January, 2020

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Announcing Our New Website and Home on the Web!

Patentably Defined

I am very happy to announce our firm’s new home on the web, www.mekiplaw.com. By constructing an entirely new website and migrating to our new domain, we’ve been able to enhance the user experience by improving navigation and overall functionality. We invite you to visit. Once again, that URL is: [link]. © 2020, Michael E. Kondoudis. The Law Office of Michael E.

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But I Didn't Read It Before I Signed It

GDB Firm Blog

We've all heard that argument before. Once again, a New York Appellate Court rejected the argument in a commercial transaction. You can't get a lot clearer than having a court say that people who sign a loan agreement are "presumed to know the contents of the instrument [they] signed and to have assented to such terms." The court went on to say, "even if, as he testified, [the guarantor] failed to read the agreement before signing it, that does not excuse him from performin

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Supreme Court Won’t Take Up Patent Eligibility for Medical Diagnostics

Bio Law Blog

The cloud of uncertainty over patent eligibility of patents for medical diagnostic methods remains. On Monday, the Supreme Court declined the opportunity to revisit patent eligibility under its two-step Mayo test when it denied certiorari in Athena Diagnostics v. Mayo Collaborative Services — a case in which the en banc Federal Circuit panel split 7 to 5 on whether medical diagnostic inventions, such as the one at issue in Athena , are patent eligible under Mayo.

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NY Legislature Expands Use Of "Design-Build" Contracts

GDB Firm Blog

Governor Cuomo rang in the new year by signing the New York City Public Works Investment Act, authorizing a variety of NYC agencies to enter into design-build contracts whereby one entity both designs and constructs the public improvement.

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Software Composition Analysis: The New Armor for Your Cybersecurity

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?

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Beware When You Contact A Customer By Cell Phone

GDB Firm Blog

I used to tell banks not to do business with customers by cell phones because the possibility of fraud was heightened. As far back as 15 years ago, I had a bank client that was tricked into sending a $20,000 unauthorized wire transfer when confirmation of a fax was obtained by calling a cell phone number that had been provided only by the fraudster.

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"No Damage For Delay" Clauses: Absolute Bars to Recovery — But Not at Pleading Stage

GDB Firm Blog

While "no damage for delay" clauses have become power weapons in the hands of owners and contractors attempting to insulate themselves from delay claims brought by those "downstream," they cannot always be used to dismiss cases in the pleading stage.

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The Right to Financial Information on a Non-Public New York Construction Project

GDB Firm Blog

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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Biosimilars in 2020: What’s Ahead

Bio Law Blog

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

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The Whole Enchilada: The Necessity of Looking at Claims as a Whole to Determine Patent Eligibility

Bio Law Blog

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.

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Biosimilar Litigation Trends and Lessons Learned in 2019

Bio Law Blog

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

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IPO Diversity in Innovation Toolkit

Women and diverse employees have the technical skill and knowledge, yet their contributions are not patented at the same rate as those of their male counterparts.This toolkit can help organizations move the needle on achieving gender parity in innovation.

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Beware Of Online Account Fraud

GDB Firm Blog

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!

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Lien Law Amendment: Right Result. Wrong Reason.

GDB Firm Blog

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.

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USMCA: Implications for Biologics and Innovation

Bio Law Blog

On Wednesday, President Donald Trump signed the United States-Mexico-Canada Agreement (USMCA) into law. The USMCA contains a number of key and last-minute revisions that implicate biologic medicines and patent obligations. In the original version of the USMCA, Canada and Mexico would have been required to extend the exclusivity provided to new biologic medicines and provide ten years of exclusivity.