Everything Compliance-Episode 63, the Novartis edition
Episode 150 -- Novartis Settles False Claims Act and Anti-Kickback Cases for $729 Million
Daily Compliance News: July 2, 2020-the Novartis Pays More edition
Compliance into the Weeds: Episode 178-the Novartis FCPA Enforcement Action
Episode 148 -- A Review of the Novartis and Alcon FCPA Enforcement Action
Americans spend on average about $1,300 per person per year on prescription drugs, which represents only about 13.3% of the total paid-for drugs in the US. Private insurers, Medicare, and Medicaid pay another 81.8%. ...more
Bye-Bye, Bitcoin: It's Time to Ban Cryptocurrencies - "International banking officials say cryptocurrencies such as bitcoin are speculative assets, not sustainable, usable money." Why this is important: This opinion piece...more
Your patent may be entitled to a later expiration date if the U.S. Patent and Trademark Office (USPTO) characterized time periods during which you could not engage in reasonable efforts to conclude prosecution as “applicant...more
In Novartis Pharmaceuticals Corp. v. Breckenridge Pharmaceutical Inc., Novartis scored another obviousness-type double patenting (OTDP) win when the Federal Circuit held that a post-URAA child patent could not be cited as an...more
In Novartis v. Lee (Fed. Cir. 2014), the Federal Circuit agreed with the USPTO that “time spent in a continued examination” does not count towards the three years the USPTO is allotted to examine a patent before if it must...more
On April 12, 2017, the Federal Circuit affirmed the determination by the US Patent and Trademark Office (USPTO), Patent Trial and Appeal Board (Board) that the claims of U.S. Patent No. 8,324,283 (“the ’283 patent”) were...more
In inter partes review proceedings, is the U.S. Patent and Trademark Office's Patent Trial and Appeal Board required to take into account a final district court determination of non-obviousness of the same claims based on the...more
In Singhal v. Lee, the U.S. District Court for the Eastern District of Virginia dismissed a complaint that challenged the Patent Term Adjustment (PTA) awarded to two patents, because the complaint failed to state a claim upon...more
On January 9, 2015, the United States Patent and Trademark Office (USPTO) published its final rules implementing changes to patent term adjustment (PTA), in view of the United States Court of Appeals for the Federal Circuit...more
Earlier this year, the U.S. Patent and Trademark Office published a final rule in the Federal Register (80 Fed. Reg. 1346) to revise the rules of practice to implement the Federal Circuit's decision in Novartis AG v. Lee. ...more
On January 9, 2015, the Federal Register published final rules implementing changes to patent term adjustment (PTA) in view of Novartis v. Lee, which the Federal Circuit decided last January. The new rules affect patents...more
The USPTO has published final Patent Term Adjustment (PTA) rules addressing the treatment of Requests for Continued Examination (RCEs) under the Federal Circuit decision in Novartis v. Lee. The final rules create a new type...more
Last month, the U.S. Patent and Trademark Office published a notice of proposed rulemaking in the Federal Register (79 Fed. Reg. 34681) discussing changes to the rules of practice to implement the Federal Circuit's decision...more
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
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
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
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
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
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
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
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