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HTMLLegislation to Reduce Consumer Cost-Sharing Takes a Back Burner in the Drug Pricing Debate
Carrie A. Roll; Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
Legal Alert/Article
June 22, 2016, previously published on June 9, 2016
As discussed in our recent post, states have turned up the heat on drug companies through both legislation and voter initiatives that would require drug companies to disclose their pricing mechanisms for certain high-cost drugs. Prior to this recent slate of drug pricing legislation and initiatives...

 

HTMLNew Compounding Policies from FDA May Affect Hospital and Health System Pharmacy Operations
Joanne S. Hawana; Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
Legal Alert/Article
June 19, 2016, previously published on May 3, 2016
Last month, FDA released three draft guidance documents that are expected to have significant implications for traditional pharmacy-based compounding and the distribution of those drug products.

 

HTMLDrug Company Payments and Prescribing Patterns Linked, Massachusetts Is An Outlier
Kate F. Stewart; Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.;
Legal Alert/Article
June 17, 2016, previously published on March 18, 2016
As reported in yesterday’s Boston Globe, compared to national averages, Massachusetts physicians are less likely to receive payments or items of value from pharmaceutical companies and less likely to be heavy prescribers of brand-name drugs. The Globe article relates to a ProPublica analysis...

 

HTMLFDA Releases Draft Guidance for 3D Printed Medical Devices
Jordan T. Cohen, Joanne S. Hawana; Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
Legal Alert/Article
June 17, 2016, previously published on May 17, 2016
On May 10, 2016, FDA released its first draft guidance for medical device manufacturers who are using additive manufacturing (AM), commonly referred to as 3D printing. The draft guidance, entitled “Technical Considerations for Additive Manufactured Devices,” was informed by a public...

 

HTMLFederal Circuit Finds Personal Jurisdiction over Mylan in Two Hatch-Waxman Appeals
Joseph D. Rutkowski, Adam P. Samansky; Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.;
Legal Alert/Article
June 16, 2016, previously published on March 24, 2016
On Friday, March 18, the Court of Appeals for the Federal Circuit affirmed two District of Delaware rulings that non-resident defendant generic ANDA filer, Mylan, is subject to personal jurisdiction in two Hatch-Waxman suits filed in the state. (See Acorda Therapeutics Inc. v. Mylan Pharmaceuticals...

 

HTMLStudies Suggest Common Acid Reflux Medication Could Cause Severe Side Effects
Law Offices of Peter G. Angelos A Professional Corporation;
Legal Alert/Article
May 27, 2016, previously published on May 6, 2016
Proton pump inhibitors (PPIs) are a class of medication used to treat a number of common abdominal conditions such as gastroesophageal reflux disease, stomach and duodenal ulcers, heartburn and erosive esophagitis. The medication works by obstructing the proton pump—an integral membrane...

 

HTMLPatent Held to not be Infringed Based on the Construction of the Claims
Adrian J. Howard, Beverley Moore, Chantal Saunders; Borden Ladner Gervais LLP;
Legal Alert/Article
May 10, 2016, previously published on April 14, 2016
Apotex sent a NOA to Shire alleging its patent was invalid and will not be infringed by Apotex. The issues were narrowed for the hearing, where issues of non-infringement, overbreadth, ambiguity, insufficiency and lack of utility were argued, as well as an argument that the claims were not relevant...

 

HTMLMotion to Strike and for Particulars Denied; Elevated Costs Ordered for Breach of Settlement Privilege
Adrian J. Howard, Beverley Moore, Chantal Saunders; Borden Ladner Gervais LLP;
Legal Alert/Article
May 10, 2016, previously published on April 14, 2016
Umano brought a motion to strike portions of the Statement of Claim, and in the alternative for further and better particulars. The motion further requested documents pursuant to Rule 206. The Court denied the motion in its entirety.

 

HTMLMotion for Interim Injunction Dismissed for Failing to Establish Irreparable Harm
Adrian J. Howard, Beverley Moore, Chantal Saunders; Borden Ladner Gervais LLP;
Legal Alert/Article
May 10, 2016, previously published on April 14, 2016
TearLab brought a motion for an interim injunction, with the hearing for an interlocutory injunction being scheduled in late April or May. TearLab is the exclusive licensee under the patent in issue and markets the TearLab Osmolarity System (TearLab System). The Court noted that almost all of the...

 

HTMLWitness' Evidence Given Less Weight because not Blinded to Patent or Issues; NOC Proceeding Dismissed
Adrian J. Howard, Beverley Moore, Chantal Saunders; Borden Ladner Gervais LLP;
Legal Alert/Article
May 10, 2016, previously published on April 14, 2016
Apotex sent a NOA in respect of a single patent, alleging obviousness and lack of utility. The Court held that allegation was justified.

 


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