Bio Law Blog

JANUARY 8, 2020

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 been slow to take shape, 26 biosimilars have now been approved (with 20 approvals in the past two years). This year we will see more litigation under the BPCIA, with biosimilar makers sharing or withholding information about their biosimilar products during the pre-suit BPCIA

Marketing 40

Marketing Marketing Settlement Litigation 40

GDB Firm Blog

JANUARY 8, 2020

Cash flow is the life blood of the construction industry. Contractors/subcontractors/suppliers want to know during the job that the money is there, is flowing, and what security there is if the flow stops. In New York, rights to this financial information depend upon the type of non-public construction project. Who can ask for (and who must furnish) information varies.

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Bio Law Blog

JANUARY 8, 2020

On Jan. 10, the Supreme Court will decide whether it will review the Federal Circuit's decisions in the Athena v. Mayo, HP Inc. v. Berkheimer and Hikma v. Vanda cases. The Solicitor General, at the invitation of the Supreme Court, submitted amicus briefs in which he recommended the Court review the Athena case and clarify the application of the Mayo test to method-of-medical-treatment claims.

Invention 40

Invention Patent Art Law 40

Bio Law Blog

JANUARY 8, 2020

It has been nearly 10 years since the U.S. Biosimilars Pathway (the Biologics Price Competition and Innovation Act) was enacted. The first biosimilar product in U.S. history was approved and launched in 2015. Ten biosimilars were approved in 2019. The Food and Drug Administration (FDA) has now approved 26 biosimilars in total, including biosimilars of nine of the world’s most important biologic medicines: Avastin (2), Epogen (1), Enbrel (2), Herceptin (5), Humira (5), Neupogen (2), Neulast

Litigation 40

Litigation Settlement Patent Patent Infringement 40

Speaker: Blackberry, OSS Consultants, & Revenera

Software is complex, which makes threats to the software supply chain more real every day. 64% of organizations have been impacted by a software supply chain attack and 60% of data breaches are due to unpatched software vulnerabilities. In the U.S. alone, cyber losses totaled $10.3 billion in 2022. All of these stats beg the question, “Do you know what’s in your software?

Technology

GDB Firm Blog

JANUARY 6, 2020

Fraudulent online account opening followed by electronic or altered check deposits is becoming the new version of the Nigerian 419 scam. An account is opened on line and funded with an ACH deposit or wire transfer. The depositor then asks that the funds be wired out, often overseas. One client told me they had three such online fraudulent account openings this month!

Business 40

Business Law 40

GDB Firm Blog

JANUARY 6, 2020

The NYS Legislature recently passed a law requiring all mechanic's liens to disclose on the face of the lien whether or not it is for a single family home. While there is a good reason for requiring this disclosure, the justification given by the legislature misses the boat.

Law 40

Law 40