Navigation Links
Former Clinton Deputy Solicitor General sheds light on flaws in Federal Trade Commission's case in FTC v. Actavis Inc.
Date:3/25/2013

WASHINGTON, March 25, 2013 /PRNewswire-USNewswire/ -- On the day the U.S. Supreme Court hears oral arguments in FTC v. Actavis, a case that challenges the rights of brand-name and generic drug manufacturers to settle patent litigation out of court, Paul Bender , who served as Principal Deputy Solicitor General under President Bill Clinton , has released a new white paper on the topic. Bender, currently professor of law and Dean Emeritus of the University of Arizona Law School, wrote the paper with colleagues Christopher A. Mohr and Michael R. Klipper . Entitled, "Inappropriate Interference With the Fundamental Right to Settle Litigation," the paper identifies a number of ways that the law supports the right of companies to include considerations in the settlement of these cases.

"There is no one more qualified to comment on these matters than Paul Bender ," said Ralph G. Neas , President and CEO of the Generic Pharmaceutical Association. "From the time that he clerked for Judge Learned Hand and then for Justice Felix Frankfurter until today, Paul has had a deep understanding of constitutional law. That, coupled with his decades of experience with the impact that policy can have on citizens, is what makes his analysis so salient.  Bender's paper confirms that not only should the court uphold the fundamental right of companies to include consideration in settling these cases, but that Congress should, too."

The white paper examines legislation currently before the Senate, S.214, that raises many of the same issues as the case facing the Court today.  The bill seeks to restrict the right of brand and generic pharmaceutical companies to settle out of court. Bender finds the premise of the law— and the FTC case— "hopelessly flawed," due to interfering with litigant rights to settle, unfair burdens of proof, conflict with the statutory presumption of patent validity, frustration of the pro-litigation provisions of Hatch-Waxman, and precluding pro-consumer settlements.

Specifically, Bender's paper takes aim at the idea that settlements are anti-competitive, stating instead that the patent is by design an anti-competitive legal measure to protect intellectual property. The paper states that "By addressing the presence of consideration in patent settlements entirely from the perspective of whether or not competition is increased, S. 214 ignores the fact that patents are themselves 'anti-competitive': the inventor has a monopoly in the inventions as a reward for innovation. That is why courts have generally held patent licenses immune from antitrust review."

He goes on to recommend that the Government use its current statutory authority to ensure that settlements are in the interest of consumers. In discussing the FTC's preferred solution of the presumptive prohibition of consideration, Bender says, "Rather than adopting that unusual and dangerous solution, the government should utilize the tools it has in hand under the Medicare Modernization Act of 2003 that require the FTC to review and prove the illegality of settlements on a case-by-case basis."

Neas said the paper represents a primer for those interested in learning more about patent settlements. "We firmly believe the Court will rule favorably for our position, as have three of four circuit courts of appeal, because patent settlements allow the introduction of the generic drug before brand patents expire. Further, they save the federal government and consumers billions of dollars annually.  This new paper provides a useful roadmap for legislators, addressing point-by-point why interfering with this legal right is the wrong thing to do."

White paper: S. 214's Inappropriate Interference With the Fundamental Right to Settle Litigation

Patent Settlements Fact Sheet

Summary of GPhA Amicus in FTC v. Actavis

GPhA represents the manufacturers and distributors of finished generic pharmaceuticals, manufacturers and distributors of bulk pharmaceutical chemicals, and suppliers of other goods and services to the generic industry. Generic pharmaceuticals fill 80 percent of the prescriptions dispensed in the U.S. but consume just 27 percent of the total drug spending. Additional information is available at gphaonline.org.

CONTACT: Claire Sheahan
202-249-7110


'/>"/>
SOURCE Generic Pharmaceutical Association
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Former NxStage Patient Nikolas Gieske Celebrates Kidney Transplant
2. Judge Upholds $3.3 Million Judgment In Favor of Fox Insurance Company Against Former Pharmacy Benefit Manager
3. Phonak and Special Olympics join forces with US Olympian, former Congressman Jim Ryun
4. Par Formulations (Formerly Edict Pharmaceuticals) Receives First ANDA Approval
5. Mike Golic, ESPN Radio Personality and Former Philadelphia Eagle, Holds Pre-Season "Training Camp" for People With Type 2 Diabetes
6. Lance Armstrong Update: Arrogant Even After Conceding Doping Charges, Asserts Former White House & WADA Spokesman Robert Weiner; Victory for Clean Sport but "Dark Message" Is Science Must Catch Up to Masking Agents Allowing Cheating
7. Cell Therapeutics, Inc. (CTI) Appoints Former Managing Director, Head of West Coast Biotechnology for Oppenheimer/CIBC Matthew J. Plunkett Executive Vice President, Corporate Development
8. Robert G. Savage, Former Worldwide Chairman, Johnson & Johnsons Pharmaceuticals Group, Joins Board of Nuovo Biologics, LLC
9. Prime Healthcare Hospitals Ranked as "Top Performers" by The Joint Commission
10. Omeros Responds to Misleading Announcement by Davis Wright Tremaine Concerning Settlement with Former Chief Financial Officer
11. NxStage Educational Reception at Annual Dialysis Conference Features Celebrity and Former NxStage User Stephen Furst
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... , June 24, 2016 ... appointment of Dr. Edward Futcher to ... Director, effective June 23, 2016.Dr. Futcher was also ... and Governance Committees.  As a non-executive member of ... expertise and strategic counsel to VolitionRx in connection ...
(Date:6/23/2016)... June 23, 2016 Any dentist who has made ... the current process. Many of them do not even offer ... difficulties and high laboratory costs involved. And those who ARE ... at such a high cost that the majority of today,s ... Dr. Parsa Zadeh , founder of Dental Evolutions Inc. ...
(Date:6/23/2016)... 23, 2016 Research and Markets has ... Market Analysis 2016 - Forecast to 2022" report to ... report contains up to date financial data derived from varied ... major trends with potential impact on the market during the ... segmentation which comprises of sub markets, regional and country level ...
Breaking Medicine Technology:
(Date:6/25/2016)... ... June 25, 2016 , ... Austin residents seeking Mohs surgery services, ... Mohs Surgery and to Dr. Russell Peckham for medical and surgical dermatology. , Dr. ... skin cancer. The selective fellowship in Mohs Micrographic Surgery completed by Dr. Dorsey was ...
(Date:6/25/2016)... ... June 25, 2016 , ... Dr. ... from injury. Recently, he has implemented orthobiologic procedures as a method for treating ... one of the first doctors to perform the treatment. Orthobiologics are substances that ...
(Date:6/24/2016)... Michigan (PRWEB) , ... June 24, 2016 , ... June ... about the dangers associated with chronic pain and the benefits of holistic treatments, ... individuals who are suffering with Sickle Cell Disease. , Sickle Cell Disease (SCD) is ...
(Date:6/24/2016)... ... 24, 2016 , ... Comfort Keepers® of San Diego, CA is excited to ... Recovery® program to drive cancer patients to and from their cancer treatments. Comfort ... quality of life and ongoing independence. Getting to and from medical treatments is ...
(Date:6/24/2016)... Las Vegas, Nevada (PRWEB) , ... June 24, ... ... their Las Vegas client, The Grove Investment Group (TGIG), has initiated cultivation and ... The Grove, in Las Vegas and Pahrump, Nevada. , Puradigm is the manufacturer ...
Breaking Medicine News(10 mins):