Webinar: Orange Book listing sheets under the microscope
Key Considerations for Reshoring U.S. Drug Manufacturing
Drug Pricing Initiatives During the Trump Presidency
Podcast: IP Life Sciences Landscape: Aiding Orange and Purple Book Patent Owners in Developing PTAB Survival Skills
Patent law in Europe: What pharmaceutical companies need to know
EU excessive pricing laws
Polsinelli Podcast - Generic Drugs to Market - What's the Climate in 2014?
The Inflation Reduction Act (“IRA”) was passed just over a year ago with a goal of lowering high drug costs for Medicare beneficiaries and reducing costs incurred by Medicare. A central piece to achieving the IRA’s goal of...more
Although legal fees spent preparing Paragraph IV notice letters must be capitalized (and thus amortized over 15 years), legal fees spent defending ANDA suits launched in response to those letters may be taken as deductions in...more
On April 27, 2021, the U.S. Tax Court issued its decision in Mylan, Inc. v. Comm’r of Internal Revenue regarding which legal fees that a generic-drug manufacturer incurs in connection with its Abbreviated New Drug Application...more
On April 27, 2021, the United States Tax Court held that legal fees incurred by generic drug manufacturers in connection with “Section 271(e)(2)” patent infringement suits are deductible as ordinary business expenses and need...more
A state appeals court in California has preempted Uber and Lyft’s threatened state-wide shutdown over a new state law ordering them to reclassify their drivers as employees by “allowing them to continue operating [under their...more
Employer plans will still be able to exclude the value of drug manufacturer coupons from annual out-of-pocket maximums, even when no generic equivalent is available, under new guidance from the Department of Labor, Department...more
Drug giants Pfizer and Mylan have inked a deal that will merge the former’s off-patent drugs with the latter’s generics business, a tie-up that creates a mammoth global seller of lower-priced medicines....more
In This Issue: - IRS in the ACA Spotlight - DOJ and FTC Examine Competition - Implementation of the Affordable Care Act - Other Federal Regulatory Initiatives - Congressional Initiatives - Other...more