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Top Stories of 2021: #7 to #9

After reflecting upon the events of the past twelve months, Patent Docs presents its 15th annual list of top patent stories. For 2021, we identified nine stories that were covered on Patent Docs last year that we believe had...more

Sen. Tillis Asks Biden Administration to Oppose WTO Waiver Proposal

Last month, the Biotechnology Innovation Organization (BIO) and Pharmaceutical Research and Manufacturers of America (PhRMA) sent separate letters urging the Biden Administration to join the European Union, United Kingdom,...more

Industry Coalition Supports Continued Efforts to Oppose Waiver Proposal

Earlier today, a group of fifteen industry and trade organizations sent a letter to five members of the Biden Administration, to express their strong support for the Administration's work to leverage international mechanisms...more

Trump Administration Considering Reduction in Biologics Exclusivity Period

On Monday, December 2, 2019, The Wall Street Journal reported that the Trump administration is considering reducing the 12-year data exclusivity period for biologic drugs set forth in the Biologics Price Competition and...more

Top Stories of 2016: #16 to #20

After reflecting upon the events of the past twelve months, Patent Docs presents its tenth annual list of top patent stories. For 2016, we identified twenty stories that were covered on Patent Docs last year that we believe...more

Top Stories of 2015: #11 to #15

After reflecting upon the events of the past twelve months, Patent Docs presents its ninth annual list of top patent stories. For 2015, we identified twenty stories that were covered on Patent Docs last year that we believe...more

Senators Send Letter on Biosimilars to FDA

A group of Senators led by Sen. Lamar Alexander (R-TN), the Chairman of the Senate Committee on Health, Education, Labor, and Pensions, sent a letter last month to Dr. Stephen Ostroff, the Acting Commissioner of the U.S. Food...more

Indiana Governor Signs Biosimilar Substitution Bill

On March 25, Indiana Governor Mike Pence signed legislation (Senate Bill 262) that will allow pharmacists in Indiana to substitute an interchangeable biosimilar product for a prescribed biological product if certain...more

Top Stories of 2013: #11 to #14

Reflecting upon the events of the past twelve months, Patent Docs presents its seventh annual list of top biotech/pharma patent stories. For 2013, we identified fourteen stories that were covered on Patent Docs last year...more

Governor Brown Vetoes California Biosimilar Bill

Last week, Governor Jerry Brown vetoed a California bill (SB-598) that would have authorized a pharmacist to select a biosimilar when filling a prescription order for a prescribed biological product, provided that the...more

California Biosimilar Bill Aligns with BIO Principles on Biologic Substitution

Yesterday, we noted that the Generic Pharmaceutical Association (GPhA) recently expressed its opposition to a California bill (SB-598) that would authorize a pharmacist to select a biosimilar when filling a prescription order...more

GPhA Opposes California Biosimilar Bill; Points to Report on Savings from Biosimilars

Last week, the Generic Pharmaceutical Association (GPhA) released a statement regarding a California bill (SB-598) that the GPhA asserted would "introduce[] burdensome provisions that could raise costs and limit patient...more

Senators Back 12-Year Data Exclusivity Period for Biosimilars and President Obama (Once Again) Does Not

On March 22, Senators Max Baucus (D-MT) and Orrin Hatch (R-UT), the Chairman and Ranking Member, respectively, of the Senate Committee on Finance, sent a letter to Ambassador Demetrios Marantis, the Acting United States Trade...more

WLF Submits Comments on Abbott's Citizen Petition on Biosimilars

Last April, Abbott Laboratories filed a Citizen Petition with the U.S. Food and Drug Administration, asking the agency to refrain from accepting biosimilar applications under the Biologics Price Competition and Innovation Act...more

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