News & Analysis as of

Manufacturing Facilities

Shortage of Relief: Recent Disasters Highlight Multifaceted Drug Shortage Problem

by Holland & Knight LLP on

• Nearly a month after Hurricane Maria swept through Puerto Rico, roughly 80 percent of the U.S. territory is still without electrical power. • The island is home to multiple drug manufacturing facilities that are directly...more

Hazardous Waste Enforcement: Alabama Department of Environmental Management and Jefferson County, Alabama Custom Paint...

The Alabama Department of Environmental Management (“ADEM”) and Titan Coatings, Inc. (“TCI”) entered into a September 5th Consent Order (“CO”) addressing alleged violations of certain hazardous waste regulations. See Consent...more

Biocon Requests Withdrawal and Re-Submission of EMA Applications for it's Trastuzumab and Pegfilgrastim Biosimilars

by Goodwin on

As we’ve posted here, Biocon and Mylan are jointly developing a portfolio of biosimilars, including Fulphila (Pegfilgrastim) and Ogivri (Trastuzumab), and have filed applications for marketing authorization in the European...more

New Property Tax Exemption for All South Carolina Manufacturers

by McNair Law Firm, P.A. on

The South Carolina Infrastructure and Economic Development Reform Act, 2017 Act 40, was recently enacted and is designed to enhance South Carolina’s economic competitiveness. The Act, commonly referred to as the gas tax bill,...more

RICO Madness: The Nuisance of Owning and Operating a Marijuana Facility

by Snell & Wilmer on

On June 7, 2017, the Tenth Circuit Court of Appeals issued its opinion in Safe Streets Alliance, et al. v. Hickenlooper, et al., (No. 16-1048), an opinion that could open the doors to property use litigation involving...more

Lehigh Valley Facilities Targeted for Unionization

Lehigh Valley residents know that the area has become home to a number of distribution and warehousing facilities, particularly in recent years. It should not come as a surprise, then, that these facilities have become...more

French ANSM Clarifies Guidance Related to Raw Materials for Pharmaceutical Use

by Jones Day on

On January 31, 2017, the French National Drug and Health Product Agency ("ANSM") issued an updated FAQ related to the authorization and declaration procedures of manufacturing, import, and distribution of raw materials for...more

Development of court practice of determining the starting date for payment of property tax on a fixed asset that is ready for...

by Dentons on

On 28 April 2017 the Commercial Court of St. Petersburg and Leningrad Region rendered a decision in case No. ?56-87465/2016 (the “Decision”) under the claim of Penobeton-Pikalevo LLC (the “Company”). The case considered the...more

Quantity - Not Quality - Matters in Assessing Liability for Patent Infringement under Section 271(f)(1)

by Bryan Cave on

In Life Technologies Corp. v. Promega Corp., the Supreme Court ruled that, as a matter of law, “the supply of a single component of a multicomponent invention” from the United States does not trigger liability under Section...more

Supreme Court Limits Potential Liability for Overseas Patent Infringement

by Lathrop Gage on

Sale from the U.S. to overseas destination of a single component cannot violate § 271(f) - On February 22, the Supreme Court announced its latest unanimous decision in a patent case....more

The Supreme Court Chooses Quantity over Quality – Supplying a Single Component of a Multicomponent Invention Does Not Constitute...

On February 22, 2017, the U.S. Supreme Court addressed the issue of whether the supply of a single component of a multicomponent invention qualifies as an infringing act under 35 USC §271(f)(1) of the U.S. Patent Act. In its...more

Applying Product Liability Theory, Washington State Sues for PCB Damages

by Beveridge & Diamond PC on

In an effort to use product liability theories to hold manufacturers culpable for environmental releases, the Attorney General of Washington State sued PCB manufacturer Monsanto in state court in December. See Complaint,...more

Supreme Court Limits § 271(f)(1) Overseas Infringement Reach: More than One Exported Component Required for Offshore Manufacturing...

The US Supreme Court held in Life Techs. Corp. v. Promega Corp., Slip No. 14-1538 (Feb. 22, 2017) that supplying a single component of a multi-component invention manufactured abroad does not give rise to patent infringement...more

U.S. Supreme Court Limits Patent Law's Reach over Extraterritorial Infringement Liability

Today, in Life Technologies Corp. v. Promega Corp.,1 the U.S. Supreme Court unanimously held that supply of a single component of a multicomponent invention for manufacture abroad does not give rise to liability under 35...more

ITC Solicits Public Comments On MTB Petitions - 45-Day Comment Period Open Until February 24, 2017

by King & Spalding on

The U.S. International Trade Commission (“ITC”) is now accepting public comments on Miscellaneous Tariff Bill (“MTB”) petitions for duty suspensions and reductions that timely were filed with the agency by December 12, 2016,...more

South Carolina DHEC Reissues the Industrial Storm Water General Permit

by Williams Mullen on

The South Carolina Department of Health and Environmental Control (DHEC) recently reissued its NPDES General Permit for Storm Water Discharges Associated with Industrial Activities (IGP). The IGP regulates discharge of storm...more

OSHA Weighs In on EPA Proposed Rule Governing the Use of New Chemical Substances

by Seyfarth Shaw LLP on

Seyfarth Synopsis: OSHA “strongly supports” EPA’s proposed updates to its existing regulations governing significant new uses of chemical substances under the Toxic Substances Control Act. The proposed changes seek to...more

Miscellaneous Tariff Bill Petition Process Goes Live - Potential for up to $500,000 in duty relief per product

by King & Spalding on

The U.S. International Trade Commission (“ITC”) has begun accepting petitions seeking temporary duty suspensions and reductions pursuant to the American Manufacturing Competitiveness Act of 2016 (“the Act”). The Act...more

Cipla to Open Biotech Facility in South Africa

by Goodwin on

Cipla has announced that it is investing 1.3 billion South African Rand (approximately 91 million USD) to open a biotech plant in South Africa. According to Cipla’s press release, this will be South Africa’s first...more

Quantum Quarterly - Issue VIII – 1st Quarter 2016

by King & Spalding on

We are pleased to present the latest edition of Quantum Quarterly, a publication of King & Spalding’s International Arbitration Group. This edition features an interview with Suzana M. Blades and Alberto F. Ravell, Managing...more

EPCRA Section 313 Reporting: Frequent Questions

by Williams Mullen on

This is the second installment of frequently asked questions regarding Toxic Release Inventory (TRI) reporting under Section 313 of the Emergency Planning with Community Right-to-Know Act (EPCRA). As noted in our first...more

OSHA Finalizes Crystalline Silica Rule, Effective June 2016

by Foley & Lardner LLP on

After years in the making and thousands of comments to the proposed rule from 2013, OSHA has finalized the Crystalline Silica Rule for General Industry and Maritime. The final rule was published in the Federal Register on...more

New Bipartisan Act Will Simplify the Temporary Tariff-Reduction Process

by Holland & Knight LLP on

President Obama signed the American Manufacturing Competitiveness Act of 2016 (the Act) into law on May 20, 2016, to overhaul the process of developing a Miscellaneous Tariff Bill (MTB). Under this Act, companies will not...more

President Obama Signs American Manufacturing Competitiveness Act of 2016

by King & Spalding on

Law Modifies Process For Duty Suspensions And Reductions - On May 20, 2016, President Obama signed the American Manufacturing Competitiveness Act of 2016 into law (the Act). The Act restores the ability of the U.S....more

EPCRA 313 Reporting – FAQs

by Williams Mullen on

The Emergency Planning and Community Right-to-know Act (EPCRA) requires Form R reports to be filed with EPA each July 1 for each listed “toxic chemical” a facility manufactures or processes in excess of 25,000 lbs., or...more

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