Registration and Continental Breakfast

Co-Chairs’ Opening Remarks

The Politics and Policy of Pharmaceutical Patents in the New Administration: Town Hall

Pharmaceutical patents, especially small molecule, Orange-Book listed patents are unique entities. Under the Hatch-Waxman-Act and its subsequent amendments, these patents fall under the jurisdiction of three government agencies, the USPTO, the FDA and the FTC. At time of press, it is expected that the leadership as well as the objectives of each of these agencies will change during the Trump presidency. This begs the question of how these changes may affect these patents and Hatch-Waxman strategies. There are also questions as to how the status of pending legislation in the New Congress, the appointment of Judges in various courts including the Supreme Court may all impact these patents as well. This panel, in town hall fashion, will take questions as it explores such matters as:

• How new PTO leadership may impact pharmaceutical patents
• Exploring the future of Patent Reform II and possible statutory IPR carve-out for Hatch- Waxman patents
• Understanding what changes at FDA and its parent agency HHS may mean for Orange Book patents
  •  calls for drug pricing reform and consequences for drug patents
• Predicting how changes at FTC may impact the future of “pay for delay” enforcement and investigations

USPTO Keynote: Patent Rights and Generic Entry – An International Perspective

• Review of leading international standards regarding the relationship between patent rights and generic entry
• Overview of the TRIPS Agreement
• US Free Trade Agreements: from Australia to Central America to the Andean Region to Korea
• Discussion of Hatch-Waxman provisions of the TPP—lessons learned
• Future agreements

Morning Coffee Break

The Dollars, Cents and Due Diligence of Pharmaceutical Patent Life Cycle Management and Litigation Planning

• Appreciating new IP and economic due diligence strategies for brand name and generic manufacturers in view of current legal considerations and market trends
• Understanding how the current stage of the patent cliff, the alternative litigation route at the PTAB and new federal court jurisprudence have reshaped Hatch-Waxman strategies
• Examining how brand names and generics are utilizing this new legal and economic paradigm in determining which patents are ripe for challenge in the PTAB and District Courts
• Comparing patent strength assessments in clinical testing phases I and II to predicted ROI in phases III and IV to determine drug value and probability of suit
• Understanding why less lucrative branded drugs are becoming more attractive targets
• Assessing probable win or loss at District Court and PTAB on patent type and recent decisions
• Exploring cost saving options for ANDA District Court litigation and PTAB filing
• Examining alternative billing, contingencies
• Evaluating use of outside funding
• Knowing when to aim, fire, fight, fold or license
• Understanding when settlement is your best option sometimes even before suit is commenced

Focus on the Final MMA Rule
Q&A with the FDA on the Final MMA Rule: Understanding the Impact for Hatch-Waxman Practice

On December 5, 2016, new regulations to implement portions of the 2003 Medicare Modernization Act went into effect. According to FDA, the new regulations are intended to “reduce unnecessary litigation, reduce delays in approval of 505(b)(2) applications and ANDAs that are otherwise ready to be approved, and provide business certainty to both brand name and generic manufacturers.” The highly technical and far-reaching regulations significantly affect how NDA and ANDA applicants will interact with one another and with FDA both during and after approval of a marketing application.

Among other things, the new regulations deal with the submission of patent information by NDA holders and patent certifications from ANDA applicants, patent use codes, 30-month patent litigation stays, application amendments and supplements, and, to some extent, 180-day exclusivity. This session, formatted in a Q&A fashion, will provide analysis other new regulations as well as strategies for incorporation into daily practice.

Revisiting Use Codes and Carve-Out Cases in Light of the Final MMA Rule

Use code manipulation, carve-outs and skinny labeling have been a proverbial tempest in the Orange Book teapot. The Supreme Court blessed the carve-out concept in 2012 with Caraco, but the utilization of carve-outs has still led to many a dogfight. The final MMA Rule seeks to put an end to this. However, questions remain as to how use code dilemmas will be handled in the aftermath of the Rule.

• Review of recent Paragraph IV carve-out and skinny labeling challenges
• Examining FDA determinations relative to use code listings
• Understanding the uniqueness and significance of the Depomed NUCYNTA ER (tapentadol) citizen’s petition
• FDA’s authority to unilaterally change use code
• Exploring how final Rule may remedy the current use code landscape

Networking Luncheon

The Ongoing Jurisdiction Debate: From Mylan to TC Heartland

• Analyzing the Federal Circuit’s finding of jurisdiction in in Acorda -Therapeutics Inc. v. Mylan Pharms. Inc. and AstraZeneca AB v. Mylan Pharms. Inc.,
• Reviewing the District of Delaware’s decisions in these matters
• Comprehending how Judges’ Sleet and Stark each found jurisdiction and how this compared to the Federal Circuit’s findings
• Examining the significance of the Federal Circuit’s dissent
• Understanding the significance of the Supreme Court’s denial of cert. in Mylan in view of the Court’s grant of cert. in TC Heartland LLC v. Kraft Food Brands Group LLC
• Exploring possibility of amendment to Hatch- Waxman to remedy jurisdictional uncertainty

On Sale Bar – Round II: Understanding The Impact of Helsinn on Pharmaceutical Patents in a Post-AIA Setting

• At the time of our last meeting, we explored the question of patent invalidity through an on sale bar in a pre-AIA setting in the Medicines Company’s Angiomax case. Now, we revisit the same question, but this time on a patent issued post-AIA.
• Analyzing the on- sale bar provision of the Patent Act as amended by the AIA
  • comparison to pre-AIA statute
• Examining the facts of Helsinn Healthcare S.A. et al. v. Teva Pharmaceuticals USA, Inc. et al. (Nos. 2016-1284, -1787) and understanding how the language of the amended statute led to the District Court’s (DNJ) finding that a so-called non-public, secret sale did not trigger the on-sale bar provision to invalidate the patent
• Anticipating the Federal Circuit’s decision in Helsinn
  • assessing repercussions which would ensue should the Federal Circuit reverse the lower court’s finding
  • what can we glean from the Federal Circuit’s ruling in The Medicines Co. v. Hospira, Inc., 827 F.3d 1363 (Fed. Cir. July 11, 2016)?
• Exploring the consequences of either scenario in future Hatch-Waxman settings

Networking Refreshment Break

Understanding the Continuing Impact of 101 on Orange Book Listed-Method Claims

• Understanding the implications of the Federal Circuit’s decision in Rapid Litigation Management Ltd., et al. v. CellzDirect, Inc., et al., No. 2015-1570 (Fed. Cir. Jul. 5, 2016) on subject matter eligibility of method claims in the life sciences sector
• Determining subject matter patentability of method patents based on this latest case and prior 101 jurisprudence post-Myriad
• Exploring the Federal Circuit’s adherence or nonadherence in 101 matters under PTO’s Alice Rules
  • MacroPoint LLC v. FourKites Inc., case number 16-1286, Federal Circuit 2016.
• Comparing the Federal Circuit’s findings in CellzDirect to two Delaware Court decisions in the last year involving 101 challenges to Orange Book listed method claims, i.e., Endo v. Actavis (2015) vs. Vanda Pharmaceuticals Inc. v. Roxane Laboratories, Inc., C.A. Nos. 13-1973, 14-757-GMS (D. Del. Aug. 25, 2016)
• Understanding how Judges Andrews and Sleet arrived at different 101 decisions with respect to the patents in question
• What can we glean from this jurisprudence with respect to drafting subject matter eligible method claims and bringing 101 motions?

Obviousness Update for PIV Litigation: Latest Developments in the Federal Courts and PTAB

Prior Art

• Understanding how the Federal Circuit’s obviousness ruling in Apple Inc. v. Samsung Electronics Co. Ltd., No. 2015-1171, __ F.3d __, 2016 WL 5864573 (Fed. Cir. Oct. 7, 2016) may impact obviousness findings in life sciences patents
• Review of recent obvious decisions involving Paragraph IV litigation at the District Court, PTAB and Federal Circuit
  • comparison of statistics for obvious invalidity findings at these courts
  • impact of Cuozzo
• Exploring unique obviousness issues in Purdue Oxycodone cases, i.e., Grunenthal GmbH et al v Teva Pharmaceuticals USA Inc, U.S. Court of Appeals, Federal Circuit, No. 2014-1311. currently on petition for cert. at the Supreme Court
  • inherency by anticipation
  • method of solving problem
• Re-visiting secondary considerations

Double Patenting- Type Obviousness

• Bayer Pharma AG v. Watson Labs., Inc., Case No. 12-1726-LPS, 2016 U.S. Dist. LEXIS 96267 (D. Del. July 18, 2016)

A View from the Bench: The Federal Judges Speak on Paragraph IV Litigation

Renowned jurists with some of the most active Paragraph IV litigation dockets in the country will share their thoughts and insights on complex challenges facing both patent holders and patent challengers. Come prepared with your most pressing questions.

Conference Adjourns to Day Two

Cocktail Party

Continental Breakfast

Co-Chairs’ Opening Remarks and Recap of Day One

Illusory Safe Harbors: Exploring Uncertainties in the Boundaries of 271 (e) (1) and the Scope of Divided and Induced Infringement

• Understanding which post-approval activities fall within the scope of the safe harbor per Amphastar Pharmaceuticals, Inc. v. Momenta Pharmaceuticals, Inc
• Revisiting the pre-approval v. post approval debate under 271(e)(1)
• Examining the state of the law on divided infringement and its implications for Hatch-Waxman
  • Akamai standard
  • Eli Lilly and Company v. Teva Parenteral Medicines, No. 10-1376, S.D. Ind, Fed. Cir. Appeal No. 15-2076
• Examining the nexus between these two categories of infringement
• Exploring scenarios in which infringement can be alleged through safe harbor violation and inducement
  • e.g., method of manufacture patent with foreign manufacturers, finishers and US distributors

The PTAB Live: Thoughts on Practice, Procedure, IPRs and More in the World of Pharmaceutical Patent Validity Challenges

IPRs have become an important component in the Hatch-Waxman arsenal. As such, knowing the “ins and outs” of PTAB practice is a critical competency for today’s Hatch-Waxman petitioner. To help you with this task, Judges from the PTAB will discuss protocols and the art of appearance before this administrative body.

Morning Coffee Break

Alternate Forums for Pharmaceutical Patent Challenges

PTAB Pharmaceutical Patent Invalidity Round-Up: Update on Wins, Losses and Appeals

• Survey of notable wins and losses at the PTAB
  • IPR vs. PGR vs. CBM
  • Altaire Pharmaceuticals, Inc. v. Paragon BioTeck Inc.
• Examining statistics for types of challenges bought and types of patents challenged
• Developing parallel proceedings protocols
• Analyzing Federal Circuit decisions relative to pharmaceutical patent challenges brought at the PTAB
  • understanding the impact of Cuozzo affirming broadest reasonable interpretation
• Exploring impact of PTAB rules package and status of pending cases impacting new rules
  • In re Aqua; motion to amend
• Update on activity of reverse patent trolls
• Status of pending patent reform legislation

Examining the ITC as an Alternate Forum in an ANDA Challenge

• Analyzing the pro and cons of using the ITC in a Hatch-Waxman related pharmaceutical patent challenge
• Examples of such proceedings and other lifesciences related proceedings where the ITC has been utilized
• Determining if ITC 337 petitions are a viable means of protecting the patent life of pharmaceutical products in a Hatch-Waxman scenario

A Magistrate Judge’s Insights on ANDA Practice

Magistrate Judges have a unique role in ANDA cases. They hear key motions and resolve the disputes which the parties encounter throughout the course of litigation.

Magistrate Judges also work closely with District Judges on these matters. This panel of esteemed Magistrate Judges will offer their insights on these  matters and the art of Paragraph IV practice.

Networking Luncheon

FTC Keynote: Update on Reverse Payment Settlements and Other Antitrust Developments Concerning Brand Name and Generic Interests

It now been almost four years since the Supreme Court issued its seminal decision in Federal Trade Commission v. Actavis. which made it clear that pharmaceutical patent settlement agreements can violate the antitrust laws. Since the Actavis decision, There have been more than twenty government and private plaintiffs’ actions working their way through the courts, including the Federal Courts of Appeal and the California State Supreme Court.

This session will reflect on the lessons from the last four years. What are the key issues in analyzing settlement agreements post-Actavis? Which, if any, of these issues has been resolved? What issues remain in dispute? What are the arguments on each side of the issues? In sum, what’s the current state of play on “pay for delay”?

We will hear the perspectives of the FTC staff on these questions and more.

Reverse Payment Settlements: The Industry Response

In this interactive session, leading antitrust attorneys for brand name and generic drug manufacturers will respond to the FTC and explore industry challenges in light of recent court decisions and the Commission’s stance with respect to designing settlement agreements which will withstand FTC scrutiny, benefit the parties and receive a judicial blessing.

Networking Coffee Break

The REMS Conundrum: Exploring Challenges for Both Brands and Generics

• Overview of the REMS process and analysis of obstacles it poses to both brand name and generic manufacturers in a Hatch-Waxman scenario
• Examining scenarios in which patent infringement can be alleged not only on the drug which is the subject of a REMS but on the REMS process itself
• Exploring scenarios of FDA intervention in brand and generic discord in REMS design
• Understanding antitrust implications
• Status of pending legislative fix

Case Studies in New Ethical Developments Impacting Paragraph IV Practice

• Exploring the status and significance of the USPTO’s proposed Rule to adopt the duty of disclosure under Therasense as an amendment to Rule 56
  • understanding the impact of this proposed Rule on Paragraph IV practice
• Examining the new willfulness standard under Halo and understanding its application in a Hatch-Waxman scenario

Conference Ends