eligibility.

For information regarding this and other related topics, please see:

• "Genetic Technologies Ltd. v. Laboratory Corp. of America Holdings (D. Del. 2014)," November 24, 2014
• "Ariosa v. Sequenom -- Ariosa's Responsive Brief," November 11, 2014
• "PTAB Decides Inter Partes Review of Patent at Issue in Ariosa v. Sequenom," September 15, 2014
• "Amicus Briefs Urging Reversal Filed in Ariosa Inc v. Sequenom, Inc.," March 6, 2014
• "Sequenom Files Opening Brief in Appeal of Summary Judgment on Section 101 Grounds," January 30, 2014

AbbVie Inc. v. Mathilda & Terence Kennedy Institute of Rheumatology Trust (Fed. Cir. 2014)

By Donald Zuhn --

Last month, in AbbVie Inc. v. Mathilda & Terence Kennedy Institute of Rheumatology Trust, the Federal Circuit affirmed a determination by the District Court for the Southern District of New York that U.S. Patent No. 7,846,442, which is owned by the Mathilda & Terence Kennedy Institute of Rheumatology Trust ("Kennedy Trust"), was invalid under the doctrine of obviousness-type double patenting in view of the Kennedy Trust's U.S. Patent No. 6,270,766.

The '766 and '442 patents are directed towards methods of treating rheumatoid arthritis by co-administering a disease-modifying antirheumatic drug (such as methotrexate) and an anti-TNFα antibody.  Representative claim 8 of the '766 patent recites (with emphasis added):

8.  A method of treating rheumatoid arthritis in an individual in need thereof comprising co-administering methotrexate and an [anti-TNFα] antibody or an antigen-binding fragment thereof to the individual, in therapeutically effective amounts.

and representative claim 1 of the '442 patent recites (with emphasis added):

1.  A method of treating an individual suffering from rheumatoid arthritis whose active disease is incompletely controlled despite already receiving methotrexate comprising adjunctively administering with methotrexate therapy a different composition comprising an anti-human [TNFα] antibody or a human [TNFα] binding fragment thereof to the individual, wherein the anti-human [TNFα] or fragment thereof (a) binds to an epitope on human [TNFα], (b) inhibits binding of human [TNFα] to human [TNFα] cell surface receptors and (c) is administered at a dosage of 0.01-100 mg/kg, and wherein such administration reduces or eliminates signs and symptoms associated with rheumatoid arthritis.

The relevant differences between the two representative claims are as follows: (1) while the '766 method is directed towards any "individual in need," the '442 method is directed towards individuals with "active disease"; (2) while the '766 method recites "co-administering" methotrexate and an anti-TNFα antibody, the '442 method recites "adjunctively administering" an anti-TNFα antibody with methotrexate.

The '766 patent application, which was filed on August 1, 1996, claimed the benefit of an application that was filed on October 8, 1992.  After the '766 patent issued in 2001, the Kennedy Trust filed the '442 patent application.  Although the specification of the '442 patent is identical to that of the '766 patent, the '442 patent only claims the benefit of the '766 patent's August 1, 1996 filing date.  As a result, while the '766 patent expired on October 8, 2012, the '442 patent does not expire until August 21, 2018.

As the opinion notes, AbbVie, Inc. and AbbVie Biotechnology Ltd. ("AbbVie"), which license the '766 patent but not the '442 patent, paid the Kennedy Trust more than $100 million in royalties in order to sell its anti-TNFα antibody, Humira, in combination with methotrexate for the treatment of rheumatoid arthritis.  However, when the '442 patent issued in 2010 and the Kennedy Trust sought an additional license from AbbVie, AbbVie instead filed a declaratory judgment action seeking a determination that the '442 patent was invalid for obviousness-type double patenting.

At trial, the Kennedy Trust contended that the '442 patent was patentable over the '766 patent because the latter claims a broad genus of methods for treating rheumatoid arthritis, and the former claims a narrower species of those treatment methods having unexpected results.  The District Court, however, determined that the claims of the '442 patent that were at issue in the declaratory judgment action were invalid over certain claims of the '766 patent.  In reaching that decision, the District Court determined that the adjunctive administration of the '442 method was one of three forms of co-administration covered by the '766 patent, and that the term "active disease" as recited in the '442 method covered all patients suffering from rheumatoid arthritis and requiring treatment.  Thus, the District Court determined that the '442 patent covered the same invention as the '766 patent, and as a result that the asserted claims of the '442 patent were invalid over the asserted claims of the '766 patent for obviousness-type double patenting.

In an opinion by Judge Dyk, joined by Judges Wallach and Chen, the Federal Circuit affirmed the District Courter's determination, finding the '442 patent invalid for obviousness-type double patenting in light of the '766 patent.  As the opinion inicates, the Kennedy Trust argued that:

[T]he statutory and policy rationales underlying the obviousness-type double patenting doctrine no longer exist and the doctrine should be discarded.  More specifically, [the] Kennedy [Trust] contends that the Uruguay Round Agreement Act (URAA), Pub. L. 103-465, 108 Stat. 4809, effective June 8, 1995, and its implementation of a 20-year period of patent protection that runs from a patent's earliest claimed priority date, eliminated the need for the obviousness-type double patenting doctrine.  . . .  Now that the patent term is measured from the earliest claimed priority date, as opposed to the date of issuance, [the] Kennedy [Trust] contends that the submarine patent problem no longer exists and that the URAA amendment vitiated the policy basis for the doctrine of obviousness-type double patenting.

The Court, however, countered that:

[T]his argument ignores another crucial purpose of the doctrine: It is designed to prevent an inventor from securing a second, later expiring patent for the same invention.  . . .  That problem still exists.  Patents claiming overlapping subject matter that were filed at the same time still can have different patent terms due to examination delays at the PTO.

As a result, the Court determined that "the doctrine of obviousness-type double patenting continues to apply where two patents that claim the same invention have different expiration dates."  With respect to the dispute between AbbVie and the Kennedy Trust, the Court stated that the Kennedy Trust was "not entitled to an extra six years of monopoly solely because it filed a separate application unless the two inventions are patentably distinct."

Before reaching a decision on whether the differences between the '766 and '442 patents rendered their claims patentably distinct, the Court addressed the disputed terms of "co-administering" and "active disease."  With respect to the first term, the Kennedy Trust argued that the District Court's construction excluded a fourth form of co-administration, namely, administration of the anti-TNFα antibody antibody alone after discontinuing the administration of methotrexate.  The Court, however, noted that "[t]he '766 patent's specification confirms the correctness of the district court's claim construction," in that "[t]he specification never uses the term 'co-administering' to refer to patients who only received the antibody after discontinuing treatment with methotrexate."

With respect to the second term, the Kennedy Trust argued that the prosecution history revealed that a more specific definition of "active disease" (i.e., particularly sick patients) was critical to the Examiner's allowance of the '442 patent claims.  "[A]ssum[ing], without deciding, that [the Kennedy Trust's] proposed construction of 'active disease' was correct," the Court noted that "[t]he consequence is the genus claimed in the '766 patent (treating all patients in need thereof) is broader than the species claimed in the '442 patent (treating patients with 'active disease,' i.e., particularly sick patients)."  As a result, the Court stated that it "must decide whether a patent that claims to treat a subset of patients with more severe rheumatoid arthritis (the '442 patent) is an obvious variant of a patent that claims treatment of rheumatoid arthritis patients generally (the '766 patent)."

While noting that "[i]t is well-settled that a narrow species can be non-obvious and patent eligible despite a patent on its genus," the opinion points out that "species are unpatentable when prior art disclosures describe the genus containing those species such that a person of ordinary skill in the art would be able to envision every member of the class."  In the instant case, the opinion stated that "it is clear that a reader of the '766 patent could have easily envisioned a species limited to sicker patients," and determined that the District Court was correct in concluding that the species of the '442 patent was not patentably distinct from the genus of the '766 patent.

As for the Kennedy Trust's argument that the species of the '442 patent showed unexpected results, the Court found that argument to be unsupported.  Looking to the specification to assess what results were expected at the time the '766 patent application was filed (which the Court stated was permissible), the Court determined that "the '442 patent merely claims the known utility of the '766 patent and does not claim a species with unexpected results."  The Court therefore concluded that the '442 patent was invalid for obviousness-type double patenting in light of the '766 patent.

AbbVie Inc. v. Mathilda & Terence Kennedy Institute of Rheumatology Trust (Fed. Cir. 2014)
Panel: Circuit Judges Dyk, Wallach, and Chen
Opinion by Circuit Judge Dyk

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