Prescription Drugs

News & Analysis as of

The Federal Circuit Found Direct Infringement Attributable to Physicians Where “No Single Actor Performs All Steps of a Claim"

Can a patient’s action in taking a generic drug be attributable to a physician such that it can support a finding of the physician’s direct patent infringement? According to a recent precedential opinion of the Court of...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

RxIP Update - February 2017

Federal Court of Appeal rules on non-infringing alternatives and apportionment as defences to an accounting of profits from patent infringement - On February 2, 2017, the Federal Court of Appeal released a significant...more

FDA Changes Warning For Fluoroquinolones

Fluoroquinolones is a drug used to treat respiratory and urinary infections. Fluoroquinolones include these drugs: - Avelox (moxifloxacin); - Cipro (ciprofloxacin); - Cipro extended-release (Cirpofloxacin...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

340B Drug Pricing Program: The Withdrawal of Mega Guidance and the Future of Patient Definition

In the wake of a recent directive issued by the Trump administration to halt pending regulations and guidance while the new leadership conducts its own review, the Department of Health and Human Services, on January 30, 2017,...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

New HHS Secretary Delays Effective Date of Part 2 Final Rule

We previously reported that the 30 year old regulations (last updated in 1987) relating to the disclosure of substance abuse treatment information has been updated by SAMHSA to bring it into the modern world of electronic...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

Judge Kicks Benicar Claims

Benicar is used to treat high blood pressure. In June 2015, numerous plaintiffs sued the manufacturer of Benicar, Daiichi Sankyo, Inc. and Forest Laboratories LLC in the St. Louis Circuit Court. Plaintiffs alleged injuries...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

Health Alert (Australia) February 13, 2017

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: Commonwealth. Federal Court 3 February 2017 - Australian Nursing and Midwifery Federation v Royal Children's...more

Federal court aids in construction of provisions for third party statutory licences following temporary ceasing of a patent but...

The ground-breaking series of decisions, relating to AU 623144 (AU ‘144), which protected the antidepressant escitalopram, has generated another first when the patentee of AU ‘144 sought judicial review of a recent Patent...more

FDA Request for Justification Found to Provide a Mere Research Suggestion—Not Conception of Claimed Formulation

In Cumberland Pharmaceuticals Inc. v. Mylan Institutional LLC, Nos. 16-1115, -1259 (Fed. Cir. Jan. 26, 2017), the Federal Circuit affirmed the lower court’s holding that a patent covering a chelating-agent-free drug...more

Health Alert (Australia) February 6, 2017

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: Commonwealth. Federal Court 31 January 2017 - Polan v Goulburn Valley Health (No 2) [2017] FCA 30 INDUSTRIAL LAW –...more

Ready, Set... Cures Act Expanded Across Policy Deadline Is Almost a Go

As we have mentioned in a previous article, the 21st Century Cures Act (enacted December 13, 2016) gave companies 60 calendar days to make their expanded access policies for certain investigational drugs publicly available....more

Nebraska Daubert Order Finds Expert a Mile Wide at the Mouth, But Only Six Inches Deep

A case from Douglas County, Nebraska, caught our eye this week for a couple of reasons. It’s a great Daubert order in an Accutane case in Nebraska state court. In addition to that, this blogger’s mother grew up on a farm in...more

What is a hard fought battle for clients? — Legal Warriors

Someone asked what was one of the most challenging cases I have worked on as a drug and medical device litigator for the past 23 years. It was the Vioxx litigation....more

340B Program Omnibus Guidance Withdrawn

The Federal Office for Management and Budget has withdrawn the proposed omnibus guidance for the 340B Drug Pricing Program (previously referred to as the “Mega-Regs”), creating further uncertainty in the 340B Program. The...more

Automated Drug Dispensing

Despite its plain text, the California Board of Pharmacy (the “BoP”) has adopted an interpretation of state statute requiring stocked removable pockets for automated drug dispensing systems (“ADDS”) to be transported to and...more

New Hampshire Finalizes Opioid Prescribing Rules

New Hampshire is starting 2017 with stepped-up efforts to manage its oft-described opioid epidemic. Though the most recent regulations are directed at individual prescribers, and do not apply to the administration of opioids...more

Endo Pharms. Inc. v. Amneal Pharms. LLC

Case Name: Endo Pharms. Inc. v. Amneal Pharms. LLC, Civ Nos. 14-1382-RGA, 14-1389-RGA, 2016 U.S. Dist. LEXIS 140112 (D. Del. Oct. 7, 2016) (Andrews, J.). Drug Product and Patent(s)-in-Suit: Opana® ER (oxymorphone...more

RX IP Update - January 2017

Apotex’s Infringement of AstraZeneca’s Omeprazole Formulation Patent Upheld - As previously reported, the Federal Court of Appeal, in a unanimous decision released on January 12, 2017 (2017 FCA 9), has affirmed the...more

"Republicans Chart New Course for US Health Care System"

While President Donald Trump made repeal of the Affordable Care Act (ACA) a centerpiece of his 2016 presidential campaign, he offered few details about how he would replace it or address other health care issues. More...more

Merck Sharp & Dohme Corp. v. Hospira Inc.

Case Name: Merck Sharp & Dohme Corp. v. Hospira Inc., 14-cv-915-RGA, 2016 U.S. Dist. LEXIS 139721 (D. Del. Oct. 7, 2016) (Andrews, J.). Drug Product and Patent(s)-in-Suit: Invanz® (ertapenem); U.S. Patents Nos. 5,952,323...more

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