Product-Hopping in the Pharmaceutical Industry: Antitrust Issues to Watch For in 2016
One of the antitrust issues expected to surge the drug industry this 2016 is the legal developments concerning the practice of product-hopping or “forced switching”. The U.S. government is getting critical in this tactic which thwarts generic competition. Recent lawsuits prove the government’s increased scrutiny of product-hopping. The appellate decision in New York v. Actavis upheld the injunction which requires the continued availability of an older Actavis drug until generic entry, after the introduction of the drug’s new version. This is to facilitate generic competition.
It is of paramount importance that in introducing a new drug formulation, branded drug firms must still consider the risk of a product-hopping lawsuit, which will eventually attract certain enforcement agencies.
In this one-hour LIVE Webcast, a panel of distinguished professionals and thought leaders will help drug companies understand the fundamental aspects of Product-Hopping in the Pharmaceutical Industry. They will provide an in-depth discussion of this significant topic. Speakers will also offer best practices in developing and implementing an effective strategy for the introduction of a new drug formulation.
Key topics include:
- Product-Hopping – Overview
- Significant Lawsuits:
- New York v. Actavis
- Mylan v. Warner-Chilcott
- Risk Mitigation Strategies
- Regulatory Forecasts
- Best Practices
- Definition -- "Product hopping" is not a well defined phrase. It is generally understood as a circumstance where a manufacturer of a branded pharmaceutical (a) introduces a new version of an existing medicine that has few or no benefits over the prior version, (b) attempts to convert the market from the old version of the product to the new version, and (c) withdraws the older version from commercial sales (d) before generic entry (e) in order to prevent generics from effectively competing with the brand, which is often defined as preventing the generics from taking advantage of state "automatic substitution" laws that call for pharmacists to fill prescriptions for brand name drugs with therapeutically equivalent generics.
- Wrongful product design -- Outside of the pharmaceutical context, a few cases have found that there is (or could be) antitrust liability from the re-design of a product. These cases involve allegations of tying (or variants of tying), where the re-design is alleged to allow the manufacturer to monopolize complementary markets (i.e. repairs or supplies). This has no analogue in the pharmaceutical context, and all courts who have issued opinions on the subject have rejected contentions that it is wrongful to introduce and market a new version of a pharmaceutical.
- Wrongful product withdrawal -- Some cases have held that it can violate the antitrust laws to withdraw a product from the market. Key decisions include the Supreme Court decision in Aspen Skiing (which did not involve pharmaceuticals), and the Second Circuit's recent decision in the Namenda litigation (which did). Namenda's holding remains controversial (as does Aspen Skiing). Even if one accepts the premise that withdrawing an older version of a drug can be actionable, numerous important questions remain unresolved: what triggers a manufacturer's alleged duty to continue to sell older products, when does the alleged duty ends, and what circumstances would justify a product withdrawal?
- Market Power and Exclusion -- The alleged injury from product hopping takes place after the generic manufacturers enter the market; the claim is that even though generics are present, they cannot effectively compete against a branded product that is not therapeutically equivalent. The decisions in Namenda and Doryx came to opposite conclusions regarding whether the generics have effective means of competition without recourse to automatic substitution laws. Questions being litigated include whether this is a question of law or fact, whether the Namenda decision reflected a uniquely vulnerable patient population, and the extent to which pharmaceutical markets respond to price signals.
- The Spirit of Hatch Waxman -- The 1984 Hatch-Waxman Amendments greatly affected the competitive landscape through amendments to the Food, Drug, and Cosmetics Act, and through amendments to the patent code. There is ongoing debate regarding the relevance of this statute -- which did not amend the antitrust laws -- to questions of antitrust liability. Even when viewed as a policy statement regarding drug competition, Hatch- Waxman provides ammunition for both sides in "product - hopping" cases. Hatch-Waxman provides a variety of incentives to encourage innovation, including providing exclusivity periods to manufacturers who develop new versions of existing medicines. On the other hand, although Hatch-Waxman does not discuss automatic substitution laws, one of the purposes of the Amendments was to enable generic manufacturers to launch their products (assumably bringing low prices with them) as soon as the relevant exclusivity period ends.
- Evaluating Product Switches
- New drugs, but not new compounds
- Legitimate justifications
- Stability, safety, anti-abuse
- Patient compliance, comfort, efficacy
- Questionable delays
- TriCor vs. Namenda
- Generic Ability to Reach Market
- Doryx vs. Namenda
- Brand vs. Generic Market Drivers
- Market share
- REMS Barriers to Entry
- Product Hopping & Settlement Agreements
- Preserving innovation options
- Maintenance of RLD and NDC
- Status on Medicare drug formulary list
- Guarding business flexibility
- Recent Cases / Cases to Watch
- Mylan v. Waner Chilcott (Doryx)
- Hartig v. Senju (Zymar/Zymaxid)
- Loestrin 24 FE Litigation
Who Should Attend:
- Antitrust lawyers
- Biotech/Pharma/Healthcare Attorneys & Advisors
- Life Sciences and Health Care Practice Consultants/Advisors
- Consultants & Clients in the Biotech, Pharmaceutical and Healthcare Industries
- Senior Management
- General Counsel in Life Sciences and Healthcare Industries
- Product Managers
- Pricing Managers
- Bio and Pharma Industries
- Other Related Professionals and Organizations
Jonathan Berman has over 20 years of litigation experience, focusing on antitrust cases, class actions, and other complex litigation matters. He focuses on the interplay between civil litigation and the laws administered by the Food and Drug Administration. Jonathan also has advised clients, on dozens of matters, regarding FDA law and practice.
Jonathan's antitrust docket has included cases involving allegations of product-hopping, pay-for-delay, and price-fixing, government challenges to mergers, exclusive contracts, and a variety of rule-of-reason and monopolization theories. He frequently litigates on behalf of clients in the health care sector. Jonathan has represented, in major litigation, pharmaceutical companies, a drug wholesaler, an insurer, and hospitals.
Jonathan Berman has over 20 years of litigation experience, focusing on antitrust cases, class actions, and other complex litigation matters. …
Mark Deming is an intellectual property attorney who regularly advises large and small companies throughout the country. Mark’s practice consists of patent, trademark, and trade dress matters, and he maintains a particular focus of Hatch-Waxman Act Paragraph IV litigation, assisting with the representation of both brand and generic pharmaceutical companies. Mark is involved in all aspects of case developments, from initial assessment to discovery, motions practice, claim construction, expert witnesses, trial and appeal. Mark is also a registered patent attorney.
Prior to joining Polsinelli, Mark clerked for two years with District Judge Michael Schneider and Magistrate Judge John Love in the United States District Court for the Eastern District of Texas, one of the nation’s busiest patent dockets. As a clerk, he developed broad experience with including patent litigation and assisted the court with conducting jury and bench trials, entering findings of fact and conclusions of law, holding Markman hearings, ruling on dispositive motions, evaluating the sufficiency of contention disclosures, resolving discovery disputes, and interpreting local rules.
Mark has a Bachelor of Science degree in Computer Engineering from the University of Illinois Department of Electrical and Computer Engineering.
Mark Deming is an intellectual property attorney who regularly advises large and small companies throughout the country. Mark’s practice consists …
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