- 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
- 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
-
November 20, 2024Eighth Circuit Affirms U.S. Merchants Victory in Trade Dress Infringement Case
-
November 15, 2024Lauren Coppola Named an Emerging Leader by Profiles in Diversity Journal
-
November 11, 2024Tommy Du Honored With 2024 Sheila Sonenshine Associate Pro Bono Award
-
December 3, 2024Can You Keep a Secret? Privacy Laws and Civil Litigation
-
December 11, 20242024 Year in Review: eDiscovery and Artificial Intelligence
-
December 12, 2024Strategies for Licensing AI: A Litigation Perspective
-
November 8, 2024Trademark tensions on the track: Court upholds First Amendment protections in Haas v. Steiner
-
November 8, 2024Destination Skiing And The DOJ's Mountain Merger Challenge
-
November 6, 2024How Recent Patent Damages Precedent May Increase Reasonable Royalty Awards
-
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. 2, No. 3
Fall 2012
The Fall 2012 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:
- GlaxoSmithKline PLC v. Hikma Pharm. Co. Ltd.
Finding that the ANDA product did not infringe the asserted claims (literally or under the doctrine of equivalents) since propylene glycol is not a saccharide; the claims were sufficiently enabled. - Pfizer Inc. v. Teva Pharm. U.S.A., Inc.
Court finds asserted patents valid and infringed, but only under doctrine of equivalents. - ISTA Pharm., Inc. v. Food and Drug Administration
ANDA applicants may rely on labeling of non-marketed drugs for purposes of generic product labeling.
Related Professionals
Reference Listed Drug, NDA Holder, Generic Drug Name, ANDA Applicant(s), Indication and Launch Date
Induced infringement may be found when all of the claimed steps are performed, regardless of the number of entities needed to perform them.
When the prior art discloses a portion of the claimed range, the patent claim at issue is invalid as obvious; the motivation of a person of ordinary skill to combine prior art does not need to be the same as that of the patentee; inherency is considered in an obviousness analysis.
Issues of fact preclude summary judgment of anticipation as priority date of reference was disputed; issues of fact precluded summary judgment of indefiniteness, lack of written description and lack of enablement.
Patent not invalid for obviousness-type double patenting.
Because prior art shows that increased drug concentration caused irritation, it taught away from claimed invention that disclosed tripling prior art ranges, and therefore asserted claims were not obvious; no inequitable conduct; not invalid for lack of written description; no standing to sue as to non-exclusive licensee.
Finding that the ANDA product did not infringe the asserted claims (literally or under the doctrine of equivalents) since propylene glycol is not a saccharide; the claims were sufficiently enabled.
Reverse payment settlements are antitrust violations.
ANDA applicants may rely on labeling of non-marketed drugs for purposes of generic product labeling.
Patent claiming 25 micrograms ethinyl estradiol not invalid based on genus/species anticipation arguments and obviousness despite the fact that the prior art disclosed a range of 20-50 micrograms of ethinyl estradiol.
Safe harbor provision of Hatch-Waxman allows post-approval batch testing.
A court may issue an injunction requiring correction of an improper use code, but may not dictate the precise terms of the corrected code.
Court finds asserted patents valid and infringed, but only under doctrine of equivalents.
Federal Circuit affirms findings of validity and infringement under the doctrine of equivalents.
Because negative claim limitations are adequately supported when the specification describes a reason to exclude the relevant limitation, finding of invalidity is reversed.
The burden for proving invalidity is clear and convincing evidence; it is not heightened if prior art references were before the Patent Office nor is it lowered if a patent issues erroneously.
Claim preclusion barred plaintiffs from asserting reexamined claims that were substantially similar to the original claims that plaintiffs asserted in a first ANDA litigation.
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.