Patent Docs

Arthrex, Inc. v. Smith & Nephew, Inc. (Fed. Cir. 2018)

February 6, 2018

By Kevin E. Noonan –

Although having built up a track record for several years and several thousand petitions and "trials," inter partes review proceedings under the Leahy-Smith America Invents Act are still relatively new. As a statute administered by an administrative agency having the power (and duty) to promulgate rules effecting implementation of that statute, IPRs, like many administrative proceedings, have in due course generated controversies on how the statute has been implemented. A fair number of these controversies have been reviewed by the Federal Circuit (see "Redline Detection, LLC v. Star Envirotech, Inc. (Fed. Cir. 2015)"; "Aqua Products, Inc. v. Matal (Fed. Cir. 2017)"; "Wi-Fi One, LLC v. Broadcom Corp. (Fed. Cir. 2018) (en banc)") and the Supreme Court (see "Cuozzo Speed Technologies LLC v. Lee (2016)"), and indeed even the constitutionality of the proceedings has put in question (see "Oil States Energy Services, LLC v. Greene's Energy Group, LLC"). This week, the Federal Circuit ruled on the proper interpretation of another PTAB Rule, entry of adverse judgment under 37 C.F.R. § 42.73(b) in Arthrex, Inc. v. Smith & Nephew, Inc., affirming the PTAB's interpretation of the rule.

The case arose in an IPR against Arthrex's U.S. Patent No. 8,821,541; claims 1-9 were challenged (remaining claims 10 and 11 were not) and claim 1 is representative:

1. A suture anchor comprising: an anchor body having a longitudinal axis, a proximal end, a distal end, a central passage, a first suture opening, and a second suture opening, wherein the central passage extends along the longitudinal axis, the central passage extends from the first suture opening which is located at the proximal end of the anchor body and through a portion of a length of the anchor body, the first suture opening is encircled by a perimeter of the anchor body, and the second suture opening extends through a portion of the anchor body; a rigid support fixed to the anchor body, wherein the rigid support extends across the central passage and has a first portion and a second portion spaced from the first portion, the first portion branching from a first wall portion of the anchor body and the second portion branching from a second wall portion of the anchor body, the rigid support spaced axially away from the first suture opening along the longitudinal axis of the anchor body, and the second suture opening is disposed near the rigid support; and at least one suture strand threaded into the central passage, wherein the at least one suture strand is supported by the rigid support and threaded through the first suture opening and the second suture opening of the anchor body.

Prior to institution of the IPR, Arthrex disclaimed claims 1-9 under 37 C.F.R. § 42.107(e) and filed their preliminary response to the petition, arguing that the Board should dismiss the petition because Rule 107(e) precludes instituting an IPR on disclaimed claims. Arthrex also asserted in its petition that it was not requesting that the Board enter an adverse judgment, rather Arthrex argued that the Board's rule precluded the Board from instituting the IPR because all the challenged claims had been disclaimed. Nevertheless, the Board entered an adverse judgment, based on its interpretation of another rule, under 37 C.F.R. § 42.73(b), which states:

A party may request judgment against itself at any time during a proceeding. Actions construed to be a request for adverse judgment include:
    (1) Disclaimer of the involved application or patent;
    (2) Cancellation or disclaimer of a claim such that the party has no remaining claim in the trial;
    (3) Concession of unpatentability or derivation of the contested subject matter; and
    (4) Abandonment of the contest.

(emphasis in opinion). The significance of entering judgment is that the estoppel provisions of 37 C.F.R. § 42.73(d)(3)(i) attached; these provisions prevent a patent owner from "taking action inconsistent with the adverse judgment, including obtaining in any patent . . . [a] claim that is not patentably distinct from a finally refused or canceled claim." This rule materially affected the scope of claims Arthrex could pursue in two pending continuation and a third more recently filed applications. Arthrex appealed; as part of that appeal the Federal Circuit denied Smith & Nephew's motion that Arthrex was precluded from appealing this decision under 35 U.S.C. § 319 because the Board had not entered a Final Written Decision.

The Federal Circuit affirmed, in an opinion by Judge Dyk joined by Judge O'Malley (who filed a concurring opinion) over a dissent by Judge Newman. The panel first held that the Board's decision was appealable, not falling within the proscriptions of 35 U.S.C. § 314(d) regarding institution decisions. The panel majority started from the presumption that PTAB decisions were appealable as for any other final administrative agency action. 5 U.S.C. §§ 701,704. The panel also found support in 28 U.S.C. § 1295(a)(4)(A), which provides for judicial review of final agency action absent statutory provisions precluding review. The Board did not find the Court's decision in St. Jude Medical, Cardiology Division, Inc. v. Volcano Corp., 749 F.3d 1373 (Fed. Cir. 2014), to be to the contrary, based on the different procedural posture in that case (which considered whether § 1295(a)(4)(A) permitted appeal of the PTAB's decision not to institute, which is precluded by § 314(d)).

Next the panel held that, Arthrex having disclaimed any argument regarding whether the PTAB had exceeded its statutory authority to promulgate the rules, the PTAB properly applied its rules under these circumstances. The panel rejected the argument that Arthrex had immunized itself from adverse judgment by specifically asserting that it was not requesting adverse judgment by disclaiming claims 1-9; the panel stated that if this was the rule then any patentee disclaiming any claims in an IPR would make the same representation; this would "render the rule a nullity," according to the Court. Moreover, the panel majority believed that the language of the rule centered around how the Board construed the disclaimer and was not dependent on representations from a patentee. The panel also rejected Arthrex's argument that an adverse judgment should be entered only if claims are disclaimed after an IPR is instituted; the panel backed the Board's interpretation that "an adverse judgment may be entered after a petition has been filed, but before an IPR proceeding has been instituted." The Board interpreted the rule to mean that there is no remaining claim "ready for trial," whether the IPR has been instituted or not. Accordingly, the panel majority stated that

The purpose of the estoppel provision is to "provide[ ] estoppel against claims that are patentably indistinct from those claims that were lost." For this purpose, there seems to be no meaningful distinction between claims that are cancelled before an IPR proceeding is instituted and claims that are cancelled after an IPR proceeding is instituted [citations omitted].

In Judge O'Malley's concurrence, the Judge agrees with the outcome under the present rule but has "doubts about whether the Director had the authority under 35 U.S.C. § 316 (or any other statutory provision) to issue that regulation or whether, if so, the regulation was properly promulgated." Specifically, the Judge finds a contradiction with the result here and the result in Facebook, Inc. v. Skky, LLC, No. CBM2016-00091, 2017 WL 4349404, at *3 (P.T.A.B. Sept. 28, 2017), where the Court held that covered business method patent review cannot be instituted on disclaimed claims. She cites the Board's position in that case as "our case law requires that statutorily disclaimed claims must be treated as if they never existed and therefore those claims cannot support institution of CBM review." If that is the case, then for Judge O'Malley it should also apply here and "if the Board lacks the authority to institute review based on statutorily disclaimed claims, as § 42.107(e) and Facebook seem to indicate, it is unclear to me why the Board would have the authority to take any other action—particularly prior to institution—with respect to disclaimed claims."

Judge O'Malley also disagreed with the Board's position that the word "proceeding" as used in Rule 73(b) includes both the time before and after institution, i.e., the entire time period from when the petition is filed until a Final Written Decision is issued. But under Shaw Industries Group, Inc. v. Automated Creel Systems, Inc., 817 F.3d 1293, 1300 (Fed. Cir. 2016), however, "[t]he IPR does not begin until it is instituted." Entering an adverse judgment in this case seems to the Judge to be a contradiction of this controlling Federal Circuit precedent. And nowhere in the AIA provisions regarding IPRs can Judge O'Malley find the authority for the Board to enter an adverse judgment in an IPR.

Judge Newman's dissent is based on her opinion that Arthrex had disclaimed all claims challenged in the petition prior to the Board's decision whether to institute an IPR, and accordingly under 37 C.F.R. § 42.107(e) there were no claims against which an adverse judgment could be entered. For Judge Newman, the relevant language of 37 C.F.R. § 42.73(b) in subparagraph (2) is that "[c]ancellation or disclaimer of a claim such that the party has no remaining claim in the trial" (emphasis in opinion), because under the factual circumstances at bar there was no trial and thus entering an adverse judgment was contrary to the express language of the rule. Judge Newman believes that the PTAB has exceeded its statutory authority, and it is "[t]he judicial obligation is to assure agency compliance with its legislated authority," citing Nat'l Broad. Co. v. United States, 319 U.S. 190, 224 (1943). For Judge Newman, "[s]ubsection (b)(2) on its face is directed to disclaimer or cancellation 'in the trial.' It is not disputed that 'in the trial' can occur only after institution." Thus, because claims 1-9 were disclaimed before the IPR was instituted, it is a misapplication of the rule for the Board to have entered an adverse judgment. Any other interpretation is for Judge Newman an explicit change in the rule, which requires rulemaking procedures specified under the APA (35 U.S.C. § 2(b)(2)(B)).

Arthrex, Inc. v. Smith & Nephew, Inc. (Fed. Cir. 2018)
Panel: Circuit Judges Newman, Dyk, and O'Malley
Opinion by Circuit Judge Dyk; concurring opinion by Circuit Judge O'Malley; dissenting opinion by Circuit Judge Newman
PTAB Life Sciences Report

February 5, 2018

By John Cravero —

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

Mylan Pharmaceuticals, Inc. v. Sanofi Aventis Deutschland GmbH

PTAB Petition: IPR2017-01526; filed June 5, 2017.

Institution of Inter Partes Review; entered December 13, 2017.

Patent at Issue: U.S. Patent No. 7,476,652 ("Acidic insulin preparations having improved stability," issued January 13, 2009) claims a pharmaceutical formulation comprising Gly(A21), Arg(B31), Arg(B32)-human insulin; at least one chemical entity chosen from polysorbate 20 and polysorbate 80; at least one preservative; and water, wherein the pharmaceutical formulation has a pH in the acidic range from 1 to 6.8.

Petitioners Mylan N.V., Biocon Research Ltd., and Biocon Ltd. are challenging the '652 patent on six grounds as being obvious under 35 U.S.C. § 103(a). View the petition here. Administrative Patent Judges Erica A. Franklin, Robert A. Pollock, and Michelle N. Ankenbrand (author) issued a decision instituting inter partes review of whether claims 1–25 of the '652 patent are unpatentable under 35 U.S.C. § 103 over the combination of Lantus Label and Lougheed; claims 7 and 24 of the '652 patent are unpatentable under 35 U.S.C. § 103 over the combination of Lantus Label and FASS; claims 7 and 24 of the '652 patent are unpatentable under 35 U.S.C. § 103 over the combination of Lantus Label and Grau; claims 1–25 of the '652 patent are unpatentable under 35 U.S.C. § 103 over the combination of Owens and Lougheed; claims 7 and 24 of the '652 patent are unpatentable under 35 U.S.C. § 103 over the combination of Owens and FASS; and claims 7 and 24 of the '652 patent are unpatentable under 35 U.S.C. § 103 over the combination of Owens and Grau.

Related Matters: According to the petition, the '652 patent is not involved in any related proceedings. However, the Patent Owner identified that the '652 patent is involved in the following civil litigations: Sanofi-Aventis U.S. LLC v. Merck Sharp & Dohme Corp., C.A. No. 1-16- cv-00812-RGA (D. Del.); Sanofi-Aventis v. Merck Sharp & Dohme Corp., C.A. No. 2-17-cv-05914 (D.N.J.). Patent Owner also identified the following concluded litigations involving the '652 patent: Sanofi-Aventis U.S. LLC v. Eli Lilly & Co., C.A. No. 1-14-cv-00113-RGA (D. Del.); Sanofi-Aventis U.S. LLC v. Eli Lilly & Co., C.A. No. 1-14-cv-00884-RGA (D. Del.). Patent Owner also identified a related inter partes review that Petitioner filed challenging U.S. Patent No. 7,713,930, which issued from a continuation application to the application that issued as the '652 patent (IPR201-01528; filed 06/05/2017; instituted 12/13/2017; pending).

Mylan Pharmaceuticals, Inc. v. Sanofi Aventis Deutschland GmbH

PTAB Petition: IPR2017-01528; filed June 5, 2017.

Institution of Inter Partes Review; entered December 13, 2017.

Patent at Issue: U.S. Patent No. 7,713,930 ("Acidic insulin preparations having improved stability," issued May 11, 2010) claims a pharmaceutical formulation comprising Gly(A21), Arg(B31), Arg(B32)-human insulin; at least one chemical entity chosen from esters and ethers of polyhydric alcohols; at least one preservative; and water, wherein the pharmaceutical formulation has a pH in the acidic range from 1 to 6.8.

Petitioners Mylan N.V., Biocon Research Ltd., and Biocon Ltd. are challenging the '930 patent on eight grounds as being obvious under 35 U.S.C. § 103(a). View the petition here. Administrative Patent Judges Erica A. Franklin, Robert A. Pollock, and Michelle N. Ankenbrand (author) issued a decision instituting inter partes review of whether claims 1–20 of the '930 patent are unpatentable under 35 U.S.C. § 103 over the combination of Lantus Label and Lougheed; claims 1–18 and 20 of the '930 patent are unpatentable under 35 U.S.C. § 103 over the combination of Lantus Label and FASS; claims 1–18 and 20 of the '930 patent are unpatentable under 35 U.S.C. § 103 over the combination of Lantus Label and Grau; claim 19 of the '930 patent is unpatentable under 35 U.S.C. § 103 over the combination of Lantus Label, FASS or Grau, and Lougheed; claims 1–20 of the '930 patent are unpatentable under 35 U.S.C. § 103 over the combination of Owens and Lougheed; claims 1–18 and 20 of the '930 patent are unpatentable under 35 U.S.C. § 103 over the combination of Owens and FASS; claims 1–18 and 20 of the '930 patent are unpatentable under 35 U.S.C. § 103 over the combination of Owens and Grau; and claim 19 of the '930 patent is unpatentable under 35 U.S.C. § 103 over the combination of Owens, FASS or Grau, and Lougheed.

Related Matters: According to the petition, the '930 patent is not involved in any related proceedings. However, the Patent Owner identified that the '930 patent is involved in the following civil litigations: Sanofi-Aventis U.S. LLC v. Merck Sharp & Dohme Corp., C.A. No. 1-16- cv-00812-RGA (D. Del.); Sanofi-Aventis v. Merck Sharp & Dohme Corp., C.A. No. 2-17-cv-05914 (D.N.J.). Patent Owner also identified the following concluded litigations involving the '930 patent: Sanofi-Avent0s U.S. LLC v. Eli Lilly & Co., C.A. No. 1-14-cv-00113-RGA (D. Del.); Sanofi-Aventis U.S. LLC v. Eli Lilly & Co., C.A. No. 1-14-cv-00884-RGA (D. Del.). Patent Owner also identified related inter partes review that Petitioner filed challenging U.S. Patent No. 7,476,652, which issued from a parent application to the application that issued as the '930 patent (IPR201-01526; filed 06/05/2017; instituted 12/13/2017; pending).

Pfizer, Inc. v. Biogen, Inc.

PTAB Petition: IPR2018-00285; filed December 14, 2017.

Patent at Issue: U.S. Patent No. 8,329,172 ("Combination therapies for B-cell lymphomas comprising administration of anti-CD20 antibody," issued February 14, 2017) claims a method of treating low grade B-cell non-Hodgkin's lymphoma in a human patient comprising administering to the patient chemotherapy consisting of CVP therapy to which the patient responds, followed by rituximab maintenance therapy, wherein the maintenance therapy comprises four weekly administrations of rituximab at a dose of 375 mg/m.sup.2 every 6 months, and wherein the maintenance therapy is provided for 2 years.

Petitioner Pfizer, Inc. is challenging the '172 patent on 2 grounds as being obvious under 35 U.S.C. § 103(a). View the petition here.

Related Matters: According to the petition, Petitioners previously filed an inter partes review petition on the '172 patent (IPR2017-01166; filed 04/21/2017; institution denied 11/13/2017; request for rehearing submitted 12/12/2017). Petitioners also identified the following additional inter partes review challenges to the '172 patent: IPR2015-00418 (Boehringer Ingelheim Pharmaceuticals, Inc.; filed 12/15/2014; institution denied 07/13/2015) and IPR2017-01093 (Celltrion Inc.; filed 03/15/2017; institution denied 10/06/2017).

10X Genomics, Inc. v. Bio-Rad Laboratories, Inc.

PTAB Petition: IPR2018-00300; filed December 14, 2017.

Patent at Issue: U.S. Patent No. 9,216,392 ("System for forming an array of emulsions," issued December 22, 2015) claims a ystem for forming an array of emulsions, comprising: a plate including an array of emulsion production units, each unit including at least one first input well to hold a continuous phase for an emulsion, a second input well to hold a dispersed phase for an emulsion, and an output well connected to the first and second input wells by a set of channels that form a channel junction, the set of channels including at least two input channels extending separately from the input wells to the channel junction and an output channel extending from the channel junction to the output well, each channel of the set of channels being circumferentially bounded; and a vacuum or pressure source configured to be connected operatively to wells of the plate to form a pressure drop between the input wells and the output well of each unit to drive the continuous phase and the dispersed phase from the first and second input wells of the unit to the channel junction, at which droplets of the dispersed phase are generated, and through the output channel for collection in the output well of the unit.

Petitioner 10X Genomics, Inc. is challenging the '392 patent on five grounds as being obvious under 35 U.S.C. § 103(a). View the petition here.

Related Matters: According to the petition, the '392 patent is involved in the following civil litigation: Bio-Rad Laboratories, Inc., et al. v. 10X Genomics, Inc., Case No. 3:17-CV-4339 (N.D. Cal.). Additionally, the '392 patent is involved in the following ITC proceeding: Re: Certain Microfluidic Devices, Investigation Number 337-TA-1068 (ITC). Petitioners concurrently filed two additional inter partes review petitions challenging claims 1-21 of the '392 patent (IPR2018-00301 and IPR2018-00302; filed 12/14/2017; pending).

10X Genomics, Inc. v. Bio-Rad Laboratories, Inc.

PTAB Petition: IPR2018-00301; filed December 14, 2017.

Patent at Issue: U.S. Patent No. 9,216,392 ("System for forming an array of emulsions," issued December 22, 2015) claims a ystem for forming an array of emulsions, comprising: a plate including an array of emulsion production units, each unit including at least one first input well to hold a continuous phase for an emulsion, a second input well to hold a dispersed phase for an emulsion, and an output well connected to the first and second input wells by a set of channels that form a channel junction, the set of channels including at least two input channels extending separately from the input wells to the channel junction and an output channel extending from the channel junction to the output well, each channel of the set of channels being circumferentially bounded; and a vacuum or pressure source configured to be connected operatively to wells of the plate to form a pressure drop between the input wells and the output well of each unit to drive the continuous phase and the dispersed phase from the first and second input wells of the unit to the channel junction, at which droplets of the dispersed phase are generated, and through the output channel for collection in the output well of the unit.

Petitioner 10X Genomics, Inc. is challenging the '392 patent on five grounds as being obvious under 35 U.S.C. § 103(a). View the petition here.

Related Matters: According to the petition, the '392 patent is involved in the following civil litigation: Bio-Rad Laboratories, Inc., et al. v. 10X Genomics, Inc., Case No. 3:17-CV-4339 (N.D. Cal.). Additionally, the '392 patent is involved in the following ITC proceeding: Re: Certain Microfluidic Devices, Investigation Number 337-TA-1068 (ITC). Petitioners concurrently filed two additional inter partes review petitions challenging claims 1-21 of the '392 patent (IPR2018-00300 and IPR2018-00302; filed 12/14/2017; pending).

10X Genomics, Inc. v. Bio-Rad Laboratories, Inc.

PTAB Petition: IPR2018-00302; filed December 14, 2017.

Patent at Issue: U.S. Patent No. 9,216,392 ("System for forming an array of emulsions," issued December 22, 2015) claims a ystem for forming an array of emulsions, comprising: a plate including an array of emulsion production units, each unit including at least one first input well to hold a continuous phase for an emulsion, a second input well to hold a dispersed phase for an emulsion, and an output well connected to the first and second input wells by a set of channels that form a channel junction, the set of channels including at least two input channels extending separately from the input wells to the channel junction and an output channel extending from the channel junction to the output well, each channel of the set of channels being circumferentially bounded; and a vacuum or pressure source configured to be connected operatively to wells of the plate to form a pressure drop between the input wells and the output well of each unit to drive the continuous phase and the dispersed phase from the first and second input wells of the unit to the channel junction, at which droplets of the dispersed phase are generated, and through the output channel for collection in the output well of the unit.

Petitioner 10X Genomics, Inc. is challenging the '392 patent on four grounds as being obvious under 35 U.S.C. § 103(a). View the petition here.

Related Matters: According to the petition, the '392 patent is involved in the following civil litigation: Bio-Rad Laboratories, Inc., et al. v. 10X Genomics, Inc., Case No. 3:17-CV-4339 (N.D. Cal.). Additionally, the '392 patent is involved in the following ITC proceeding: Re: Certain Microfluidic Devices, Investigation Number 337-TA-1068 (ITC). Petitioners concurrently filed two additional inter partes review petitions challenging claims 1-21 of the '392 patent (IPR2018-00300 and IPR2018-00301; filed 12/14/2017; pending).

Becton, Dickinson and Company v. B. Braun Melsungen AG

PTAB Petition: IPR2017-01586; filed June 16, 2017.

Institution of Inter Partes Review; entered December 15, 2017.

Patent at Issue: U.S. Patent No. 8,328,762 ("Catheter insertion device," issued December 11, 2012) claims a embodiments of a catheter insertion device.

Petitioner Becton, Dickinson and Company is challenging the '762 patent on four grounds as being obvious under 35 U.S.C. § 103(a). View the petition here. Administrative Patent Judges Scott A. Daniels (author), Michael L. Woods, and Robert L. Kinder issued a decision instituting inter partes review of whether claims 18 and 22 are unpatentable under 35 U.S.C. § 102(b) as obvious over Van Heugten; whether claim 25 is unpatentable under 35 U.S.C. § 102(b) as obvious over Van Heugten and Lynn; and whether claim 22 is unpatentable under 35 U.S.C. § 102(b) as obvious over Van Heugten and Tauschinski.

Related Matters: According to the petition, the '762 patent is the subject of the following civil litigation: B. Braun Melsungen AG et al. v. Becton, Dickinson & Co. et al., No. 1:16-cv-00411 (D. Del.). Petitioner also filed petitions for inter partes review in related U.S. Patent Nos. 9,149,626 (IPR2017-01587; filed 06/16/2017; instituted 12/15/2017; pending); 8,333,735 (IPR2017-01583; filed 06/16/2017; institution denied 11/29/2017); 8,337,463 (IPR2017-01585; filed 06/16/2017; institution denied 12/15/2017); 8,540,728 (IPR2017-01584; filed 06/16/2017; institution denied 11/29/2017); 8,597,249 (IPR2017-01589; filed 06/16/2017; instituted 01/12/2018; pending); 8,460,247 (IPR2017-01588; filed 06/16/2017; instituted 12/21/2017; pending); and 9,370,641 (IPR2017-01590; filed 06/16/2017; instituted 01/11/2018; pending).

Becton, Dickinson and Company v. B. Braun Melsungen AG

PTAB Petition: IPR2017-01587; filed June 16, 2017.

Institution of Inter Partes Review; entered December 15, 2017.

Patent at Issue: U.S. Patent No. 9,149,626 ("Catheter insertion device," issued October 6, 2015) claims a embodiments of a catheter insertion device.

Petitioner Becton, Dickinson and Company is challenging the '626 patent on four grounds as being obvious under 35 U.S.C. § 103(a). View the petition here. Administrative Patent Judges Scott A. Daniels, Michael L. Woods, and Robert L. Kinder (author) issued a decision instituting inter partes review of whether claims 11 and 20 are unpatentable under 35 U.S.C. § 102(b) as obvious over Van Heugten.

Related Matters: According to the petition, the '626 patent is the subject of the following civil litigation: B. Braun Melsungen AG et al. v. Becton, Dickinson & Co. et al., No. 1:16-cv-00411 (D. Del.). Petitioner also filed petitions for inter partes review in related U.S. Patent Nos. 8,328,762 (IPR2017-01586; filed 06/16/2017; instituted 12/15/2017; pending); 8,333,735 (IPR2017-01583; filed 06/16/2017; institution denied 11/29/2017); 8,337,463 (IPR2017-01585; filed 06/16/2017; institution denied 12/15/2017); 8,540,728 (IPR2017-01584; filed 06/16/2017; institution denied 11/29/2017); 8,597,249 (IPR2017-01589; filed 06/16/2017; instituted 01/12/2018; pending); 8,460,247 (IPR2017-01588; filed 06/16/2017; instituted 12/21/2017; pending); and 9,370,641 (IPR2017-01590; filed 06/16/2017; instituted 01/11/2018; pending).
Move, Inc. v. Real Estate Alliance Ltd. (Fed. Cir. 2018)

February 4, 2018

By Michael Borella —

One of the more frustrating aspects of the current judicial patent eligibility framework is the propensity for courts, even the Federal Circuit, to carry out the two-part test from Alice Corp. v. CLS Bank Int'l in a conclusory fashion. When this occurs, the claims under review are most likely going to be found non-statutory and invalid under 35 U.S.C. § 101. In this case, the Federal Circuit actually provides ample reasoning for finding that claims fail the test, albeit in a nonprecedential case.

Real Estate Alliance Ltd. ("REAL"), is the assignee of U.S. Patent Nos. 5,032,989 and 4,870,576 (both expired over the course of this long litigation, but still relevant for purposes of determining past infringement). The '989 patent is a continuation-in-part of the '576 patent, and both are directed to geographically searching for real estate properties on a computer. This process involves "identifying a geographic region of interest for acquiring property and then selecting an inner area within this geographic region by designating boundaries on a map displayed on the screen." Then, the inner area is "zoomed in on and a second area is selected within the zoomed region." One can "change the world coordinate display" such that the "size of the viewport remains constant" and the "display now appears to have zoomed down closer to earth." The elected area "is then cross-referenced with the database of available properties whose approximate locations are then pictorially displayed on screen." Keep in mind that the '576 patent was filed in 1986 and the '989 patent was filed in 1989, well before such technologies were widely available on personal computers and smartphones.

Claim 1 of the '989 patent recites:

A method using a computer for locating available real estate properties comprising the steps of:
    a) creating a database of the available real estate properties;
    b) displaying a map of a desired geographic area;
    c) selecting a first area having boundaries within the geographic area;
    d) zooming in on the first area of the displayed map to about the boundaries of the first area to display a higher level of detail than the displayed map;
    e) displaying the zoomed first area;
    f) selecting a second area having boundaries within the zoomed first area;
    g) displaying the second area and a plurality of points within the second area, each point representing the appropriate geographic location of an available real estate property; and
    h) identifying available real estate properties within the database which are located within the second area.

The aforementioned Alice case set forth a test to determine whether claims are directed to patent-eligible subject matter under § 101. One must first decide whether the claim at hand is directed to a judicially-excluded law of nature, a natural phenomenon, or an abstract idea. If so, then one must further decide whether any element or combination of elements in the claim is sufficient to ensure that the claim amounts to "significantly more" than the judicial exclusion. But generic computer implementation of an otherwise abstract process does not qualify as significantly more. On the other hand, a claimed improvement to a computer or technological process is typically patent-eligible.

The District Court for the Central District of California applied the test and found that the '989 patent was directed to "a method for collecting and organizing information about available real estate properties and displaying this information on a digital map that can be manipulated by the user." This, according to the District Court, is an abstract idea.

Reviewing this decision, the Federal Circuit stated that the part one analysis "requires us to consider the claims in their entirety to ascertain whether their character as a whole is directed to excluded subject matter." The Court quickly determined that the level of detail in claim 1 was insufficient to conclude that it was anything other than abstract. Particularly, the claim "is aspirational in nature and devoid of any implementation details or technical description." The Court helpfully clarified that not "every claim involving the collection, organization, manipulation, or display of data is necessarily directed to an abstract idea." On the other hand, the Court found that claim 1 had much in common with the ineligible data processing claims of Electric Power Group, LLC v. Alstom S.A. and Intellectual Ventures I LLC v. Capital One Fin. Corp.

Indeed, the Court observed that the claim was similar to others that were found to fail the Alice test due to "simply us[ing] computers to serve a conventional business purpose." In those cases, the claims recited at a high level what method steps were to be carried out, but not how these steps were implemented. Thus, the claims were not limited to a particular implementation. Similarly, while claim 1 "provide[s] steps for using the computer to perform the search, they contain no technical details or explanation of how to implement the claimed abstract idea using the computer."

REAL attempted to counter this position by arguing that the "creating a database" and "zooming in" steps were technical advancements. REAL relied on expert testimony to do so, the expert asserting that "databases at the time of the invention could not be queried graphically and that zooming on a computer-displayed map to depict a higher level of detail was neither routine nor conventional." But the Court remained hung up with the lack of detail in the claim — recitation of the function to be performed rather than the way that this function is carried out was problematic in the Court's view. That, and the claim's business focus, failed to convince the Court that there was a technical improvement recited.

Instead, the Court looked to the specification for discussion of such an improvement. In doing so, the Court looked for evidence that the invention improved the operation of a computer, as opposed to the business goal of identifying available real estate properties. Finding none, the Court determined that the claim was directed to an abstract idea.

Turning to part two of Alice, the Court described this inquiry as "examin[ing] the claim limitations more microscopically, to determine whether they contain additional features constituting an inventive concept." But any such recited features (i.e., a "computer" and a "database") were determined to be generic, thus having no weight in the inventive concept analysis. Further, the specification stated that the invention could be carried out on a general purpose computer.

As noted above, REAL's expert argued that the invention provided a technical improvement, stating that:

It was considered neither routine nor conventional in the mid-1980s for a computer-displayed map to be able to zoom to display a higher level of detail in the sense of displaying information that wasn't present at the lower level of detail at all, and this zooming step cannot be performed by a human.

But the Court dismissed this testimony as conclusory, noting that "[the expert's] declaration provides no citations to support this assertion and contains no additional rationale." This, combined that the observations that "the claim language does not explain what is inventive about the zoom feature or explain how it is accomplished" and that "REAL also has not pointed us to any portion of the specification that fills this gap," resulted in the Court concluding that the claim did not recite "significantly more" than the abstract idea therein. Consequently, failing both steps of the Alice test, the claim was held to be invalid under § 101.

While not providing a formal precedent, the Federal Circuit's reasoning herein points to a few observations that can be made regarding the ability of a claim to survive a § 101 challenge.

First, the Court was looking for a nexus between the invention as claimed and an improvement to technology. This nexus will not be found in a claim that recites steps at a high level that can be performed on generic hardware.

Second, while the Court repeatedly focused on the claim's lack of implementation detail, it was willing to look to the specification for an explanation of how the invention was a technical improvement. This approach harmonizes well with other cases, such as Core Wireless Licensing S.A.R.L. v. LG Electronics, Inc. and Thales Visionix Inc. v. U.S., in which very broad and arguably vague claims were found eligible because their specifications explained how they were advancements in their technical fields. In other words, claim language matters, but the specification may matter just as much.

Third, expert testimony as to the improvements provided by an invention had best be more than conclusory. The mere opinion of an expert may not be sufficient, and the expert should supplement this opinion with at least some support from other sources. This also reopens a can of worms regarding what is the evidentiary standard for both sides in a § 101 challenge, a question that has yet to be answered.

Move, Inc. v. Real Estate Alliance Ltd. (Fed. Cir. 2018)
Nonprecedential disposition
Panel: Circuit Judges Lourie, Wallach, and Stoll
Opinion by Circuit Judge Stoll
Conference & CLE Calendar

February 4, 2018

February 8, 2018 – "Exhaustion Tamed? Early Reports and New Ideas after Lexmark" (Intellectual Property Owners Association) – 2:00 to 3:00 pm (ET)

February 8, 2018 – "There Will Be Blood (and Beer): A Brief Panel Discussion on Oil States Services LLC v. Greene's Energy Group, LLC" (Intellectual Property Law Association of Chicago Young Members Committee) – 5:30 to 8:00 pm (CT) Chicago, IL

February 13, 2018 – "Patent Drafting for Machine Learning: Structural Claim Limitations, Avoiding §101 or §112 Rejections" (Strafford) – 1:00 to 2:30 pm (EST)

February 13, 2018 - "eMod Update: Patent Center and Structured Text" (U.S. Patent and Trademark Office) – 12:00 to 1:00 pm (ET)

February 14, 2018 – "Sect. 112 Indefiniteness in Chemical and Biotech Patent Claims — Drafting and Prosecuting Patent Claims That Will Hold Up Under Any Definiteness Standard" (Strafford) – 1:00 to 2:30 pm (EST)

February 20, 2018 – "Patent-Eligibility in 2018: Current Status and Best Practices" (McDonnell Boehnen Hulbert & Berghoff LLP) – 10:00 am to 11:15 am (CT)

February 21-22, 2018 – Advanced Summit on Life Sciences Patents (American Conference Institute) – New York, NY

March 5-6, 2018 – Advanced Patent Law Seminar (Chisum Patent Academy) – Houston, TX

March 8-9, 2018 – Advanced Patent Law Seminar (Chisum Patent Academy) – Cincinnati, OH
Webinar on Patent-Eligibility in 2018

February 3, 2018

McDonnell Boehnen Hulbert & Berghoff LLP will be offering a live webinar entitled "Patent-Eligibility in 2018: Current Status and Best Practices" on February 20, 2018 from 10:00 am to 11:15 am (CT). In this presentation, Patent Docs author and MBHB attorney Michael Borella will discuss the state of software and business method patent-eligibility in 2018 by reviewing what changed (and what did not change) in 2017. Topics to be covered include:

• Overview of the most recent Federal Circuit case law regarding Section 101;
• Where this law is relatively clear, and where it is not;
• The impact of the USPTO not making any significant updates to its subject matter eligibility guidelines;
• Best practices for drafting and prosecuting software and business method inventions in light of the above.

While there is no fee to participate, attendees must register in advance. Those wishing to register can do so here. CLE credit is pending for the states of California, Illinois, New Jersey, New York, North Carolina, and Virginia.
IPO Webinar on Patent Exhaustion after Lexmark

February 3, 2018

The Intellectual Property Owners Association (IPO) will offer a one-hour webinar entitled "Exhaustion Tamed? Early Reports and New Ideas after Lexmark" on February 8, 2018 from 2:00 to 3:00 pm (ET). Jorge Goldstein of Sterne, Kessler, Goldstein & Fox, PLLC; Brian Kacedon of Finnegan, Henderson, Farabow, Garrett & Dunner LLP; and William Krovatin of Merck & Co Inc. will discuss strategies and recent court cases that involve:

• Staking out the claim that a sale is not an "authorized sale" — Chrimar v. Alcatel Lucent and Sunoco v. U.S. Venture;
• Using claims of tortious interference under state law against competitors if they interfere with the patent owner’s contracts with purchasers;
• Obtaining patent protection on each component of a system, as well as on the system as a whole; and
• Obtaining separate patents on an inventions’ different methods of use.

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.
USPTO Patent Quality Chat Webinar Series

February 3, 2018

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 February 13, 2018. The latest webinar, entitled "eMod Update: Patent Center and Structured Text" will be hosted by Richard Fernandez, eMod Project Manager, and Lisa Tran, Communications Manager for eCommerce, who will discuss:

• New structured text features;
• Filing structured text via the electronic filing system (EFS-Web); and
• Accessing structured text submissions, structured text office actions, and XML downloads using the Private Patent Application Information Retrieval (PAIR) system.

The eMod team will also share information about the upcoming Patent Center Beta Release for participants to use the new Patent Center tool (to replace EFS-Web and PAIR), and provide feedback for further improvements.

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.
Panel Discussion on Oil States Services v. Greene’s Energy Group

February 3, 2018

The Intellectual Property Law Association of Chicago (IPLAC) Young Members Committee will be presenting a panel discussion entitled "There Will Be Blood (and Beer): A Brief Panel Discussion on Oil States Services LLC v. Greene's Energy Group, LLC" on February 8, 2018 from 5:30 to 8:00 pm (CT) at the offices of Foley & Lardner in Chicago, IL. The panel will discuss Oil States Energy Services LLC v. Greene's Energy Group, LLC, including the proceedings before the Supreme Court, and offer commentary on the issue of whether inter partes review violates the Constitution by extinguishing private property rights through a non-Article III forum without a jury.

The registration fee for the webinar is $30 (IPLAC members), $10 (IPLAC student memebrs), or $50 (non-members). Those interested in registering for event can do so here. Additional information regarding the seminar can be found here.
PTAB Releases Another Update to Its Motions to Amend Study

February 1, 2018

By Andrew Williams —

On January 12, 2018, the U.S. Patent and Trademark Office's Patent Trial and Appeal Board announced that it had updated its Motion to Amend Study to include all AIA trials through the end of Fiscal Year 2017 (which ended on September 30, 2017). The original study included data through April 30, 2016. At that time, only two motions to amend had been granted outright, with another four granted-in-part. This study was updated last year with data through May 31, 2017. At that time, two additional motions to amend had been granted outright, with an additional four granted-in-part. The current study includes no new motions to amend granted outright, but there are two more that have been granted-in-part. In total, fourteen motions to amend had been granted at least in part as of September 30, 2017 (out of a total of 275 completed trials in which a motion to amend was filed). Of course, the cut off for this study misses any impact of the October 4, 2017 Aqua Products, Inc. v. Matal decision. We, however, believe that no additional motions to amend have been granted so far this fiscal year.

This updated Motion to Amend Study includes several charts that present data that was obtained. The first such chart reproduced above highlights just how few trials actually include a motion to amend. The Purple and Yellow slices represent trials that are still pending, either with or without a filed motion to amend, respectively. They were otherwise not included in the calculations that followed. For completed trials, only 275 out of 2,766 trials (or 8%) included a motion to amend. The Board counted a trial as "completed" when it was terminated due to settlement, when there was a request for adverse judgement, when it was dismissed, or when there was a final written decision. Moreover, joined or consolidated trials were only counted once in the statistics. The second chart provided by the Board (not reproduced here) explains the outcome of the motions to amend, whether it was decided in the Final Written Decision, whether it was rendered moot because the claims were patentable, whether it was withdrawn, whether the case settled, whether adverse judgement was requested, whether the case was dismissed, or whether the motion was solely to cancel the claims. Out of the 275 trials, only 170 motions to amend with substitute claims were decided.

Tellingly, the third chart shows the outcome of the 170 decided motions to amend in which substitute claims were proposed. In 156 of these cases, or 92%, the Board denied the motion. The four motions to amend that were granted outright represent 2% of all motions to amend with substitute claims that were decided, and represent a much smaller percentage of all motions to amend. The ten motions to amend that were granted-in-part represented 6% of the total decided. The Study included a separate spreadsheet that contained the data from the 275 trials. This spreadsheet explains in which post-issuance proceedings that motions to amend were granted. The following tables were compiled from this data:

IPR2014-00090 was interesting because the Board originally denied the motion to amend on April 23, 2015. However, the Federal Circuit vacated the case in part because it found that the Board had erred on its sole ground for denying the motion. As a result, on remand, the Board granted the motion-in-part.

Looking forward to the first few months of fiscal year 2018, we do not believe that the Board has yet granted any motions to amend other than the one in Taiwan Semiconductor Manufacturing Co. v. Godo Kaisha IP Bridge (IPR2016-01249) (reported here). This is interesting because the Aqua Products case came out just as the fiscal year was starting. At that time, approximately 38 motions to amend were pending. It is possible that no such motions were granted because practitioners were essentially stuck with the briefing that had already occurred. The Board has been willing in most cases to allow additional briefing, but it has not been a blanket rule in all case. As an example, we need look no further than the first PTAB paper after the Aqua Products case, Minerva Surgical, Inc. v. Hologic, Inc., IPR2016-00868, Paper 57. In that case, the Chief Judge "determined that good cause exists to extend the one-year period for issuing a Final Written Decision" pursuant to 37 C.F.R. § 42.100(c). This order was most likely entered on October 5, 2017 because the one-year deadline was set to expire on October 6, 2017. Nevertheless, when the Final Written Decision issued on December 15, 2017, the Board held that "considering the entirety of the record before us, we determine that the preponderance of the evidence shows that the proposed substitute claims are not patentable over the prior art of record." Cynically, one could speculate that the Board had already come to this conclusion and merely used the language of Aqua Products to insulate its decision. Nevertheless, the Board in that case did allow the parties additional briefing, so it is probable that the Patent Owner was able to put forth its best argument. It remains to be seen what will happen in the more recent cases that have only just been instituted, because the Patent Owners in these cases will be able to take full advantage of the knowledge of the Aqua Products case. Of course, we will probably need to wait about a year for those cases to work through the system. Nevertheless, they should be captured in some future update of the PTAB's Motion to Amend Study.
PTAB Life Sciences Report

January 31, 2018

By John Cravero —

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

Acclarent, Inc. v. Ford Albritton, IV

PTAB Petition: IPR2018-00268; filed December 1, 2017.

Patent at Issue: U.S. Patent No. 9,011,412 ("Apparatus, system and method for manipulating a surgical catheter and working device with a single hand," issued April 21, 2015) claims a system, comprising: a guide catheter insertable through an external body passage of a subject, said guide catheter having a substantially rigid shaft, a proximal opening, a distal opening and a lumen extending between the proximal opening and the distal opening; a handle coupled to the guide catheter, the handle having a handle opening, a handle coupling and a structure, wherein the structure is configured to allow a position of the guide catheter to be controlled by some or all of three fingers of one hand of an operator of the handle, and wherein the handle coupling is configured to couple a source of suction to the lumen; and a working device adapted to be insertable through the handle opening into the lumen of the guide catheter, wherein the structure of the handle is adapted to permit the operator to position a thumb and index finger of the hand to manipulate the working device via a portion of the working device immediately adjacent to the handle opening and to control, by one of the thumb or index finger, an amount of suction coupled to the distal opening of the lumen.

Petitioner Acclarent, Inc. is challenging the '412 patent on two grounds as being obvious under 35 U.S.C. § 103(a). View the petition here.

Related Matters: According to the petition, the '412 patent is involved in the following litigation: Dr. Ford Albritton IV v. Acclarent, Inc., Civil Action No. 3:16-cv-03340-D (N.D. Tex.).

Trans Ova Genetics, LC v. XY, LLC

PTAB Petition: IPR2018-00250; filed December 1, 2017.

Patent at Issue: U.S. Patent No. 8,652,769 ("Methods for separating frozen-thawed spermatozoa into X-chromosome bearing and Y-chromosome bearing populations," issued February 18, 2014) claims a method of producing a frozen-thawed sorted artificial insemination sample.

Petitioners Intrexon Corp. and Trans Ova Genetics, LC are challenging the '769 patent on five grounds as being obvious under 35 U.S.C. § 103(a). View the petition here.

Related Matters: According to the petition, the '769 patent is the subject of the following litigation: XY, LLC et al. v. Trans Ova Genetics, LC, No. 1:17-cv-00944 (D. Colo.). Petitioners have also filed inter partes review petitions on U.S. Patent No. 7,723,116 (IPR2018-00247 and IPR2018-00248; filed 11/30/2017; pending).

Pfizer, Inc. v. Chugai Pharmaceutical Co.

PTAB Petition: IPR2017-01357; filed May 19, 2017.

Institution of Inter Partes Review; entered December 1, 2017.

Patent at Issue: U.S. Patent No. 7,332,289 ("Method of purifying protein," issued February 19, 2008) claims a method for removing contaminant DNA in an antibody-containing sample.

Petitioner Pfizer, Inc. is challenging the '289 patent on two grounds as being anticipated under 35 U.S.C. § 102(b) (ground 1) or as obvious under 35 U.S.C. § 103(a) (ground 2). View the petition here. Administrative Patent Judges Grace Karaffa Obermann, Rama G. Elluru, and Jacqueline T. Harlow (author) issued a decision instituting inter partes review of whether claims 1-8 and 13 are anticipated under 35 U.S.C. § 102(b) by Shadle; and whether claims 1-8 and 13 are unpatentable under 35 U.S.C. § 103(a) over Shadle.

Related Matters: According to the petition, Petitioner has filed a petition for inter partes review of related U.S. Patent No. 7,927,815 (IPR2017-01358; filed 05/19/2017; Instituted 12/01/2017; pending).

Pfizer, Inc. v. Chugai Pharmaceutical Co.

PTAB Petition: IPR2017-01358; filed May 19, 2017.

Institution of Inter Partes Review; entered December 1, 2017.

Patent at Issue: U.S. Patent No. 7,927,815 ("Protein purification method," issued April 19, 2011) claims a method for removing contaminant DNA in a sample containing a physiologically active protein.

Petitioner Pfizer, Inc. is challenging the '815 patent on two grounds as being anticipated under 35 U.S.C. § 102(b) (ground 1) or as obvious under 35 U.S.C. § 103(a) (ground 2). View the petition here. Administrative Patent Judges Grace Karaffa Obermann, Rama G. Elluru, and Jacqueline T. Harlow (author) issued a decision instituting inter partes review of whether claims 1-7 and 12 are anticipated under 35 U.S.C. § 102(b) by Shadle; and whether claims 1-7 and 12 are unpatentable under 35 U.S.C. § 103(a) over Shadle.

Related Matters: According to the petition, Petitioner has filed a petition for inter partes review of related U.S. Patent No. 7,332,289 (IPR2017-01358; filed 05/19/2017; Instituted 12/01/2017; pending).

Celltrion Inc. v. Genentech, Inc.

PTAB Petition: IPR2017-01373; filed May 9, 2017.

Institution of Inter Partes Review; entered December 1, 2017.

Patent at Issue: U.S. Patent No. 6,407,213 ("Method for making humanized antibodies," issued June 18, 2002) claims a humanized antibody variable domain comprising non-human Complementarity Determining Region (CDR) amino acid residues which bind an antigen incorporated into a human antibody variable domain, and further comprising a Framework Region (FR) amino acid substitution at a site selected from the group consisting of: 4L, 38L, 43L, 44L, 58L, 62L, 65L, 66L, 67L, 68L, 69L, 73L, 85L, 98L, 2H, 4H, 36H, 39H, 43H, 45H, 69H, 70H, 74H, and 92H, utilizing the numbering system set forth in Kabat.

Petitioner Pfizer, Inc. is challenging the '213 patent on seven grounds as being obvious under 35 U.S.C. § 103(a). View the petition here. Administrative Patent Judges Sheridan K. Snedden, Zhenyu Yang (author), and Robert A. Pollock issued a decision instituting inter partes review of whether claims 1-7 and 12 are anticipated under 35 U.S.C. § 102(b) by Shadle; and whether claims 1-7 and 12 are unpatentable under 35 U.S.C. § 103(a) over Shadle.

Related Matters: According to the petition, Petitioner has filed a petition for inter partes review of the same claims of the '213 patent based on different art references. The '213 patent is also the subject of inter partes reviews IPR2016-01693 (Mylan Pharmaceuticals Inc.; filed 08/30/2016; terminated by settlement before institution 03/10/2017); IPR2016-01694 (Mylan Pharmaceuticals Inc.; filed 08/30/2016; terminated by settlement before institution 03/10/2017). According to the Institution of Inter Partes Review, the '213 patent is the subject of inter partes reviews IPR2017-01488 (Pfizer, Inc.; filed 05/25/2017; pending); IPR2017-01489 (Pfizer, Inc.; filed 05/25/2017); IPR2017-02031 (Boehringer Ingelheim Pharmaceuticals, Inc.; filed 08/31/2017); IPR2017-02032 (Boehringer Ingelheim Pharmaceuticals, Inc.; filed 08/31/2017); IPR2017-02139 (Samsung Bioepis Co., Ltd.; filed 09/29/2017; pending); and IPR2017-02139 (Samsung Bioepis Co., Ltd.; filed 09/29/2017; pending).

Trans Ova Genetics, LC v. XY, LLC

PTAB Petition: IPR2018-00249; filed December 4, 2017.

Patent at Issue: U.S. Patent No. 6,372,422 ("Multiple sexed embryo production system for mammals," issued April 16, 2002) claims a method of producing multiple, sexed embryos from a non-human female mammal.

Petitioners Intrexon Corp. and Trans Ova Genetics, LC are challenging the '422 patent on six grounds as being anticipated under 35 U.S.C. § 102(b) (ground 1) or as obvious under 35 U.S.C. § 103(a) (grounds 2-5). View the petition here.

Related Matters: According to the petition, the '422 patent is the subject of the following litigation: XY, LLC et al. v. Trans Ova Genetics, LC, No. 1:17-cv-00944 (D. Colo.). Petitioners have filed separate inter partes review petitions on U.S. Patent No. 7,723,116 (IPR2018-00247 and IPR2018-00248; filed 11/30/2017; pending) and U.S. Patent No. 8,652,769 (IPR2018-00250; filed 12/01/2017; pending).

KVK-Tech, Inc. v. Shire PLC

PTAB Petition: IPR2018-00290; filed December 11, 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; wherein the second delayed release bead comprises at least one amphetamine salt layered onto or incorporated into a core; a delayed release coating layered onto the amphetamine core; and a sustained release coating layered onto the delayed release coating, wherein the sustained release coating is pH-independent; and wherein the first delayed release bead and the second delayed release bead comprise an enteric coating.

Petitioners KVK-Tech, Inc. and Abhai LLC are challenging the '938 patent on three grounds as being anticipated under 35 U.S.C. § 102(b) (ground 1) or as obvious under 35 U.S.C. § 103(a) (grounds 2 and 3). View the petition here.

Related Matters: According to the petition, Petitioners concurrently filed an inter partes review petition on related U.S. Patent No. 9,173,857 (IPR2018-00293; filed 12/11/2017; pending).

KVK-Tech, Inc. v. Shire PLC

PTAB Petition: IPR2018-00293; filed December 11, 2017.

Patent at Issue: U.S. Patent No. 9,173,857 ("Controlled dose drug delivery system," issued November 3, 2015) claims a method for treating attention deficit hyperactivity disorder (ADHD) which comprises: administering to a patient in need thereof, 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; wherein the second delayed release bead comprises at least one amphetamine salt layered onto or incorporated into a core; a delayed release coating layered onto the amphetamine core; and a sustained release coating layered onto the delayed release coating, wherein the sustained release coating is pH-independent; and wherein the first delayed release bead and the second delayed release bead comprise an enteric coating.

Petitioners KVK-Tech, Inc. and Abhai LLC are challenging the '938 patent on three grounds as being anticipated under 35 U.S.C. § 102(b) (ground 1) or as obvious under 35 U.S.C. § 103(a) (grounds 2 and 3). View the petition here.

Related Matters: According to the petition, Petitioners concurrently filed an inter partes review petition on related U.S. Patent No. 8,846,100 (IPR2018-00290; filed 12/11/2017; pending).

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