Main Conference – Day 1 Tuesday, April 24, 2012
7:15 Registration and Continental Breakfast
8:00 Co-Chairs’ Opening Remarks
Guy Donatiello
Vice President, Intellectual Property
Endo Pharmaceuticals (Chadds Ford, PA )
Timothy X. Witkowski, M.S., J.D.
Executive Director & Executive Counsel, Intellectual Property
Boehringer Ingelheim (Ridgefield, CT)
Immediate Past Co-Chairs
Brian P. Murphy
Partner
Edwards Wildman Palmer LLP (New York, NY)
Barry S. White
Partner
Frommer Lawrence & Haug LLP (New York, NY)
8:30 Anticipating and Reassessing Paragraph IV Challenges in the Era of the Patent Cliff
Anjan Chatterji
Business Valuations - Life Sciences Advisory
Deloitte Financial Advisory Services LLP
(New York, NY)
Jennifer L. Fox
Counsel
Brinks Hofer Gilson & Lione
(Research Triangle Park, NC)
Pablo D. Hendler
Partner
Ropes and Gray LLP (New York, NY)
Len Smith
Principal Intellectual Property Counsel
Medicis (Scottsdale, AZ)
- Understanding how the arrival of the ‘patent cliff’ has changed a patent holder’s Paragraph IV due diligence strategies
- Evaluating the strength of the patents in your current portfolio in light of the new industry dynamics created by the patent cliff
- Orange Book and non-Orange Book eligible patents
- Examining the Orange Book ‘to list or not list’ dilemma
- which types of patents should you list?
- alternatives to compound patents
- special listing considerations for small proteins filed through an NDA as opposed to a BLA in light BPCIA biosimilar provisions
- what is the protein’s method of manufacture
- is it chemically derived or made through a biotechnological process?
- Gauging when to reasonably expect a Paragraph IV filing by a generic competitor in the era of the ‘patent cliff’
- Learning to look beyond the ‘blockbuster patents’
- understanding why patents on smaller products may be more vulnerable to challenge in some instances
- Exploring brand name exclusivities and their correlation to the start of a Paragraph IV challenge
- NCE
- possible extension of NCE exclusivity from 5 to 12 years?
- new use or indication
- new formulation
- orphan drug- pediatric
- Preparing for litigation
- developing discovery check-lists
- implementation of document retention policy
- when is a litigation hold put on all documents which may be discoverable
- e-discovery
- possible e-discovery restraints in various jurisdictions
- “call back” rule for inadvertent disclosure
- Preventing a Paragraph IV challenge
- entering an authorized generics agreement
- claiming the label
- filing a citizen’s petition
- OTC switches
- Understanding how changes in the US Patent System under the AIA may influence Orange Book listing strategies
- first to file
- third party pre-issuance submissions
- file early, file often
- provisional applications
- prior user rights
9:30 Invalidity and Non-Infringement Post-Microsoft: Reaffirmation of The ANDA Applicant’s Pre-Litigation Obligations and Assertions
Stephen R. Auten
Vice President, Head of IP, North America
Sandoz, Inc. (Princeton, NJ)
Richard J. Berman
Partner
Arent Fox LLP (Washington, DC)
Dr. Alpesh Pathak
Head-API Patent Cell
Alembic Pharmaceuticals (Vadodara Area, India)
Joseph M. Reisman, Ph.D.
Partner
Knobbe Martens Olson & Bear LLP(San Diego, CA)
- Reexamining the initial obligations of the ANDA applicant under Paragraph IV in light of the Supreme Court’s ruling in Microsoft v. i4i
- when is there “clear and convincing” evidence that patent is invalid and therefore not infringed
- assessing the consequences of not meeting this burden of proof
- Weighing your options in light of the burden: should you file a Paragraph IV certification or choose another ANDA route?
- Choosing which Orange Book patents to challenge
- compounds
- formulations
- process
- methods of use
- polymorphs
- factoring “forfeiture” into your Orange Book strategy
- skinny labeling and carve-out considerations via Caraco
- obviousness assessments
- How Patent Reform may impact Orange Book patent challenges
- elimination of Best Mode defense
- prior user rights
- exploring new Post Grant Review and Inter Partes Review as another mechanism for invalidating an Orange Book patent
- Understanding the role of non-Orange Book patents in your PIV ANDA strategies
- innovator / non-innovator
- API
- Procuring legal opinions on invalidity and non-infringement
- assessing when opinions are needed
- opinion of in-house v. outside counsel
- questions of privilege
- Rule 26 (b) (4) revisions regarding expert opinions
- Filing the ANDA
- fulfilling requirements for FDA approval:
- pharmaceutically equivalent
- bioequivalent
- identifying triggers which may necessitate new bioequivalence studies
- Contents of the Paragraph IV certification
10:30 Morning Coffee Break
10:45 The Throwing of the Gauntlet: The Paragraph IV Notice Letter
For the Brand Name Side:
Denise L. Loring
Partner
Ropes & Gray LLP (New York, NY)
Peter Waibel
Head US Patent Litigation
Novartis Pharmaceuticals Corporation
(East Hanover, NJ)
For the Generic Side:
Shashank Upadhye
Former Vice President - Global Intellectual Property
Apotex, Inc. (Toronto, ON)
Tedd Van Buskirk
Partner
K & L Gates LLP (New York, NY)
Moderator:
Dominick A. Conde
Partner
Fitzpatrick, Cella, Harper & Scinto(New York, NY)
Generic Side
Procedural requirements
- Perfecting the Paragraph IV Certification
- Contents of the Notice letter
- Delivery/service of Notice Letter
- Making necessary amendments to the ANDA
Substantive requirements
- Identifying the proposed product covered by the ANDA
- Identifying the patent of the corresponding branded product which is the subject of the Paragraph IV letter
- Legal and factual basis
- Examining the detailed statement and questions of confidentiality- Nycomed v. Tolmar Civ. No. 10-2635, 2011 (D.N.J. Apr. 28, 2011)
- Exploring the use of opinion letters in relation to notice letters- are they still needed in view of Patent Reform- how detailed do they need to be to avoid sanctions vis- â- vis Takeda
Branded Side
The response
- Making productive use of the 45 day period
- Information gathering techniques strategies- confidentiality agreements and document requests
- scope of information that can reasonably expected
- negotiations
- Extending the 45 day period
- When should a patent owner file suit?
- other options to explore
- license
- Strategies to consider with multiple ANDA filers
Questions for both sides to consider:
- Options to explore if suit is not commenced in 45 days
- pros, cons and consequences of:
- forfeiture of 30 month stay
- suing for damages
- declaratory judgment actions
- no contest letter
12:00 Networking Luncheon
1:15 New Claim Construction Considerations in Paragraph IV Litigation
Lisa M. Ferri
Partner
Mayer Brown LLP (New York, NY)
Jonathan A. Harris
Partner
Axinn, Veltrop & Harkrider LLP (Hartford, CT)
Martin B. Pavane
Member
Cozen O’Connor (New York, NY)
Moderator:
Catherine Nyarady
Partner
Paul, Weiss, Rifkind, Wharton & Garrison LLP (New York, NY)
- How the split in Federal Circuit on claim construction may impact Paragraph IV challenges
- more narrow reading of claims vs. broader reading
- Cybor and Phillips
- The significance of dissent in Retractable Technologies, Inc. v. Becton, Dickinson and Company (Fed. Cir. 2011)
- viewing claim construction as the most important event in the course of a patent litigation in contrast to the ‘ill defined and inconsistent rules’ in the Federal Circuit
- Revisiting 112 written description and enablement distinction requirements vis-à-vis Ariad v. Lilly and Centacor relative to clarity of claims
- reviewing specification requirements
- understandability
- inventorship
- Strategies for working around these inconsistencies at Paragraph IV Markman hearings
2:00 Prior Art Obviousness and Obvious-Type Double Patenting: Legal Analysis and Practical Applications for Brand Names and Generics
Michael A. Davitz
Partner
Axinn, Veltrop & Harkrider LLP (New York, NY)
Steven J. Lee
Partner
Kenyon & Kenyon (New York, NY)
Joseph M. O’Malley, Jr.
Partner and Global Co-Chair, Intellectual Property Practice
Paul Hastings LLP (New York, NY)
Sanya Sukduang
Partner
Finnegan, Henderson, Farabow, Garrett & Dunner, LLP (Washington, DC)
Richard Ruzich
Partner
Cozen O'Connor (Chicago, IL)
Moderator
Anthony J. Fitzpatrick
Partner
Duane Morris LLP (Boston, MA)
Legal Analysis
Prior Art Obviousness
- Exploring the reaffirmation of KSR through In Re Kao (Fed. Cir. 2011)
- examining secondary considerations before the PTO under current procedures
- under new AIA Post Grant Review procedure
- Understanding the impact of KSR and its progeny on primary compound and composition claims vis-à-vis a Paragraph IV challenge
- impact on secondary patents
- enantiomers
- isomers
- polymorphs
- new formulations
- new indications
- crystallizations
- salts
- Examining questions of ‘secret prior art’ and ‘inherent anticipation’
- Teva Pharmaceutical Industries Ltd. v. AstraZeneca Pharmaceuticals LP (Crestor)
- Assessing the impact of the AIA’s prior art provisions in Paragraph IV related obvious challenges
Obviousness-Type Double Patenting
- Analyzing the evolving state of the law on obviousness-type double patenting and its impact on Paragraph IV litigation
- Sun Pharm. Indus. v. Eli Lilly & Co., No. 2010-1105 (Fed. Cir. 2010)
- Boehringer Ingleheim Int’l, et al. v. Barr Labs, Inc., et al., 592 F.3d 1340 (Fed. Cir. 2010)
- Brand-name and generic strategies for navigating the new double patenting landscape
Practical Applications
- Strategies for invoking and responding to an obviousness challenge in concurrence with current law
- brand name and generic tactics for addressing prior art and double patenting controversies
- PTO and District Court redress
- Summary judgment assessments
- Discovery approaches
- considerations regarding the deposing of primary reference authors
- Experts
- should the same expert be used for both infringement and invalidity opinions?
- new expert report provisions under Rule 26 (b) (4)
3:00 Afternoon Refreshment Break
3:15 And They’re Off: The Start of the Paragraph IV Law Suit - Pleadings and Other Initial Considerations and Analyses
For the Brand Name Side:
Chad J. Peterman
Partner
Patterson Belknap Webb & Tyler, LLP (New York, NY)
For the Generic Side:
Gary E. Hood
Shareholder
Polsinelli Shughart PC (Chicago, IL)
Jim Mahanna
Director, Intellectual Property Law
Actavis (Elizabeth, NJ)
Moderator:
Kathleen B. Carr
Partner
Edwards Wildman Palmer LLP (Boston, MA)
Initial considerations
- Where should suit be filed?
- attempts by the generic to influence where and when the suit will occur
- exploring transfer motions and writs of mandamus relative to venue/jurisdiction
- examining joinder provisions and Hatch-Waxman exceptions under AIA relative to venue
- Assessing subject matter jurisdiction
- Sunovion v. Sandoz (2011)
- Cephalon v. Sebelius (2011)
- Questions of standing
- considerations for multinationals and subsidiaries
- weighing probability for motions to dismiss
- Handicapping of judges and jurisdictions
- Surveying local patent rules
- knowing which district rules favor patent holders and patent challengers
- New Jersey
- E.D. Texas
- Delaware
- Question of jury trial: exploring circumstances that may put you in front of a jury
- Exploring possible parallel proceedings before the PTO in view of Patent Reform
Crafting the initial pleadings
- The complaint
- challenging the Paragraph IV certification: alleging the patent is valid and infringed
- what claims are made in the ANDA?
- avoiding Rule 11 sanctions
- assessing whether attorney’s fees can be properly sought?
- The answer and counterclaims
- de-listing improperly listed patents
- antitrust and unfair competition claims
- counterclaims relative to the label under MMA
- assertions of inequitable conduct
- the generic point of view:
Considerations with Multiple ANDA Filers
Branded Side
- Choosing who to sue
- ANDA filers; others?
- when does it make sense to only sue the first filer or a few as opposed to all ANDA filers?
- what are the consequences of not suing all ANDA filers?
- Special forum selection considerations for multiples
- Amending pleadings for later ANDA filers
Generic Side
- The generic’s position in the queue
- general considerations for first to file
- thoughts for second and later filers
- Consolidation vs. separate cases
The Changing Dynamics of Branded and Generic Pharma
- How the ‘blurring of the lines’ between branded and generic companies are influencing initial considerations in the course of Paragraph IV litigation
- Generic Generic Law Suits
- exploring circumstances in which the generic on the pleadings behaves as an innovator
- pleading protection of market exclusivity
Declaratory Judgments
- Understanding the MMA declaratory judgment provisions and the CAFC’s interpretation of these provisions
- When is it appropriate to move for a DJ
- Circumstances when a DJ will be granted?
- Should DJ be sought on all patents – listed and not listed?
Factoring - in the 30 month stay
- Commencement of the statutory 30 month stay
- understanding the scope and limits of the 30 month stay under the MMA
- The 30-month stay in the course of litigation
- options and strategies for the patent holder if the stay expires during the course of litigation
- early termination of the stay
4:45 A View From the Bench
Honorable Garrett E. Brown, U.S.D.J. (Ret.)
Chief Judge, United States Federal District Court
District of New Jersey (Trenton, NJ)
Honorable Joel A. Pisano, U.S.D.J.
United States Federal District Court
District of New Jersey (Trenton, NJ)
Honorable Tonianne Bongiovanni, U.S.M.J.
United States Federal District Court
District of New Jersey (Trenton, NJ)
Moderators:
Brian P. Murphy
Partner
Edwards Wildman Palmer LLP(New York, NY)
Barry S. White
Partner
Frommer Lawrence & Haug LLP(New York, NY)
Renowned jurists with some of the most active Paragraph IV litigation dockets in the country will share their thought and insights on some of the most pressing issues facing both patent holders and patent challengers. Come prepared with your most pressing questions.
6:00 Conference Adjourns to Day 2
6:00 Cocktail Reception
Main Conference – Day 2 Wednesday, April 25, 2012
7:15 Registration and Continental Breakfast
8:00 Co-Chairs’ Opening Remarks and Recap of Day One
8:15 Of Labels, Patents and Use Codes: The Significance and Possible Repercussions of Novo Nordisk v. Caraco to Hatch-Waxman Challenges
Aaron F. Barkoff, Ph.D.
Partner
McAndrews, Held & Malloy Ltd. (Chicago, IL)
James F. Hurst
Partner
Winston Strawn LLP (Chicago, IL)
Michael A. Sitzman
Partner
Gibson, Dunn & Crutcher LLP (San Francisco, CA)
Anthony J. Viola
Partner
Edwards Wildman Palmer LLP (New York, NY)
Moderator:
Terry G. Mahn
Principal
Fish & Richardson P.C. (Washington, DC)
- Exploring the relationship between a drug’s label, patents, use codes and Orange Book listings relative to Hatch-Waxman litigation
- Deciphering therapeutic equivalence evaluation codes
- what are the roles of AB ratings and OB use codes in the Orange Book
- Defining Section viii carve–outs and understanding their significance to Orange Book listings and Paragraph IV challenges
- skinny labeling
- off-label uses
- Examining how the Supreme Court’s pending ruling in Novo Nordisk A/S v. Caraco Pharmaceutical Laboratories, Ltd. may alter the landscape in this area with respect to:
- the interpretation of the counterclaim provision challenging method of use patents per the MMA amendments
- delisting strategies based on use codes and labeling controversies
- when can use codes be altered?
- seeking permission from the FDA to carve-out patent protected language to allow for generic entry
- possible consequences of narrowing vs. expanding the use code narrative
- Understanding the significance of Solicitor General’s /U.S. government’s position and arguments in this matter
9:15 Reassessing Paragraph IV Strategies for Method Treatment Patents in View of Recent and Pending Decisions Regarding Inducement and Divided Infringement
David P. Frazier Ph.D.
Partner
Finnegan, Henderson, Farabow, Garrett & Dunner, LLP (Washington, DC)
Keith J. Grady
Shareholder
Polsinelli Shughart LLP (St. Louis, MO)
Lisa A. Jakob
Legal Director, IP Litigation
Merck & Company (Rahway, NJ)
Meg Snowden
VP, Intellectual Property
Impax Laboratories, Inc. (Haywood, CA)
Moderator:
Sandra A. Bresnick
Partner
Quinn Emanuel Urquhart & Sullivan, LLP (New York, NY)
- Defining inducement of infringement and divided infringement under current law
- how the Supreme Court’s ruling in Global Tech v. SEB has altered the standard for inducement findings
- mens rea requirements
- willful blindness vs. deliberate indifference
- indirect vs. direct infringement
- the concept of divided and joint infringement vis-à-vis Akamai Technologies, Inc. v. Limelight Networks, Inc. (Fed. Cir. 2011) and McKesson Technologies Inc. v. Epic Systems Corp. (Fed. Cir. 2011)
- Exploring the relationship between inducement actions and divided infringement allegations and how they apply to methods of treatment claims in pharmaceutical patents
- Examining inducement and divided infringement challenges to methods of treatment claims listed in the Orange Book
- AstraZeneca LP v. Apotex, Inc.: exploring the role of Section viii carve-outs and the inducement controversy
- How may the Federal Circuit’s en banc rulings in Akamai and McKesson influence Paragraph IV challenge of these types of Orange Book listed patents going forward?
10:15 Morning Coffee Break
10:30 Exclusivities and Forfeitures: New Developments, Controversies and Concerns Relative to Paragraph IV Litigation
Michael P. Dougherty
Special Counsel
Cadwalader, Wickersham & Taft LLP (New York, NY)
Kelly J. Eberspecher
Shareholder
Brinks Hofer Gilson & Lione (Chicago, IL)
D. Christopher Ohly
Partner
Schiff Hardin LLP (Washington, DC)
Moderator:
Thomas J. Filarski
Partner
Steptoe & Johnson LLP (Chicago, IL)
- Assessing the possible impact of the proposed FAIR Generics Act on 180 day exclusivity
- evisceration of 180 day market exclusivity?
- sharing of exclusivities among competitors
- proposed extension of NCE exclusivity and related impact on 180-day market exclusivity
- Deciphering the FDA’s stance on pre and post–MMA 180-day exclusivity
- When can the 180-day exclusivity period be transferred to another ANDA applicant?
- Evaluating when the 180-day exclusivity period can be relinquished, and exploring the consequences
- When can a brand “park” a generic’s exclusivity?
- Defining “shared exclusivity”
- How have authorized generics changed the playing field relative to 180-day exclusivity?
- Exploring regulatory bars to exclusivity
- Forfeiture provisions: circumstances under which exclusivity is forfeited
- identifying circumstances under which forfeiture of another’s exclusivity may occur?
- Interpreting the “earlier of”, later of” language in making a forfeiture determination
- Evaluating the strength of “the failure to market” provision post-Lipitor
- Exploring simultaneous qualification for and forfeiture of exclusivity for failure to obtain tentative approval
- Evaluating the impact of “delisting” on forfeiture
- Forfeiture relative to patent expiration
- Understanding the relationship between forfeiture and the increase in generic/generic litigation
- Revisiting the relationship between exclusivity, forfeiture and the 30 month stay
- circumstances under which a second stay may be granted impact on grant of exclusivity
11:15 Pay-for- Delay Update
Markus H. Meier
Assistant Director of the Health Care Division
Bureau of Competition Federal Trade Commission (Washington, DC)
The FTC continues to vigorously use its enforcement and policy tools to prevent anticompetitive business practices in the pharmaceutical industry. Over the last several years, the Commission has used much of this arsenal on the matter of “reverse settlement” or “pay-for-delay” agreements which it views as a very anticompetitive practice. The FTC is not alone in this view, as the DOJ and some members of Congress have also come to the conclusion that these agreements are in restraint of trade and cause great harm to the consumer.
Markus Meier, Assistant Director of the FTC’s Bureau of Competition’s Health Care Division will discuss the current status of the FTC’s efforts to end “pay-for-delay” settlements and address such matters as:
- The status of pending FTC litigation concerning patent settlements
- The status of pending legislation regarding “pay-for-delay” settlements
- The enforcement of the MMA reporting requirements
- The findings of the FTC’s authorized generic’s study
12:00 Networking Luncheon
1:15 New Standards in Inequitable Conduct Post-Therasense: Ethical Considerations for Paragraph IV Cases
Matthew P. Blischak
Executive Counsel, Global Branded IP Litigation
Teva Pharmaceuticals (Horsham, PA)
Vincent L. Capuano, Ph.D.
Partner
Duane Morris LLP (Boston, MA)
Stephen J. Moore
Partner
Kelley Drye & Warren LLP (Stanford, CT)
Bruce M. Wexler
Partner
Paul Hastings LLP (New York, NY)
Moderator:
Mark E. Waddell
Partner
Loeb & Loeb LLP (New York, NY)
- Examining the Federal Circuit’s tightening of the of the inequitable conduct standard in Therasense
- intent to deceive
- single most reasonable inference
- materiality
- ‘but’ for test
- possible Supreme Court review?
- Exploring the application of Therasense in a Paragraph IV scenario
- Pfizer v. Teva
- awarding sanctions for asserting unsubstantiated claims of inequitable conduct
- repercussions of this ruling and its impact for future inequitable conduct filings
- Re-examining the relationship between inequitable conduct and corporate fraud
- future question of corporate intent in a Hatch-Waxman setting
- Inequitable conduct and Patent Reform
- supplemental proceedings under the AIA: an opportunity to cure inequitable conduct?
2:15 Afternoon Refreshment Break
2:30 New Controversies Surrounding Damages and Injunctions Relative to At Risk Launches
William F. Cavanaugh, Jr.
Partner
Patterson Belknap Webb & Tyler LLP (New York, NY)
Nicholas Groombridge
Partner
Paul, Weiss, Rifkind, Wharton & Garrison LLP (New York, NY)
David A. Manspeizer
Partner
Wilmer Cutler Pickering Hale and Dorr LLP (New York, NY)
Don J. Mizerk
Partner
Husch Blackwell LLP (Chicago, IL)
- Launching at risk during litigation or the appeal period
- - benefits and risks analysis Injunctions
- Examining the inconsistencies between the Federal Circuit and the Supreme Court relative to the granting of a preliminary injunction
- - intra-Circuit split
- - Kimberly-Clark Worldwide, Inc. v. First Quality Baby Products, LLC, Case No. 10-1382 (Fed. Cir., Sept. 29, 2011)
- - eBay Inc. v. MercExchange, LLC, 547 U.S. 388 (2006)
- - considerations by the District Courts in light of this inconsistency
- Practical strategies for brand names and generics in dealing with this discord before the District Courts and Federal Circuit
- Seeking a preliminary injunction in the event that the stay ends in the course of the litigation
- - posting of bond by the branded side
- Exploring the possibility of a stipulated injunction
- - why a stipulated injunction may be of benefit to both sides
Damages Analysis
Yogesh Bahl Partner
Deloitte Financial Advisory Services LLP (New York, NY)
Jeffrey N. Myers
VP and Assistant General Counsel, Intellectual Property Enforcement
Pfizer Inc (New York, NY)
The question of damages in at risk launch has caused considerable concern of late. Not too long ago, all eyes were on Sanofi v. Apotex (Plavix) and its provisions on stipulated damages. Now, the industry is carefully watching the Protonix litigation to see how damages may be assessed in an at risk launch in the absence of such stipulation. This panel will explore these matters as well as:
- The quantification of damages
- brand–name vs. generic point of view
- small v. large generic company concerns
- Lost profits:
- assessment of profit as a true measure of damages
- is the drug profitable?
- a question of sales
- when is it the only thing that you can seek?
- Reasonable royalties:
- basis for royalty
- looking at market share
- the point where infringement began
- Mitigating factors impacting damage award
4:00 Parallel Proceedings in Paragraph IV Disputes: Strategies for Balancing and Streamlining Proceedings Before the Federal Courts, PTO and ITC
Asim M. Bhansali
Partner
Keker and VanNest (San Francisco, CA)
Timothy R. Howe, Ph.D., JD, CLP
Vice President, Legal Affairs
General Counsel and Head, Acquisitions and Licensing Transactions
Sanofi Pasteur (Swiftwater, PA)
Thomas J. Kowalski
Shareholder
Vedder Price (New York, NY)
The passage of the America Invents Act and the recent acceptance of a Paragraph IV case by the ITC have brought the matter of parallel proceedings in Hatch-Waxman litigation into greater focus. This panel will examine the different forums and proceedings before which Paragraph IV litigants may seek simultaneous redress. Points of discussion will include:
- Forums in which parallel Paragraph IV challenges may be brought
- PTO
- Federal District Court
- ITC
- Evaluating the types of proceedings which may run parallel to a Paragraph IV Dispute
- traditional District Court litigation
- new PTO proceedings
- post grant review
- inter partes review
- existing ex partes reexam mechanism
- ITC investigatory actions under section 337 of the Tariff Act of 1930
- Analyzing whether parallel proceedings make sense in view of the particular circumstances of your Paragraph IV challenge
- Cost and time comparisons
- which proceedings make the most economic sense in terms of time and money?
- Specific concerns for joinder relative to District Court and PTO Procedures under the AIA
- Exploring circumstances in which a 337 Complaint can be brought before the ITC in a Paragraph IV matter
- In the Matter of Certain Gemcitabine and Products Containing the Same (Eli Lilly Section 337 Complaint)
- Stays of District Court and ITC proceedings in view of pending decisions from the PTO
- Federal Circuit appeals during the pendency of parallel proceedings
- Factoring in new rules relating to:
- how each type of proceeding will be conducted
- e.g., what types of validity attacks can be raised in each proceeding
- scope of proceeding
- scope of discovery in each type of proceeding
- legal standards of review
- Estoppel effects
5:00 Conference Ends
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