November 3, 2016
Strategic Considerations in Asserting or
Challenging Patents in the
Biologic/Biosimilar Space
A. The BPCIA Statute and What it Amends
• Public Health Service Act 42 U.S.C. § 262
o
“351(k)” – biosimilar application requirement
o
“351(l)” – patent exchanges procedures
• Patent Statutes 35 U.S.C. § 271
o 271(e)(2)(c) – new artificial act of infringement
2
The BPCIA Patent Dance
l(2)(A)
Biosimilar
files
Application
Biosimilar
Application
accepted by
FDA
20 days
l(3)(A)
Biosimilar
provides
confidential
info to RPS
60 days
l(4)(A) & (B)
RPS & Biosimilar
negotiate final list of
patents to litigate
yes
Agreement
Reached
60 days
Biosimilar provides
RPS with patent list
and detailed invalidity
statement
l(3)(C)
15 days
no
30 days
l(6)(A)
RPS provides
patent list to
Biosimilar
l(3)(B)(i) & (ii)
RPS provides
Biosimilar with
detailed statement re
infringement/validity
60 days
Biosimilar identifies
number of patents
that can be asserted
l(5)(A)
5 days
Simultaneous exchange
of patent lists
RPS files complaint
l(5)(B)
30 days
RPS files complaint
Potential
Litigation
3
l(6)(B)
IPR Overview
4
IPR vs. Patent Dance
IPR
Patent Dance
~8 Months
5
IPR vs. Patent Dance vs District Court Litigation
IPR
Patent Dance
~8 Months
District Court
Litigation
36 Months*
6
Biologics patents challenged in IPR
7
BioPharma IPR Filings Steadily Increase
IPRs Filed in TC1600
200
186
180
160
151
140
125
120
100
80
60
44
40
20
0
2013
2014
2015
Source: LexMachina, data current as of 10/25/2016;
projecting 186 IPRs in TC1600 at year end
8
2016 YTD
Technology Breakdown by USPTO Tech Center (2013Present)
Chemical
6%
Bio/Pharma
9%
Mechanical/Business
Method
26%
Electrical/Computer
59%
Source: LexMachina, data
current as of 10/23/2016; Design
Patents make up <1% of
remaining petitions
9
BioPharma by the Numbers
• 60% of biopharma AIA petitions instituted
• The other 40% were either denied or settled before institution
• Settlement rate of about 30%
• 15% settled before PTAB issued a decision on institution
• FY2015 institution rates for IPR (all tech centers v. biopharma)
All IPRs
Granted
336
(25.2%)
Denied
Granted in
Part
BioPharma IPRs
16
(17.8%)
426
(32.0%)
568
(42.7%)
46
(51.1%)
10
28
(31.1%)
BioPharma IPR Status
• 506 total biopharma IPR petitions filed since 2013*
14,
7%
99, 20%
24, 12%
Open (post-institution)
69, 33%
91, 18%
207, 41%
32, 15%
Joined to Other Trial
Settled (post-institution)
Patent Owner Disclaimed
FWD
108, 21%
68, 33%
Settled/Dismissed (pre-institution)
Open (pre-institution)
Instituted
Denied Institution
Source: LexMachina, data current as of
10/25/2016;
*1 petition in which patent owner disclaimed
pre-institution
11
FWD Outcomes – BioPharma IPRs (2013-2016)
• 69 petitions filed since 2013 have reached a Final Written Decision
All Claims
Amended, 2,
3%
All Claims
Upheld, 29,
42%
All Claims
Unpatentable,
34, 49%
Mixed Claim
Findings, 4, 6%
Source: LexMachina, data current as of 10/25/2016;
12
Contact Fish & Richardson
Download the presentation and access other valuable materials at
www.fishlifesciences.com
Contact us with your questions and comments.
Chad Shear
Principal
Fish & Richardson
[email protected]
858-678-4730
Dorothy Whelan
Principal
Fish & Richardson
[email protected]
612-337-2509
Leslie Robbins
Guest Panelist
Vice President, Intellectual Property
Coherus Biosciences, Inc.
Michael Kane
Principal
Fish & Richardson
[email protected]
612-337-2502
13