American Conference Institute’s 8th Annual
Paragraph IV Disputes
Expert Insights on Hatch-Waxman Litigation Strategies for Brand Names and Generics
Best Practice Tips from
April 28-29, 2014 | The Conrad – New York | New York City
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Christopher R. Noyes
Wilmer Curler Pickering Hale and Dorr LLP
Best Practice Tips
Use of IPR and Other PTO Proceedings in A Paragraph IV Challenge: Strategies For Brand Names and Generics in
Navigating PTO Proceedings in ANDA Litigation
Although the ways in which generic challengers might use Inter Partes Review (“IPR”) against Orange Book listed
patents are still developing, an innovator facing potential Paragraph IV litigation and/or IPR proceedings should take
preemptive measures to prepare for these potential challenges:
a. Identify and prepare experts – Identify and retain testifying and consulting experts well in advance of a
potential IPR or Paragraph IV challenge to secure access to the best experts. Early retention also allows experts
to fully investigate, among other things, the prior art of record, objective indicia of non-obviousness, and claim
b. Develop claim construction positions – Develop preliminary claim construction positions under the broadest
reasonable construction standard applied by the PTAB. Given the short time to respond to an IPR petition,
having claim construction positions vetted may be essential to an effective response;
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c. Investigate and develop objective indicia of non-obviousness –Recent Federal Circuit decisions reaffirm that
objective indicia of non-obviousness are important evidence in responding to an obviousness attack.
Innovators should investigate and develop objective indicia early and gather a robust portfolio of evidence,
particularly given the time constraints and limited discovery available in IPR proceedings;
d. Investigate prior art of record – Investigate the prior art of record and work with experts to develop novelty
and non-obviousness defenses. Given the applicable disclosure standard (relevant information that is
inconsistent with a position advanced under 37 C.F.R. 42.51(b)(1)(iii)), innovators should think carefully before
investigating potential prior art that is not in the file history.
After Paragraph IV litigation begins, innovators should consider the following when addressing or anticipating
parallel IPR proceedings:
a. Evidence and potential estoppel – When taking positions in either proceeding, keep in mind that arguments
made during IPR proceedings may be introduced as evidence in district court litigation, for example, during
claim construction; and PTAB decisions may be relied upon to invoke estoppel;
b. Prosecution Bars – Draft any prosecution bar in a protective order or Offer of Confidential Access to ensure
that your counsel for the IPR proceedings are not precluded from reviewing confidential information in the
district court litigation, or that counsel who had access to a generic’s confidential information are not
precluded from participating in the IPR proceeding;
c. Motion to Stay Paragraph IV litigation pending IPR – If an IPR is filed during Paragraph IV litigation, innovators
should consider how and if the 30-month stay of FDA approval would be tolled.
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Under 21 U.S.C. § 355(j)(5)(B)(iii), a court can extend the 30-month stay if “either party of the action failed to
reasonably cooperate in expediting the action.” Courts have held that seeking a motion to stay alone is
failing to “reasonably cooperate in expediting the action.” Depending on the desired outcome, innovators
should tailor their response or opposition to any motion to stay with the potential impact on the 30-month
stay in mind;
d. Consider intersection of Section 103 and 112 – Arguments to overcome obviousness attacks in an IPR
proceeding may, at least in certain circumstances, appear inconsistent with responses to written description,
enablement and utility challenges in district court litigation. Develop and put forth positions that take into account
any potential inconsistencies.
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David A. Manspeizer
Wilmer Cutler Pickering Hale and Dorr LLP
The Law on Damages In Generic Drug Launches Remains Vague
It was a stunning number, purportedly the largest patent settlement in history. During trial, defendants Teva
($1.6billion) and Sun ($550 million) agreed to pay plaintiffs Wyeth and Nycomed a combined $2.15 billion to settle
litigation stemming from their “at-risk” launches of generic versions of Wyeth and Nycomed’s Protonix product.
At-risk launches have become a popular tactic by generic companies over the last 10 years. As a result, counsel for
branded and generic companies are increasingly litigating highly complex damages issues. However, the law on
patent damages as applied to the interactions between generic and branded products in the pharmaceutical
marketplace remains largely undeveloped.
Before 2002, the idea that a generic company would begin selling its product before a favorable decision from the
U.S. Court of Appeals for the Federal Circuit seemed only a theoretical possibility. The risk that a product launch
would result in damages exceeding its profits, together with the purpose of the Hatch-Waxman Act itself,
appeared to mean that no generic company would launch before such certainty (generic drugs are typically sold at
a substantial discount to the brand).
For the complete article click here
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Paul A. Ragusa
Baker Botts L.L.P.
Pharmaceutical Product Switching: Antitrust Pitfalls
The terms “product switching,” “product hopping” and “line extension” are often used to describe the strategy of
protecting market share by reformulating or otherwise modifying an existing branded pharmaceutical product in a
manner which requires approval from the U.S. Food and Drug Administration. Under this approach a
pharmaceutical company introduces a product line extension to a branded drug product before generic entry, and
promotes the extension product instead of the old product. In some instances, the company also removes the old
product from the market, and/or changes the product’s National Drug Data File (NDDF) code to “obsolete.” State
drug product selection (DPS) laws often permit a physician to substitute a so-called “AB-rated” generic for a
branded drug, resulting in a reduced market share for the branded product. However, a company can reduce or
delay the impact of generic entry to a branded product by product switching, since any approved generic will likely
be AB-rated only as to the old product, and therefore can not be substituted for the new line extension product.
If the market shifts in favor of the new line extension product by the time generics enter the market with a generic
of the old branded product, the impact on the company’s sales will thus be reduced. However, antitrust issues can
arise for certain product switching scenarios, as further discussed below.
For the complete article click here
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Stephen R. Auten
Partner, Chair of Pharmaceutical & Life
Taft Stettinius & Hollister LLP
Best Practice Tips
Join Mr. Austen's Hatch-Waxman ANDA Litigation Forum Group
• Understanding the business motivation of clients, as the litigation budget has to be prepared in view of the
internal value of the project.
• Knowing the interplay between FDA regulations and how a patent design around may delay or ultimately
doom final product approval.