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Sandoz Was Disinvited to the Patent Dance: The Federal Circuit's First Interpretation of the BPCIA Will Have to Wait

Since the 1984 enactment of the Drug Price Competition and Patent Term Restoration Act, Hatch-Waxman litigation has dominated the sphere of life-sciences patent litigation. The battle between proprietary and generic...more

Status Updates - October 2014 #12

..Unfree speech? In the United States, the First Amendment would likely prevent the prosecution of someone who posted racist or anti-Semitic messages on a social media platform. But social media platforms operate worldwide,...more

If At First You Don’t Succeed, Try, Try Again: Illinois General Assembly Sends Revised Version of Click-Through Nexus Law to the...

In 2011, Illinois became one of the first states to follow New York’s lead by enacting “click-through nexus” legislation. The Illinois law created nexus for any out-of-state retailer that contracted with a person in Illinois...more

Socially Aware - Volume 4, Issue 2 - December 2013

In This Issue: Peering Into the Future: Google Glass and the Law; Ownership of Business-Related Social Media Accounts; Two Circuits Address the First Amendment Status of Facebook Activity; Collaborative Consumption –...more

Drug Quality and Security Act Creates New Laws for Compounding Pharmacies

On November 27, 2013, the Drug Quality and Security Act was signed into law. This new law provides clarity to the existing pharmacy compounding laws within Section 503A of the Food, Drug & Cosmetic Act (FDCA) and creates new...more

United States Supreme Court Refuses to Review New York High Court Ruling Requiring Online Retailers to Collect New York State...

On December 2, 2013, the United States Supreme Court denied certiorari in the consolidated cases Amazon.com LLC v. N.Y. Dept. of Taxation and Overstock.com v. N.Y. Dept. of Taxation, thereby allowing the New York state law...more

Developments in Multistate Taxation -- November 2013

U.S. Supreme Court - On August 23, 2013, an online retailer filed a petition for a writ of certiorari with the U.S. Supreme Court seeking review of the New York Court of Appeals’ determination that a New York statute...more

Spotlight on SALT: Illinois Supreme Court Invalidates the State's "Click-Through Nexus" Statute Under the Internet Tax Freedom Act

Illinois joined a number of other states in 2011 and enacted a "click-through nexus" statute targeting internet retailers for sales and use tax collection obligations. Under the Illinois and similar statutes enacted in other...more

Illinois Supreme Court Invalidates 'Amazon' Sales Tax Law: Now What?

The Illinois Supreme Court, affirming a lower court decision, invalidated the state's "click-through" nexus law. This law required out-of-state Internet retailers who use in-state web marketing "affiliates" to collect sales...more

Illinois Click-Through Nexus Law Preempted by the Internet Tax Freedom Act

In a 6-1 decision, the Illinois Supreme Court affirmed an Illinois Circuit Court holding that Illinois Public Act 96-1544 (The Click-Through Nexus Act), requiring out-of-state retailers to collect and remit use tax, violates...more

Medical Device Company Files First Amendment Lawsuit Challenging OIG’s Criticism of Physician-Owned Distributors (PODs)

On October 8, 2013, Reliance Medical Systems, LLC (“Reliance”) filed a Complaint against the HHS OIG in the United States District Court for the Central District of California. The Complaint alleges that OIG’s assertion in a...more

Federal Court Upholds California County’s Safe Drug Disposal Ordinance

On August 28, 2013, the U.S. District Court for the Northern District of California issued an order upholding Alameda County's Safe Drug Disposal Ordinance as constitutional. The ordinance, passed in July 2012 by the Alameda...more

Caronia And The First Amendment Defense To Off-Label Marketing: A Six Month Re-Assessment

When the Second Circuit issued its December 3, 2012 decision in United States v. Caronia, the opinion was proclaimed by many to signal a sea change in the prosecution of off-label promotion....more

Marketplace Fairness Act of 2013 Passes United States Senate

On May 6, 2013, the United States Senate passed the Marketplace Fairness Act of 2013 (the "Act") by a vote of 69 to 27. The legislation (S. 743) now moves to the House of Representatives for consideration....more

Are "Click-Through" Internet Marketing Tax Laws Constitutional?

Our preview of the oral arguments at the Illinois Supreme Court during the May term concludes with Performance Marketing Association, Inc. v. Hamer. PMA will be heard by the Court during the 9:00 a.m. session on Thursday, May...more

Online Sales Taxes Emerging as New York Court of Appeals Shoots Down Overstock and Amazon’s Constitutional Objections

In a March 28, 2013 decision, New York’s highest state court, the New York State Court of Appeals, held that New York’s “click-through” nexus statute, Tax Law § 1101 (b)(8)(vi), does not violate the United States Constitution...more

Proposed E-Commerce Taxation Bill Might be Unconstitutional

Much attention has been paid to the Marketplace Fairness Act currently under consideration in Congress. Understandably, that coverage has focused on whether the bill, which would permit states to require out-of-state...more

E-Commerce Providers Take Note: New York’s Highest Court Upholds “Amazon” Sales Tax Statute

On March 28, 2013, the Court of Appeals, New York’s highest court, issued a decision in Overstock.com, Inc. & Amazon.com, LLC, et al., holding that New York’s “click-through nexus” statute does not violate the Commerce Clause...more

Federal Court Orders FDA to Approve OTC Sales of “Morning-After Pill,” Finds Current Age and Point-of-Sale Restrictions to be...

On April 5, 2013, Judge Edward R. Korman of the United States District Court for the Eastern District of New York found that the Secretary of Health and Human Service’s (“HHS”) decision to limit over-the-counter (“OTC”)...more

The First Amendment and Off-Label Promotion: United States v. Caronia

For years, the U.S. Department of Justice has aggressively pursued and brought charges over “off-label promotions”—the promotion of drugs for uses that have not received FDA approval—by pharmaceutical manufacturers and their...more

Spotlight on SALT: New York Court of Appeals Upholds the State's "Click-Through Nexus" Statute

On March 28, 2013, in Overstock.com, LLC v. New York State Dept. of Taxation and Finance, the New York Court of Appeals, New York's highest court, upheld the New York State "click-through nexus" statute against a challenge...more

Court Upholds Executive’s Conviction Stemming from Off-Label Drug Promotion

The U.S. Court of Appeals for the Ninth Circuit has upheld the wire fraud and misbranding convictions and sentence of InterMune Inc. founder W. Scott Harkonen. United States v. Harkonen, No. 11-10209 (9th Cir. March 4, 2013)....more

Casinos Go Virtual

In late February 2013 the New Jersey Legislature passed legislation allowing on-line wagering, subject to certain limitations. This legislation was signed into law by Governor Chris Christie. Under the new law, licensed...more

Ninth Circuit Off-Label Marketing Decision Suggests More Prosecutions Will Be Coming

The Ninth Circuit has reopened a door for off-label marketing prosecutions, and it is important to review your compliance and risk management programs in light of this recent decision. Last December, the pharmaceutical and...more

A Cure For Antitrust Standing?

Recently, the Third Circuit reexamined the test for antitrust standing in Ethypharm S. A. France v. Abbott Laboratories. The importance of the opinion, however, lies not just in the court’s affirmation of the multifactor test...more

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