throbber
No. 16-712
`
`IN THE
`Supreme Court of the United States
`_______________________
`
`OIL STATES ENERGY SERVICES, LLC.,
`
`
`
`
`
`Petitioner,
`
`v.
`
`GREENE’S ENERGY GROUP, LLC, ET AL.,
`
`
`
`
`
`Respondents.
`_________________________
`
`ON WRIT OF CERTIORARI TO THE UNITED STATES
`COURT OF APPEALS FOR THE FEDERAL CIRCUIT
`__________________________________
`
`BRIEF FOR AARP AND AARP FOUNDATION
`AS AMICI CURIAE
`IN SUPPORT OF RESPONDENTS
`___________________________________
`
`JAMAICA P. SZELIGA
`SEYFARTH SHAW LLP
`975 F STREET, NW
`WASHINGTON, DC 20004
`202-828-5364
`
`
`BARBARA A. JONES
`Counsel of Record
`WILLIAM ALVARADO RIVERA
`AARP FOUNDATION
`LITIGATION
`601 E STREET, NW
`WASHINGTON, DC 20049
`323-215-6124
`
`bjones@aarp.org
`
`Counsel for Amici Curiae
`AARP and AARP Foundation
`
`
`
`

`

`i
`
`TABLE OF CONTENTS
`
`
`TABLE OF AUTHORITIES ......................................................... iii
`
`Page
`
`INTEREST OF AMICI CURIAE ................................................... 1
`
`SUMMARY OF THE ARGUMENT............................................. 2
`
`ARGUMENT ....................................................................................... 4
`
`I.
`
`II.
`
`III.
`
`IV.
`
`Congress Passed the AIA to Address a
`Growing Concern That Patent Litigation
`Was Negatively Affecting the Climate
`for Investment and Innovation .......................................... 4
`
`
`Prolonged Patent Litigation Can Inhibit
`Medical Research .................................................................. 6
`
`Invalid Patents Foreclose Competition
`and Increase Consumer Costs ........................................... 8
`
`The IPR Process Provides Distinct
`Advantages Over Litigating Invalid
`Patents ..................................................................................... 9
`
`The IPR Process Complements
`the Hatch-Waxman Act’s Statutory
`Scheme ....................................................................... 9
`
`A.
`
`
`
`B.
`
`Generic Companies Use the IPR
`Process to Cancel Invalid Patents ....................11
`
`
`

`

`ii
`
`C.
`
`Biosimilar Companies Use the IPR
`Process to Cancel Invalid Patents ....................14
`
`
`D. Medical Device Companies Use the
`IPR Process to Cancel Invalid
`Patents .....................................................................18
`
`
`CONCLUSION .............................................................................. 21
`
`

`

`iii
`
`TABLE OF AUTHORITIES
`
`
`Cases
`
`Akorn, Inc. v Senju Pharm. Co., Ltd.,
`
`No. IPR2015-01205 (Nov. 22, 2015). .............................. 13
`
`Alzheimer’s Inst. of Am., Inc. v. Avid
`
`RadioPharmaceuticals, No. 2:10-cv-
`
`06908-TJS, 2015 U.S. Dist. LEXIS
`
`40013 (E.D. Pa. Mar. 30, 2015) ..................................... 6, 7
`
`Alzheimer’s Inst. of Am., Inc. v. CoMentis, Inc.,
`
`No. 5:09-cv-01366-F, 2012 U.S.
`
`Dist. LEXIS 197821 (W.D. Okla.Dec. 17, 2012) ............ 7
`
`Alzheimer’s Inst. of Am., Inc. v. Elan Pharmaceuticals,
`
`Inc., No. 3:10-cv-00482-EDL, 2012 U.S. Dist.
`
`LEXIS 196376 (C.D. Cal. Aug. 3, 2012) .......................... 7
`
`Alzheimer’s Inst. of Am., Inc. v. Pfizer, Inc.,
`
`No. 4:09-cv-01026-CAS (E.D. Mo.
`
`dismissed Nov. 12, 2010). .................................................... 7
`
`Anacor Pharms., Inc. v. Matal,
`
` App. No. 17-1947 (Fed. Cir. appeal
`
`docketed, Apr. 25, 2017) .................................................... 13
`
`Ass’n for Molecular Pathology v. Myriad
`
`Genetics, Inc., 133 S. Ct. 2107 (2013) ........................... 2, 6
`
`BMC Medical Co. LTD. v. ResMed Limited,
`
`Nos. IPR2014-01196 (P.T.A.B. Jan. 19, 2016) ............. 19
`
`

`

`iv
`
`Cardiocom, LLC v. Robert Bosch Healthcare
`Systems, Inc., No. IPR2013-00431
`(P.T.A.B. Jan. 15, 2015). .................................................... 19
`
`
`
`Chums, Inc. v. Cablz, Inc.,
`
`No. IPR2014-01240 (P.T.A.B. Feb. 8, 2016). ................ 18
`
`Coal. For Affordable Drugs II LLC v. NPS
`
`Pharm., Inc., No. IPR2015-00990
`
`(Oct. 21, 2016). ...................................................................... 13
`
`Coal. For Affordable Drugs X LLC v. Anacor
`
`Pharms., Inc., Nos. IPR2015-01776;
`
`IPR2015-01780; IPR2015-1785
`
`(Feb. 23, 2017). ..................................................................... 13
`
`Covidien LP v. Ethicon Endo-Surgery, Inc.,
`
`No. IPR2013-00209 (P.T.A.B. Jun. 9, 2014) ................. 19
`
`Cuozzo Speed Techs., LLC v. Lee,
`
`136 S. Ct. 2131 (2016) .................................................. 2, 10
`
`Edward Katzinger Co. v. Chicago Metallic Mfg. Co.,
`
`329 U.S. 394 (1947) ............................................................... 8
`
`Elan Pharmaceuticals v. Mayo Found. for Med.
`
`Educ. & Research, 346 F.3d 1051 (Fed. Cir. 2003). ...... 7
`
`Fed. Trade Comm’n v. Actavis,
`
`133 S. Ct. 2223 (2013). ............................................ 2, 8, 10
`
`Fresenius Kabi USA, LLC v. Bass,
`
`App. No. 17-2402 (Fed. Cir. appeal docketed,
` Aug 8, 2017) .......................................................................... 14
`
`

`

`v
`
`
`In re Barr Labs., Inc.,
`
`930 F.2d 72 (D.C. Cir. 1991). ............................................ 11
`
`In re NPS Pharms., Inc.,
`
`App. No. 17-1392 (Fed. Cir. appeal
`
`docketed, Dec. 21, 2016) ..................................................... 13
`
`Karl Storz Endoscopy-America, Inc. v.
`
`Novadaq Technologies, Inc.,
`
`No. IPR2015-01847 (P.T.A.B. Mar. 8,
`
`2017) ....................................................................................... 19
`
`J. Kyle Bass et al. v. Fresenius Kabi USA, LLC,
`
`No. IPR2016-00254 (June 7, 2017). ................................ 14
`
`Lear, Inc. v. Adkins,
`
`395 U.S. 653 (1969). .............................................................. 8
`
`McNeil-PPC, Inc. v. L. Perrigo Co.,
`
`337 F.3d 1362 (Fed. Cir. 2003). .......................................... 8
`
`Medtronic, Inc. v. Norred,
`
`Nos. IPR2014-00110 (P.T.A.B. Apr. 23, 2015) ............ 18
`
`Mercoid Corp. v. Mid-continent Investment Co.
`
`320 U.S. 661 (1944) ............................................................... 8
`
`Mylan Pharms, Inc. v. Yeda Research & Development
`
`Co., Nos. IPR2015-00830 (P.T.A.B. Sept. 1,
`
`2016), IPR2015-00643 (P.T.A.B. Aug. 24,
`
`2016), IPR2015-00644 (P.T.A.B. Aug. 24, 2016) ......... 12
`
`
`
`

`

`vi
`
`Norred v. Medtronic, Inc.,
`
`640 Fed. Appx. 994 (Fed. Cir. 2016) ............................... 20
`
`Novartis AG v. Noven Pharms, Inc.,
`
`853 F.3d 1289 (Fed. Cir. 2017) ................................. 11, 12
`
`Pope Mfg. Co. v. Gormully,
`
`144 U.S. 224 (1892). .............................................................. 8
`
`Sandoz Inc. v. Amgen Inc.,
`
`582 U.S. ___ (2017) ....................................................... 15
`
`Senju Pharm. Co., Ltd. v. Akorn, Inc.,
`
`App. No. 17-1511 (Fed. Cir. appeal docketed,
`
`Jan. 24, 2017) ....................................................................... 13
`
`Tissue Transplant Technology, Ltd. v. MiMedx
`Group, No. IPR2015-00420 (P.T.A.B. July 7,
`2016). .................................................................................... 18
`
`
`
`Zimmer Biomet Holdings, Inc. v. Four Mile Bay, LLC,
`
`IPR2016-00012 (P.T.A.B. Mar. 10, 2017). .................... 19
`
`Statutes and Regulations
`
`21 U.S.C. § 355(c)(3)(E)(ii)-(iv) ........................................................ 11
`21 U.S.C. § 355(j) ............................................................................... 10
`21 U.S.C. § 355(j)(2)(A)(vii)(IV) ....................................................... 10
`21 U.S.C. § 355(j)(5)(B)(iii)(I) ........................................................... 10
`21 U.S.C. § 355(j)(5)(F)(ii)-(v). ......................................................... 11
`
`35 U.S.C. § 102. .................................................................................... 3
`35 U.S.C. § 103. .................................................................................... 3
`35 U.S.C. § 156 ................................................................................... 11
`
`

`

`vii
`
`35 U.S.C. § 285. .................................................................................... 7
`35 U.S.C. § 271(e)(2)(A) .................................................................... 10
`35 U.S.C. § 311(b). ............................................................................... 3
`
`42 U.S.C. § 262(k)(7)(A).................................................................... 11
`
`Public Laws and Statutes
`
`Biologics Price Competition and Innovation
`Act (BPCIA), Pub. L. No. 111-148, 124
`Stat. 119 (2009) .................................................................... 15
`
`
`Drug Price Competition and Patent Term
`Restoration (Hatch-Waxman) Act,
`Pub. L. No. 98-417, 98 Stat. 1585 (1984). ...................... 10
`
`
`Leahy-Smith America Invents Act (AIA),
`Pub. L. No. 112-29, 125 Stat. 284 (2011) ......................... 2
`
`
`Legislative History
`
`157 Cong. Rec. S1034,1036-37 (daily ed. Mar. 1,
`
`2011) (statement of Sen. Klobuchar) ................................ 5
`
`157 Cong. Rec. S1323, 1326 (daily ed. Mar. 7, 2011)
`(statement of Sen. Sessions). ......................................... 3, 5
`
`
`157 Cong. Rec. S5370, 5374 (daily ed. Sep. 7, 2011) ................... 5
`157 Cong. Rec. S7413-14 (daily ed. Nov. 14, 2011)
`
`(statement of Sen. Kyl). ....................................................... 5
`
`H.R. Rep. No. 98-112, pt. 1, at 39-40, 48 (2011). .......................... 4
`
`
`
`

`

`viii
`
`Other Authorities
`
`CDC, Nat’l Ctr. for Health Stats., Number of Deaths
`
`for Leading Causes of Death,
`
`https://goo.gl/jkVxKE .......................................................... 20
`
`Jillian Dabney, Shire’s Acquisition Gives It Natpara
`
`and Gattex, Market Realist (Apr. 7, 2015) ...........................14
`
`Fed. Trade Comm., To Promote Innovation: The
`
`Proper Balance of Competition and Patent
`
`Law and Policy 28 (Oct. 2003),
`http://1.usa.gov/1d7fQwQ. ................................................... 6
`
`
`GoodRx, https://www.goodrx.com. ................................ 12, 13, 14
`
`Erica Check Hayden, Patent Dispute Threatens
`
`US Alzheimer’s Research, 472 Nature 20
`
`(2011). ............................................................. 6, 7
`
`Ben Hirschler & Michael Shields, Novartis
`
`launches first U.S. ‘biosimilar’ drug at
`
`15 percent discount, Reuters (Sept. 3,
`
`2015) ....................................................................................... 15
`
`Int’l Trade Admin., Medical Technology Spotlight,
`
`https:// www.selectusa.gov/medical-
`
`technology-industry- united-states. ................................ 18
`
`Harriet Komisar, The Effects of Rising Health Care
`
`Costs on Middle-Class Economic Security,
`
`Middle Class Security Project, An Initiative
`
`of the AARP Public Policy Institute (Jan. 2013) ............ 9
`
`
`

`

`ix
`
`Steven Kozlowski, et al., Developing the Nation’s
`
`Biosimilar Program, 365 New Eng. J.
`
`Med. 385 (Aug. 4, 2011). .................................................... 14
`
`Shayna B. Kravetz & Rosemary Frei, Patent
`
`Reform Proposals Raise the Stakes for
`
`Researchers, Manufacturers of Biologics,
`
`1(2) Am. Health & Drug Benefits 13 (Mar. 2008). ...... 16
`
`Hilal Maradit Kremers, et al., Prevalence of Total
`
`Hip and Knee Replacement in the United
`
`States, 97(17) J. Bone Joint Surg. Am.
`
`1386 (Sept. 2015) ................................................................ .19
`
`Megan M. La Belle, Standing to Sue in the Myriad
`
`Genetics Case, 2 Calif. L. Rev. Circuit 68
`
`(2011) ................................................................................... 8, 9
`
`Brianna Lennon, Antitrust Implications of
`
`Technology Patents, 1 ABA Young
`
`Lawyer Div. Antitrust Law Comm.
`
`Newsl. 8 (2012), http://bit.ly/1fej47A................................. 8
`
`Letter from James C. Greenwood, Pres. & CEO of
`
`BIO & John C. Castellani, Pres. & CEO of
`
`PhRMA to Members of House & Senate
`
`Judiciary Comm. (July 15, 2015). ................................... 11
`
`Doug Lichtman & Mark Lemley, Rethinking
`
`Patent Law’s Presumption of Validity,
`
`60 Stan. L. Rev. 45 (2007) ................................................... 6
`
`Robert Love, Why our Drugs Cost So Much, AARP
`
`Bulletin (May 2017) .............................................................. 2
`
`

`

`x
`
`
`Joe Matal, A Guide to the Legislative History of the
`
`America Invents Act: Part II of II, 21 Fed.
`
`Circuit B.J. 539 (2012). ........................................................ 3
`
`Francis Megerlin, et al., Biosimilars and the
`
`European Experience: Implications for the
`
`United States, 32 Health Aff. 1803 (Oct.
`
`2013). .............................................................................. 14, 15
`
`Shruti Mehta, Copaxone Litigation in the US:
`
`Generics soon to be launched? IMS Health
`
`(Mar. 2017) .................................................................... 12, 13
`
`John Molenda & Richard Praseuth, Current Trends
`
`In Biologics-Related Inter Partes Reviews,
`
`Law360 (July 20, 2017) .................................................... 17
`
`Matthew R. Reynolds, et al., Cost-Effectiveness of
`Transcatheter Aortic Valve Replacement
`With a Self-Expanding Prosthesis Versus
`Surgical Aortic Valve Replacement, 67(1)
`J. of Am. Coll. of Cardiology 29 (Jan. 2016) .............. 20
`
`
`
`
`
`Eric Sagonowsky, Targeting a $5B brand,
`
`Samsung and Merck launch Remicade
`
`biosim at 35% discount, FiercePharma
`
`(July 24, 2017) ...................................................................... 16
`
`Stephen W. Shondelmeyer & Leigh Purvis, AARP:
`
`Rx Price Watch Brand Name Prescription
`Drug Prices Increase by Double-Digit
`Percentage for Fourth Straight Year
`(Dec. 2016) ............................................................................... 2
`
`

`

`xi
`
`
`Michael T. Siekman & Oona M. Johnstone, Impact
`
`of Post-Grant Proceedings on Biologics and
`Biosimilars, BioProcess Int’l (Jan. 19, 2017) ................ 16
`
`
`Lars G. Svensson, Aortic valve replacement: Options,
`Improvements, and Costs, 80(4) Cleveland
`Clinic J. of Medicine (Apr. 2013).............................. 18, 20
`
`
`
`John R. Thomas, The Responsibility of the
`
`Rulemaker: Comparative Approaches to
`
`Patent Administration Reform, 17
`
`Berkeley Tech. L.J. 727 (2002)........................................... 8
`
`USPTO Perf. and Accountability Rep. FY 2016 ......................... 5
`
`United States Food and Drug Administration,
`
`Orange Book : Approved Drug Products
`
`with Therapeutic Equivalence Evaluations,
`
`“Patent and Exclusivity for: N020622,” ......................... 12
`
`
`
`
`

`

`1
`
`INTEREST OF AMICI CURIAE1
`
`
`
`AARP is the nation’s largest nonprofit, nonpartisan
`organization dedicated to empowering Americans 50 and
`older to choose how they live as they age. With nearly 38
`million members and offices in every state, the District of
`Columbia, Puerto Rico, and the U.S. Virgin Islands, AARP
`works to strengthen communities and advocate for what
`matters most to families, with a focus on health security,
`financial stability, and personal fulfillment. AARP’s charitable
`affiliate, AARP Foundation, works to ensure that low-income
`older adults have nutritious food, affordable housing, a steady
`income, and strong and sustaining bonds.
`
`AARP and AARP Foundation have a longstanding
`interest in individuals’ access to affordable healthcare,
`including access to lower-cost prescription drugs. In light of
`the impact that the cost of drugs in particular has on
`healthcare expenditures, AARP’s Public Policy Institute (PPI)
`has been tracking the cost of widely used prescription drugs
`since 2004 and publishes the Rx Price Watch series, reporting
`on changes in the cost of drugs widely used by older
`Americans.2 In a report dated December 2016, PPI
`determined that brand name prescription drug prices
`
`
`1
`In accordance with Supreme Court Rule 37.6, AARP and AARP
`Foundation state that: (1) no counsel to a party authored this brief, in whole
`or in part; and (2) no person or entity, other than AARP Foundation, AARP,
`its members and its counsel have made a monetary contribution to the
`preparation or submission of this brief. The parties have consented to the
`filing of amicus briefs through the filing of blanket consent letters.
`
` 2
`
` The latest reports on trends in the retail prices of generic, brand-name,
`and specialty drugs are available at http://www.aarp.org/ppi/info-2016/trends-
`in-retail-prices-of-drugs.html.
`
`
`

`

`2
`
`increased for the fourth straight year by double digits.3 Other
`data collected suggest that almost 20% of those taking
`prescription drugs have skipped a drug or cut the dose to
`reduce the cost.4 AARP and AARP Foundation have filed
`several amici curiae briefs before this Court in cases that
`impact the cost of healthcare. E.g., Ass’n for Molecular
`Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107 (2013); Fed.
`Trade Comm’n v. Actavis, 133 S. Ct. 2223 (2013). AARP and
`AARP Foundation briefs also have supported the use of inter
`partes review (IPR) to expedite the removal of invalid patents
`and thus enable faster drug entry for the benefit of consumers
`and the U.S. healthcare system. Cuozzo Speed Techs., LLC v.
`Lee, 136 S. Ct. 2131 (2016).
`
`Inasmuch as invalid patents have a direct impact on
`the cost of healthcare, to the detriment of older individuals
`and the general public, AARP and AARP Foundation submit
`this brief urging the Court to affirm the decision below.
`
`
`SUMMARY OF THE ARGUMENT
`
`
`
`Congress passed the Leahy-Smith America Invents
`Act (AIA), Pub. L. No. 112-29, 125 Stat. 284 (2011), to improve
`patent quality and address a growing concern that patent
`litigation was negatively affecting the climate for investment
`and innovation. The AIA created IPR, a time-limited review
`
`3 Stephen W. Shondelmeyer & Leigh Purvis, AARP: Rx Price Watch
`Brand Name Prescription Drug Prices Increase by Double-Digit Percentage
`for
`Fourth
`Straight
`Year
`(Dec.
`2016),
`http://www.aarp.org/content/dam/aarp/ppi/2016-12/brand-name-prescription-
`drug-prices-increase.pdf.
`
` 4
`
` Robert Love, Why our Drugs Cost So Much, AARP Bulletin (May 2017),
`http://www.aarp.org/health/drugs-supplements/info-2017/rx-prescription-
`drug-pricing.html.
`
`

`

`3
`
`process, that allows the Patent Trial and Appeal Board
`(PTAB) to review the patentability of one or more claims in a
`patent only on the limited grounds of 35 U.S.C. §§ 102 or 103.
`See 35 U.S.C. § 311(b). The IPR process is designed to correct
`the issuance of invalid patents. The process provides no right
`to monetary damages; it affords only the relief of cancellation
`of a patent.
`
`they undermine
`invalid,
`When patents are
`
`competition and increase healthcare and other consumer
`costs, with no offsetting benefit to consumers. The cost of
`litigating patent claims that result from poor patent quality is
`exceedingly high to both businesses and consumers. See Joe
`Matal, A Guide to the Legislative History of the America
`Invents Act: Part II of II, 21 Fed. Circuit B.J. 539, 600 (2012).
`The intent of the AIA was to create a streamlined process to
`correct the errors of the Patent and Trademark Office (PTO)
`and allow “invalid patents that were mistakenly issued by the
`PTO to be fixed early in their life, before they disrupt an entire
`industry or result in expensive litigation.” 157 Cong. Rec.
`S1323, 1326 (daily ed. Mar. 7, 2011) (statement of Sen.
`Sessions).
`
`As a result of the monopolies created by drug patents,
`
`healthcare consumers pay ever-increasing prices
`for
`prescription medications. The public has a paramount
`interest in seeing that patent monopolies are kept within their
`legitimate scope. Invalid patents can have a direct impact on
`the cost of pharmaceutical drugs to the public, generally, and
`particularly to the detriment of older individuals, who
`disproportionately rely upon pharmaceuticals for their health.
`Medical device costs also may be artificially inflated when
`invalid patents are issued. The PTAB should be permitted to
`correct the PTO’s errors (including errors in not finding
`
`

`

`4
`
`relevant prior art), and third parties should be able to ask
`them to do so without spending millions of dollars in
`traditional district court litigation. The Court should affirm
`the judgment of the Federal Circuit.
`
`
`ARGUMENT
`
`
`I.
`
`Congress Passed the AIA to Address a
`Growing Concern That Patent Litigation
`Was Negatively Affecting the Climate for
`Investment and Innovation.
`
`Congress passed the AIA to “improve patent quality”
`and address a growing concern that the costs of patent
`litigation were negatively affecting the climate for investment
`and innovation. H.R. Rep. No. 98-112, pt. 1, at 39-40, 48
`(2011). The cost of litigating patent claims that result from
`poor patent quality was noted to be exceedingly high to both
`businesses and consumers. See Matal, supra, at 600 (noting
`that the cost of litigating against a dubious patent can be
`millions of dollars and that “it is often prohibitively expensive
`or even impossible to test the validity of a newly-issued patent
`that is of dubious validity, and that the continued existence of
`a patent can disrupt product development in a field of
`technology for years.”)
`
`Congress created the IPR process to “establish a more
`efficient and streamlined patent system that will improve
`patent quality and limit unnecessary and counterproductive
`litigation costs,” in response to “a growing sense that
`questionable patents are too easily obtained and are too
`difficult to challenge.” H.R. Rep. No. 98-112, pt. 1, at 39-40.
`Essentially, the AIA was designed to get rid of patents that
`should not have been issued in the first place. One of the
`
`

`

`5
`
`purposes of the act was “to correct egregious errors” made by
`the PTO in granting patents. See 157 Cong. Rec. S7413-14
`(daily ed. Nov. 14, 2011) (statement of Sen. Kyl).
`
`In discussing the bill that became the AIA, Senator
`Amy Klobuchar observed that the PTO “too often issues low-
`quality patents” and noted that:
`
`The legislation also provides a modernized
`streamlined mechanism for third parties who
`want to challenge recently issued, low-quality
`patents that should never have issued in the
`first place. Eliminating these potentially trivial
`patents will help the entire patent system by
`improving certainty for both users and
`inventors.
`
`
`157 Cong. Rec. S1034,1036-37 (daily ed. Mar. 1, 2011)
`(statement of Sen. Klobuchar); see also 157 Cong. Rec.
`S1323,1326 (daily ed. Mar. 7, 2011) (statement of Sen.
`Sessions) (“This will allow invalid patents that were
`mistakenly issued by the PTO to be fixed early in their life,
`before they disrupt an entire industry or result in expensive
`litigation”); 157 Cong. Rec. S5370, 5374 (daily ed. Sep. 7, 2011)
`(statement of Sen. Whitehouse) (“Unfortunately, numerous
`poor quality patents have issued in recent years, resulting in
`seemingly endless litigation that casts a cloud over patent
`ownership”).
`
`It is well known that the PTO receives a large number
`of patent applications. In 2016, applicants filed over 650,000
`new patent applications requiring examination. USPTO Perf.
`and Accountability Rep. FY 2016, at 78. The PTO’s initial
`determinations granting patents are often reached “under
`
`

`

`6
`
`tight time constraints and on an ex parte basis allowing
`minimal opportunity to hear a third party’s opposing views.”
`Fed. Trade Comm., To Promote Innovation: The Proper
`Balance of Competition and Patent Law and Policy 28 (Oct.
`2003), http://1.usa.gov/1d7fQwQ. Given the fact that patents
`are granted on an ex parte basis, without the benefit of the
`views of other interested parties, several commentators have
`noted that it is not surprising that mistakes in granting
`patents are made. E.g., Doug Lichtman & Mark Lemley,
`Rethinking Patent Law’s Presumption of Validity, 60 Stan. L.
`Rev. 45, 47 (2007) (noting that, given the high volume of
`patent applications, “it is hardly a surprise that the PTO
`makes mistakes during the initial process of patent review,
`granting patents that, on the merits, should never have been
`issued”). The IPR process is designed to correct these
`mistakes. The process provides no right to monetary damages;
`it affords only the relief of cancellation of a patent.
`
`II.
`
`Prolonged Patent Litigation Can Inhibit
`Medical Research.
`
`
`Prolonged patent litigation and the omnipresent
`threat of multi-million dollar patent lawsuits are known to
`have a chilling effect on medical research. As an example,
`prior to the decision in Association for Molecular Pathology v.
`Myriad Genetics, supra, there were a number of patent
`infringement lawsuits that “cast a pall over the Alzheimer’s-
`research field.” Erica Check Hayden, Patent Dispute
`Threatens US Alzheimer’s Research, 472 Nature 20 (2011),
`http://www.nature.com/news/2011/110405/full/472020a.
`html. For example, the Alzheimer’s Institute of America, Inc.,
`sued several defendants who were in the course of Alzheimer’s
`Disease research. See, e.g, Alzheimer’s Inst. of Am., Inc. v. Avid
`RadioPharmaceuticals, No. 2:10-cv-06908-TJS, 2015 U.S.
`
`

`

`7
`
`Dist. LEXIS 40013 (E.D. Pa. Mar. 30, 2015); Alzheimer’s Inst.
`of Am., Inc. v. CoMentis, Inc., No. 5:09-cv-01366-F, 2012 U.S.
`Dist. LEXIS 197821 (W.D. Okla. Dec. 17, 2012); Alzheimer’s
`Inst. of Am., Inc. v. Elan Pharmaceuticals, Inc., No. 3:10-cv-
`00482-EDL, 2012 U.S. Dist. LEXIS 196376 (C.D. Cal. Aug. 3,
`2012); Alzheimer’s Inst. of Am., Inc. v. Pfizer, Inc., No. 4:09-cv-
`01026-CAS (E.D. Mo. dismissed Nov. 12, 2010). Elan
`Pharmaceuticals, Inc., which owns Athena Neurosciences,
`Inc., also filed a lawsuit against the Mayo Foundation,
`alleging that Mayo’s use and distribution of transgenic mice
`infringed patents held by Elan. Elan Pharmaceuticals v. Mayo
`Found. for Med. Educ. & Research, 346 F.3d 1051 (Fed. Cir.
`2003).
`
`
`The cost of eliminating invalid patents in these
`lawsuits can be devastating to the defendants—particularly
`for universities and other non-profit institutions. In the Avid
`RadioPharmaceuticals case above, Avid spent over $6.5
`million in attorneys’ fees and $222,000 in costs trying a patent
`case that resulted in a defense verdict. Declaration of L. Scott
`Burwell in Support of Avid RadioPharmaceuticals’ Motion for
`Attorney’s Fees under 35 U.S.C. § 285, Avid, No. 2:10-cv-
`06908-TJS (E.D. Pa. June 1, 2012), ECF No. 317-4; Avid
`RadioPharmaceuticals’ Bill of Costs and Incorporated
`Supporting Memorandum, Avid, No. 2:10-cv-06908-TJS (E.D.
`Pa. June 1, 2012), ECF No. 318-1. Additionally, as one
`Alzheimer’s researcher noted,
`lawsuits over patents
`“constitute a large drain on valuable scientific resources at a
`time when scientific funds are increasingly tight.” Hayden,
`supra, at 20 (quoting Benjamin Wolozin, an Alzheimer’s
`researcher at Boston University).
`
`
`
`

`

`8
`
`III.
`
`Invalid Patents Foreclose Competition
`and Increase Consumer Costs.
`
`
`This Court recently reaffirmed the important patent
`policy of eliminating unwarranted patent grants so that the
`public will not “continually be required to pay tribute to would-
`monopolists without need or justification.” Actavis, 133 S. Ct.
`at 2233 (quoting Lear, Inc. v. Adkins, 395 U.S. 653 (1969)).
`When patents are improperly granted, competition in the
`marketplace is foreclosed and the public is forced to pay higher
`prices. McNeil-PPC, Inc. v. L. Perrigo Co., 337 F.3d 1362, 1368
`(Fed. Cir. 2003). This Court has often recognized that “[i]t is
`the public interest which is dominant in the patent system.”
`Edward Katzinger Co. v. Chicago Metallic Mfg. Co., 329 U.S.
`394, 401 (1947) (quoting Mercoid Corp. v. Mid-continent
`Investment Co., 320 U.S. 661, 665 (1944)) (internal quotation
`marks omitted). It is as “important to the public that
`competition should not be repressed by worthless patents, as
`that the patentee of a really valuable invention should be
`protected in his monopoly.” Pope Mfg. Co. v. Gormully, 144
`U.S. 224, 234 (1892). “Large numbers of improvidently
`granted patents may create
`in terrorem effects on
`entrepreneurship, ranging from holdup licensing to patent
`thickets.” John R. Thomas, The Responsibility of the
`Rulemaker:
`Comparative
`Approaches
`to
`Patent
`Administration Reform, 17 Berkeley Tech. L.J. 727, 731
`(2002).
`
`Unfortunately, the costs of patent litigation “are
`inevitably passed onto consumers, regardless of the outcome
`of the case.” Brianna Lennon, Antitrust Implications of
`Technology Patents, 1 ABA Young Lawyer Div. Antitrust Law
`Comm. Newsl. 8, 9 (2012), http://bit.ly/1fej47A; Megan M. La
`Belle, Standing to Sue in the Myriad Genetics Case, 2 Calif. L.
`
`

`

`9
`
`Rev. Circuit 68, 85 (2011) (“[W]hen private parties invalidate
`bad patents the public as a whole benefits from robust
`competition, increased consumer choice, and lower prices. . . .
`While patent litigation certainly implicates private interests,
`the public is the primary intended beneficiary of our patent
`system.”)
`
`
`Improperly granted patents also increase the cost of
`health care to the detriment of older people and the public,
`generally. Health care costs are a growing burden for middle-
`class families across all age groups. A significant number (one
`in five) have problems paying medical bills. Many of these
`families experience serious financial stress, such as problems
`paying for other necessities such as food, clothing, and
`housing, or medically related bankruptcy.5
`
`
`IV.
`
`The IPR Process Provides Distinct
`Advantages Over Litigating Invalid
`Patents.
`
`A.
`
`The IPR Process Complements the
`Hatch-Waxman Act’s Statutory
`Scheme.
`
`Drug manufacturers that intend to market a generic
`version of a patented brand-name drug product may pursue
`expedited Food and Drug Administration (FDA) approval by
`filing an Abbreviated New Drug Application (ANDA)
`
`
`5 Harriet Komisar, The Effects of Rising Health Care Costs on Middle-
`Class Economic Security, Middle Class Security Project, An Initiative of the
`AARP
`Public
`Policy
`Institute
`1,
`6
`(Jan.
`2013),
`http://www.aarp.org/content/dam/aarp/research/
`public_policy_institute/security/2013/impact-of-rising-health
`AARP-ppi-sec.pdf.
`
`care-costs-
`
`

`

`10
`
`pursuant to the Drug Price Competition and Patent Term
`Restoration (Hatch-Waxman) Act, Pub. L. No. 98-417, 98 Stat.
`1585 (1984). See 21 U.S.C. §355(j) (describing ANDA
`procedures). In response to a common form of ANDA filing
`known as Paragraph IV certification, where the generic
`certifies that the patent either does not apply to it, or is
`invalid, patented brand-name drug makers may bring patent
`infringement suits against the ANDA applicant under the
`Hatch-Waxman Act. See 21 U.S.C. § 355(j)(2)(A)(vii)(IV)
`(allowing Paragraph IV certification, whereby a generic
`manufacturer certifies that the brand-name product’s
`underlying patents are invalid or will not be infringed); 35
`U.S.C. § 271(e)(2)(A) (authorizing suit following Paragraph IV
`certification). When such suits are brought, the FDA is
`statutorily prohibited from approving the applicant’s ANDA
`for thirty months unless the district court decides the patent is
`invalid or not infringed before the expiration of this thirty-
`month stay. 21 U.S.C. § 355(j)(5)(B)(iii)(I); Actavis, 133 S. Ct.
`at 2228. As noted by the Generic Pharmaceutical Association,
`“[b]rand-name drug makers have a strong interest in delaying
`resolution of such cases to maximize the benefits of the 30-
`month stay, and thus often sue in slower jurisdictions.” Brief
`of Generic Pharmaceutical Association and America’s Health
`Insurance Plans as Amici Curiae at 2, Cuozzo Speed Techs.,
`LLC v. Lee, 136 S. Ct. 2131 (2016). ANDA applicants and the
`consumers who depend on generic and biosimilar drugs have
`a correspondingly strong interest in the resolution of patent
`issues as quickly as possible.
`
`The IPR system for challenging patents created by the
`AIA is a valuable tool for ANDA applicants. While amici
`curiae PhRMA and the Biotechnology Industry Organization
`urged Congress

This document is available on Docket Alarm but you must sign up to view it.


Or .

Accessing this document will incur an additional charge of $.

After purchase, you can access this document again without charge.

Accept $ Charge
throbber

Still Working On It

This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.

Give it another minute or two to complete, and then try the refresh button.

throbber

A few More Minutes ... Still Working

It can take up to 5 minutes for us to download a document if the court servers are running slowly.

Thank you for your continued patience.

This document could not be displayed.

We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.

Your account does not support viewing this document.

You need a Paid Account to view this document. Click here to change your account type.

Your account does not support viewing this document.

Set your membership status to view this document.

With a Docket Alarm membership, you'll get a whole lot more, including:

  • Up-to-date information for this case.
  • Email alerts whenever there is an update.
  • Full text search for other cases.
  • Get email alerts whenever a new case matches your search.

Become a Member

One Moment Please

The filing “” is large (MB) and is being downloaded.

Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.

Your document is on its way!

If you do not receive the document in five minutes, contact support at support@docketalarm.com.

Sealed Document

We are unable to display this document, it may be under a court ordered seal.

If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.


Access Government Site

We are redirecting you
to a mobile optimized page.





Document Unreadable or Corrupt

Refresh this Document
Go to the Docket

We are unable to display this document.

Refresh this Document
Go to the Docket