Presentations and Publications

Presentations

“Risk Evaluation and Mitigation Strategies (REMS): Update,” 7th Annual Pharma IPR Conference, Mumbai, India, March 2018.
“The US Supreme Court Ruling on Amgen vs. Sandoz Case and What Developers Need To Know?,” 2nd China Pharma IP Summit, December 2017.
“Paragraph IV Litigation Trends, Analysis and Future Predictions,” ACI’s Master Symposium on Hatch-Waxman, October 2017.
“Illusory Safe Harbors: Exploring Uncertainties in the Boundaries of 271 (e) (1) and the Scope of Divided and Induced Infringement,” ACI’s Paragraph Disputes Conference, April 2017.
“On Sale Bar – Round II: Understanding The Impact of Helsinn on Pharmaceutical Patents in a Post – AIA Setting,” ACI’s Paragraph Disputes Conference, April 2017.
“Streamlining Section 271(e) and the Safe Harbor,” ACI’s Master Symposium on Hatch-Waxman, September 2016.
“On Sale Bar in a Hatch-Waxman Setting: Analyzing Patent Impediments Caused by Contract Manufacturing and Its Impact on Pharmaceutical Product Market Access,” ACI’s Paragraph Disputes Conference, April 2016.
“In the Limelight: Examining Lily v. Teva and its Larger Implications for Divided and Induced Infringement in a Hatch-Waxman Setting,” ACI’s Paragraph Disputes Conference, April 2016.
“Paragraph IV Due Diligence Analysis: Economic Impact of Pharmaceutical Patent Wins and Losses at District Courts and PTAB,” ACI’s Paragraph Disputes Conference, September 2015.
“Exploring the Utilization of Reissue Applications to Cure Invalidity Findings at the PTAB and District Courts,” ACI’s Paragraph Disputes Conference, April 2015.
“Limelight vs. Akamai: Assessing its Impact on Method of Treatment Patents and Section viii Label Carve Outs,” ACI’s Paragraph Disputes Conference, April 2015.
“Biosimilars Litigation Spotlight: Immediate Action Plans for Innovators and Biosimilars to Prepare For the Battles to Come,” ACI’s Summit on U.S. Biosimilars, April 2015.
“Biosimilar Expert Panel,” William Blair & Company, February 2015.
“The Legal Framework of Biosimilars: What do we know, what do we not?” December 2014.
“Taft’s October 2014 Update on U.S. Hatch-Waxman Issues,” October 2014.
“Predictions for the Future: Biopharmaceuticals and Exclusivity,” BIO International Convention, June 2014.
“Due Diligence and Risk Management,” Biotechnology Law and New Frontiers Seminar, Budapest, April 2014.
“Looking Beyond 180 Days: New Exclusivity Challenges for Brand Names and Generics and Related Implications for Paragraph IV Challenges,” ACI’s 8th Annual Paragraph IV Disputes Conference, New York, April 2014.
“Supremely Looking Forward in 2014 – U.S. Supreme Court Review,” SIU Law Intellectual Property Seminar, April 2014.
“Use of IPR and Other PTO Proceedings in a Paragraph IV Challenge,” Paragraph IV Disputes Master Symposium, Chicago, October 2013.
“Examining Branded-Generic Alliances that Maximize the Potential of Biosimilars and Minimize Investment Risks,” Legal and Regulatory Summit on Generic Drugs, NYC, July 2013.
“Analyzing How New Safe Harbor Controversies Will Impact Paragraph IV Disputes,” ACI’s 7th Annual P-IV Disputes Conference, NYC, May 2013.
“Biosimilars: Strategic Considerations for Regulatory Approval & Patents Under the BPCIA,” BIO International Convention, Chicago, April 2013.
“Discovery in Complex Litigation: Production of Source Code & Social Media,” Federal Circuit Bar Association’s Advanced Complex Litigation Series, Chicago, April 2013.
“A Conversation with Industry,” IIT Chicago-Kent College of Law’s PatCon3, Chicago, April 2013.
“How the America Invents Act Impacts Orange Book Patent Challenges,” ACI’s 6th Annual Paragraph IV Disputes Conference, NYC, April 2012.
“Northern District of Illinois Legal Update & Judicial Perspectives,” panel moderator with Chief Judge Holderman, Chicago Daily Law Bulletin’s 8th Annual Corporate IP Law Conference, Chicago, February 2013.
“Through the Looking Glass — Fine-tune Fundamentals of Hatch-Waxman and Anticipation of Future Developments in Patent Litigation,” CBI’s 4th Annual Life Sciences Congress, Washington DC, Oct. 2012.
“Legal and Patent Strategies for the Generics Industry,” World Generic Medicines Congress 2012, Washington D.C., November 2012.
“Lifecycle Management Under the Biosimilars Act,” ACI’s 12th Annual Maximizing Pharmaceutical Patent Life Cycles, NYC, Oct. 2011.
“Assessing the Changing Generics Market to Enhance Your Product Portfolio,” Marcus Evans’ 4th Annual Product & Pipeline, VA, July 2011.
“Scrutinizing the Financial Viability of Biosimilars,” ACI’s 2nd Annual Biosimilars Conference, NYC, June 2011.
“Comprehending the Newfound Significance of Inducement Actions in Paragraph IV Litigation,” ACI’s 5th Annual Paragraph IV Disputes, May 2011.
“Inter-Generic Legal & Regulatory Strategies,” CBI’s 3rd annual Congress of P-IV Disputes, Alexandria, October 2010.
“A Closer Look at Generic v. Generic Law Suits,” ACI’s 4th Annual Paragraph IV Disputes Conference, NYC, April 2010.
“Achieving Harmony: Branded & Generics Dual Identity,” DCAT’s 8th Annual Business Development Program, NYC, March 2010.
“How to Ensure Access, Management and Protection of IP,” World Generics Medicines Congress, Wash. D.C., November 2009.
“Developing a Risk-Balanced Patent Strategy to Mitigate Lawsuits,” Marcus Evans Product & Portfolio, VA, June 2009.
“Mastering the Interplay Between 180-Day Exclusivity, Forfeiture Provisions, and Citizen’s Petitions,” ACI’s Paragraph IV Disputes, NYC, April 2009.
“Hatch-Waxman First-to-File Marketing Exclusivity: Getting it, Keeping it & Avoiding Forfeiture,” World Generic Medicines Congress, NYC, November 2008.
“Mastering the Interplay Between 180-Day Exclusivity; Forfeiture Provisions and Paragraph IV Litigation,” ACI’s Paragraph IV Disputes, NYC, May 2008.
“Issues at the Intersection of Patent Law, FDA and Antitrust,” annual meeting of Intellectual Property Owners Association, NYC, September 2007.
“The Future of Antitrust Allegations in Patent Litigation,” 3rd Patent Strategies, NYC, March 2007.
“The Future of Follow-On Biologics: Trickle or Onslaught? Contemplating Change After Omnitrope,” Pharma/Biotech Industry Forum on Patent Portfolio Management, NYC, February 2007.
“Overview of Recent, Important Cases and the Future Implications,” Pharmaceutical and Biotech Patent Strategies, Philadelphia, September 2006.

Publications

“Must Whole Patent Be Nixed to Forfeit 180-Day Exclusivity?,” July 2018.
“J&J Case Raises Estoppel Issue for Successful IPR Litigants,” April 2018.
“ALIMTA Anomaly (or maybe a pemetrexed paradox?),” September 2017.
“Isosulfan Blue Maps Equivalents in Chemical Cases,” August 2017.
“The Federal Circuit Vacates on VELCADE (or bounces on bortezomib),” July 2017.
“The ALOXI (Palonosetron) Patents are Regurgitated as Invalid,” May 2017.
“Sandoz/Momenta Can’t Coagulate an Antitrust Affirmance on Enoxaparin,” March 2017.
“Sandoz Loses Rhythm in MULTAQ Litigation; Judge Andrews Cites Our Chapter,” February 2017.
“Pay It (to) Forward; Biogen Settles on TECFIDERA (dimethyl fumarate),” January 2017.
“Protection From Generics Without a Patent?,” December 2016.
“The Palonosetron Paradox — when is a clinical formulation ready for patenting?,” October 2016.
“Don’t try this at home. Especially not in the shower. Several generics win challenge to AXIRON (testosterone),” September 2016.
“Can an OOS Batch Support Infringement?,” July 2016.
“TREANDA Patents Upheld, and SUBOXONE May Stay Afloat Until 2024,” June 2016.
“Hey, No Flare! Hikma’s Carve Out Leads to Takeda’s Dismissal on Colchicine,” May 2016.
“Ezra Attacks the PTE Grant on Gilenya,” March 2016.
“Gilead Going to the Mat with Merck on Sovaldi?” February 2016.
“Purdue’s Pain Continues with OxyContin Ruling,” February 2016.
“In Momenta II, the Federal Circuit May Have Closed the Harbor But Opened the World,” November 2015.
“OxyContin Oh No!! Did Purdue Dismiss its Complaint Too Early?” August 2015.
“Federal Circuit Judges the Patent Dance Not Ballroom-Worthy,” July 2015.
“Mylan Can’t Conceive New Contentions in its Lo Loestrin Fe Litigation,” June 2015.
“Brand’s Use of ANDA Limited to “Sufficiently Related” Patents Only,” June 2015.
“Should Isomers Remain Patentable Subject Matter, or Will Myriad and Mayo Eliminate Them?” April 2015.
“Benicar Benefits! Generics Can DJ Disclaimed Patents and Trigger Forfeiture Without TA at Filing,” April 2015.
“Let’s Get this Party (in Interest) Started! Allergan Gets IPRs Dismissed for Petitioners Failing to Include Parent with the Power,” March 2015.
“2014 In Review — Countdown of the Top Ten Hatch-Waxman and Biosimilar Decisions/Events of the Past Year,” December 2014.
“Strike Three Yer Out!! Celltrion’s DJ Action Against the Kennedy Trust Over a Remicade Biosimilar Suffers the Same Fate as Sandoz’s DJ Complaint on Etanercept,” December 2014.
“Is a Notice Letter Sufficient for Specific Jurisdiction? Mylan Loses that Issue in the ONGLYZA (saxagliptin) Litigation. Is Actavis Next?” November 2014.
“Is Cash Required for a Reverse Payment? Several Cases Are Racing to the Appeal,” October 2014.
“Pre-Clinical R&D,” ANDA Litigation: Strategies & Tactics for Pharmaceutical Patent Litigators, 2nd ed. ABA Publishing, September 2014.
“Citizen Petitions: Strategies and Market Tactics,” ANDA Litigation: Strategies & Tactics for Pharmaceutical Patent Litigators, 2nd ed. ABA Publishing, September 2014.
“Ferring Falters at the Federal Circuit on LYSTEDA (tranexamic acid) Due to Advisory Opinions and Post-Trial ANDA Amendments to Evade Infringement,” September 2014.
“Is Your Claim In or Out? A Split of Authority Over Declaratory Judgment Claims and Unlisted Patents,” August 2014.
“You’ve Been Served! But When? Amneal Beats the IPR Deadline by One Day in its Challenge to Endo’s OPANA ER (oxymorphone),” July 2014.
“One Patent Survives Watson’s Motion to Dismiss in the LYSTEDA (tranexamic acid) Litigation; Will Ferring Ever Collect its Damages?” July 2014.
“Get It In Writing! Mylan Loses Trial But Wins Oral Settlement Against Endo in the FROVA (frovatriptan) Litigation,” June 2014.
“Safe (Harbor) No More—How Octane Fitness Burned Classen, Scorching It with an Exceptional Case Finding,” May 22, 2014.
“Product-Liability Plaintiffs Get a Present on Preemption—District Court Finds an Exception to the Bartlett Decision,” May 2014.
“What’s Your Damage (Heather)? Federal Circuit Affirms Damages for Sanofi/Abbott and Against Glenmark Regarding the At-Risk Launch of Generic TARKA (trandolapril + verapamil),” April 2014.
“Reverse Payment Remand; Refund Coming? District Court in Georgia Says No to Par, Paddock, and Solvay’s Motion to Dismiss the ANDROGEL Case Post FTC v. Actavis,”April 2014.
“Barr Wins Appeal Against Alcon Over TRAVATAN Z (travopost), Obtaining Affirmance on Non-infringement; Alcon’s Consolation is a Reversal on Invalidity,” April 2014.
“Mesalamine Mistake – the Federal Circuit Reverses on Claim Construction. Does Zydus Face Forfeiture?,” March 2014.
“Invalid Patent? No Problem! The Reissue Route Can Fix Anything as Teva Tries on COPAXONE (glatiramer acetate),” March 2014.
“Clean Up On Aisle Seven! Moxifloxacin Mess is No More with Trial, Appeal, and Inter Partes Review Dismissed,” February 2014.
“Zydus’s Heartburn Ends as its P-IV Challenge to Takeda’s PREVACID SOLUTAB (lansoprazole), Winning the Appeal,” February 2014.
“Jazz Can’t Put On a Red Light to Stop Roxane’s Equitable Defenses in the XYREM (sodium oxybate) Litigation,” February 2014.
“The Safe Harbor Continues to Confuse – Will the Federal Circuit Finally Be Our Lighthouse? Trial Court Dismisses Classen’s Latest Case,” January 2014.
“Tolmar clears its skin with a win over Galderma on appeal of DIFFERIN GEL (adapalene) 0.3%. Are all incremental patents to be cleansed next?” December 2013.
“Astra Zeneca Breathes Life into its PULMICORT RESPULES (budesonide) Patent, Overturning the Claim Construction on Appeal,” October 2013.
“Inherent Anticipation and the Polymorph Paradox–A Look at the 4 Oct. 2013 trial decision in SUSTIVA (efavirenz),” October 2013.
“Strategic Considerations Under the Biologics Price Competition & Innovation Act,” Expert Opinion on Therapeutic Patents, Vol. 23, No. 8, pp. 925-928, August 2013.
“The AVODART (dutasteride) Trial is not a Disasteride for GSK, Winning Several Challenges to its Compound Patent,” August 2013.
“Supreme Court: Reverse Payment Settlements Subject to Antitrust Scrutiny,” Pharmaceutical Commerce, August 2013.
“Are Validation Batches Exempt Under Hatch-Waxman’s Safe Harbor, or Are They a Commercial Infringement?” August 2013.
“IP: Obamacare’s Constitutional Impact on Patents,” Inside Counsel, April 2013.
“Five Practice Tips from the Recent Rambus Rulings,” Inside Counsel, February 2013.
“Analysis of Use Codes in ANDA Litigation in view of Caraco Pharma v. Novo Nordisk,” 2012 Chicago Kent Supreme Court IP Review, Chicago, Sept. 2012.
“Health-Care Reform Creates Large Dollar Biosimilar Drug Market,” Chicago Daily Law Bulletin, November 2012.