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© 2017 Winthrop & Weinstine, P.A. www.winthrop.com
Challenges, Opportunities and
Strategies in P-IV Filings
Sri Krishna Sankaran
Winthrop & Weinstine
© 2012 Winthrop & Weinstine, P.A. www.winthrop.com© 2017 Winthrop & Weinstine, P.A. www.winthrop.com 2
Challenges
• Data from Lex Machina
• ANDA patent lawsuit filings in 2016
• Declined for first time in 3 years
• 468 cases in 2015
• 316 cases in 2016
• Down 32.5%
• Is the Party Over?
© 2012 Winthrop & Weinstine, P.A. www.winthrop.com© 2017 Winthrop & Weinstine, P.A. www.winthrop.com 3
Challenges
• Increased Plant Inspections
• Waves of Bad News Over Past Few Years
• Data Manipulation
• CC TV Captures Document Destruction
• “Why Did You Install that Shredder 4
Days Before FDA Arrived?”
© 2012 Winthrop & Weinstine, P.A. www.winthrop.com© 2017 Winthrop & Weinstine, P.A. www.winthrop.com 4
Challenges
• FDA Inspectors Based in India
• Form 483’s
• Mild to Severe
• Import Bans
• Ipca (June 2017)
• Increasing GDUFAs
• $71k to $171k
© 2012 Winthrop & Weinstine, P.A. www.winthrop.com© 2017 Winthrop & Weinstine, P.A. www.winthrop.com 5
Challenges
• Increased Competition
• Mid-Size Players Have Arrived
• Start as API Company
• Then Make Formulations
– Out-license or Partner
• Then File ANDAs Solo
© 2012 Winthrop & Weinstine, P.A. www.winthrop.com© 2017 Winthrop & Weinstine, P.A. www.winthrop.com 6
Challenges
• Net Result: Days of 1-3 Filers Are Gone
• Many Filers Per Product
• Requires Cost Effective API
• Good Distribution Channel
• Pressure on Profit Margin
© 2012 Winthrop & Weinstine, P.A. www.winthrop.com© 2017 Winthrop & Weinstine, P.A. www.winthrop.com 7
Challenges
• Antitrust Scrutiny
• Investigations by DOJ & States
• Allegations of Price-Fixing
• Principals of One U.S. Subsidiary
• Pleaded Guilty & Cooperating with Govt
• Class Action Plaintiffs’ Bar Circling
© 2012 Winthrop & Weinstine, P.A. www.winthrop.com© 2017 Winthrop & Weinstine, P.A. www.winthrop.com 8
Opportunities
• US Generic Drug Market Remains Strong
• Some Say It Stabilizes the Industry
• Back to Statistics
• 2016 ANDA suit filings (316)
• Still higher than any year since 2013
• Still above historic average (269)
– Spike in 2014 & 2015
© 2012 Winthrop & Weinstine, P.A. www.winthrop.com© 2017 Winthrop & Weinstine, P.A. www.winthrop.com 9
Opportunities
• Most Frequent Generic Litigants
• Actavis (incl. Watson & Allergan) (427)
• Mylan (290)
• Teva (232)
© 2012 Winthrop & Weinstine, P.A. www.winthrop.com© 2017 Winthrop & Weinstine, P.A. www.winthrop.com 10
Opportunities
• Most Frequent Brand Litigants
• AstraZeneca (156)
• Novartis (144)
• Pfizer (143)
© 2012 Winthrop & Weinstine, P.A. www.winthrop.com© 2017 Winthrop & Weinstine, P.A. www.winthrop.com 11
Opportunities
• US Market Drawing in New Players
• Most Surprising
• Largest Category is “Other”
• Great & Increasing Diversity of Players
© 2012 Winthrop & Weinstine, P.A. www.winthrop.com© 2017 Winthrop & Weinstine, P.A. www.winthrop.com 12
Opportunities
• New Players Chasing Opportunity
• Most Litigated Products
• Abilify 63 cases
• Oxycontin 59 cases
• New NCE-1 Targets Every Year/Month
• Likelihood of Settlement in ANDA 58%
• Other Cases 78%
© 2012 Winthrop & Weinstine, P.A. www.winthrop.com© 2017 Winthrop & Weinstine, P.A. www.winthrop.com 13
Strategies
• Venue
• Significant Statistical Disparities
• Outcome by Jurisdiction
– Some places more/less patent friendly
• Time to Trial
– Rocket Dockets
• Real Difference Makers (Sproqit Techs.)
© 2012 Winthrop & Weinstine, P.A. www.winthrop.com© 2017 Winthrop & Weinstine, P.A. www.winthrop.com 14
Strategies
• Venue Largely Overlooked
• Shifting Legal Landscape
• TC Heartland (U.S. Sup. Ct. May 2017)
• Made it Harder to Capture Defendants in
Plaintiff’s Preferred Forum
– No company is at “home” everywhere
– But where is “home”
© 2012 Winthrop & Weinstine, P.A. www.winthrop.com© 2017 Winthrop & Weinstine, P.A. www.winthrop.com 15
Strategies
• Application of TC Heartland to ANDA
• Remains Unsettled
• Ongoing Litigation
• Weekly Watches & Updates
• Likely Must Be Resolved by Sup. Ct.
© 2012 Winthrop & Weinstine, P.A. www.winthrop.com© 2017 Winthrop & Weinstine, P.A. www.winthrop.com 16
Strategies
• Why Does It Matter
• Most Frequent ANDA Venues
• Delaware (1114 Cases)
– up 22% since 2015
• New Jersey (850 Cases)
– Up 17% since 2015
• (Only 38 ANDA cases in ED Texas)
© 2012 Winthrop & Weinstine, P.A. www.winthrop.com© 2017 Winthrop & Weinstine, P.A. www.winthrop.com 17
Strategies
• Plan US Base of Operations with Venue in
Mind
• N.D. California
• More Defendant-Friendly in Patent
Cases
• E.D. Virginia/W.D. Wisconsin
• Rocket Dockets
© 2012 Winthrop & Weinstine, P.A. www.winthrop.com© 2017 Winthrop & Weinstine, P.A. www.winthrop.com 18
Strategies
• Avoid the Herd Mentality
• “Group Projects” are Challenging
• Especially as JDGs Get Larger
• Uneven Quality
• Out-Voted by the Group
• Different Products Have Different Values
for Different Players
© 2012 Winthrop & Weinstine, P.A. www.winthrop.com© 2017 Winthrop & Weinstine, P.A. www.winthrop.com 19
Strategies
• Avoid the Classic Model
• Senior Materializes for Key Events
• Otherwise Juniors Run the Show
• Inefficient, Costly & Ineffective
• Juniors Must Do Everything
• Can’t Delete Tasks
• Juniors Create the Factual Record
© 2012 Winthrop & Weinstine, P.A. www.winthrop.com© 2017 Winthrop & Weinstine, P.A. www.winthrop.com 20
Strategies
• By the Time Senior Arrives (C.C. or Trial)
• Its too Late to Correct
• Effectively Playing the Hand Dealt
• Best Efforts with Record Created by
Others
© 2012 Winthrop & Weinstine, P.A. www.winthrop.com© 2017 Winthrop & Weinstine, P.A. www.winthrop.com 21
Strategies
• Alternative Approach
• Have Lead Counsel Run the Show
• Focus on What’s Needed to Win
• Can Choose What Not To Do
– Saves money & effort
• Generate the Factual Record Needed to
Win
© 2012 Winthrop & Weinstine, P.A. www.winthrop.com© 2017 Winthrop & Weinstine, P.A. www.winthrop.com 22
Strategies
• Need Cost-Effective Support
• Molecular Connections
• Searching
• Post-Search Analysis & Explanation
• API, Formulations, Etc.
• Organic Chemistry, Medicinal Chemistry
• Non-Chemical Arts
© 2012 Winthrop & Weinstine, P.A. www.winthrop.com© 2017 Winthrop & Weinstine, P.A. www.winthrop.com 23
Strategies
• Many Tasks Don’t Require a J.D.
• We Explain What We Need
• Superbly Qualified Domain Specialists
• Thoughtful & Diligent
• Extremely Hardworking
• Ask Us Questions as Needed
• Real Adults
© 2012 Winthrop & Weinstine, P.A. www.winthrop.com© 2017 Winthrop & Weinstine, P.A. www.winthrop.com 24
Strategies
• IP Strategies for ANDA Cases
• Help Us Understand the Art
• Help Us Understand the Technology
• The Protein Side of Drug Design
• Constant Availability
© 2012 Winthrop & Weinstine, P.A. www.winthrop.com© 2017 Winthrop & Weinstine, P.A. www.winthrop.com 25
Strategies
• Claim Charts
• Interrogatory Responses
• Technical Analysis of Prior Art
• 100+ References
• Short Turn Around in ITC
• Review of Exhibit Lists
© 2012 Winthrop & Weinstine, P.A. www.winthrop.com© 2017 Winthrop & Weinstine, P.A. www.winthrop.com 26
Strategies
• Highly Cost Effective
• A Force Multiplier
• Tremendous Value
• Brand/Big Firm Strength is Numbers
• Makes it a Fair Fight
• “Molecular Solutions”
© 2012 Winthrop & Weinstine, P.A. www.winthrop.com© 2017 Winthrop & Weinstine, P.A. www.winthrop.com 27
Conclusion
Thank you!

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II-PIC 2017: Pharmaceutical Players – Strategies, Challenges, & Opportunities in Para-IV

  • 1. © 2017 Winthrop & Weinstine, P.A. www.winthrop.com Challenges, Opportunities and Strategies in P-IV Filings Sri Krishna Sankaran Winthrop & Weinstine
  • 2. © 2012 Winthrop & Weinstine, P.A. www.winthrop.com© 2017 Winthrop & Weinstine, P.A. www.winthrop.com 2 Challenges • Data from Lex Machina • ANDA patent lawsuit filings in 2016 • Declined for first time in 3 years • 468 cases in 2015 • 316 cases in 2016 • Down 32.5% • Is the Party Over?
  • 3. © 2012 Winthrop & Weinstine, P.A. www.winthrop.com© 2017 Winthrop & Weinstine, P.A. www.winthrop.com 3 Challenges • Increased Plant Inspections • Waves of Bad News Over Past Few Years • Data Manipulation • CC TV Captures Document Destruction • “Why Did You Install that Shredder 4 Days Before FDA Arrived?”
  • 4. © 2012 Winthrop & Weinstine, P.A. www.winthrop.com© 2017 Winthrop & Weinstine, P.A. www.winthrop.com 4 Challenges • FDA Inspectors Based in India • Form 483’s • Mild to Severe • Import Bans • Ipca (June 2017) • Increasing GDUFAs • $71k to $171k
  • 5. © 2012 Winthrop & Weinstine, P.A. www.winthrop.com© 2017 Winthrop & Weinstine, P.A. www.winthrop.com 5 Challenges • Increased Competition • Mid-Size Players Have Arrived • Start as API Company • Then Make Formulations – Out-license or Partner • Then File ANDAs Solo
  • 6. © 2012 Winthrop & Weinstine, P.A. www.winthrop.com© 2017 Winthrop & Weinstine, P.A. www.winthrop.com 6 Challenges • Net Result: Days of 1-3 Filers Are Gone • Many Filers Per Product • Requires Cost Effective API • Good Distribution Channel • Pressure on Profit Margin
  • 7. © 2012 Winthrop & Weinstine, P.A. www.winthrop.com© 2017 Winthrop & Weinstine, P.A. www.winthrop.com 7 Challenges • Antitrust Scrutiny • Investigations by DOJ & States • Allegations of Price-Fixing • Principals of One U.S. Subsidiary • Pleaded Guilty & Cooperating with Govt • Class Action Plaintiffs’ Bar Circling
  • 8. © 2012 Winthrop & Weinstine, P.A. www.winthrop.com© 2017 Winthrop & Weinstine, P.A. www.winthrop.com 8 Opportunities • US Generic Drug Market Remains Strong • Some Say It Stabilizes the Industry • Back to Statistics • 2016 ANDA suit filings (316) • Still higher than any year since 2013 • Still above historic average (269) – Spike in 2014 & 2015
  • 9. © 2012 Winthrop & Weinstine, P.A. www.winthrop.com© 2017 Winthrop & Weinstine, P.A. www.winthrop.com 9 Opportunities • Most Frequent Generic Litigants • Actavis (incl. Watson & Allergan) (427) • Mylan (290) • Teva (232)
  • 10. © 2012 Winthrop & Weinstine, P.A. www.winthrop.com© 2017 Winthrop & Weinstine, P.A. www.winthrop.com 10 Opportunities • Most Frequent Brand Litigants • AstraZeneca (156) • Novartis (144) • Pfizer (143)
  • 11. © 2012 Winthrop & Weinstine, P.A. www.winthrop.com© 2017 Winthrop & Weinstine, P.A. www.winthrop.com 11 Opportunities • US Market Drawing in New Players • Most Surprising • Largest Category is “Other” • Great & Increasing Diversity of Players
  • 12. © 2012 Winthrop & Weinstine, P.A. www.winthrop.com© 2017 Winthrop & Weinstine, P.A. www.winthrop.com 12 Opportunities • New Players Chasing Opportunity • Most Litigated Products • Abilify 63 cases • Oxycontin 59 cases • New NCE-1 Targets Every Year/Month • Likelihood of Settlement in ANDA 58% • Other Cases 78%
  • 13. © 2012 Winthrop & Weinstine, P.A. www.winthrop.com© 2017 Winthrop & Weinstine, P.A. www.winthrop.com 13 Strategies • Venue • Significant Statistical Disparities • Outcome by Jurisdiction – Some places more/less patent friendly • Time to Trial – Rocket Dockets • Real Difference Makers (Sproqit Techs.)
  • 14. © 2012 Winthrop & Weinstine, P.A. www.winthrop.com© 2017 Winthrop & Weinstine, P.A. www.winthrop.com 14 Strategies • Venue Largely Overlooked • Shifting Legal Landscape • TC Heartland (U.S. Sup. Ct. May 2017) • Made it Harder to Capture Defendants in Plaintiff’s Preferred Forum – No company is at “home” everywhere – But where is “home”
  • 15. © 2012 Winthrop & Weinstine, P.A. www.winthrop.com© 2017 Winthrop & Weinstine, P.A. www.winthrop.com 15 Strategies • Application of TC Heartland to ANDA • Remains Unsettled • Ongoing Litigation • Weekly Watches & Updates • Likely Must Be Resolved by Sup. Ct.
  • 16. © 2012 Winthrop & Weinstine, P.A. www.winthrop.com© 2017 Winthrop & Weinstine, P.A. www.winthrop.com 16 Strategies • Why Does It Matter • Most Frequent ANDA Venues • Delaware (1114 Cases) – up 22% since 2015 • New Jersey (850 Cases) – Up 17% since 2015 • (Only 38 ANDA cases in ED Texas)
  • 17. © 2012 Winthrop & Weinstine, P.A. www.winthrop.com© 2017 Winthrop & Weinstine, P.A. www.winthrop.com 17 Strategies • Plan US Base of Operations with Venue in Mind • N.D. California • More Defendant-Friendly in Patent Cases • E.D. Virginia/W.D. Wisconsin • Rocket Dockets
  • 18. © 2012 Winthrop & Weinstine, P.A. www.winthrop.com© 2017 Winthrop & Weinstine, P.A. www.winthrop.com 18 Strategies • Avoid the Herd Mentality • “Group Projects” are Challenging • Especially as JDGs Get Larger • Uneven Quality • Out-Voted by the Group • Different Products Have Different Values for Different Players
  • 19. © 2012 Winthrop & Weinstine, P.A. www.winthrop.com© 2017 Winthrop & Weinstine, P.A. www.winthrop.com 19 Strategies • Avoid the Classic Model • Senior Materializes for Key Events • Otherwise Juniors Run the Show • Inefficient, Costly & Ineffective • Juniors Must Do Everything • Can’t Delete Tasks • Juniors Create the Factual Record
  • 20. © 2012 Winthrop & Weinstine, P.A. www.winthrop.com© 2017 Winthrop & Weinstine, P.A. www.winthrop.com 20 Strategies • By the Time Senior Arrives (C.C. or Trial) • Its too Late to Correct • Effectively Playing the Hand Dealt • Best Efforts with Record Created by Others
  • 21. © 2012 Winthrop & Weinstine, P.A. www.winthrop.com© 2017 Winthrop & Weinstine, P.A. www.winthrop.com 21 Strategies • Alternative Approach • Have Lead Counsel Run the Show • Focus on What’s Needed to Win • Can Choose What Not To Do – Saves money & effort • Generate the Factual Record Needed to Win
  • 22. © 2012 Winthrop & Weinstine, P.A. www.winthrop.com© 2017 Winthrop & Weinstine, P.A. www.winthrop.com 22 Strategies • Need Cost-Effective Support • Molecular Connections • Searching • Post-Search Analysis & Explanation • API, Formulations, Etc. • Organic Chemistry, Medicinal Chemistry • Non-Chemical Arts
  • 23. © 2012 Winthrop & Weinstine, P.A. www.winthrop.com© 2017 Winthrop & Weinstine, P.A. www.winthrop.com 23 Strategies • Many Tasks Don’t Require a J.D. • We Explain What We Need • Superbly Qualified Domain Specialists • Thoughtful & Diligent • Extremely Hardworking • Ask Us Questions as Needed • Real Adults
  • 24. © 2012 Winthrop & Weinstine, P.A. www.winthrop.com© 2017 Winthrop & Weinstine, P.A. www.winthrop.com 24 Strategies • IP Strategies for ANDA Cases • Help Us Understand the Art • Help Us Understand the Technology • The Protein Side of Drug Design • Constant Availability
  • 25. © 2012 Winthrop & Weinstine, P.A. www.winthrop.com© 2017 Winthrop & Weinstine, P.A. www.winthrop.com 25 Strategies • Claim Charts • Interrogatory Responses • Technical Analysis of Prior Art • 100+ References • Short Turn Around in ITC • Review of Exhibit Lists
  • 26. © 2012 Winthrop & Weinstine, P.A. www.winthrop.com© 2017 Winthrop & Weinstine, P.A. www.winthrop.com 26 Strategies • Highly Cost Effective • A Force Multiplier • Tremendous Value • Brand/Big Firm Strength is Numbers • Makes it a Fair Fight • “Molecular Solutions”
  • 27. © 2012 Winthrop & Weinstine, P.A. www.winthrop.com© 2017 Winthrop & Weinstine, P.A. www.winthrop.com 27 Conclusion Thank you!