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- USPTO and DOJ Statement of Interest in Collision Communications: Another Thumb on the Scale in Favor of NPE Patent Plaintiffs
- Oasis Tooling, Inc. v. Siemens Industry Software Inc. (Fed. Cir. 2026)
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Category: Biosimilars
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By Kevin E. Noonan — As reported today in The Wall Street Journal, the innovator biotechnology industry scored a major victory in the Senate on Monday, when that chamber's Health, Education, Labor and Pensions Committee approved an amendment providing a 12-year data exclusivity period for biologic drug makers. The committee voted 16-7 in favor…
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By Donald Zuhn — On Friday, the National Venture Capital Association (NVCA) released the results of a study suggesting that "a data exclusivity period of at least 12 years for innovator products is a critical fulcrum in the effort to balance cost with the preservation of biotech innovation." The results of the NVCA-commissioned study…
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By Donald Zuhn — On the same day that BIO CEO Jim Greenwood was briefing the media regarding follow-on biologics legislation in the current Congress, the National Coalition on Health Care (NCHC) was making its position on the legislation known in a letter sent to Senate Committee on Health, Education, Labor, and Pensions (HELP)…
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By Kevin E. Noonan — Yesterday, Senator Ted Kennedy (D-MA) proposed that innovator biologic drugmakers should be given up to 13.5 years of data exclusivity in any follow-on biologics legislation to be considered by Congress this session. As reported by Catherine Larkin at Bloomberg.com, the Senator's proposal was introduced as a "placeholder" that could…
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By Donald Zuhn — During a Wednesday afternoon teleconference, Jim Greenwood, the President and CEO of the Biotechnology Industry Organization (BIO), discussed a recent "flurry of activity" surrounding follow-on biologics legislation currently being debated in Congress. Noting that the Senate Committee on Health, Education, Labor, and Pensions had reported follow-on biologics legislation providing 12…
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By Donald Zuhn — IPO Continues to Support 14-Year Exclusivity Period The Intellectual Property Owners Association (IPO), reporting on last week's announcement that the White House believes a 7-year data exclusivity period "strikes the appropriate balance between innovation and competition," reminded its members today that the IPO Board adopted a resolution in September 2008…
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By Donald Zuhn — Reuters reports that the White House sent a letter to Rep. Henry Waxman (D-CA), the Chairman of the House Energy and Commerce Committee, on Thursday stating that a follow-on biologics regulatory pathway providing a 7-year data exclusivity period would "strike[] the appropriate balance between innovation and competition." According to the…
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By Kevin E. Noonan — As reported last week by FierceBiotech, EvaluatePharma, a market forecasting firm specializing in the life sciences sector, released its prediction on the future of the pharmaceutical industry. According to EvaluatePharma, six of the top ten selling drugs by 2014 will be biologics. Today, half of the top ten best-selling…
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By Donald Zuhn — In a follow-on biologics report that has received widespread media attention, the Federal Trade Commission concluded last week that a 12-14 year data exclusivity period was not needed to promote innovation by pioneer biologics companies (see "No One Seems Happy with Follow-on Biologics According to the FTC"). The FTC's conclusion…
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By Kevin E. Noonan — Last week, the Federal Trade Commission issued a report on follow-on biologics ("Emerging Health Care Issues: Follow-on Biologic Drug Competition"). As many patent practitioners did a few years ago when the FTC issued a report on patent reform, many in the biotech and pharma community, generics companies, and Congress…
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