- Acumen Powered by Robins Kaplan LLP®
- American Indian Law and Policy
- Antitrust and Trade Regulation
- Appellate Advocacy and Guidance
- Business Litigation
- Civil Rights and Police Misconduct
- Class Action Litigation
- Corporate Governance and Special Situations
- Corporate Restructuring and Bankruptcy
- Domestic and International Arbitration
- Entertainment and Media Litigation
- Health Care Litigation
- Insurance and Catastrophic Loss
- Intellectual Property and Technology Litigation
- Mass Tort Attorneys
- Medical Malpractice Attorneys
- Personal Injury Attorneys
- Telecommunications Litigation and Arbitration
- Wealth Planning, Administration, and Fiduciary Disputes
Acumen Powered by Robins Kaplan LLP®
Ediscovery, Applied Science and Economics, and Litigation Support Solutions
-
June 17, 2024Emily Tremblay Named IP Rising Star by Euromoney in 2024 Women in Business Law Awards
-
June 17, 2024Three Robins Kaplan Partners Named BTI Client Service All-Stars
-
June 13, 2024Brendan Johnson Named South Dakota Trial Lawyer of The Year
-
June 27, 2024Sex Abuse Litigation
-
June 10-11, 20242024 Probate and Trust Law Section Conference
-
June 11, 2024FBA 2024 Federal Practice Seminar
-
June 2024Robins Kaplan Secures Landmark $7.75 Million Verdict in Aerosol Duster Misuse Case
-
June 2024To Seize or Not to Seize: Campus Protests and Police Uses of Force
-
June 2024Communicating Your Estate Plan: A Helpful Tool, Not a Fix-All
-
September 16, 2022Uber Company Systems Compromised by Widespread Cyber Hack
-
September 15, 2022US Averts Rail Workers Strike With Last-Minute Tentative Deal
-
September 14, 2022Hotter-Than-Expected August Inflation Prompts Massive Wall Street Selloff
Find additional firm contact information for press inquiries.
Find resources to help navigate legal and business complexities.
Read our attorneys' take on the latest news and trends in the legal and business industries.
GENERICally Speaking Hatch Waxman Bulletin
The Hatch-Waxman Litigation practice group at Robins Kaplan LLP is pleased to offer the latest edition of their quarterly publication regarding ANDA patent litigation issues and the generics business.
Vol. 6, No. 1
Spring 2016
Relevant court decisions highlighted in this issue:
- Acorda Therapeutics Inc. v. Mylan Pharms. Inc.
The act of filing an ANDA, coupled with intent to market a generic drug in Delaware, was sufficient basis to establish specific personal jurisdiction in Delaware. - Warner Chilcott Co., LLC v. Teva Pharms. USA, Inc.
One of skill in the art would be motivated to obtain the logical goal of a drug to have bioavailability that is affected by coadministration with food. - Purdue Pharma L.P. v. Epic Pharma, LLC
In affirming judgment of invalidity, the Federal Circuit credited the district court’s findings concerning the disclosure of the prior art and the adequacy and reliability of Defendants’ expert’s testing results and methodology.
- ANDA Approvals
- ANDA Litigation Settlements
- Generic Launches
- New ANDA Cases
Related Professionals
The act of filing an ANDA, coupled with intent to market a generic drug in Delaware, was sufficient basis to establish specific personal jurisdiction in Delaware.
ANDA must be “received” by FDA for district court litigation to proceed.
All that was required to constitute standing by ANDA filer was to show that a patent’s listing constituted an independent barrier to entry into the drug market and that a judicial decision could remove that barrier.
Because the ANDA product does not satisfy the claimed volume limitation of the patent and the use claimed in the patent is not FDA-approved, the ANDA product does not infringe the patent-in-suit.
The district court applied the law of on-sale bar and the written description requirement to support findings that defendant did not meet its burden to show patent invalidity.
In affirming judgment of invalidity, the Federal Circuit credited the district court’s findings concerning the disclosure of the prior art and the adequacy and reliability of Defendants’ expert’s testing results and methodology.
Applying the Federal Circuit’s claim construction on remand, the district court found that Defendant’s’ ANDA product will infringe the asserted claims of the patent-in-suit.
Based on the court’s claim construction, two of the three patents-in-suit were found infringed, and all three were not invalid.
One of skill in the art would be motivated to obtain the logical goal of a drug to have bioavailability that is affected by coadministration with food.
Any information that you send us in an e-mail message should not be confidential or otherwise privileged information. Sending us an e-mail message will not make you a client of Robins Kaplan LLP. We do not accept representation until we have had an opportunity to evaluate your matter, including but not limited to an ethical evaluation of whether we are in a conflict position to represent you. Accordingly, the information you provide to us in an e-mail should not be information for which you would have an expectation of confidentiality.
If you are interested in having us represent you, you should call us so we can determine whether the matter is one for which we are willing or able to accept professional responsibility. We will not make this determination by e-mail communication. The telephone numbers and addresses for our offices are listed on this page. We reserve the right to decline any representation. We may be required to decline representation if it would create a conflict of interest with our other clients.
By accepting these terms, you are confirming that you have read and understood this important notice.
If you are interested in having us represent you, you should call us so we can determine whether the matter is one for which we are willing or able to accept professional responsibility. We will not make this determination by e-mail communication. The telephone numbers and addresses for our offices are listed on this page. We reserve the right to decline any representation. We may be required to decline representation if it would create a conflict of interest with our other clients.
By accepting these terms, you are confirming that you have read and understood this important notice.