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Safe Harbor Exemption May Not Be So Safe | Troutman Pepper

Safe Harbor Exemption May Not Be So Safe | Troutman Pepper
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Biosimilars 2021 Year in Review | Fish & Richardson

2021 saw several important milestones in the biosimilars space, including the much anticipated first interchangeable designations by FDA and the approval of the first ophthalmology. ....

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Third Circuit Denies 340B Program Contract Pharmacy Arrangements

Wednesday, July 7, 2021
Recent court decisions and the subsequent rescission of a key advisory opinion have left the status of contract pharmacy programs in continued flux. On 30 December 2020, the Department of Health and Human Services (HHS) released Advisory Opinion 20-06 (the Advisory Opinion) stating that drug manufacturers are required to deliver drugs to contract pharmacies and charge no more than the 340B ceiling price. On 16 June 2021, the U.S. District Court for the District of Delaware issued a Memorandum Opinion (Decision) in
AstraZeneca Pharmaceuticals LP v. Becerra, a case that challenged the validity of the Advisory Opinion, narrowly holding that Congress has not clearly and unambiguously spoken regarding the unlimited use of contract pharmacies by covered entities under the 340B Program. ....

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Late But Not Too Late | Submitting Post-Filing Data During Patent Prosecution in Selected Jurisdictions | Kilpatrick Townsend & Stockton LLP

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Intellectual Property counsel often face the dilemma of when to file a patent application: as soon as possible, or wait and gather more support? Filing an application “early” helps to avoid anticipatory prior art but if the application is filed too early, the applicant may risk rejections during examination for lack of supportive evidence.
On the other hand, if the application is filed too late, the applicant may lose the priority date. This is especially problematic for biopharma industry applicants where on one hand, these data are often critical for securing a patent; on the other hand, the research and development cycle is long and generating experimental and clinical trial data require significant resources and time to obtain, and business and financial reasons can also render it difficult to predict when the data will become available. Frequently supporting data and related information are not available ....

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Chief Judge Leads Federal Circuit in Reconsidering its Appetite for Skinny Labels | Dechert LLP

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The Chief Judge of the U.S. Court of Appeals for the Federal Circuit Sharon Prost, has quipped that, with her experience in both the legislative and judicial branches of government, she is a “walking separation of powers.”
1 Prior to her appointment to the Federal Circuit in 2001, where she has presided as chief since 2014, she served as a lawyer for the Senate, including as Senator Orrin Hatch (R-Utah)’s chief counsel on the Senate Judiciary Committee. With this resume, Judge Prost has amassed decades of exposure to and expertise with IP issues affecting the pharmaceutical industry. ....

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