Manufacturers

News & Analysis as of

How The Failure To Comply With The Conflict Minerals Law Can Expose Manufacturers To Criminal Penalties

Last year, we provided an overview regarding the requirement that U.S. publicly traded companies disclose their use of “conflict minerals.”  As of 2014, the Government Accounting Office reported that 1,321 companies filed the...more

Japan Amends Industrial Safety and Health Law

The Ministry of Health, Labor, and Welfare has issued 2016 Cabinet Order No. 50 to amend the Industrial Safety and Health Law (ISHL), and 2016 Health, Labor, and Welfare Order No. 24 to amend the Occupational Safety and...more

Competition News July-August 2016

The French Competition Authority severely punished the exclusivity practices put in place by company in a dominant position - On June 23, 2016, the French Competition Authority punished the Belgian group Umicore for...more

En Banc CAFC Requires UCC Sale For On Sale Bar

In an en banc decision issued in The Medicines Company v. Hospira, Inc., the Federal Circuit determined that in order for a commercial transaction to trigger the on-sale bar of § 35 USC 102(b), it must “bear the general...more

A One-Two Punch Case With An Off-Label Twist

When we were young(er), we had a pretty good memory. It is not bad now, as far as we recall, particularly when it comes to pulling up bits of esoteric nonsense. For more important stuff, we find qualifiers like “vague” and...more

AGG Food and Drug Newsletter - July 2016

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

BioPharma Patents Quick Tips & News – July 2016

U.S. FDA Orange Book Refresher Edition - What types of patents can be listed on the FDA’s Orange Book? Listable = Pharmaceutical-related patents are allowed in the FDA’s Orange Book only if they’re “composition” or...more

Federal Circuit Patent Updates - July 2016 #2

WBIP, LLC v. Kohler Co. (No. 2015-1038, -1044, 7/19/16) (Moore, O'Malley, Chen) - Moore, J. Affirming denial of JMOL that patent was invalid as obvious and lacked an adequate written description, affirming finding of...more

2016 Chemical Data Reporting – New TSCA Requirements Apply for Confidential Business Information Claims

On June 22, 2016, President Obama signed into law the Frank R. Lautenberg Chemical Safety for the 21st Century Act (the Act). Passed with significant bipartisan support, the Act is the first major update to a federal...more

Congress Finds the Formula to Reform Chemical Regulation

The Toxic Substance Control Act (TSCA) is the primary federal law by which the manufacture, import and use of chemical substances are regulated in the United States. Since its inception in 1976, TSCA has not been updated...more

Landmark Overhaul of the Toxic Substances Control Act

EPA Issues First Year Implementation Plan - On June 22, 2016, the Frank R. Lautenberg Chemical Safety for the 21st Century Act was signed into law. This law amends the Toxic Substance Control Act (TSCA) and is the first...more

Environmental Notes - July 2016

CONGRESS FINDS THE FORMULA TO REFORM CHEMICAL REGULATION - The Toxic Substance Control Act (TSCA) is the primary federal law by which the manufacture, import and use of chemical substances are regulated in the United...more

CMS Guidance Addresses Impact of Value-Based Purchasing on Medicaid Drug Rebates

CMS has received questions from manufacturers regarding whether price concessions and services offered to payers within Value-Based Purchasing (VBP) arrangements in the pharmaceutical marketplace could impact their drug’s...more

Something Went Right In Brazil

Zika virus, Olympic unpreparedness, economic collapse, presidential impeachment - a lot of things have gone wrong in Brazil lately. But we’re not here to talk about any of that. Here’s something that went right: Brazil v....more

Sale of Manufacturing Services Does Not Trigger On Sale Bar Under Pre-AIA §102

In The Medicines Company v. Hospira, Inc., [2014-1469, 2014,1504] (July 11, 2016), the en banc Federal Circuit reversed a panel decision finding that U.S. Patent Nos. 7,582,727 and 7,598,343 were invalid under the on-sale bar...more

INTERPOL can expect more politically motivated requests from Venezuela – this time with sights on Kimberly-Clark representatives

Venezuela’s president, Nicolas Maduro, has threatened to at least attempt to continue Venezuela’s abuse of INTERPOL’s Red Notice system. The paper product supplier Kimberly-Clark stopped production in Venezuela several weeks...more

Products Liability: Appellate Victory of Children's Products Manufacturer Shows the Importance of Understanding State Products...

On July 5, 2016, the United States Court of Appeals for the Eighth Circuit affirmed a jury verdict in favor of Dorel Juvenile Group, Inc. ("Dorel") in a case involving claims that a defective doorknob cover manufactured by...more

Lowered Risk for Inventors Who Use Contract Product Development or Manufacturing

On July 11, in The Medicines Company v. Hospira, Inc., the Federal Circuit held that a contract manufacturer's sale of manufacturing services to an inventor did not constitute a commercial sale of the patented invention for...more

Toxic Substances Control Act

For the first time in 40 years and after years of negotiation, on June 22, the President signed the compromise legislation updating the Toxic Substances Control Act (TSCA) of 1976. The bipartisan bill, H.R. 2576, the Frank R....more

Federal Circuit Helps Clarify What Constitutes a Commercial Sale under Pfaff

In The Medicines Co. v. Hospira Inc., Appeal No. 2014-1469 (Fed. Cir. July 11, 2016), the Federal Circuit issued a unanimous en banc decision ruling that the on-sale bar was not triggered by a supplier’s sale of manufacturing...more

Federal Circuit Provides Guidance On When An Agreement For Services Triggers The On-Sale Bar

On July 11, 2016, the Federal Circuit, en banc, overruled the merits panel and affirmed the District of Delaware’s decision in The Medicines Company v. Hospira, Inc. finding that an assignee’s entry into a manufacturing...more

Hidden Threats to Your Supply Chain

In 1997, during a period of peak demand, a factory fire at Aisin Seiki Co., one of Toyota's key suppliers, shut down production of P-valves, a small but vital component in Toyota's braking systems. Toyota, champion of...more

FDA Offers Draft Guidance for Generic Drug Label Updates

In July 2016, the U.S. Food and Drug Administration (FDA) published draft guidance outlining when drug companies should update a generic drug’s label after the brand name drug on which the generic is based has been withdrawn...more

OECD Publishes Dossier Summaries for CNTs, Fullerenes, and Silicon Dioxide

The Organization for Economic Cooperation and Development (OECD) recently published several dossier summaries for nanomaterials tested as part of its Testing Program of Manufactured Nanomaterials....more

New FDA Draft Guidance on Updates to Certain Generic Labeling

On July 8, 2016, the U.S. Food and Drug Administration released draft guidance amending the process for manufacturers to update labeling of generic drugs in situations where the reference drug labeling has been withdrawn for...more

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