Novartis

News & Analysis as of

A Minor Shift in Patent Term Adjustment Calculations - Novartis AG v. Lee; Exelixis, Inc. v. Lee

Presented with a challenge to patent term adjustments as determined by the Patent and Trademark Office (PTO) under 35 U.S.C. § 154(b), the U.S. Court of Appeals for the Federal Circuit held that post-allowance delays are ...more

News from Abroad: A Strict Approach to Priority Entitlement by the UK Court of Appeal

The Decision of the Court of Appeal in Hospira UK Generics Ltd. v. Novartis AG, [2013] EWCA Civ. 1663 was issued on 19 December 2013....more

Federal Circuit Partially Confirms Longer Patent Terms Under Exelixis and Novartis

On January 15, 2014, the U.S. Court of Appeals for the Federal Circuit confirmed that patent owners may be entitled to extended patent terms, a finding that is especially important for select pharmaceutical, biotech, and...more

New Paradigm In Australian Patent Oppositions

For many years the pre-grant patent opposition process has been a useful, but somewhat problematic mechanism for a person to challenge the validity of a patent application. As a specialist tribunal, the Patent Office could...more

Court Report - February 09, 2014

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Novartis Pharmaceuticals Corp. et al. v. Dr. Reddy's Laboratories Ltd. et al. 1:14-cv-00157; filed February 5, 2014 in...more

Federal Circuit Decision Impacts Patent Term Adjustment Calculation

Recently, the Federal Circuit issued a decision in Novartis v. Lee (2013-1160, Fed. Cir., Jan. 15, 2014) which alters Patent Term Adjustment (PTA) calculations for patents where a Request for Continued Examination (RCE) was...more

Court Report - Part II: February 03, 2014

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Novartis Pharmaceuticals Corp. et al. v. Noven Pharmaceuticals Inc. et al. 1:14-cv-00111; filed January 30, 2014 in the...more

Federal Circuit Clarifies Calculation of Patent Term Adjustment for Applications with Continued Examination Requests

In a recent ruling, the Federal Circuit clarified the scope of available Patent Term Adjustment (PTA) resulting from the U.S. Patent and Trademark Office's (PTO) failure to issue a patent within three years from the date the...more

Federal Circuit Clarifies Patent Term Adjustments

The Federal Circuit ruled last week that the Patent Office had incorrectly calculated the patent term adjustments for patents owned by Novartis and opened the door to longer patent terms....more

Federal Circuit Decisions Result in Minor Adjustments to Patent Term Adjustment

Novartis v. Lee and Exelixis v. Lee (2013-1160, 2013-1179, 2013-1175, Fed. Cir. 2014) - Summary: For a patent application issuing after 3 years, an RCE filed at any time during prosecution will reduce patent...more

Re-Calculating Patent Term Adjustments Once Again

The Federal Circuit has adjusted the way we calculate Patent Term Adjustments (PTA) once again with its holdings in Novartis and Exelixis. The Federal Circuit held that the United States Patent and Trademark Office (USPTO)...more

Novartis v. Lee: New Math for Calculating Patent Term Adjustment

Recently, in Novartis v. Lee (2013-1160, Fed. Cir., Jan. 15, 2014), the United States Court of Appeals for the Federal Circuit revised the method by which the United States Patent and Trademark Office (USPTO) calculates...more

Patent Term Adjustment Update - Novartis v. Lee

A recent ruling by the Federal Circuit in Novartis AG v. Lee resolved the issues raised in the Exelixis I, Exelixis II and Novartis decisions regarding the effect of a Request for Continued Examination (RCE) on patent term...more

Health Services Provider’s Settlement with DOJ Includes Detailed Factual Admissions and Agreement to Cooperate Against...

On January 8, 2014, pharmaceutical provider BioScrip, Inc. (BioScrip) reached a settlement with the Department of Justice (DOJ) to resolve claims under the False Claims Act (FCA) and the Anti-Kickback Statute (AKS), stemming...more

Federal Circuit Grants Patent Term Adjustment After Allowance When Continued Examination Requested

On January 15, 2014, the U.S. Court of Appeals for the Federal Circuit decided Novartis v. Lee (No. 2013-1160, -1179), holding that time spent in “continued examination” is excluded from a patent term adjustment even where...more

Novartis AG v. Lee (Fed. Cir. 2014)

In an opinion issued earlier today, the Federal Circuit affirmed a determination by the District Court for the District of Columbia that challenges of patent term adjustment (PTA) determinations by the U.S. Patent and...more

Reverse payment deals under the microscope in the EU

Lessons from the latest Commission decision on agreements affecting generic entry: - The European Commission’s crack down on so-called “reverse payment” agreements continues. - In the EU these agreements may...more

St. Jude's Hospital Sues Novartis over Research Tool Patents

Lest anyone think that Myriad Genetics is the only patentee asserting rights in patents having claims to isolated DNA molecules or other biological molecules, St. Jude's Children's Research Hospital, Inc. has sued Novartis...more

California Cuts Manufacturers Some Slack

As this space has pointed out on several occasions, California’s laws are nothing, if not unique. One such law is California’s Business & Professions Code Section 12606.2 which prohibits a container or package from having...more

Applied Biosystems Seeks PTA for 2007 Patent

On August 21, 2013, Life Technologies, Corp., Life Technologies, Ltd., Applied Biosystems LLC, and Molecular Probes, Inc. (collectively, “Plaintiffs”) brought suit in the U.S. District Court for the Eastern District of...more

Corporate Venture Capital - Big Second Quarter

CB Insights has published summary data regarding Q2 2013 corporate venture capital investing, showing CVC investment in 126 deals with total funding of US$1.7 billion. ...more

Court Report - Part II: 7-17-2013

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Aptalis Pharma US Inc. et al. v. Mylan Pharamaceuticals, Inc. et al. 3:13-cv-04158; filed July 5, 2013 in the District...more

Getting the Best Medical Care: a Newsletter from Patrick Malone - July 2013

In This Issue: - Is There a Problem? Let Us Count the Ways - A Growing Awareness - Getting Objective Information - Recent Health Care News You Should Know About - Excerpt from Navigating Through Medical...more

News from Abroad: UK Court of Appeal Rules on Interim Injunctions

The Court of Appeal recently issued a decision concerning the issues that should be considered when granting an interim injunction. The proceedings related to Novartis' product zoledronic acid, which was used to treat...more

Physicians Are My Friends; Surely I Can Get Paid to Talk to Them!

On April 26, 2013, the U. S. Department of Justice (DOJ) intervened in a whistleblower case alleging Novartis Pharmaceuticals Corporation (Novartis) knowingly and willfully violated the federal FCA by inducing physicians to...more

32 Results
|
View per page
Page: of 2