Intellectual Property Law Issues for Health Care Providers
IP|Trend: Inter Partes Review: What to Consider When Filing Your Petition
Inter-Partes Review of Patents: The Case So Far (CLE)
IP|Trend: New Era in Protection of Software by Intellectual Property Law?
Inter Partes Review: Validity Before the PTAB
IP|Trend: Discovering Source Code
Ropes & Gray: Advantages of the Patent Trial and Appeal Board
Post-Grant Insights: The Significance of a Three-Judge Panel
IP|Trend: The Importance of Consumer Surveys in Patent Litigation
Post-Grant Insights: The Need for Seamless Coordination of District Court & PTAB Litigation
IP|Trend: Inter Partes Review: Is it Litigation or Something Else?
Post-Grant Insights: The Preparation and Pace of the PTAB
Controlling the Cost of Patent Litigation
Post-Grant Insights: The Impact of PTAB Appeals on the Federal Circuit
Post-Grant Insights: Key Considerations in PTAB Oral Hearings
Post-Grant Insights: What claims to include in your PTAB petition
What are the Implications of Alice v. CLS?
What Does the Supreme Court Ruling in Alice v. CLS Mean to a Software Entrepreneur?
Derivation Proceedings: What You Need to Know
What is Graphene? Fenwick Patent Attorney Has the Answer
Since the 1984 enactment of the Drug Price Competition and Patent Term Restoration Act, Hatch-Waxman litigation has dominated the sphere of life-sciences patent litigation. The battle between proprietary and generic...more
On December 9, 2014, the Patent Trial and Appeal Board (“PTAB”) upheld the validity of three Supernus Pharmaceutical’s patents relating to once-daily formulations of doxycycline. The trio of decisions is significant because...more
The pharmaceutical industry has been closing watching the proceedings at the Patent Trial and Appeal Board ("PTAB" or "Board") to see if inter partes review ("IPR") will be a viable option for generic drug companies seeking...more
Kowa Company Ltd. v. Aurobindo Pharma Ltd., et al.
Case Number: 1:14-cv-02497-PAC -
Defendant Mylan asked the court to apply the Local Patent Rules to the case, specifically requiring plaintiff to serve its...more
This morning, the Food and Drug Administration (FDA) opened a public docket and requested comments on its proposed criteria for expedited review of "first generic" Abbreviated New Drug Applications (ANDAs). The comment period...more
Nature of the Case and Issue(s) Presented: The issue here concerns whether the owner of a pharmaceutical patent may simultaneously assert a claim for infringement under § 271(e)(2), and a claim pursuant to the Declaratory...more
Nature of the Case and Issue(s) Presented: Depomed sued Actavis for infringing seven patents related to a dosage form capable of being retained in the stomach, allowing for the delayed-release of gabapentin in the small...more
Nature of the Case and Issue(s) Presented: Plaintiff filed suit alleging infringement of claims 1, 16, 36, and 37 of each of the patents-in-suit. The patents-in-suit all claim pharmaceutical compositions containing propofol...more
Nature of the Case and Issue(s) Presented: Apotex appealed the district court’s finding that the ’556 patent was unenforceable due to inequitable conduct. The ’556 patent describes a method for making moexipril tablets used...more
Ferring B.V. v. Watson Labs., Inc. -
In Hatch-Waxman litigation that involved Abbreviated New Drug Applications (ANDAs) that were silent as to certain claimed limitations, the U.S. Court of Appeals for the Federal...more
Hatch-Waxman Litigation in a Nutshell -
Hatch-Waxman litigation refers to pharmaceutical patent litigation between a brand drug manufacturer and a generic drug manufacturer under the Hatch-Waxman Act (“Act”). The Act...more
Under what is commonly known as “Noerr-Pennington immunity,” persons exercising their First Amendment right to petition the government for redress are generally immune from antitrust liability, even though their actions may...more
Mylan filed a complaint on April 25, 2014, challenging a letter decision by the FDA, addressing the marketing exclusivity eligibility of celecoxib Abbreviated New Drug Application applicants. Mylan then filed a motion for...more
Last year’s Supreme Court decision in FTC v. Actavis cleared the way for more antitrust challenges to settlements between generic and branded pharmaceutical companies resolving Hatch-Waxman patent litigation. As a result,...more
In This Issue:
- WHAT ARE REVERSE PAYMENT SETTLEMENT AGREEMENTS?
..The Basic Framework of Hatch-Waxman Litigation
..The Federal Trade Commission’s View of Reverse Payment Settlements and Its...more
The Hatch-Waxman Litigation and Life Sciences practice groups at Robins, Kaplan, Miller & Ciresi L.L.P. are pleased to offer the latest edition of their quarterly publication regarding ANDA patent litigation issues and the...more
When does a prior art disclosure of a concentration range of a medicament render obvious the use of a species that falls within that range, when that same use was also known in the prior art? After all, common sense should...more
RECENT DECISIONS -
Federal Trade Commission v. Actavis -
Patent Holding: (5-3) reverse payment settlement agreements should be reviewed based on a “rule of reason.
In a split...more
Last week, two district courts dispensed with lawsuits based on the protections afforded by the safe harbor provision of the Hatch-Waxman statute. Both of the cases relied heavily on the Federal Circuit case Momenta Pharm....more
The old adage "Bad cases make bad law" is invoked when the facts of a case lead a court to rule in favor of the particular entities before it rather than applying the law consistently. (Although anyone familiar with recent...more
A divided Supreme Court recently held in an opinion by Justice Breyer that “reverse payment” or “pay for delay” agreements between patent holders and potential competitors are not immune from scrutiny under antitrust laws....more
Antitrust challenges to so-called “pay-for-delay” settlements in drug patent suits are allowed under the U.S. Supreme Court’s recent decision in Federal Trade Commission v. Actavis, Inc....more
One of the most controversial antitrust issues for the pharmaceutical industry during the last decade has been the treatment of patent settlements in which a patent-holding branded manufacturer made payments to its generic...more
On June 17, 2013, the United States Supreme Court announced a rule that blurs the lines between antitrust and patent law in the context of Hatch-Waxman litigation....more
- Patent settlements must be analyzed under the rule of reason, requiring a full analysis of the net competitive effects
- Payments to an alleged infringer may be permissible if justified by, for...more
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