California Employment News: Pay Transparency Coming to California
Employment Law Now VI-121 - Top 5 Fall Things You Need To Know
California's New COVID-19 Sick Leave Mandate: What Employers Need to Know
FLSA and Wage and Hour Issues for Restaurants
Practical Training for Project Managers & Supervisors Two-Part Webinar Series: Part Two
NGE OnDemand: The Importance of Timely Reporting Occurrences, Claims and Suits to Insurers with Paul Walker-Bright
#WorkforceWednesday: DOL Electronic Notices Guidance, EEO-1 Reporting Delayed, CA COVID-19 Paid Sick Leave - Employment Law This Week®
Advancing Agriculture: Security Interests and Article 9 Challenges (Part 2)
#WorkforceWednesday: Sick Leave in New York, California Law Update, and Oregon’s Workplace Fairness Act Takes Effect
Navigating the New Normal: Risk Management and Legal Considerations for Real Estate Companies
COBRA: Avoid Getting Snakebit! (Notice Update, Deadline Update, Litigation Update)
Cutting Costs With Employee Benefit Plans (Part 5 of 5) – Implementation
Butler's Thursday Tips #7 | Civil Remedy Notices
The Blunt Truth About Testing Employees For Marijuana In California (part one)
#BigIdeas2020: Facial Recognition Technology and Employer Compliance - Employment Law This Week® - Trending News
CF on Cyber: Key Takeaways from the California AG’s Proposed CCPA Regulations
Contractual Notice Requirements: Do You Really Need Them?
Report: Chinese Military Now Hacking American Businesses
Safeguards against Data Security Breaches (Part One)
FTC Hits Path with $800k Fine, Continues to Make Mobile Privacy a Priority
Yes. Pharmaceutical companies within the Fortune 500 are universally notifying Californians of their right to request access to, or the deletion of, their personal information....more
The Federal Circuit held that supplemental applications submitted to the Food and Drug Administration (FDA) to further support approval of a biosimilar product under Section 262(k) of the Biologics Price Competition and...more
4550 words (or 18 double spaced pages). In addition to their primary privacy policies, pharmaceutical companies often post separate California-specific supplemental privacy notices or appendices that comply (or attempt to...more
The Biologics Price Competition and Innovation Act of 2009 (BPCIA) was passed as part of health reform signed into law by President Obama in March 2010. This year, the BPCIA turns 10. While the U.S. Biosimilars Pathway has...more
Pharmaceutical industry stakeholders know that drug prices, market competition, supply chain challenges, and shortages of critical drug products have been top of mind for policymakers in recent years. Among others tackling...more
In an opinion issued on December 14, 2017, the United States Court of Appeals for the Federal Circuit held that the 2010 Biologics Price Competition and Innovation Act (“BPCIA”) preempts the use of state law to penalize...more
On Monday, June 12, 2017, the United States Supreme Court in a unanimous decision held that manufacturers making biosimilars of biologic drugs did not have to wait until after gaining federal approval of the biosimilar to...more
On June 12, 2017, the Supreme Court issued a unanimous opinion in Sandoz v. Amgen, interpreting key provisions of the Biologics Price Competition and Innovation Act (BPCIA) in favor of biosimilar manufacturers...more
The Supreme Court handed down its opinion in Sandoz Inc. v. Amgen Inc., marking the first time the Court has interpreted the Biologics Price Competition and Innovation Act (“BPCIA”) for the approval of biosimilar drugs. On...more
On June 12, 2017, in Sandoz Inc. v. Amgen Inc., the United States Supreme Court unanimously held that a drug manufacturer may give a required 180-day notice of its intent to market a biosimilar drug before receiving FDA...more
The Supreme Court could issue its decision in the Amgen v. Sandoz biosimilar patent dance case any day now. Last week I participated in a panel discussion with industry stakeholders considering how the decision might–or might...more
We previously reported on the oral argument in Sandoz v. Amgen. Justice Thomas has delivered the opinion for a unanimous U.S. Supreme Court in Sandoz v. Amgen. Briefly, the Supreme Court held that notice of commercial...more
On April 26, 2017, the U.S. Supreme Court heard oral argument in Sandoz Inc. v. Amgen Inc. (Nos. 15-1039, 15-1195), on appeal from the Federal Circuit's July 21, 2015, opinion interpreting various provisions of the Biologics...more
On April 26, 2017, the Supreme Court heard oral arguments in Amgen v. Sandoz, where the parties have asked the Court to interpret two of the biosimilar patent dance provisions of the Biologics Price Competition and Innovation...more
On April 26, 2017, the U.S. Supreme Court heard oral argument in the much-anticipated Amgen v. Sandoz case, representing the first time the Court has had to grapple with the Biologics Price Competition and Innovation Act...more
The Agency of Transportation has submitted a proposal to the House Transportation Committee that would allow the agency to seek damages from a utility that fails to move or adjust a utility line that is in a state or local...more
On January 13, 2017, the Supreme Court granted certiorari in Amgen v. Sandoz, 794. F.3d 1347 (Fed. Cir. 2015) and Sandoz v. Amgen, 773 F.3d 1274 (Fed. Cir. 2014), appealed from the Federal Circuit. The petitions involve the...more
The U.S. Supreme Court has agreed to review some of the patent dispute resolution provisions of the Biologics Price Competition and Innovation Act (BPCIA). The Court granted certiorari in the dispute between Amgen and Sandoz,...more
On Friday, Jan. 13, the Supreme Court granted the appellant’s petition and the respondent’s cross-petition for a writ of certiorari in Sandoz Inc. v. Amgen Inc. This is the first time the Court will construe the Biologics...more
On January 13, 2017, the Supreme Court granted Sandoz’s petition for certiorari and Amgen’s cross-petition in Amgen v. Sandoz, case nos. 15-1039 and 15-1195. The two cases were consolidated, and an hour was allotted for oral...more
Many of the complaints from patent holders over the PTO's inter partes review process under the Leahy-Smith America Invents Act (codified in pertinent part at 35 U.S.C. §§ 311-319) stem from how the Office has implemented...more
The Federal Circuit affirmed the decision by the Patent Trial and Appeals Board (PTAB) in an inter partes review (IPR) that the claims of Genzyme's U.S Patent Nos. 7,351,410 and 7,655,226 were obvious, in Genzyme Therapeutic...more
Since the Biologics Price Competition and Innovation Act of 2009 (BPCIA) was signed into law in 2010, only a small handful of abbreviated Biologics Licensing Applications (“aBLAs”) have been filed and of those the FDA has...more
In Amgen v. Apotex, the Federal Circuit held that under the Biologics Price Competition and Innovation Act (“BPCIA”), “an applicant must provide a reference product sponsor with 180 days’ post-licensure notice before...more
On July 5, 2016, the U.S. Court of Appeals for the Federal Circuit (Federal Circuit) unanimously ruled in Amgen v. Apotex that biosimilar makers must provide brand-name rivals with a 180-day notice only after receipt of...more