News & Analysis as of

Generic Drugs

New York Institutes New Medicaid Drug Price Control Measures

by King & Spalding on

State Budget Includes Medicaid Drug Expenditure Cap - On April 20, 2017, New York Governor Andrew Cuomo signed into law certain cost-control measures that attempt to cap the state’s Medicaid drug spending, making New York...more

Appeal for Legislative Action to Address REMS Concerns

by Goodwin on

Last month, during the Biosimilar and Generics User Fee Acts (BsUFA II and GDUFA II) reauthorization hearing, a subject of considerable discussion was Risk Evaluation and Mitigation Strategies (REMS). REMS is a provision...more

New State Substitution Laws, and a Busy Spring for Biosimilars

We recently updated our chart that tracks state biosimilar substitution laws to include new laws in Iowa and Montana. These new laws bring the total number of states with biosimilar substitution laws to 27, plus Puerto Rico....more

Congressional Leaders Seek Input in UFA Reauthorization Draft Bill by April 28, 2017

On April 14, 2017, leaders from the Senate HELP Committee and the House Energy & Commerce Committee released the first discussion draft of the 2017 FDA user fee reauthorization bill. As we’ve been reporting, these two...more

Generic consistency evaluation in China: the coming paradigm shift in drug pricing and patent cliff

by Allen & Overy LLP on

China is one of the largest generic drug markets in the world. As part of the drug approval reform, the ongoing generic consistency evaluation (GCE) is likely to have significant, long-lasting impacts on the market landscape,...more

Novartis v. Noven: The PTAB is not Bound by Prior Decisions of District Courts

Novartis, together with LTS Lohmann Therapie-Systeme, owns a pair of patents covering rivastigmine transdermal patches. These patches are useful for treating Alzheimer’s disease. Noven Pharmaceuticals filed an abbreviated new...more

Non-Existent Duty to Warn of Mensing Not Enough to Get Around Mensing Preemption

by Reed Smith on

Earlier this week, we discussed how the presentation of the federal question of express preemption from the face of a complaint can lead to removal. Part of why the defendant drug or device manufacturer may prefer federal...more

Markush Madness: Watson Avoids Infringement by Adding an Element to a Formulation

by K&L Gates LLP on

On February 1, 2017, in Shire Development, LLC v. Watson Pharmaceuticals, Inc., the U.S. Court of Appeals for the Federal Circuit held that Watson’s proposed generic version of Shire’s LIALDA® did not infringe claims 1 and 3...more

Trump’s Nominee for FDA Commissioner Likely Dooms Generic Drug Labeling Rule

President Trump recently announced his intent to nominate a new commissioner of the U.S. Food and Drug Administration (FDA), likely sealing the fate of FDA’s proposed generic drug labeling rule. The proposed rule would give...more

Seventh Circuit Grants Interlocutory Appeal in Rx Discount Program Qui Tam Suit to Answer Several Important Questions

by Ropes & Gray LLP on

In United States ex rel. Garbe v. Kmart Co., 824 F.3d 632 (7th Cir. 2016), the Seventh Circuit granted interlocutory appeal following numerous motions for partial summary judgment to consider four questions: (1) whether the...more

Ontario Superior Court dismisses summary judgment motion in Lansoprazole Section 8 Claim

by Smart & Biggar on

On February 27, 2017, the Ontario Superior Court of Justice (2017 ONSC 1348) dismissed a motion for summary judgment brought by Abbott Laboratories and Takeda Pharmaceuticals, the defendants in an action for damages brought...more

FDA User Fee Hearings Picking Up Steam on Capitol Hill

As we noted previously in our introductory blog post on the 2017 User Fee Act (UFA) reauthorization process, the first UFA hearing on Capitol Hill was convened on March 2, 2017 by the House Energy & Commerce Committee’s (E&C)...more

[Webinar] Pharmaceutical Life Cycle Management: Updates on Navigating the IP, FDA and Antitrust Terrain - April 5th, 12:00pm EST

by BakerHostetler on

There’s been a sea change in the political climate. The regulatory forecast is still uncertain, and pharmaceutical evolution continues to develop....more

BPCIA Helps Amgen Gain Dismissal of Genentech Complaint

Recently, the U.S. District Court of Delaware dismissed a complaint filed by Genentech under the Biologics Price Competition and Innovation Act (“BPCIA”). The complaint was filed in response to Amgen seeking FDA approval to...more

Dechert survey: Developments in securities fraud class actions against U.S. life sciences companies

by Dechert LLP on

Life sciences companies continued to be popular targets of securities fraud class action lawsuits filed in 2016, and prudent life sciences companies should take heed of the results of this year’s decisions. In 2016,...more

Competition News March 2017

by Dentons on

The French Supreme Court confirms the French Competition Authority’s approach on the squeeze-out strategies shared between a supplier and its distributor - In this case, Reckitt Benckiser (Reckitt), holder of rights on...more

February 2017: Life Sciences Litigation Update

Recently Amended FDA Rules Can Affect Settlements in Pharmaceutical Litigations. After more than thirteen years of bureaucratic analysis and rulemaking, the U.S. Food and Drug Administration recently implemented its new rules...more

Genentech’s BPCIA Complaint Against Amgen Dismissed

Today, Judge Gregory Sleet of the U.S. District Court of Delaware orally dismissed Genentech’s lawsuit against Amgen alleging violations of the BPCIA. Judge Sleet did not issue a written opinion, but his order states that...more

SCOTUS to Weigh In on Two Biosimilar Patents, Provisions of the BPCIA in 2017

2017 is shaping up to be a big year for biosimilars and for the Biologics Price Competition and Innovation Act of 2009 (BPCIA) specifically. The Supreme Court is scheduled to hear oral arguments on April 26, 2017, that will...more

The Government Seeks to Intervene in its Third Generic Drug Price-fixing Lawsuit

Since we last reported on the state and federal government’s generic drug pricing investigations and litigations (click here to read more), the U.S. Department of Justice (“DOJ”) has obtained its first guilty pleas. On...more

Wrong Inventor Defense Fails in Pharmaceutical Litigation

by McDermott Will & Emery on

Addressing derivation and obviousness issues, the US Court of Appeals for the Federal Circuit affirmed the district court’s denial of a generic drug manufacturer’s attempt to invalidate a patent based on the theory that the...more

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

by Miles & Stockbridge P.C. on

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

Will You, Won't You Join The Biosimilar Patent Dance?

by Foley & Lardner LLP on

In the latest dispute surrounding the “patent dance” provisions of the Biologics Price Competition and Innovation Act (BPCIA), Genentech, Inc. has filed a complaint against Amgen, Inc., alleging that after opting into the...more

On-Sale Bar for Contractor and Supplier Activities

The Federal Circuit addressed the potential for contract manufacturing to create an “on sale” bar to patentability, in a decision that could affect how supplier relationships are managed. Whether a sale or offer for sale of...more

Fed. Circ. Provides Cautionary Tale on Markush Claiming

Originally published in Law360 - February 22nd, 2017. The Federal Circuit’s decision in Shire Development LLC v. Watson Pharmaceuticals Inc., No. 16-1785, 2017 WL 541013 (Fed. Cir. Feb. 10, 2017), provides a cautionary...more

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