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

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Sri K. Sankaran (Winthrop & Weinstine, USA)

The pharmaceutical industry is going through a turmoil with death of many block buster drugs, increasing number of filers on NCE, pricing war, and stiff generic competition. All the Pharma companies are pursuing a Paragraph IV strategy to be competitive in the market. The reality is any Pharmaceutical product can be challenged. First-to-file comes with many advantage but you have to strategize/execute well to become first-to-market and beat the competition. This can be taken care effectively by involving external Law Firms and Search providers in Product targeting, ANDA filing strategy & support, E-discovery, Court proceedings, etc. Here the presenter would cover a case study on how external collaboration would help companies save time, costs and yet increase the success ratio.

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

  1. 1. © 2017 Winthrop & Weinstine, P.A. www.winthrop.com Challenges, Opportunities and Strategies in P-IV Filings Sri Krishna Sankaran Winthrop & Weinstine
  2. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 27. © 2012 Winthrop & Weinstine, P.A. www.winthrop.com© 2017 Winthrop & Weinstine, P.A. www.winthrop.com 27 Conclusion Thank you!

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