- Acumen Powered by Robins Kaplan LLP™
- Affirmative Recovery
- American Indian Law and Policy
- Antitrust and Trade Regulation
- Appellate Advocacy and Guidance
- Business Litigation
- Civil Rights and Police Misconduct
- Class Action Litigation
- Commercial/Project Finance and Real Estate
- Corporate Governance and Special Situations
- Corporate Restructuring and Bankruptcy
- Domestic and International Arbitration
- 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 Disputes
-
June 22, 2021Michele Detherage Named President of the Massachusetts Insurance and Reinsurance Bar Association
-
June 16, 2021Robins Kaplan Receives High Ranks from Managing Intellectual Property Magazine in 2021; Six Partners Recognized as “IP Stars”
-
June 8. 2021Robins Kaplan Attorneys Named To 2021 “Southern California Rising Stars” List
-
June 25, 202118th International Conference on Artificial Intelligence and Law (ICAIL 2021): AI & Patents Workshop
-
June 28, 2021Pride Month CLE
-
July 22, 2021Navigating Healthcare Changes with the Biden Administration: What’s in Store for MedTech Leaders
-
Summer 2021Family Feud: A Cautionary Tale of the Costs, Risks, and Uncertainty of Minority-Shareholder Litigation
-
Summer 2021In the Beginning: Choosing the Right Corporate Entity
-
Summer 2021Life After Settlement: Crafting Agreements to Avoid Future Disputes
-
June 23, 2021Financial Daily Dose 6.23.2021 | Top Story: Home Buying Slows, but Median Prices Hit Record High in U.S.
-
June 22, 2021Financial Daily Dose 6.22.2021 | Top Story: EU Opens Antitrust Probe into Google’s Ad Services
-
June 21, 2021Financial Daily Dose 6.21.2021 | Top Story: Credit Suisse Turns Off Cash Spigot for SoftBank and Masa Son
Find additional firm contact information for press inquiries.
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. 4, No. 4
Winter 2014
The Winter 2014 issue of the GENERICally Speaking email campaign provides you and your company with some of the knowledge beneficial to remaining attentive to the complexity of ANDA patent litigation.
Relevant court decisions highlighted in this issue:
- Mylan Pharms., Inc. v. FDA
- Sandoz Inc. v. Amgen Inc.
- Par Pharm., Inc. v. TWI Pharms., Inc.
Read more about these and other important court decisions, New ANDA Cases, ANDA Litigation Settlements, ANDA Approvals, and Generic Launches.
Related Professionals
The FDA responded to the application by identifying various deficiencies.
The issue here concerns whether the Federal Circuit should conduct an en banc hearing regarding the issue of whether evidence that post-dates the effective filing date of the patent may be used to demonstrate unexpected results to defeat an obviousness challenge.
Cubist alleged that Hospira’s ANDA products infringe the asserted claims of the patents-in-suit. The court held a five-day bench trial.
Glenmark, who was not the first ANDA filer, was attempting to obtain FDA approval to market a generic version of drug claimed by the ’340 patent.
The issue here concerns whether the Hatch-Waxman Act requires ANDA applicants to certify as to both an original and a subsequent reissue patent.
Par sued TWi for infringing its patent related to the use of nanosized megestrol formulations to “increase the body mass in a human patient suffering from anorexia, cachexia, or loss of body mass.”
When a POSA would have to undertake significant guesswork to vary the parameters of prior-art compounds in order to formulate the claimed composition, and prior-art lead compounds taught away from the claimed composition, the court found the patents-in-suit not obvious.
The issue here is whether an alleged infringer can file declaratory judgment action seeking a finding of non-infringement and/or invalidity of patents when the alleged infringer has not filed an application with the FDA.
Because the ANDA product did not meet the claimed dosage strength, summary-judgment of non-infringement was granted; issues concerning invalidity were not amenable to summary judgment as disputes of material fact remained.
Hikma launched the accused product, Mitigare, an oral single-ingredient colchicine product indicated for prophylaxis of gout flares in adults.
Generic drug manufacturer was liable for patent infringement as a matter of law when the level of acceptable impurities described in the manufacturer’s ANDA included the range of acceptable impurities claimed in the patent, and its invalidity defenses—anticipation, obviousness, non-enablement, and inequitable conduct—were rejected by the court.
The issue here concerns whether the district court was correct in granting summary judgment in favor of the defendants, finding that the asserted claims of the patents-in-suit were invalid due to obviousness.
Reference Listed Drug, NDA Holder, Generic Drug Name, ANDA Applicant(s), Indication and Launch Date
Subscribe to our quarterly GENERICally Speaking Update.
Subscribe Now
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.