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Category: Biosimilars
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BIO and Biosimilars By Andrew Williams — The 2011 BIO International Convention in Washington, D.C. begins next week. If you are planning on attending, Patent Docs is highlighting a few sessions, in thematic fashion, to help navigate your way through the convention. Last week, we highlighted four sessions on how the Supreme Court is impacting…
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By Kevin E. Noonan — Under the biologics pathway provisions of the Patient Protection and Affordable Care Act (P.L. 111-148), § 351(k) of the Public Health Service Act, codified at 42 U.S.C. § 262(k)), the FDA is given the authority to develop procedures for approving biosimilar applications. Recognizing the complexities of the issues involved, Congress…
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By Donald Zuhn — On Monday, the U.S. Food and Drug Administration published a notice in the Federal Register (76 Fed. Reg. 27062) requesting comments related to the development of a user fee program for biosimilar and interchangeable biological products under the approval pathway for biosimilar biological products established by the Patient Protection and Affordable…
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By Juan Serrano — The Federal Commission for Protection Against Sanitary Risks (COFEPRIS) is the Mexican equivalent of the U.S. Food and Drug Administration (FDA). For the past three years this Commission was headed by Miguel Angel Toscano, who had previously held a position at the Ministry of Economy. Mr. Toscano's exit from COFEPRIS has…
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By Donald Zuhn — President Obama unveiled his 2012 budget last week, and while the President's budget calls for cuts in many areas of government, he would like to raise investment in basic research. As a result, under the President's budget proposal, funding for the National Institutes of Health (NIH) would rise from the current…
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By Kevin E. Noonan — A debate has begun on the meaning of the term "exclusivity" in the follow-on biologics pathway provisions of the Patient Protection and Affordable Care Act (P.L. 111-148), § 351(k) of the Public Health Service Act, codified at 42 U.S.C. § 262(k)). The debate centers on the availability of innovator drug…
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By Kevin E. Noonan — Members of Congress, from both houses, have let the Food and Drug Administration know their views on the distinction between "data exclusivity" and "market exclusivity" under the follow-on biologics pathway provisions of the Patient Protection and Affordable Care Act (P.L. 111-148, § 351(k) of the Public Health Service Act, codified…
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By Kevin E. Noonan — Members of Congress having sent their letter to the Food and Drug Administration on December 21st (see "Representatives Send Letter to FDA to Explain Data Exclusivity Provisions of Biosimilars Legislation"), on January 7th, it was the Senate's turn. In their letter, Senators Kay Hagan (D-NC), Orrin Hatch (R-UT), Michael Enzi…
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Representatives Send Letter to FDA to Explain Data Exclusivity Provisions of Biosimilars Legislation
By Kevin E. Noonan — Members of Congress (Rep. Anna G. Eshoo (D-CA) (at right), Rep. Jan Inslee (D-WA), and Rep. Joe Barton (R-TX)) who sponsored the follow-on biologics portion of the comprehensive health care reform bill past year (Patient Protection and Affordable Care Act (H.R. 3590, now P.L. 111-148)) have sent a letter to the…
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By Donald Zuhn — Reflecting upon the events of the past twelve months, Patent Docs presents its fourth annual list of top biotech/pharma patent stories. For 2010, we identified a dozen stories that we covered on Patent Docs last year that we believe had (or are likely to have) the greatest impact on biotech/pharma patent…
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