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Adobe PDFAlabama No Longer an Outlier State: Legislature Says “No” to Innovator Liability
Christopher S. Berdy, John H. Dollarhide, Ashley Nader Stubbs; Butler Snow LLP;
Legal Alert/Article
January 21, 2016, previously published on Fall 2015
Since the United States Supreme Court’s decision in Pliva, Inc. v. Mensing1, the plaintiffs’ bar has been feverishly searching for an alternate theory of recovery when the claimant took a generic prescription drug. One of those alternate theories is “innovator liability,”...

 

HTMLDecisions re Motions to Strike Upheld: Agreement with Ratiopharm Does Not Preclude Teva Section 8 Claim
Adrian J. Howard, Beverley Moore, Chantal Saunders; Borden Ladner Gervais LLP;
Legal Alert/Article
January 5, 2016, previously published on December 17, 2015
The Pfizer appellants (Pfizer) appealed the decision of the Court denying their motion for summary judgment in respect of the action by Teva Canada Limited (Teva) pursuant to section 8 of the Patented Medicines (Notice of Compliance) Regulations (Regulations). The issue in Pfizer's motion related...

 

HTMLClass Action Certification against Pfizer for an Allegation of Unlawful Abuse of the Patent System is Overturned
Adrian J. Howard, Beverley Moore, Chantal Saunders; Borden Ladner Gervais LLP;
Legal Alert/Article
January 5, 2016, previously published on December 17, 2015
The British Columbia Court of Appeal has overturned the certification of a class action relating to the drug Viagra, dismissing the action.

 

HTMLThe Pharmacy Industry - 2015 Year In Review
Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
Legal Alert/Article
December 29, 2015, previously published on December 8, 2015
With 2015 coming to a close, we wanted to provide a recap of the major updates impacting the pharmacy industry and what pharmaceutical manufacturers, pharmacy benefit managers (“PBMs”), and pharmacies might expect in 2016. This past year saw significant changes in the pharmacy industry....

 

HTMLOIG Proposes Alternative Part B Payment Methodologies for 340B Drugs: Is This the End of 340B As We Know It?
Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
Legal Alert/Article
December 29, 2015, previously published on December 2, 2015
Last week, under the cover of the impending Thanksgiving Holiday, OIG lobbed another grenade at the 340B Drug Discount Program.

 

HTMLFDA Legal and Regulatory - 2015 Year In Review
Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
Legal Alert/Article
December 29, 2015, previously published on December 14, 2015
Looking back on 2015, it’s apparent that this was another very busy year for the Food and Drug Administration (FDA or Agency), whose oversight responsibilities are estimated to touch 25% of American consumers’ spending on various regulated products. There was no shortage of significant...

 

HTMLFDA Provides Additional Warnings for SGLT2 Inhibitors
Law Offices of Peter G. Angelos A Professional Corporation;
Legal Alert/Article
December 10, 2015, previously published on December 7, 2015
In May, the United States Food and Drug Administration released information advising physicians and patients to be cautious about the risks related to SGLT2 inhibitors. Now, the FDA has updated the warning label for the drugs to include the risk of ketoacidosis and severe urinary tract infection.

 

HTMLXarelto Bellwether Trials to Begin in 2017
Law Offices of Peter G. Angelos A Professional Corporation;
Legal Alert/Article
December 10, 2015, previously published on November 16, 2015
Pretrial discovery and bellwether trial selection for the Xarelto multidistrict litigation (MDL) has begun. The first trials will consist of a selection of four cases, from a pool of forty, that have been considered to represent the majority of the cases filed around the nation. The first of the...

 

Adobe PDFPTAB Holds Claims Invalid That Were Held To Be Not Invalid In Litigation Appeal
Robert H. Resis; Banner & Witcoff, Ltd.;
Legal Alert/Article
December 2, 2015, previously published on November 17, 2015
The Patent Trial and Appeal Board recently held claims in two separate patents to be invalid that were previously held to be not invalid in a litigation appeal. In separate inter partes review proceedings, the PTAB held that the district court decision, affirmed by the Federal Circuit, upholding...

 

HTMLPatent is Not Found to be a Selection Patent, and thus was Anticipated and Obvious
Adrian J. Howard, Beverley Moore, Chantal Saunders; Borden Ladner Gervais LLP;
Legal Alert/Article
December 2, 2015, previously published on November 25, 2015
The Federal Court has dismissed an application for prohibition to prevent the Minister of Health from issuing an NOC to Mylan for cinacalcet hydrochloride.

 


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