Pharmaceutical Industry

News & Analysis as of

Multiple Actors May Perform Steps in Method Claims for Purposes of Inducement

Addressing the issue of divided infringement, the US Court of Appeals for the Federal Circuit affirmed the district court’s finding of induced infringement even though no single actor performed all steps of the asserted...more

News from Abroad -- Swiss-style Patent Claims Can Be Very Valuable in Australia

The scope for enforcement of Swiss-style claims may be broader in Australia than for method of medical treatment claims. Second medical use inventions can be claimed in an ever increasing number of claim formats depending on...more

On Alternative Design, Take Two - Negligence

Back in 2013, inspired by a win of our own that we were actually allowed to blog about, we put up a post entitled “On Alternative Design.” Taking the alternative design requirement for strict liability as a given, we...more

Medical Device Alert – Finalised texts of the new EU Regulations on medical devices and in-vitro diagnostic medical devices are...

On 22 February 2017, the Council of the European Union issued the final versions of the draft texts of the European Union (“EU”) Medical Device Regulations (“MDR”) and the In Vitro Diagnostics Regulation (“IVDR”)....more

Sixth Circuit Affirms Branded Drug Preemption and Trial Win

In the aftermath of Levine, with its generous interpretation of the CBE regulation and its novel “clear evidence” standard, we wondered how long it would be until we saw a court holding that a failure to warn claim with a...more

Ethicon To Acquire Torax Medical, Inc

Ethicon Inc. announced on February 17 that it reached an agreement to acquire Torax Medical, Inc. According to its website, Torax Medical is a privately held medical device company developing a minimally invasive surgical...more

Antitrust, Competition and Economic Regulation Quarterly Newsletter - Winter 2017

FTC takes another look at merger remedies - On 3 February 2017, the U.S. Federal Trade Commission (“FTC”) released its Merger Remedies Study, which analyzed the success of merger remedies imposed by the FTC from 2006 to...more

Health Care Fraud and Abuse in the Middle District of Florida in 2016 - a Year in Review

The United States Attorney’s Office (USAO) for the Middle District of Florida (USAO-MDFL) prosecuted several civil health care fraud matters in 2016 and issued related press releases. A review of the USAO-MDFL’s criminal and...more

Insider Trading Around Private Placements: Was Tom Price’s Investment Down Under Above Board?

On February 10, the Senate confirmed Representative Tom Price (R-GA) as Secretary of Health and Human Services, where he will oversee the U.S. Food and Drug Administration (FDA). His nomination has not been without...more

Your Daily Dose of Financial News

Activist investor Carl Icahn has taken a sizeable stake in Bristol-Myers Squibb, a move that reportedly caught execs at the drugmaker unawares and sets the stage for a potential sale....more

OIG Publishes Online Portfolio Highlighting its Body of Work on Drug Pricing and Reimbursement

For several years now, the public outcry over the issue of drug pricing and reimbursement has increased in frequency and fervor. At least one government agency wants you to know that it has been listening and wants to help...more

Extension to the EMA's Multinational Assessment Team Initiative as of April 2017

Starting in April 2017, the European Medicines Agency (“EMA”) will expand the Multinational Assessment Team (“MNAT”) Initiative to post-authorisation assessments. From this date, the MNAT Initiative will allow national...more

China’s State Council Announces Major Policies to Reform the Pharmaceutical Industry

China will launch further reforms in the pharmaceutical sector as part of the healthcare reform initiatives announced by the State Council in its February 9, 2017 Circular on Several Opinions Concerning Further Reforms of the...more

Tokyo Dispute Resolution & Crisis Management Newsletter – February 2017

Product Pricing and Antitrust Law in the United States - A recent US court action by a Japanese company in respect of a competitor’s volume discounts - Introduction - The current position in the US on the rules...more

Expanding Duties and Eroding Protections for Medical Device Manufacturers

Earlier this month, the Washington Supreme Court saddled medical device manufacturers with a new duty to warn under Washington law—the duty to warn hospitals about potential risks their products may pose—and eroded exemptions...more

Non-Physician Learned Intermediaries

One of us was asked a question the other day that we couldn’t answer immediately. “Does the learned intermediary rule apply to a physician’s assistant?” We didn’t remember any cases actually deciding that issue. So we did...more

Noodle This! The Yin and Yang of Two Courts, Two Antitrust Cases, Two Class Certification Motions, Two Daubert Challenges, Two...

Noodle this: Two significant orders on class certification in antitrust matters issued last week. Both were heavily influenced by the threshold determination of Daubert challenges to the plaintiffs’ expert evidence. In one...more

FDA Hardens Its Stance on Intended Use and Off-Label Use and Industry Responds

From 2015 to 2016, FDA appeared to open the door to loosening the standards around intended use and off-label use, but recent rule-making and public comments suggest that FDA is becoming more sclerotic instead of flexible....more

News from the Vermont State House - An analysis from DRM's Government & Public Affairs Team - February 2017 #2

Governor’s $35 Million Housing Bond Discussed in Ways and Means Committee - Executive Director Gus Selig of the Vermont Housing and Conservation Board revealed some of the details this week behind the $35 million bond...more

Six Key Changes to the Common Rule

On January 19, 2017, sixteen federal agencies, including the Departments of Health and Human Services and Labor, published the first revision to the federal regulations governing the protection of human subjects participating...more

Your Daily Dose of Financial News

Acting SEC Chair Michael Piwowar has reportedly scaled back some of the agency’s enforcement staff’s use of delegated authority by funneling all subpoena issuance and probe initiation through the SEC’s director of...more

AGG Food and Drug Newsletter - February 2017

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

Federal Trade Commission Deploys Antitrust Weaponry Against Pharmaceutical Company

In Federal Trade Commission v. Shire ViroPharma Inc. (D. Del. Feb. 7, 2017), the FTC has, for the first time, deployed its antitrust weaponry against a pharmaceutical company’s alleged practice of using the FDA’s...more

TrumpCare: The Pharmaceutical Industry and FDA

Hope in the Midst of Uncertainty - The New Year ushered a period of uncertainty for the pharmaceutical industry. We face the beginning of the Trump Administration and a Congress with both houses controlled by Republicans...more

California Rule Change: Drug Labeling Requirements

Recently, the California Board of Pharmacy announced changes to its drug labeling rules that will take effect on April 1, 2017. The Board of Pharmacy amended Section 1744 of Article 5 of Division 17 of Title 16 of the...more

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