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Letters, Testimony & Comments

USPTO's proposed 5-year Strategic Plan
October 6, 2006
Perhaps no other industry is as dependent upon patents as is the biotech industry.  In 2004 alone, more than 10% of the PTO's application filings were in the biotechnology sector.  This is because patents are often the most valuable...
Findings from a replication of the CMS ASP+5% calculation
October 6, 2006
From the Moran Company
BIO's written comments regarding USPTO's proposed 5-year Strategic Plan
October 6, 2006
Ferring B.V. and Aventis Pharmaceuticals, Inc. v. Barr Laboratories, Inc.
October 1, 2006
Oregon Draft Policy Recommendations for Plant-Made Pharmaceuticals
September 26, 2006
To: Oregon Department of Agriculture, Oregon Department of Human Services and Members of the Biopharming Ad Hoc Committee The Biotechnology Industry Organization (BIO) and Oregonians for Food & Shelter (OFS) appreciate the opportunity to...
Draft of Chapter 6 of the Medicare Part D Manual
September 26, 2006
Comments to CMS on the draft.
Oregon Draft Policy Recommendations for Plant-Made Pharmaceuticals
September 26, 2006
BIO and Oregonians for Food and Shelter (OFS) letter to the Oregon Department of Agriculture.
"National Coverage Determinations with Data Collection as a Condition of Coverage: Coverage with Evidence Development (CED)."
September 22, 2006
Comments to CMS on the guidance document
BIO Letter to Chairman and Ranking Member of the Senate Committee on Finance on strengthening criteria such as a recipient country's competitiveness in the agricultural sector, the enforcement of intellectual property rights and the elimination of non-tar
September 18, 2006
BIO Letter to Chairman and Ranking Member of the Senate Committee on Finance on strengthening criteria such as a recipient country's competitiveness in the agricultural sector, the enforcement of intellectual property rights and the...
Medicare Prescription Drug Benefit Manual Draft - Chapter 5
September 18, 2006
Comments to CMS
Letter, China's Compliance with WTO Commitments
September 18, 2006
Office of the U.S. Trade Representative
Comments to the USPTO on the proposed rule changes to Information Disclosure Statements
September 9, 2006
Attention: Hiram H. Bernstein Comments to Proposed Rulemaking Entitled: Changes to Information Disclosure Requirements and Other Related Matters Dear Mr. Bernstein: The Biotechnology Industry Organization (BIO) appreciates the opportunity to...
Letter to the State Intellectual Property Office of the Peoples' Republic of China
August 28, 2006
Dear Mr. Tian: I am writing on behalf of the Biotechnology Industry Organization (BIO) in response to your request for comments on the draft amendments to Patent Law of the Peoples' Republic of China.
Letter, Patent Law of the People's Republic of China
August 28, 2006
To the State Intellectual Property Office of the People's Republic of China
Comments to CMS on the RVU's and Practice Expense Methodology
August 21, 2006
BIO's comments regarding the CMS proposed notice on the five-year review of work relative value units (RVUs) and proposed changes to the practice expense methodology under the physician fee schedule.
APC Panel
August 18, 2006
The Biotechnology Industry Organization (BIO) appreciates this opportunity to testify before the Advisory Panel on Ambulatory Payment Classifications (the APC Panel). BIO is the largest trade organization to serve and represent the biotechnology...
Comments on NCA Tracking Sheet for Clinical Trial Policy
August 9, 2006
BIO's comments on the CMS' Tracking Sheet regarding the development of a Clinical Research Policy (CRP) as a reconsideration of its national coverage decision (NCD) on Medicare coverage of clinical trials.
A side-by-side summary of BIO's comments to the IPPS proposed rule and CMS' response
August 8, 2006
On August 1, 2006 the Centers for Medicare and Medicaid Services (CMS) released the fiscal year (FY) 2007 hospital inpatient prospective payment system (IPPS) final rule. /1 The rule will be published in Federal Register on Friday, August 18, and...
Comments to CMS' proposed rule regarding the competitive bidding program for DMEPOS
June 30, 2006
BIO Comments, Proposed California IP regulation for Non-profit Organizations
June 16, 2006