The
Fourth Henry Stewart One-Day Briefing on
Latest Thinking on
Attacking/Defending Patent Rights in the
U.S. Pharmaceutical and Biotechnology Markets
Chair:
David B. Clissold
Director
Hyman Phelps & McNamara, P.C.
Speakers:
David A. Balto
Partner
Robins Kaplan Miller & Ciresi, LLP
Karen I. Boyd
Principal
Fish & Richardson, P.C.
James Czaban
Shareholder
Heller Ehrman, LLP
Anthony M. Insogna
Partner
Jones Day
Thomas M. Saunders
Partner
Brown Rudnick Berlack Israels, LLP
John Serio
Senior Counsel
Brown Rudnick Berlack Israels, LLP
David K. Tellekson
Principal
Darby & Darby, P.C.
William R. Zimmerman
Partner
Knobbe, Martens, Olson & Bear, LLP
Regulatory
Exclusivity Strategies for Branded and Generic Companies Under
Hatch-Waxman, the MMA and Bioshield-2
The pharmaceutical industry is regulated under complex laws
that address both medical and economic issues. The interplay
of these issues under the rapidly changing law provides fertile
ground for companies to seek myriad types of marketing protection
above and beyond any patent rights applicable to drug products.
Understanding this landscape is crucial for both innovator and
generic drug companies. This presentation will address the laws
and regulations governing FDA regulatory exclusivities, and
provide real-world examples and strategies that have been used,
successfully and unsuccessfully, by innovator and generic pharmaceutical
companies. Issues to be covered include:
• Available regulatory exclusivities, including NCE exclusivity,
New Product (3-year) exclusivity, pediatric exclusivity extensions,
Orphan Drug Exclusivity and 180-day generic exclusivity
• The impact of recent changes to Hatch-Waxman under the
Medicare Modernization Act (MMA) and the status of FDA rulemaking
to implement MMA
• Patent term extension opportunities and strategies
• The impact of pending “Bioshield-2” legislation
on regulatory exclusivities and patent term extensions
• Recent court decisions interpreting the scope and applicability
of Hatch-Waxman exclusivity rights
James Czaban
Shareholder
Heller Ehrman, LLP
Merck
v. Integra - The Supreme Court Speaks on the 271(e)(1) Safe
Harbor
Merck v. Integra, which goes to the breadth and depth of the
“safe harbor” from patent infringement for activities
“solely for uses reasonably related” to FDA filings,
was argued April 21, 2005. We expect a decision in advance of
the conference. Ms. Boyd will discuss:
• The Supreme Court’s decision: what is it (and what
isn’t it)?
• What is black and white about the decision and where
are there still grey areas?
• How are the lower courts likely to apply the decision
in later cases?
• How do generics or innovators need to change their approach
to research and litigation?
Karen I. Boyd
Principal
Fish & Richardson, P.C.
Navigating
the Antitrust Risks while Protecting IP Rights
The intersection of IP and antitrust law creates a thicket of
a challenging litigation, counseling and transactional issues
in the pharmaceutical industry. There has been a tremendous
upsurge of litigation in this area. Mr Balto’s presentation
will address:
• How to settle pharmaceutical patent litigation without
incurring substantial antitrust risks
• New antitrust theories on strategic conduct
• Antitrust counterclaims in patent litigation
• Resolving litigation through strategic alliances and
joint ventures
• Antitrust on strategic alliances
David A. Balto
Partner
Robins Kaplan Miller & Ciresi, LLP
Coordinating
Worldwide Pharmaceutical Patent Litigation
• Choosing the proper forums and the timing of litigation
in various forums
• Factors to consider in selecting forums for patent challenges
• Things to consider when coordinating multi-country litigation
• Key issues regarding the use of prosecution history from
various jurisdictions in other jurisdictions
William R. Zimmerman
Partner
Knobbe, Martens, Olson & Bear, LLP
ANDA
Recipe: Costs, Hurdles and Timing on the Way to ANDA Filing
and 180 Days of Heaven
You will need
• A weak patent on a drug
• $25,000 – $50,000 for a non-infringement Paragraph
IV opinion
• $1,000,000 to a lot of money as a litigation reserve
(or a law firm with a taste for contingency work and about half
of the money)
• A non-infringing formulation that is bioequivalent
Abbreviated New Drug Application practice under Paragraph IV
acts as a letter of marque for vulnerable patents. Aggressive
generic houses actively search and destroy patents or settle
for greenmail on the courthouse steps. The prize of 180 days
of exclusivity market (but for the original manufacturer) is
enticing. So enticing that VCs are now funding the war chest.
Game theory and defense options will be addressed.
Thomas M. Saunders
Partner
Brown Rudnick Berlack Israels, LLP
Latest
Thinking on Patent Portfolio Strategy and Management
A strong patent portfolio for drug products, whether small molecule
pharmaceuticals or biopharmaceuticals, requires cutting edge
science and innovation. Careful monitoring of the research and
development process is needed to ensure that inventions are
immediately identified and properly protected. The speaker will
discuss:
• Invention spotting - where to look for inventions along
the drug discovery and development continuum
• How to prepare and when to file essential pharmaceutical
invention patent applications
• Recent case law developments on novelty (§102) and
written description and enablement (§112) and their impact
on application preparation
Anthony M. Insogna
Partner
Jones Day
Strategies
for Attacking and Defending Pharmaceutical Patents; a Modern
Take on “The Art of War”
• Inequitable conduct - “takeaways” from Purdue
Pharma v. Endo Pharmaceuticals, Inc.
• Inherent and accidental anticipation: contending with
polymorphs and enantiomers
• Defending/preventing validity challenges based on written
description and enablement
• Public Use Defenses; clinical trials
• Claim construction issues: Phillips v. AWH Corporation
• Best mode of attack/defense
• Proving and avoiding infringement: Festo and its Progeny
David K. Tellekson
Principal
Darby & Darby, P.C.
Patent
Opposition in the U.S.: Qui Bono
Proposed legislation creates a post-grant opposition procedure
in the U.S. This is in harmony with European practice. The opposition
procedure will offer the public an opportunity to challenge
issued patents. In theory such challenges will be more efficient
than the current thermonuclear litigation procedures. Post grant
opposition is strongly favored by the PTO and several other
Federal agencies. Implementation will have significant impact
on prosecution and litigation strategies. Are you ready?
The speaker will discuss:
• Proposed opposition framework – functional or Kafkaesque?
• Comparison with European oppositions
• Is the existing sole post-grant option –
re-examination – more than a mirage?
• Opposition as a litigation adjunct or litigation replacement
• Striking at your competition. When is the iron hot?
John Serio
Senior Counsel
Brown Rudnick Berlack Israels, LLP
Media Partners
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