Transcript Slide 0

NewYorkBio Conference May 5, 2015
Large Molecules, Small Proceedings:
The Intersection of Biologics and IPRs
The Panel
Larry Coury

Director of Dispute Resolution, Regeneron Pharmaceuticals, Inc.
Peter Waibel

Vice President, Head of Patent Litigation, Novartis Pharmaceuticals
Brian Walsh

Senior Corporate Counsel and Head of the Immunology Patent Group at
Bristol-Myers Squibb
Justin Oliver

Partner and Chair of the PTO Contested Proceedings Practice Group at
Fitzpatrick Cella Harper & Scinto
Alicia Russo - Moderator

Partner at Fitzpatrick Cella Harper & Scinto
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Mechanics of IPRs (35 U.S.C. § 311 et al.)
 Replaced Inter Partes Reexaminations
 Grounds for request
– §§102 and 103
– Patents and printed publications only
 When can it be requested
– Patent filing date on or before March 16, 2013 – any time
– Patent filing date after March 16, 2013 – after the later of:
 Nine months after date of issue, or
 Termination of a post-grant review, if instituted
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Mechanics of IPRs
 Timeline – a final decision is rendered within about 18 months from the
filing date of the petition
 Estoppel – applies to petitioner, real party in interest, and privy of
petitioner
– Cannot assert invalidity on any ground that was raised or
reasonably could have been raised in an IPR that reached a final
decision
 Standing
– No requirement for a proof of injury or other interest
 If petitioner does not succeed before the PTAB, it will need
standing to appeal to the Federal Circuit
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Mechanics of IPRs
 Claim Amendments
– Claim amendments are allowed, but the burden is on Patent
Owner to prove patentability over all prior art and written
description support
– Previous grant rate of motion was about 5%
– Via motion to amend
 15 page limit – now changed to 25 pages
 New rule - appendix for the amended claims permitted
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Mechanics of IPRs
IPR
PGR
When
After nine months of grant
Within nine months of grant
Threshold showing
Reasonable likelihood of
success
More likely than not or novel
legal question
Grounds
102, 103
101, 102, 103, 112
Estoppel
Issues raised or reasonably
could have been raised
Issues raised or reasonably
could have been raised
Appeal
Both parties may appeal to
Federal Circuit (assuming
standing)
Both parties may appeal to
Federal Circuit (assuming
standing)
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Mechanics of IPRs
 Miscellaneous
– Redundancy
– Conclusory basis for reason to combine
– Statistics
 IPR – 73% rate of cancelation/unpatentability for cases
reaching final decision
• 16% of analyzed claims were canceled by Patent Owner
• 59% of those cases were computer/electrical/data
processing
• 3% were pharma
http://www.postgranthq.com/statistics/
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Different Standards at the PTAB v. District Court
 Threshold for institution
– PTAB
 “reasonable likelihood that the petitioner would prevail with
respect to at least 1 of the claims challenged in the petition” (§
314 (a))
– District Court
 No requirement
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Different Standards at the PTAB v. District Court
 Presumption of validity
– PTAB
 No presumption of validity
 Petitioner has the burden to prove invalidity
• Except for amended claim
– District Court
 Patent is presumed valid
 Burden is on the party asserting invalidity to overcome the
presumption of validity (35 U.S.C. § 282(a))
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Different Standards at the PTAB v. District Court
 Burden of proof
– PTAB
 Preponderance of evidence
– District Court
 Clear and convincing evidence
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Different Standards at the PTAB v. District Court
 Claim Construction
– PTAB

“Broadest reasonable interpretation” (In re Cuozzo Speed
Technologies, LLC., Fed. Cir. Feb. 4, 2015)

No Markman hearing
– District Court

Federal Circuit – “the meaning that [a] term would have to a person of
ordinary skill in the art in question at the time of the invention.”
(Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005))

Markman hearing to decide claim construction
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Different Standards at the PTAB v. District Court
 Practical effects
– Success rate of § 102 challenge IPR
 PTAB – 37.5%
 District Court – 31.1%
– Success rate of § 103 challenge IPR
 PTAB – 57.5%
 District Court – 27.8%
http://www.postgranthq.com/statistics/
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Biologics IPR Decisions
 BioMarin Pharmaceutical Inc. v. Genzyme Therapeutic Products Ltd.
(IPR2013-00534, IPR2013-00537)
 BioMarin Pharmaceutical Inc. v. Duke University (IPR2013-00535)
– Genzyme’s Myozyme product is used for the treatment of Pompe
disease
–
Representative Claim - A method of treating a human patient with Pompe's disease,
comprising intravenously administering biweekly to the patient a therapeutically
effective amount of human acid alpha glucosidase, whereby the concentration of
accumulated glycogen in the patient is reduced and/or further accumulation of
glycogen is arrested.
 The PTAB determined that all of the challenged claims of the patents
were obvious in view of various combinations of several references
 BioMarin is currently conducting clinical trials on a competing product
for the treatment of Pompe disease
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Biologics IPR Decisions
 Biologics decisions since BioMarin
– Baxter/Apatech v. Millenium Biologix (IPR2013-00590; IPR201300582)
 On March 18, 2015, PTAB determined that Petitioner has
shown by a preponderance of evidence that the challenged
claims were obvious
– Aker Biomarine/Enzymotec v. Neptune/Bioressources (IPR201400003)
 On March 23, 2015, PTAB determined that the Petitioner has
established by preponderance of evidence that all but two of
the challenged claims are unpatentable under both 102 and
103 grounds
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Biologics IPR Decisions
 Often, Patent Owner cancels challenged claims or reaches settlement
– CroFab – Laboratories Silanes v. BTG Int’l (IPR2014-01269)

Laboratories Silanes filed petition in August 2014

BTG announced settlement, IPR terminated in December 2014
– Eprex – Hospira v. Janssen (IPR2013-00365)

Hospira filed IPR but Janssen disclaimed all challenged claims
 Pending
– Herceptin – Phigenix v. Immunogen/Genentech (IPR2014-00676)

Decision to institute reached in October 2014
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Biologics IPR Decisions
 Effects of IPR decisions on Biologics/Pharma products
– The BioMarin decisions mark one of the first times that the PTAB
has invalidated a biologics patent in the context of an IPR
– In light of the recent decisions, IPR proceedings warrant the
attention of Patent Owners and would-be Petitioners alike
 103 ground for invalidation should be considered in light of the
recent decisions from the PTAB
 “Preponderance of evidence” standard may be easier to meet
 “Broadest reasonable interpretation” of claim scope potentially
increases the prior art available for anticipation and
obviousness arguments
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Rule Changes/Proposed New Rules – Impact on IPRs
 USPTO Rule Changes/Proposed New Rules (1st Quick Fix)
– Petitioner’s Reply Brief and PO’s Motion to Amend

Old Rule: 15-Page limit

New Proposed Rule: Increase page limit to 25 pages
http://www.uspto.gov/blog/director/entry/ptab_s_quick_fixes_for
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Rule Changes/Proposed New Rules – Impact on IPRs
 USPTO Rule Changes/Proposed New Rules (2nd Rule Package)
– Motion to Amend
 Old Rule: Patent Owner required to prove patentability over all
prior art
 New Proposed Rule: Patent Owner will be required to prove
patentability of the amended claims over the art of record
before the Office
http://www.uspto.gov/blog/director/entry/ptab_s_quick_fixes_for
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Rule Changes/Proposed New Rules – Impact on IPRs
 USPTO Rule Changes/Proposed New Rules (2nd Rule Package)
– Patent Owner’s Preliminary Response

Old Rule: No new testimonial evidence allowed

New Proposed Rule: Supporting evidence will be allowed
– Establishing the real party-in-interest (RPI)
 Old rule: limited discovery by Patent Owner to establish RPI
 New Rule: ample discovery to determine RPI
http://www.uspto.gov/blog/director/entry/ptab_s_quick_fixes_for
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Rule Changes/Proposed New Rules – Impact on IPRs
 USPTO Rule Changes/Proposed New Rules (3rd Pilot Program)
– PTAB Panel
 Old Rule: Judges participating in a decision to institute a trial
also part of the panel deciding the case on its merits
 New Proposed Rule: A pilot program where a single judge
would make the decision on whether to institute a trial and two
new judges would be added to the panel only when and if a
trial is instituted
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Proposed Legislation – STRONG Patents Act
 STRONG Patents Act - Spearheaded by Senator Christopher Coons
(DEL) and introduced 03/03/2015
 Proposed changes (http://patentlyo.com/patent/2015/03/strong-patentsenator.html)
– Claim Construction standard will:

Be “ordinary and customary meaning”

No longer use “broadest reasonable interpretation”
– Claim amendments to be allowed if “reasonable”
– Presumption of validity – burden of proof is “clear and convincing
evidence”
– Patent Owner’s Preliminary Response – supporting evidence will
be allowed
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Proposed Legislation – STRONG Patents
 STRONG Patents Act - Proposed changes (cont’d)
– Block anonymous petitions – will allow Patent Owner to discover
the RPI associated with the petition
– Standing to file a petition will be limited to only entities charged
with infringement
 Entities such as the Coalition for Affordable Drugs, a wholly
owned subsidiary of Hayman Credes Master Fund, LP, will no
longer be permitted to file IPR petitions
• the founder of Hayman Capital, publicly announced his intention
to go “activist” against the U.S. pharmaceutical industry and its
patents, calling it a “short activist strategy”
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Proposed Legislation – Innovation Act
 Bill passed the House in 2013 as H.R. 3309 – introduced by Rep.
Goodlatte
 Bill was re-introduced as H.R. 9 on February 5, 2015, and is the same
as H.R. 3309
 Proposed changes
– PGR: remove “reasonably could have raised” from the estoppel
provisions of § 325(e)(2)
– IPR and PGR: mandate the use of a district court-style claim
construction in IPR and PGR proceedings
 But Federal Circuit has upheld the USPTO’s use of the
“broadest reasonable interpretation” of the claims
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