Novartis

News & Analysis as of

Court Report - July 2014 #2

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Eli Lilly and Company et al. v. Panacea Biotec, Ltd. 1:14-cv-01064; filed June 26, 2014 in the Southern District of...more

Drug Distributor and Pharmacies Obtain Partial Dismissal of State and Federal FCA Claims

On June 10, 2014, a New York federal court dismissed, in part, state and federal False Claims Act (FCA) claims brought against Novartis Pharmaceuticals Corporation and pharmacies to which it distributed (CVS Caremark Corp.,...more

What is Patent Term Adjustment and Why Does It Matter?

For patents granted on applications filed on or after June 8, 1995, the enforceable patent term begins on the day the patent issues and generally expires 20 years from the earliest effective filing date of the application. ...more

Court Report - June 2014 #5

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Novartis Pharmaceuticals Corp. et al. v. Mylan Inc. et al. 1:14-cv-00777; filed June 19, 2014 in the District Court of...more

USPTO Proposes Revised Patent Term Adjustment Rules for RCEs Under Novartis

The USPTO has published proposed rules for calculating Patent Term Adjustment (PTA) for applications in which a Request for Continued Examination (RCE) has been filed, after the Federal Circuit held in Novartis v. Lee that...more

USPTO Finally Updates Patent Term Adjustment Calculator – Sort of

In a Federal Register Notice issued May 15, 2014, the USPTO announced that its Patent Term Adjustment (PTA) calculator finally has been updated to implement the changes to the PTA statute embodied in the Technical Corrections...more

Law Lags Science? Not in the Ninth Circuit

In 1996, Judge Posner of the Seventh Circuit burnished his reputation for pithy legalisms by observing that “the courtroom is not the place for scientific guesswork, even of the inspired sort. Law lags science; it does not...more

Plaintiff Precluded from Using Deposition Testimony of Defense Expert Where Plaintiff Procured the Absence of the Expert

Novartis sought to use the deposition testimony of defendant's expert at trial under Fed.R.Civ.P. 32(a)(4)(B). As explained by the district court, "the Rule provides that a party may use the deposition of a witness for any...more

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 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

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