新上市专利药的定价方法

目的为完善我国新上市专利药品价格管理提供参考,特研究新上市专利药品定价方法。方法总结我国现阶段专利药品价格管理方式,讨论不足之处。结果与讨论提出药物经济学定价的方法。     

2008年专利到期药品数据分析

目的通过对2008年美国和中国专利到期药品数据的分析,提出目前我国仿制药业的机遇与挑战.方法从Pharmaproject数据库和中国国家知识产权局专利数据库中抽取2008年中美两国专利到期药品数据,并利用分类统计和对比分析的方法对此进行分析.结果2008年美国市场有50种药品专利到期,中国市场有11种药品专利到期.结论中国仿制药业应注重非专利药所针对疾病类型及新型药物剂型的开发.     

我国的药品专利强制许可制度

专利在药品市场中扮演着重要角色.据美国著名经济学家曼斯菲尔德研究分析和调查统计,如果没有专利保护,药品发明有60%研究不出来,有65%不会被利用[1].专利制度激励了新药投资、保证了新药研发,但有时因为专利持有人行使独占权和排他权而导致药品价格居高不下,致使包括我国在内的发展中国家的患者很难获得廉价的治疗药物.而专利强制许可制度能够有效地解决药品专利权保护与增加药品可获得性之间的矛盾.本文通过对专利强制许可制度的介绍,结合药品专利强制许可在发展中国家的新实践,提出推动我国药品专利强制许可制度实施的策略.……     

中国药品专利质量评价指标体系建立初探

药品专利质量指标是科学技术创新指标的重要部分。建立以药品专利的数量、质量、结构及专利法保护水平四大模块组成的专利评价指标体系,为增强我国药品专利指标国际可比性和分析、制定国家、区域和产业政策提供依据。     

抗心律失常药物市场分析

在全球药品市场上,心血管类药物是居于首位的药物。随着新释药技术在药物制剂中的广泛应用。使许多普药得到了有效的挖潜。遏制了因产品专利保护期满、新化合物药物开发进程缓慢和药品价格调整三大因素导致的全球医药市场增长率的下滑。我国是发展中国家,心血管类药物是仅次于全身用抗感染类药物的品种。近年来,在国家医疗体制改革、药品招标采购、药品降价、国产新药开发后成果转化的工业化生产逐渐替代了进口品种等多种因素的影响下,心血管类药物市场金额的增长指数已呈现出缓慢增长的态势。这无疑在减少患者医药费支出和社会医疗保障体系的沉重负担上起到了一定缓解作用。     

德法两国仿制药品市场发展的比较分析

目的 分析德国、法国仿制药品发展的影响因素.方法 对比分析专利保护、定价、报销政策、处方替换和处方预算制度这五个因素对德法两国仿制药品发展的影响.结果 和结论 低廉的药品价格和专利法规是阻碍法国市场发展的关键因素,加强教育和鼓励医生在处方中使用药品通用名称有助于促进仿制药品市场发展.在德国,随着仿制药品市场的成熟,参照价格体系的作用越来越不明显,医生的处方行为将是影响市场发展的关键因素.     

药品专利保护指标体系构建及其应用（一）

构建一个药品专利保护强度指标体系,并对药品专利保护强度进行客观的测量,不仅是经济学研究的基础,也是对各类理论模型加以验证的前提条件,更为重要的是,可以借此进行药品专利保护强度的国际比较。本研究遵循药品专利保护强度应是立法强度与执法强度综合的原则,构连了由2个一级指标、11个二级指标以及37个三级指标组成的药品专利保护指标体系。     

药品专利保护指标体系构建及其应用（二）

构建一个药品专利保护强度指标体系,并对药品专利保护强度进行客观的测量,不仅是经济学研究的基础,也是对各类理论模型加以验证的前提条件,更为重要的是,可以借此进行药品专利保护强度的国际比较,本研究遵循药品专利保护强度应是立法强度与执法强度综合的原则,构建了由2个一级指标、11个二级指标以及37个三级指标组成的药品专利保护指标体系。     

欧盟非专利药品市场发展的现状和对策

目的对欧盟各国非专利药品市场发展不均衡的现状给予解决对策。方法在分析欧盟非专利药品市场发展现状的基础上，归纳非专利药品市场发展的制约因素，并根据这些制约因素探讨对策。结果和结论影响非专利药品市场发展的因素可以分成供给和需求两个方面，为了促进该市场的发展，政府可以制定政策促使专利药厂接受非专利药品生产商的竞争，鼓励非专利药品市场的价格竞争，完善药品信息传递渠道，建立一个协调的非专利药品市场监管政策系统，不断提高非专利药品的质量，减少医生、药剂师对非专利药品消费的阻碍。     

专利战略在华禧联合科技药品研发中的应用

药品研发的生命周期（从研发到上市）至少要经过10年的时间，但是药品的复制却并不复杂，可能只需要几个人几个月的时间，因此专利的保护对药品就显得特别重要，可以说专利是药品唯一的保护手段。北京华禧联合科技发展有限公司自成立以来就十分注重药物研发中的创新，通过专利的手段对研发过程中的创新进行定义与保护。     

Pricing strategy and moral hazard: Copay coupons in pharmaceuticals

Branded drug manufacturers issue copay coupons to compete with generics as their brands are coming off patent. To explore the impact of copay coupons on pricing and welfare, I estimate a model of demand and supply using data on sales, advertising, and copayment for cholesterol-lowering drugs and perform a counterfactual analysis to simulate equilibrium pricing with copay coupons used for price discrimination and moral hazard. Copay coupons issued for price discrimination make the drug with coupons affordable for more consumers and increase consumer welfare even when a small fraction of consumers receive a coupon. Coupons used for moral hazard significantly mitigate price competition and improve consumer welfare only when coupon penetration is sufficiently high.     

欧洲主要国家药品定价和补偿制度的比较分析

通过比较分析的方法深入探讨欧洲各主要国家药品定价和补偿制度的特点以及经济学评价的应用情况。如何评价新药的创新性已成为各国政府在规制药品市场时共同面临的关键性问题,而与创新水平评价密切相关的带有“双重定价”意味的定价体制值得我国政府在平衡控制药品费用和激发医药产业创新实力这一矛盾时借鉴学习。     

PATENT DAMAGES AND SPATIAL COMPETITION*

We analyze price competition between a spatially differentiated product patentee and an imitator anticipating probabilistic future patent damages. We compare the performance of three damage regimes. The ‘reasonable royalty’ regime, which yields symmetric equilibrium pricing, maximizes static welfare and yields the highest innovation incentives when patent enforcement is nearly certain. The ‘lost profits’ regime, which may deter infringement, yields the highest innovation incentives when patent enforcement is less‐than‐certain and products are sufficiently valuable. The ‘unjust enrichment’ regime yields low static efficiency and low innovation incentives. We offer new insights into the ‘hypothetical negotiation’ that courts use to construct reasonable royalties.     

Economics at the FTC: Drug and PBM Mergers and Drip Pricing

Economists at the Federal Trade Commission pursue the agency??s competition and consumer protection missions. In this year??s essay, in antitrust, we discuss two recent mergers that involved Rx drugs: First, we describe key elements of the inquiry into the Express Scripts/Medco transaction in the pharmacy benefit management industry. Next, we analyze a merger that involved drugs that are used to treat patent ductus arteriosus: a condition that affects premature babies. On the consumer protection side, we discuss a pricing strategy??drip pricing??that involves the release of price information about a multi-part product over time as the consumer goes through the purchase process.     

Moving beyond simple examples: Assessing the incremental value rule within standards

This paper presents a model of patent licensing in a standard setting context when patented technologies are heterogeneous in multiple dimensions. The model allows us to assess a policy proposal put forth in the literature: that an incremental value pricing rule should define Fair, Reasonable, and Non-Discriminatory (FRAND) patent licensing within Standard Setting Organizations as it replicates the ex ante efficient competition outcome. We find that when patented technologies must be weighed on numerous factors, and not simply one-dimensional cost-savings, there is unlikely to be a single incremental value that can be agreed upon by all relevant parties. Furthermore, ex ante competition fails to select the efficient technologies by penalizing the more versatile ones. These results cast some doubt on the usefulness of the incremental value as a precise benchmark for FRAND.     

Optimal bid disclosure in patent license auctions under alternative modes of competition

The literature on patent license auctions in oligopoly assumed that the auctioneer reveals the winning bid and stressed that this gives firms an incentive to bid high in order to signal an aggressive output strategy in a downstream Cournot market game, and conversely bid low to signal acquiescent pricing in a Bertrand market game. The present paper examines the information revealed by publishing the winning or the losing or no bid, assuming an oligopoly with differentiated goods. We rank disclosure rules and find that it is not optimal for the innovator to disclose the winning bid, regardless of the mode of competition.     

A NAASTy alternative to RAND pricing commitments

Voluntary standard setting organizations (SSOs) typically require participants to disclose their patents during the standard-setting process, and will endorse a standard only if patent holders commit to license them on reasonable and non-discriminatory or RAND terms. This policy is unworkable—the RAND standard is ambiguous and thus extremely hard to adjudicate. As an alternative, a policy of Non-Assertion After Specified Time, or NAAST pricing, is proposed. Under NAAST, technology vendors commit not to assert their patent after some previous specified time, but would be free to collect royalties as they wish up until that point. Under this proposal, technology producers would be compensated, vendors would have quick and eventually free access to standards and a large element of uncertainty due to litigation would be eliminated.