Patent Docs

USPTO Forms Working Group on Regulatory Reform

April 12, 2017

By Donald Zuhn —

Last month, the U.S. Patent and Trademark Office posted a notice on its website announcing the formation of a Working Group on Regulatory Reform "to consider, review, and recommend ways that USPTO regulations can be improved, revised, and streamlined." Members of the Working Group will be familiar with all of the agency's regulations, and will also represent the USPTO on the Department of Commerce's Regulatory Reform Task Force. The Office notes that the Working Group, which will be led by Nicolas Oettinger, Senior Counsel for Regulatory and Legislative Affairs in the USPTO's Office of General Counsel, will be seeking public input for any rulemaking that would revise or eliminate regulations. Stakeholders wishing to submit suggestions to improve, revise, and streamline USPTO regulations can do so by e-mailing those suggestions to RegulatoryReformGroup@uspto.gov.

According to the Office notice, the formation of the Working Group implements two Executive orders issued by President Trump — Executive Order 13771, entitled "Presidential Executive Order on Reducing Regulation and Controlling Regulatory Costs," (January 30, 2017), and Executive Order 13777, entitled "Presidential Executive Order on Enforcing the Regulatory Reform Agenda" (February 24, 2017).

Executive Order 13771 states that "it is important that for every one new regulation issued, at least two prior regulations be identified for elimination, and that the cost of planned regulations be prudently managed and controlled through a budgeting process." The Executive Order further states that "[u]nless prohibited by law, whenever an executive department or agency (agency) publicly proposes for notice and comment or otherwise promulgates a new regulation, it shall identify at least two existing regulations to be repealed."

Executive Order 13777 requires that each agency designate an agency official as its Regulatory Reform Officer (RRO) by April 25, 2017, and also establish a Regulatory Reform Task Force. Pursuant to the Executive Order, each Regulatory Reform Task Force shall "evaluate existing regulations . . . and make recommendations to the agency head regarding their repeal, replacement, or modification, consistent with applicable law," and "[a]t a minimum, . . . shall attempt to identify regulations" that:

(i) eliminate jobs, or inhibit job creation;
(ii) are outdated, unnecessary, or ineffective;
(iii) impose costs that exceed benefits;
(iv) create a serious inconsistency or otherwise interfere with regulatory reform initiatives and policies;
(v) are inconsistent with the requirements of section 515 of the Treasury and General Government Appropriations Act, 2001 (44 U.S.C. 3516 note), or the guidance issued pursuant to that provision, in particular those regulations that rely in whole or in part on data, information, or methods that are not publicly available or that are insufficiently transparent to meet the standard for reproducibility; or
(vi) derive from or implement Executive Orders or other Presidential directives that have been subsequently rescinded or substantially modified.

Each Regulatory Reform Task Force shall also provide a report to the agency head by May 25, 2017, detailing the agency's progress toward, inter alia, "identifying regulations for repeal, replacement, or modification."
PTAB Life Sciences Report — Part IV

April 11, 2017

By John Cravero —

About the PTAB Life Sciences Report: Each month we will report on developments at the PTAB involving life sciences patents.

Smith & Nephew, Inc. v. ConforMIS, Inc.

PTAB Petition: IPR2017-00778; filed January 26, 2017.

Patent at Issue: U.S. Patent No. 8,062,302 ("Surgical tools for arthroplasty," issued November 22, 2011) claims patient-specific surgical tool for use in surgically repairing a joint of a patient.

Petitioner Smith & Nephew, Inc. is challenging the '302 patent on three grounds as obvious under 35 U.S.C. § 103(a). View the petition here.

Related Matters: According to the petition, the '302 patent is the subject of litigation in ConforMIS, Inc. v. Smith & Nephew, Inc., No. 1:16-cv-10420-IT (D. Mass.). Petitioner is concurrently filing two additional petitions for inter partes review of the '302 patent (IPR2017-00779 and IPR2017-00780). Also, Petitioner filed petitions requesting inter partes review of related ConforMIS patents: U.S. Patent Nos. 9,055,953 (IPR2016-01874; filed 09/21/2016; pending); 9,216,025 (IPR2017-00115; filed 10/20/2016; pending) and (IPR2017-00307; filed 11/21/2016; pending); 8,377,129 (IPR2017-00372; filed 11/30/2016; pending); 8,551,169 (IPR2017-00373; filed 11/30/2016; pending); 9,295,482 (IPR2017-00487; filed 12/14/2016; pending) and (IPR2017-00488; filed 12/14/2016; pending); 7,981,158 (IPR2017-00510; filed 12/20/2016; pending) and (IPR2017-00511; filed 12/20/2016; pending); and 7,534,263 (IPR2017-00544; filed 12/27/2016; pending) and (IPR2017-00545; filed 12/27/2016; pending).

Smith & Nephew, Inc. v. ConforMIS, Inc.

PTAB Petition: IPR2017-00779; filed January 26, 2017.

Patent at Issue: U.S. Patent No. 8,062,302 ("Surgical tools for arthroplasty," issued November 22, 2011) claims patient-specific surgical tool for use in surgically repairing a joint of a patient.

Petitioner Smith & Nephew, Inc. is challenging the '302 patent on three grounds as obvious under 35 U.S.C. § 103(a). View the petition here.

Related Matters: According to the petition, the '302 patent is the subject of litigation in ConforMIS, Inc. v. Smith & Nephew, Inc., No. 1:16-cv-10420-IT (D. Mass.). Petitioner is concurrently filing two additional petitions for inter partes review of the '302 patent (IPR2017-00778 and IPR2017-00780). Also, Petitioner filed petitions requesting inter partes review of related ConforMIS patents: U.S. Patent Nos. 9,055,953 (IPR2016-01874; filed 09/21/2016; pending); 9,216,025 (IPR2017-00115; filed 10/20/2016; pending) and (IPR2017-00307; filed 11/21/2016; pending); 8,377,129 (IPR2017-00372; filed 11/30/2016; pending); 8,551,169 (IPR2017-00373; filed 11/30/2016; pending); 9,295,482 (IPR2017-00487; filed 12/14/2016; pending) and (IPR2017-00488; filed 12/14/2016; pending); 7,981,158 (IPR2017-00510; filed 12/20/2016; pending) and (IPR2017-00511; filed 12/20/2016; pending); and 7,534,263 (IPR2017-00544; filed 12/27/2016; pending) and (IPR2017-00545; filed 12/27/2016; pending).

Smith & Nephew, Inc. v. ConforMIS, Inc.

PTAB Petition: IPR2017-00780; filed January 26, 2017.

Patent at Issue: U.S. Patent No. 8,062,302 ("Surgical tools for arthroplasty," issued November 22, 2011) claims patient-specific surgical tool for use in surgically repairing a joint of a patient.

Petitioner Smith & Nephew, Inc. is challenging the '302 patent on two grounds as obvious under 35 U.S.C. § 103(a). View the petition here.

Related Matters: According to the petition, the '302 patent is the subject of litigation in ConforMIS, Inc. v. Smith & Nephew, Inc., No. 1:16-cv-10420-IT (D. Mass.). Petitioner is concurrently filing two additional petitions for inter partes review of the '302 patent (IPR2017-00778 and IPR2017-00779). Also, Petitioner filed petitions requesting inter partes review of related ConforMIS patents: U.S. Patent Nos. 9,055,953 (IPR2016-01874; filed 09/21/2016; pending); 9,216,025 (IPR2017-00115; filed 10/20/2016; pending) and (IPR2017-00307; filed 11/21/2016; pending); 8,377,129 (IPR2017-00372; filed 11/30/2016; pending); 8,551,169 (IPR2017-00373; filed 11/30/2016; pending); 9,295,482 (IPR2017-00487; filed 12/14/2016; pending) and (IPR2017-00488; filed 12/14/2016; pending); 7,981,158 (IPR2017-00510; filed 12/20/2016; pending) and (IPR2017-00511; filed 12/20/2016; pending); and 7,534,263 (IPR2017-00544; filed 12/27/2016; pending) and (IPR2017-00545; filed 12/27/2016; pending).

Hospira, Inc. v. Genentech, Inc.

PTAB Petition: IPR2017-00804; filed January 30, 2017.

Patent at Issue: U.S. Patent No. 6,627,196 ("Dosages for treatment with anti-ErbB2 antibodies," issued September 30, 2003) claims a method for the treatment of a human patient diagnosed with cancer characterized by overexpression of ErbB2 receptor, comprising administering an effective amount of an anti-ErbB2 antibody to the human patient, the method comprising: administering to the patient an initial dose of at least approximately 5 mg/kg of the anti-ErbB2 antibody; and administering to the patient a plurality of subsequent doses of the antibody in an amount that is approximately the same or less than the initial dose, wherein the subsequent doses are separated in time from each other by at least two weeks.

Petitioners Hospira, Inc. and Pfizer Inc. are challenging the '196 patent on one ground as obvious under 35 U.S.C. § 103(a). View the petition here.

Related Matters: According to the petition, Petitioner concurrently filed a petition for inter partes review of U.S. Patent No. 7,371,379. According to the petition, the '196 patent is not involved in any other related judicial or administrative matters.

Hospira, Inc. v. Genentech, Inc.

PTAB Petition: IPR2017-00805; filed January 30, 2017.

Patent at Issue: U.S. Patent No. 7,371,379 ("Dosages for treatment with anti-ErbB2 antibodies," issued May 13, 2008) claims a method for the treatment of a human patient diagnosed with cancer characterized by overexpression of ErbB2 receptor, comprising administering an effective amount of an anti-ErbB2 antibody to the human patient, the method comprising: administering to the patient an initial dose of at least approximately 5 mg/kg of the anti-ErbB2 antibody; and administering to the patient a plurality of subsequent doses of the antibody in an amount that is approximately the same or less than the initial dose, wherein the subsequent doses are separated in time from each other by at least two weeks; and further comprising administering an effective amount of a chemotherapeutic agent to the patient.

Petitioners Hospira, Inc. and Pfizer Inc. are challenging the '379 patent on one ground as obvious under 35 U.S.C. § 103(a). View the petition here.

Related Matters: According to the petition, Petitioner concurrently filed a petition for inter partes review of U.S. Patent No. 6,627,196. According to the petition, the '379 patent is not involved in any other related judicial or administrative matters.

Obalon Therapeutics, Inc. v. Polyzen, Inc.

PTAB Petition: IPR2017-00812; filed January 30, 2017.

Patent at Issue: U.S. Patent No. 7,682,306 ("Therapeutic intervention systems employing implantable balloon devices," issued March 23, 2010) claims a method of therapeutic intervention for treatment of a patient in need of such treatment, said method comprising introducing to a physiological locus of said patient a balloon formed from two vacuum thermoformed half-sections of a multilayer film comprising a layer of sealing film and at least one layer of thermoplastic polymer.

Petitioner Obalon Therapeutics, Inc. is challenging the '306 patent on three grounds as obvious under 35 U.S.C. § 103(a). View the petition here.

Related Matters: According to the petition, Petitioners concurrently filed a petition for inter partes review of related U.S. Patent Nos. Nos. 6,712,832 (filed 03/03/2017) and 7,883,491. According to the petition, the '306 patent is not involved in any other related judicial or administrative matters.

Obalon Therapeutics, Inc. v. Polyzen, Inc.

PTAB Petition: IPR2017-00813; filed January 30, 2017.

Patent at Issue: U.S. Patent No. 7,883,491 ("Extrusion laminate polymeric film article and gastric occlusive device comprising same," issued February 8, 2011) claims a gastric occlusive device comprising a layer of sealing film and at least one layer of thermoplastic polymer.

Petitioner Obalon Therapeutics, Inc. is challenging the '491 patent on two grounds as obvious under 35 U.S.C. § 103(a). View the petition here.

Related Matters: According to the petition, Petitioners concurrently filed a petition for inter partes review of related U.S. Patent Nos. Nos. 6,712,832 (filed 03/03/2017) and 7,682,306. According to the petition, the '491 patent is not involved in any other related judicial or administrative matters.

Mylan Pharmaceuticals, Inc. v. Boehringer Ingelheim International GmbH

PTAB Petition: IPR2016-01564; filed July 8, 2016.

PTAB Trial Instituted; filed January 31, 2017.

Patent at Issue: U.S. Patent No. 8,846,695 ("Treatment for diabetes in patients with inadequate glycemic control despite metformin therapy comprising a DPP-IV inhibitor," issued September 30, 2014) claims a method for treating type 2 diabetes mellitus in a patient with inadequate glycemic control despite therapy with metformin comprising orally administering 1-[(4-methyl-quinazolin-2-yl)methyl]-3-methyl-7-(2-butyn-1-yl)-8-(3-(R)-a- mino-piperidin-1-yl)-xanthine to the patient in combination with metformin.

Petitioners Mylan Pharmaceuticals, Inc., Mylan Laboratories Ltd., Mylan Inc., and Mylan N.V. are challenging the '695 patent on two grounds as obvious under 35 U.S.C. § 103(a). View the petition here. Administrative Patent Judges Toni R. Scheiner, Brian P. Murphy, and Zhenyu Yang (author) issued a decision instituting inter partes review of claims 1–4 as obvious under 35 U.S.C. § 103(a) over Charbonnel or Hughes in view of the '940 Publication; and claims 1–4 as obvious under 35 U.S.C. § 103(a) over Nauck or Ahrén 2008 in view of the '940 Publication.

Related Matters: According to the petition, the '695 patent is the subject of litigation in Boehringer Ingelheim Pharmaceuticals Inc., et al. v. HEC Pharm Group, et al., No. 3:15-cv-05982-PGS-TJB (D.N.J.).
PTAB Update — Shire Has Rare Motion to Amend Granted

April 10, 2017

By Andrew Williams —

On March 31, 2017, the Patent Trial and Appeals Board ("PTAB" or "Board") granted a motion to amend claims in Amerigen Pharmaceuticals Ltd. v. Shire LLC (IPR2015-02009). This is, of course, an uncommon event. Depending on how you keep score, the PTAB had previously only granted less than ten such motions (at least in part). Almost a year ago, on April 30, 2016, the PTAB reported in its Motion to Amend Study that only 6 motions to amend had been granted (or granted-in-part). This was out of a total of 118 motions filed in 1539 instituted and completed AIA proceedings, which amounts to a positive outcome for the patent owner in 5% of the cases in which a motion was filed. Moreover, since that time, only two additional motions were granted prior to the Amerigen case: CBM2015-00040 (Google Inc. v. ContentGuard Holdings, Inc.) on June 21, 2016; and IPR2015-01225 (Globel Tel*Link Corp. v. Securus Technologies, Inc.) on December 14, 2016. The situation has garnered so much attention that the Federal Circuit sitting en banc is even considering the Board's motion to amend practice. On December 9, 2016, the Court heard oral arguments in In re Aqua Products, Inc. The Federal Circuit is reconsidering whether the patent owner bears the burden of persuasion regarding the patentability of amended claims, and whether the Board can sua sponte raise challenges to the proposed claims when the petitioner does not challenge their patentability (and if so, where do the burden's lie). A decision should be rendered shortly in that case.

In the present one, IPR2015-02009 relates to Shire's reissue patent RE42,096. This patent is listed in the Orange Book for Adderall XR^®, a treatment for Attention Deficit Hyperactivity Disorder (ADHD). Shire had asserted this patent in several district court cases, including one against Amerigen Pharmaceuticals that was terminated on March 2, 2017 because of settlement. The papers in the IPR proceeding explained that ADHD is conventionally treated by administering two separate doses of medication, one in the morning and one 4-6 hours later. As can be imagined, this is problematic because it is time-consuming, inconvenient, and because some children have difficulties swallowing the tablets. The '096 patent disclosed compositions comprising "an oral multiple pulsed dose delivery system for amphetamine salts and mixtures thereof . . . in which there is immediate release of drug and enteric release of drug" that "retards or delays" the release for a predetermined time, at which time the release is rapid and complete.

Petitioner Amerigen Pharmaceuticals challenged claims 1-3, 5, 8, 9, 11, 18-21, 23, and 25 of the '096 patent. Independent claims 1 and 18 were highlighted as representative:

1. A pharmaceutical composition for delivery of one or more pharmaceutically active amphetamine salts, comprising:
    (a) one or more pharmaceutically active amphetamine salts covered with an immediate release coating; and
    (b) one or more pharmaceutically active amphetamine salts that are covered with an enteric release coating that provides for delayed pulsed enteric release,
    wherein said enteric release coating releases essentially all of said one or more pharmaceutically active amphetamine salts coated with said enteric coating within about 60 minutes after initiation of said delayed pulsed enteric release;
    wherein the pharmaceutically active amphetamine salts in (a) and (b) comprise mixed amphetamine salts.

18. A pharmaceutical composition for delivery of one or more pharmaceutically active amphetamine salts comprising:
    (a) one or more pharmaceutically active amphetamine salts covered with an immediate release coating;
    (b) one or more pharmaceutically active amphetamine salts that are covered with an enteric release coating that provides for delayed pulsed enteric release, wherein said enteric release coating releases said one or more pharmaceutically active amphetamine salts coated with said enteric coating within about 60 minutes after initiation of said delayed pulsed enteric release; and
    (c) a protective layer between the at least one pharmaceutically active amphetamine salt and the enteric release coating.

One of the key references cited by petitioner was U.S. Patent No. 5,837,284 ("Mehta"), which was alleged to both anticipate and render obvious in combination both of these claims. In its institution decision, the Board pointed out that claim 1 and related claims contain the limitation that "essentially all" of the enteric coated amphetamine salts is released within about 60 minutes. However, Mehta did not disclose that any formulation reached 80% released in about 60 minutes. Therefore, because inherency "may not be established by probabilities or possibilities," the Board was not persuaded that Mehta's disclosure necessarily met the claim limitation. Therefore, it did not institute trial with regard to claims 1-3, 5, 8, 9, and 11.

Claim 18, and related claims, had a different outcome. Whereas the claim language does require that "said enteric release coating releases said one or more pharmaceutically active amphetamine salts coated with said enteric coating within about 60 minutes," the Board found that this did not require "essentially all" be released. As such, Mehta's disclosure did not need to satisfy the "essentially all" hurdle for petitioner to establish a reasonable likelihood that it would prevail on its anticipation and obviousness challenges. Correspondingly, trial was instituted on claims 18-21 and 23 for anticipation and 18-21, 23, and 25 for obviousness.

Shire's motion to amend only related to one claim (claim 25), which read:

25. The pharmaceutical composition of any one of claims 2, 13 or 18 to 20 wherein the pharmaceutically active amphetamine salt in (a) and (b) comprises mixed amphetamine salts.

This claim depended from instituted claims 18-20, but also depended from two of the claims (2 and 13) for which institution was denied. Therefore, Shire sought only one substitute claim which removed the multiple dependencies to the instituted claims:

26. The pharmaceutical composition of any one of claims 2[[,]] or 13 or 18 to 20 wherein the pharmaceutically active amphetamine salt in (a) and (b) comprises mixed amphetamine salts.

At the same time, Shire sought to cancel claims all of the other claims that were instituted. It argued that because claim 26 only depends from non-instituted claims, it should itself not be subject to trial (in other words that it was patentable). Petitioner instead argued that the motion should be denied because Shire did not separately demonstrate the patentability of claim 26. Even though the Board has lessened the Idle Free requirement that patent owners demonstrate patentability over all prior art known to it, patent owners are still required to address all prior art of record. Amerigen Pharmaceuticals asserted that Mylan had identified additional art in a related IPR proceeding (IPR2016-01033), and that Shire had not addressed this art. Nevertheless, the Board accepted Shire's position that "[e]ffectively, no claim is being amended, and claims are only being cancelled, because claims 18-24 are being removed, and proposed claim 26 removes three multiple dependent claims (claim 25 as it depends from claims 18-20) . . . ." As such, there was no requirement that Shire prove "that originally non-amended claims are patentable over all potential prior art, especially non-instituted claims." Correspondingly, the Board granted the motion.

It is unclear if the experience of Shire will be useful for other patent owners, although if in a similar situation, the strategy should be successful. Nevertheless, the rules for motions to amend could be rewritten by the Federal Circuit in the In re Aqua Products case, so patent owners may not need the roadmap presented by the Amerigen Pharmaceuticals case. We will continue to report on the status of motions to amend before the PTAB, especially with regard to the outcome of the Aqua Products case.
The Medicines Company v. Mylan, Inc. (Fed. Cir. 2017)

April 9, 2017

By Kevin E. Noonan —

The Federal Circuit returned to its consideration of the outcome in the District Court of The Medicines Company's ANDA litigation against Mylan and Bioniche Pharma over a proposed generic version of Medicines' bivalirudin drug (sold as Angiomax®), an anticoagulant used in heart surgery. In doing so, the Court focused on claim construction, basing its decision to reverse a finding of infringement under 35 U.S.C. § 271(e)(2) on differences with the District Court's claim construction.

The invention claimed in the patents-in-suit, U.S. Patent Nos. 7,582,727 and 7,598,343, can be appreciated by the following representative claims:

Claim 1 of the '727 patent:

1. Pharmaceutical batches of a drug product comprising bivalirudin (SEQ ID NO: 1: [Phe Pro Arg Pro Gly Gly Gly Gly Asn Gly Asp Phe Glu Glu Ile Pro Glu Glu Tyr Leu]) and a pharmaceutically acceptable carrier for use as an anticoagulant in a subject in need thereof, wherein the batches have a pH adjusted by a base, said pH is about 5-6 when reconstituted in an aqueous solution for injection, and wherein the batches have a maximum impurity level of Asp9-bivalirudin that does not exceed about 0.6% as measured by HPLC.

Claim 1 of the '343 patent:

1. Pharmaceutical batches of a drug product comprising bivalirudin … prepared by a compounding process comprising:
    (i) dissolving bivalirudin in a solvent to form a first solution;
    (ii) efficiently mixing a pH-adjusting solution with the first solution to form a second solution, wherein the pH-adjusting solution comprises a pH-adjusting solution solvent; and
    (iii) removing the solvent and pH-adjusting solution solvent from the second solution;
    wherein the batches have a pH adjusted by a base, said pH is about 5-6 when reconstituted in an aqueous solution for injection, and wherein the batches have a maximum impurity level of Asp9-bivalirudin that does not exceed about 0.6% as measured by HPLC.

The patents-in-suit arose from Medicines' solution to production problems with the drug, which led to the production of a degradation product, Asp9 bivalirudin (caused by deamination of Asn9); in high enough concentrations (>1.5%) Asp9 bivalirudin contaminants were unacceptable (per FDA). Production of bivalirudin batches contaminated with high levels of Asp9 bivalirudin caused Medicines to shut down commercial production for more than a year. The company's attempts to produce formulations of the drug for commercial sale were unsuccessful, and led Medicines to develop certain ways of adjusting the pH that reduced the impurity levels to less than 0.6% and resulted in the '343 and '727 patents.

These patents were the subject of litigation between Medicines and Hospira, where coincidentally the same panel that rendered the instant decision determined that the claims were invalid under the on-sale bar of 35 U.S.C. § 102(b)(among other grounds) (see "The Medicines Company v. Hospira (Fed. Cir. 2015)"). The Federal Circuit thereafter vacated the panel opinion and reinstituted the appeal en banc, ordering the parties (and amici) to brief issues relating to the on-sale bar and its application to the relationship between Medicines and its contract manufacturer. The en banc court reversed the decision by the merits panel that the on-sale bar applied, in a unanimous court by Judge O'Malley (see "The Medicines Company v. Hospira, Inc. (Fed. Cir. 2016) (en banc)").

The Federal Circuit (which had dismissed Medicines' and Mylan's cross-appeals in view of the merit panel's decision in the Hospira case) then reinstated this appeal between Medicines and Mylan. The District Court had granted summary judgment of non-infringement to Mylan as to the claims of the '343 patent, based on Mylan's ANDA specifying methods for formulating that did not use the claimed "efficient mixing" limitation of that patent's claims. After a bench trial, the District Court had granted judgment in Medicines' favor, expressly because the '727 patent claims did not recite the "efficient mixing" limitation.

The Federal Circuit affirmed the District Court's summary judgment decision regarding the '343 patent claims, but reversed the judgment regarding the '727 patent claims, in an opinion by Judge Dyk joined by Judges Hughes and Wallach. The Court expressly based its decision on construction of the term "batches" in the '727 patent claims, which required the use of efficient mixing methods as disclosed in the specification shared in common by both patents. This specification defined "batches" as:

As used here, "batch" or "pharmaceutical batch" refers to material produced by a single execution of a compounding process of various embodiments of the present invention. "Batches" or "pharmaceutical batches" as defined herein may include a single batch, wherein the single batch is representative of all commercial batches (see generally, Manual of Policies and Procedures, Center for Drug Evaluation and Research, MAPP 5225.1, Guidance on the Packaging of Test Batches at 1), and wherein the levels of, for example, Asp9-bivalirudin, total impurities, and largest unknown impurity, and the reconstitution time represent levels for all potential batches made by said process. "Batches" may also include all batches prepared by a same compounding process.

The District Court construed the term "pharmaceutical batches" consistent with specification, to be either a single batch representative of all commercial batches "made by a compounding process" having consistent levels of all impurities (including Asp9-bivalirudin) or all batches made by the compounding process; the Federal Circuit opinion notes that the parties consented to this construction. With regard to the term "efficient mixing," the District Court based its construction on two examples in the common specification: one the "inefficient" mixing according to earlier Medicines' processes (Example 4), and the efficient process disclosed in the specifications (Example 5); the District Court further held that Medicines had disclaimed the old inefficient mixing process.

With regard to its review of claim construction, the opinion notes that claim construction here is reviewed as a matter of law because the District Court did not consider anything outside the intrinsic evidence, under the Supreme Court's Teva Pharmaceuticals v. Sandoz decision. The panel based its contrary decision on the District Court's failure to interpret the "batches" limitation to require efficient mixing for the claims of the '727 patent. The panel's rationale was that the "batches" limitation requires the claims to encompass only those having impurity levels less than 0.6%, and that this limitation cannot cover individual batches because it was undisputed that such batches were known in the prior art (i.e., batches Medicines made prior to the disruption that led to this invention). The opinion states: "[r]ather, properly construed, what the batches limitation requires is the use of a process that achieves batch consistency," expressly construing the "batches" claim limitation in view of the specification. "The batches limitation therefore requires a process that achieves consistency between batches produced from the 'same compounding process'—i.e., batch consistency," said the Court. Indeed, the panel viewed this consistency as being what distinguished these claims from the prior art (including Medicines' own prior methods and batches). Without tying the interpretation of the term "batches" to the disclosed more efficient methods, the opinion asserts that there would be no way of effectively deciding when and whether infringement would lie. The opinion foresees a need for "forward-looking assessments of whether future batches would infringe" (i.e., only after the batches were tested to determine the level of Asp9-bivalirudin levels). According to the opinion:

To illustrate, if a defendant using the same compounding process produced fifty batches each having an Asp9 level below 0.6 percent, each of those fifty batches would infringe. But the defendant would not know whether any of the batches infringed until all fifty batches had been produced because if even one of those batches was determined to have an Asp9 level higher than 0.6 percent, none of the batches would infringe.

In this regard, the opinion posits that such an interpretation would not provide the "reasonable certainty" required by Nautilus, Inc. v. Biosig Instruments, Inc., 134 S. Ct. 2120, 2129 (2014).

The opinion further found support for the Court's interpretation in the specification and prosecution history (particularly with regard to the claims patentability over inter alia the Medicines' own prior art).

Having determined that proper construction of the "batch" limitation required the use of a compounding process that achieves batch consistency, the opinion then turned to whether this compounding process must entail "efficient mixing." Evidence for this requirement the Court found in the specification, particularly disclosure that "pH-adjusting solution will be efficiently mixed," and that "[e]fficient mixing of the pH-adjusting solution . . . will minimize levels of Asp9-bivalirudin." Moreover, the Court states that the specification disclosed no other method capable of producing such batches with the necessary consistency (relating to the comparison between the methods disclosed in Examples 4 and 5). The opinion also asserted that the District Court's determination that Medicines disclaimed inefficient mixing was not inconsistent with its determination that what the claims required was efficient mixing.

The opinion also rejected Medicines' contention that this interpretation would make the claims of the '343 patent "superfluous" (more accurately, implicate double patenting) by noting there may be overlap between certain of the claims but that the more specific recitations in the '343 claims distinguished them from the '727 claims. The opinion also asserted that adopting Medicines' construction would potentially encompass the prior art, and thus impermissibly extending Medicines' "monopoly" beyond the invention disclosed in the common specification.

The Court then turned to what is meant by "efficient mixing." This term is explicitly defined in the common specification to mean "'mixing [that] is characterized by minimizing levels of Asp9-bivalirudin in the compounding solution,' i.e., below 0.6 percent Asp9-bivalirudin in the intermediate solution." The panel rejected this interpretation, insofar as "it does not accord with the linguistic formula used by the patentee to signal the designation of other defined terms—including 'batches.'" By this it appears the Court meant to distinguish between how this statement was phrased and how other terms were expressly defined, i.e., where "the defined term [is] in quotation marks, followed by the terms 'refers to' or 'as defined herein.'" The Court also rejected Medicines' assertion that its phrase was definitional on the basis that is was "a mere recitation of the results obtained" rather than constituting a definition of what "efficient mixing" is, according to the opinion. Using Medicines' definition "would expand the scope of 'efficient mixing' to cover any way of mixing that achieves a compounding solution having an Asp9 level of less than 0.6 percent" in violation of the written description requirement, said the panel, citing Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1352–53 (Fed. Cir. 2010) (en banc). The Court found no art-recognized definition of the term "efficient mixing," and the other portions of the specification Medicines' argued disclosed alternative methods were "vague and unhelpful" (and were not relied upon by the District Court or the parties). Finally, the opinion (relying with some irony on Medicines' criticism of the District Court for defining "efficient mixing" with regard to what it is not, i.e., prior art methods) notes that the skilled artisan would rely upon the methods recited in Example 5 to understand what efficient mixing is. In the Court's opinion, this Example is the only description of efficient mixing in the specification and not just an embodiment. According to the panel, this Example provides "a clear 'objective standard by which to measure the scope of the term.'"

The opinion concluded that, in order to infringe a batch must be compounded using a efficient mixing process according to Example 5 for claims of either the '727 and '343 patents.

There is some logic underlying this decision, but it can be understood if Medicines' views the Federal Circuit's logic as imposing a definition from the specification onto the claims, contrary to the claim construction rubric that limitations should not be incorporated from the specification into the claims. This aspect of the decision brings to mind District Court Judge Vaughn Walker's discussion of how vexatious this rule can be, as set forth his dissent in Medegen MMS, Inc. v. ICU Medical, Inc. (Fed. Cir. 2008):

The issues before the Court presented "a conundrum often faced by district courts when construing" claim terms, citing the "twin axioms" of claim construction that produced the conundrum: "[o]n the one hand, claims 'must be read in view of the specification'," citing Markman, while "[o]n the other hand, it is improper to read a limitation from the specification into the claims," citing Arlington Indus. Inc. v. Bridgeport Fittings, Inc. The problem with these axioms, according to Judge Walker, is that "the axioms themselves seldom provide an answer, but instead merely frame the question to be resolved."

"As a jurist more accustomed to working on the front lines of patent litigation than reviewing decisions from above, it is my experience that claim construction — determining how one of ordinary skill in the art would understand the patent at the time of invention — often requires making fact-like determinations not well suited to appellate review."

The Supreme Court's decision in Teva v. Sandoz reversed the Federal Circuit's practice of giving no deference to factual underpinnings of claim construction as set forth in Cybor Corp. v. FAS Technologies, Inc. The instant decision shows that while the problems attendant upon failure to give factual deference have been diminished they have not been overcome entirely.

The Medicines Company v. Mylan, Inc. (Fed. Cir. 2017)
Panel: Circuit Judges Dyk, Wallach, and Hughes
Opinion by Circuit Judge Dyk
Conference & CLE Calendar

April 9, 2017

April 11, 2017 - Patent Quality Chat webinar series – "Examination Time Analysis" (U.S. Patent and Trademark Office) – 12:00 to 1:00 pm (ET)

April 18, 2017 – "The Defend Trade Secrets Act at (Almost) One" (McDonnell Boehnen Hulbert & Berghoff LLP) – 10:00 am to 11:15 am (CT)

April 18, 2017 – "A Patent Exhaustion Doctrine for the 21st Century" (Intellectual Property Law Association of Chicago Patent Committee – 4:00 to 6:00 pm (CT), Chicago, IL

April 19, 2017 – "The Intersection of the PTO Practice and the Courts" (Federal Circuit Bar Association and Wayne State University) – Wayne State University McGregor Memorial Conference Center, Detroit, MI – 9:00 am to 5:00 pm (ET)

April 20, 2017 – "Settlement Agreements as Comparables: New Comprehensive Analysis from the Federal Circuit" (Intellectual Property Owners Association) – 2:00 to 3:00 pm (ET)

April 20, 2017 – "Double Patenting: Defeating Double Patenting Rejections and Avoiding Terminal Disclaimers" (Strafford) – 1:00 to 2:30 pm (EDT)

April 27, 2017 – "Navigating Section 112 Issues in IPR Proceedings: Using Section 112 as a Sword or a Shield — Addressing Section 112 Issues in IPR Petitions, Establishing Priority or Earlier Critical Date of Asserted Reference, and More" (Strafford) – 1:00 to 2:30 pm (EDT)

***Patent Docs is a media partner of this conference or CLE
USPTO Patent Quality Chat Webinar Series

April 8, 2017

The U.S. Patent and Trademark Office will be offering the next webinar in its Patent Quality Chat webinar series from 12:00 to 1:00 pm (ET) on April 11, 2017. Daniel Sullivan, Director, Technology Center 1600, and Eddie Leftkowitz, Director, Technology Center 2100, will discuss "Examination Time Analysis." The presenters will discuss examination time goals, which vary by technology and represent the average amount of time a patent examiner is expected to spend examining an application, and the use of examination time goals in the USPTO's production system.

Instructions for viewing the webinar can be found here.

Additional information regarding the Patent Quality Chat webinar series can be found on the USPTO's Patent Quality Chat webpage.
IPO Webinar on Settlement Agreements

April 8, 2017

The Intellectual Property Owners Association (IPO) will offer a one-hour webinar entitled "Settlement Agreements as Comparables: New Comprehensive Analysis from the Federal Circuit" on April 20, 2017 from 2:00 to 3:00 pm (ET). Stephen Holzen of Stout Risius Ross, Samuel Walling of Robins Kaplan LLP, and Karen Weil of Knobbe, Martens, Olson & Bear LLP will discuss how to best leverage Prism v. Sprint — in which the Federal Circuit laid out a road map to the admissibility of settlements in patent infringement litigation — to keep settlements both in and out of evidence.

The registration fee for the webinar is $135 (government and academic rates are available upon request). Those interested in registering for the webinar can do so here.
Webinar on Navigating Section 112 Issues in IPR Proceedings

April 8, 2017

Strafford will be offering a webinar/teleconference entitled "Navigating Section 112 Issues in IPR Proceedings: Using Section 112 as a Sword or a Shield — Addressing Section 112 Issues in IPR Petitions, Establishing Priority or Earlier Critical Date of Asserted Reference, and More" on April 27, 2017 from 1:00 to 2:30 pm (EDT). Jonathan R. Bowser and Roger H. Lee of Buchanan Ingersoll & Rooney will provide guidance on Section 112 issues that arise during the course of an inter partes review (IPR) proceeding, address the PTAB's response to assertions that claims do not comply with Section 112, discuss related claim constructions issues, offer best practices for handling Section 112 issues in IPRs, and explore how district courts treat Section 112 issues addressed by the PTAB in IPR proceedings. The webinar will review the following issues:

• How has the PTAB responded to assertions made by IPR petitioners that claims do not comply with Section 112?
• What must patent owners show to establish priority to an earlier application or antedate an asserted reference?
• What IPR petitioners must show to meet the claim construction requirements for means-plus-function claims under Section 112(f)?

The registration fee for the webinar is $297. Those interested in registering for the webinar, can do so here.
PTAB Life Sciences Report — Part III

April 6, 2017

By John Cravero —

About the PTAB Life Sciences Report: Each month we will report on developments at the PTAB involving life sciences patents.

Complex Innovations, LLC. v. AstraZeneca AB

PTAB Petition: IPR2017-00631; filed January 9, 2017.

Patent at Issue: U.S. Patent No. 7,759,328 ("Composition for inhalation," issued July 20, 2010) claims pharmaceutical composition comprising formoterol fumarate dihydrate, budesonide, 1,1,1,2,3,3,3-heptafluoropropane (HFA227), PVP K25 (polyvinyl pyrrolidone with a nominal K-value of 25), and PEG-1000 (polyethylene glycol with an average molecular weight of 1,000) as well as a method of treating symptoms of a respiratory disorder.

Petitioner Complex Innovations, LLC is challenging the '328 patent on four grounds as being anticipated under 35 U.S.C. § 102(b) (grounds 1 and 2) or as obvious under 35 U.S.C. § 103(a) (grounds 3 and 4). View the petition here.

Related Matters: According to the petition, the '328 patent is not involved in any related matters.

Apotex Corp. v. OSI Pharmaceuticals, Inc.

PTAB Petition: IPR2016-01284; filed June 28, 2016.

PTAB Trial Instituted; entered January 9, 2017.

Patent at Issue: U.S. Patent No. 6,900,221 ("Stable polymorph on N-(3-ethynylphenyl)-6, 7-bis (2methoxyethoxy)-4-quinazolinamine hydrochloride, methods of production, and pharmaceutical uses thereof," issued May 31, 2005) claims a homogeneous crystalline polymorph of the hydrochloride salt of N-(3-ethynylphenyl)-6,7-bis(2-methoxyethoxy)-4-Quinazolinamine designated the B polymorph.

Petitioners Apotex Inc., Apotex Corp., Apotex Pharmaceuticals Holdings Inc., and Apotex Holdings, Inc. are challenging the '221 patent on three grounds as being anticipated under 35 U.S.C. § 102(b) (ground 3) or as obvious under 35 U.S.C. § 103(a) (grounds 1 and 2). View the petition here. Administrative Patent Judges Lora M. Green (author), Rama G. Elluru, and Zhenyu Yang issued a decision instituting inter partes review of claims 44‒46 and 53 as obvious in view of Schnur and OSI's 10-K or Gibbs; and claim 47 as obvious in view of Schnur, Gibbs, and Moscatello.

Related Matters: According to the petition, the '221 patent is involved in the following litigations: OSI Pharmaceuticals, LLC and Genentech, Inc. v. Apotex Inc. and Apotex Corp., No. 1:15-cv-00772-SLR (D. Del); and  Pfizer Inc., OSI Pharmaceuticals, LLC and Genentech, Inc. v. Breckenridge Pharmaceutical, Inc. and Natco Pharma Ltd., No. 1:15-cv-01063-SLR (D. Del.).

Mylan Pharmaceuticals Inc. v. Janssen Oncology, Inc.

PTAB Petition: IPR2016-01332; filed June 30, 2016.

PTAB Trial Instituted; entered January 10, 2017.

Patent at Issue: U.S. Patent No. 8,822,438 ("Methods and compositions for treating cancer," issued September 2, 2014) claims a method for the treatment of a prostate cancer in a human comprising administering to said human a therapeutically effective amount of abiraterone acetate or a pharmaceutically acceptable salt thereof and a therapeutically effective amount of prednisone.

Petitioners Mylan Pharmaceuticals Inc., Mylan Inc., Mylan N.V., and Mylan LLC are challenging the '438 patent on two grounds as obvious under 35 U.S.C. § 103(a). Petitioners concurrently filed a Motion for Joinder seeking to join this case, under 35 U.S.C. § 315(c), with the inter partes review in IPR2016-00286 (Amerigen Pharmaceuticals, Ltd. v. Janssen Oncology, Inc.; filed 12/04/2015; instituted 05/31/2016). View the petition here and the Motion for Joinder here. Administrative Patent Judges Lora M. Green, Rama G. Elluru, and Kristina M. Kalan (author) issued a decision instituting inter partes review of claims 1–20 as obvious in view of O'Donnell and Gerber; and claims 1–4 and 6–11 as obvious in view of Barrie and Gerber. In their decision, the Board denied Petitioners' Motion for Joinder.

Related Matters: According to the petition, the '438 patent is involved in the following litigations: BTG Int'l Ltd. v. Actavis Labs. FL, Inc., No. 15-cv-5909-KM-JBC (D.N.J.); BTG Int'l Ltd. v. Amerigen Pharms., Inc., No. 16-cv-02449-KM-JBC (D.N.J.); Janssen Biotech, Inc. v. Mylan Pharms. Inc., No. 15-cv-00130-IMK (N.D.W. Va.); and BTG Int'l Ltd. v. Glenmark Pharms. Inc., USA, No. 16-cv-03743-KM-JBC (D.N.J.). The '438 patent is also the subject of IPR2016-00286 (Petitioner Amerigen Pharmaceuticals Inc.; filed on 12/04/2015; instituted 05/31/2016; pending) and IPR2016-01317 (Petitioner Argentum Pharmaceuticals LLC; filed 06/29/2016; instituted 09/19/2016; joined with IPR2016-00286 09/19/2016; pending).

Amerigen Pharmaceuticals Limited v. Shire, LLC.

PTAB Petition: IPR2017-00665; filed January 13, 2017.

Patent at Issue: U.S. Patent No. 8,846,100 ("Controlled dose drug delivery system," issued September 30, 2014) claims a pharmaceutical composition comprising: (a) an immediate release bead comprising at least one amphetamine salt; (b) a first delayed release bead comprising at least one amphetamine salt; and (c) a second delayed release bead comprising at least one amphetamine salt; wherein the first delayed release bead provides pulsed release of the at least one amphetamine salt and the second delayed release bead provides sustained release of the at least one amphetamine salt.

Petitioner Amerigen Pharmaceuticals Ltd. is challenging the '100 patent on one ground as being anticipated under 35 U.S.C. § 102(b). View the petition here.

Related Matters: According to the petition, the '100 patent is not involved in any related matters.

Amneal Pharmaceuticals LLC. v. Purdue Pharma L.P. et al.

PTAB Petition: IPR2016-01413; filed July 15, 2016.

PTAB Trial Instituted; entered January 18, 2017.

Patent at Issue: U.S. Patent No. 9,034,376 ("Pharmaceutical formulation containing gelling agent," issued May 19, 2015) claims a controlled release oral solid dosage form comprising: a controlled release matrix comprising a mixture of oxycodone or a pharmaceutically acceptable salt thereof and a gelling agent comprising polyethylene oxide and hydroxypropylmethylcellulose.

Petitioner Amneal Pharmaceuticals LLC is challenging the '376 patent on one ground as obvious under 35 U.S.C. § 103(a). View the petition here. Administrative Patent Judges Michael P. Tierney, Lora M. Green, and Christopher G. Paulraj (author) issued a decision instituting inter partes review of claims 1-13 and 16–19 as obvious over the combination of Royce, McGinity, Hoffmeister, Joshi, and PDR.

Related Matters: According to the petition, the '376 patent is involved in the following litigations: Purdue Pharma L.P. et al. v. Amneal Pharmaceuticals LLC, No. 1:15-cv-00831 (D.E.D.), and Purdue Pharma L.P. et al. v. Amneal Pharmaceuticals LLC, 1-15-cv-01152 (D.E.D.). Petitioner concurrently filed a second inter partes review IPR2016-01412 seeking cancellation of these same claims on other grounds. Petitioner previously filed IPR2016-01027 (filed 05/11/2016; instituted 11/09/2016; pending) and IPR2016-01028 (filed 05/11/2016; instituted 11/09/2016; pending) seeking cancellation of claim 1 of U.S. Patent No. 9,060,976, which is a member of this patent family.

Mylan Institutional Inc. v. Fresenius Kabi USA, LLC

PTAB Petition: IPR2017-00645; filed January 19, 2017.

Patent at Issue: U.S. Patent No. 9,006,289 ("Levothyroxine formulations," issued April 14, 2015) claims a lyophilized solid composition, comprising levothyroxine sodium; a phosphate buffer; and mannitol.

Petitioners Mylan Inc., Mylan Institutional Inc., and Mylan NV are challenging the '289 patent on three grounds as obvious under 35 U.S.C. § 103(a). View the petition here.

Related Matters: According to the petition, the '289 patent is currently the subject of the following litigations: Fresenius Kabi USA, LLC v. Fera Pharmaceuticals, LLC, 17-01099 (Fed. Cir.); Fresenius Kabi USA, LLC v. Innopharma Licensing, LLC et al., 2:15-cv-03655-KM-MAH (D.N.J.); Fresenius Kabi USA, LLC v. Fera Pharmaceuticals, LLC, 2:15-cv-03654-KM-MAH (D.N.J.); Fresenius Kabi USA, LLC v. Par Sterile Products, LLC et al., No. 2:15-cv-03852-KM-MAH (D.N.J.); Fresenius Kabi USA, LLC v. Dr. Reddy's Laboratories, Inc. et al., 1:16-cv-00169-GMS (D. Del.); Fresenius Kabi USA, LLC v. Dr. Reddy's Laboratories, Inc. et al., 2:16-cv-01542-KM-MAH (D.N.J.); Fresenius Kabi USA, LLC v. Maia Pharmaceuticals, Inc., 1:16-cv-00237-GMS (D. Del.); Fresenius Kabi USA, LLC v. Dr. Reddy's Laboratories, Inc. et al., 2:16-cv-03316-KM-MAH (D.N.J.); and Fresenius Kabi USA, LLC v. Maia Pharmaceuticals, Inc., 2:16-cv-03315-KM-MAH (D.N.J.).

Hospira, Inc. v. Genentech, Inc.

PTAB Petition: IPR2017-00731; filed January 20, 2017.

Patent at Issue: U.S. Patent No. 7,846,441 ("Treatment with anti-ErbB2 antibodies," issued December 7, 2010) claims a method for the treatment of a human patient with a malignant progressing tumor or cancer characterized by overexpression of ErbB2 receptor, comprising administering a combination of an intact antibody which binds to epitope 4D5 within the ErbB2 extracellular domain sequence and a taxoid, in the absence of an anthracycline derivative, to the human patient in an amount effective to extend the time to disease progression.

Petitioners Hospira, Inc. and Pfizer Inc. are challenging the '441 patent on two grounds as obvious under 35 U.S.C. § 103(a). View the petition here.

Related Matters: According to the petition, Petitioner concurrently filed two inter partes petitions for claims of U.S. Patent No. 7,892,549. According to the petition, the '441 patent is not involved in any other related judicial or administrative matters.

Hospira, Inc. v. Genentech, Inc.

PTAB Petition: IPR2017-00737; filed January 20, 2017.

Patent at Issue: U.S. Patent No. 7,892,549 ("Treatment with anti-ErbB2 antibodies," issued February 22, 2011) claims a method for the treatment of a human patient with breast cancer that overexpresses ErbB2 receptor, comprising administering a combination of an antibody that binds ErbB2, a taxoid, and a further growth inhibitory agent to the human patient.

Petitioners Hospira, Inc. and Pfizer Inc. are challenging the '549 patent on six grounds as obvious under 35 U.S.C. § 103(a). View the petition here.

Related Matters: According to the petition, Petitioner concurrently filed an inter partes petition for claims of U.S. Patent No. 7,846,441 and two inter partes petitions for claims of U.S. Patent No. 7,892,549. According to the petition, the '549 patent is not involved in any other related judicial or administrative matters.

Hospira, Inc. v. Genentech, Inc.

PTAB Petition: IPR2017-00739; filed January 20, 2017.

Patent at Issue: U.S. Patent No. 7,892,549 ("Treatment with anti-ErbB2 antibodies," issued February 22, 2011) claims a method for the treatment of a human patient with breast cancer that overexpresses ErbB2 receptor, comprising administering a combination of an antibody that binds ErbB2, a taxoid, and a further growth inhibitory agent to the human patient.

Petitioners Hospira, Inc. and Pfizer Inc. are challenging the '549 patent on three grounds as anticipated under 35 U.S.C. § 102(a) (grounds 2 and 3) and § 102(b) (ground 1). View the petition here.

Related Matters: According to the petition, Petitioner concurrently filed an inter partes petition for claims of U.S. Patent No. 7,846,441 and two inter partes petitions for claims of U.S. Patent No. 7,892,549. According to the petition, the '549 patent is not involved in any other related judicial or administrative matters.
Novartis AG v. Noven Pharmaceuticals Inc. (Fed. Cir. 2017)

April 4, 2017

By Andrew Williams —

In inter partes review proceedings, is the U.S. Patent and Trademark Office's Patent Trial and Appeal Board required to take into account a final district court determination of non-obviousness of the same claims based on the same prior art? In Novartis AG v. Noven Pharmaceuticals Inc., the Federal Circuit responded in the negative. Of course, this ruling will have an impact on the many parallel Patent Office and district court proceedings, which have been increasing significantly since the passage of the AIA. Ultimately, the Court rested its decision on the different burdens of proof required in the two different types of proceedings. Therefore, as a matter of law, "the PTAB properly may reach a different conclusion based on the same evidence." The Federal Circuit defended its decision by citing to the Supreme Court's Cuozzo Speed Techs., LLC v. Lee case, which noted that the "different evidentiary burdens mean that the possibility of inconsistent results is inherent to Congress'[s] regulatory design." Cuozzo, 136 S. Ct. 2131, 2146 (2016). But is there a problem with a system in which a patent owner's rights can sit precariously between the "preponderance of the evidence" and the "clear and convincing evidence" burdens of proof.

To be fair, Novartis did not argue during the oral hearing that the Board should be bound by the District Court decision. Instead, it took the position that the Board should be required in such circumstances to explain why the difference in burdens of proof matters: "The Board should have recognized the findings of the district court and explained why it came to a different conclusion on the same evidence that was before the district court." Oral Hearing at 3:48. Such an argument makes sense in view of prior IPR appeals that resulted in the Federal Circuit vacating and remanding the Board's decision. For example, appellants have been successful in convincing the Court that when the PTAB's final written decision does not sufficiently explain the rationale for invaliding a claim, it must be remanded. Nevertheless, the panel was quick to point out that the Board in this case not only explained why the claims were obvious, but it explained that the difference in burdens of proof allowed it to come to a different conclusion. In other words, the Federal Circuit held that the Board is not required to take the additional step to explain why the prior art might be invaliding under one standard, but might not be invalidating under the other.

This case is not significantly different than In re Baxter International, Inc., 678 F.3d 1357 (Fed. Cir. 2012). In that case, the Patent Office invalidated claims in a reexamination that were previously upheld by a district court. The difference between these two cases, other than the type of Patent Office proceeding involved, was that in Baxter the reexamination rejections were based "on prior art references that were not squarely at issue during the trial on the invalidity issues . . . ." Nevertheless, the Federal Circuit came to the similar conclusion in both cases, that because "the two proceedings necessarily applied different burdens of proof and relied on different records, the PTO did not err in failing to provide the detailed explanation now sought by Baxter as to why the PTO came to a different determination than the court system in the Fresenius litigation."

Novartis, however, focused on a subsequent comment found in the Baxter case: "When a party who has lost in a court proceeding challenging a patent, from which no additional appeal is possible, provokes a reexamination in the PTO, using the same presentations and arguments, even with a more lenient standard of proof, the PTO ideally should not arrive at a different conclusion" (emphasis added). It essentially argued that the use of the word "ideally" was a signal to the Patent Office that on identical records, the outcomes must be the same. But Chief Judge Prost responded during the oral hearing: "And let's hope it doesn't snow tonight." In other words, as the opinion makes clear, the use of the term "ideally" in Baxter appeared to connote aspiration, not a mandate. Moreover, again as Chief Judge Prost pointed out during the hearing, the Baxter decision follows up that above sentence with the all-important word: "However . . . ."

Judge Wallach, who authored the Novartis AG opinion, had another observation that also dispenses with the "ideally" language from Baxter — the factual records between the cases were not the same. Sure, for at least one of the patents at issue, the prior art relied upon by the Board was exactly the same as the art cited by the District Court, and the same experts were used in both cases. But as Judge Wallach pointed out, the expert reports were not identical in the two proceedings. In fact, Novartis had to acknowledge that that the experts' testimony was only "substantively the same." As the Court put it, "[i]t is unsurprising that different records may lead to different findings and conclusions." But such an outcome appears to put form over substance — experts will almost never prepare identical reports in different proceedings and the deposition testimony will certainly vary both in the questions being asked and the exact answer that are provided. But the cited art does not change, and the issue of whether the claims are anticipated or are obvious should not fluctuate based on the length of the expert report or whether the expert was asked the same questions at her deposition. Moreover, it sets up incentives to harass a patent owner by providing only slightly different testimony in the two different proceedings, thereby potentially getting two bites at the apple.

The technology at issue in this case was a pharmaceutical composition comprising both a compound known as rivastigmine and an antioxidant. Such a composition is described as being useful for the treatment of Alzheimer's disease. The Board had invalidated the relevant claims as obvious in view of two references: Enz and Sasaki. Enz disclosed a rivastigmine transdermal patch containing an acrylic polymer. Sasaki was described as teaching that compounds combined with acrylic polymers tend to have their therapeutic effect reduced due to breakdown and dissipation of the drug over time; and that adding an antioxidant will slow this process. With regard to its substantive arguments, Novartis focused on the motivation to combine. Specifically, it alleged that there was no evidence that a PHOSITA would have been motived to add an antioxidant "absent evidence of oxidative degradation." As counsel put it during the oral hearing, the old adage applies: "if it ain't broke, don't fix it."

Nevertheless, the Federal Circuit found that there was substantial evidence for the Board's decision. It first pointed out that the Board found that the level of skill of a PHOSITA included the ability to analyze and recognize certain characteristics of a compound. Moreover, the Court reduced the remaining assertions of Novartis to requests to give more weight to Dr. Alexander M. Klibanov testimony, Novartis' expert. And of course, the Court declined: "Novartis asks us to give greater weight to the testimony of Dr. Klibanov than did the PTAB, which we may not do." As a result, the Court affirmed the final written decisions of the Board related to the patents at issue.

Novartis AG v. Noven Pharmaceuticals Inc. (Fed. Cir. 2017)
Panel: Chief Judge Prost and Circuit Judges Wallach and Stoll
Opinion by Circuit Judge Wallach

recent posts

about