Longitudinal study of the impact of three major regulations on the Korean pharmaceutical industry in the last 30 years

Background The pharmaceutical industry is heavily regulated. Partly for this reason, new drugs generally take over 10 years from the product development stage to market entry. Although regulations affect the pharmaceutical industry over a long period, previous studies investigating the impact of new regulatory policies have usually focused on the short period before and after implementing that policy. Therefore, the purpose of this study is to examine whether and how significantly regulatory policies affect long-term innovation in the pharmaceutical industry in Korea. Methods This study focused on three significant regulatory policies: the introduction of the product patent system, changes in the Good Manufacturing Practice (GMP) system, and the Drug Expenditure Rationalization Plan (DERP). The study used interrupted time series (ITS) analysis to investigate the long-term impacts of the policies before and after implementation. Results Our results show that introducing the product patent system in 1987 significantly increased the number of Korean patent applications. The effect of the revised GMP policies was also statistically significant, both before and after implementation and between pre-emptive companies and non-pre-emptive ones. However, due to the companies' negotiations with the regulatory authorities or the regulatory system that links drug approval and price evaluation, the DERP did not significantly delay new drug registration in Korea. Conclusion This study showed that the policies of the product patent system, GMP policies, and DERP regulations have significantly encouraged pharmaceutical companies to strive to meet regulatory requirements and promote innovation in Korea. The study suggests that it is necessary for companies to pre-emptively respond to systemic changes in development and production strategies to deal with regulatory changes and achieve sustainable growth. Also, our study results indicate that since government policies motivate the innovative system of the pharmaceutical industry, governmental authorities, when formulating pharmaceutical policies, need to consider the impact on the long-term innovation of the industry.

Instruments to Challenge the Grant of a Patent as a Third Party: Suggestions for the Review of New Zealand's Patent System

<p>In recent decades, intellectual property law (in particular patent law) has had to face new challenges due to the accelerating development of technology. Patents can have a negative effect on a country's economy if too many invalid or overly broad patents are granted. Such patents have the potential to impose high costs on society without providing substantial benefits. If a patent regime cannot avoid the grant of such patents, or does not provide instruments to remove them from the register, the negative effect may stifle innovation instead of encouraging it. In 2008, in consideration of these problems, the government of New Zealand introduced a Patents Bill. This Bill is the culmination of the government's review process, which started in the late 1980s. The aim of the Bill is to update New Zealand's patent law in order to bring it in line with international practise and to reduce the costs to society arising from invalid and overly broad patents. The provisions of the Bill cover all principal aspects of the patent regime: standards of examination and procedures, challenges on the grant of a patent, and provisions for updating the regulatory regime for patent attorneys. This dissertation focuses on analysing how the quality of New Zealand's patents could be enhanced using the knowledge and experience of third parties. Because the current examination standards may allow the grant of overly broad patents, this dissertation analyses specifically which changes in the examination procedure could help prevent the grant of "bad" patents without overburdening the resources of the IPONZ. In the next step, the dissertation analyses third-party instruments under the current patent system and under the Patents Bill 2008, proving that neither approach by itself would be sufficient to bring about an effective patent reviewing system for New Zealand. The approach under the current system is too expensive and has the potential to delay the granting procedure, whereas the approach proposed by the Patents Bill 2008 limits the influence of third parties before the grant of a patent to such an extent that most patents may remain in the register. The overall aim of this dissertation is to suggest a new approach that includes aspects of both of the others in order to find a balanced solution and an optimal fit for the specific needs of New Zealand.</p>

Instruments to Challenge the Grant of a Patent as a Third Party: Suggestions for the Review of New Zealand's Patent System

<p>In recent decades, intellectual property law (in particular patent law) has had to face new challenges due to the accelerating development of technology. Patents can have a negative effect on a country's economy if too many invalid or overly broad patents are granted. Such patents have the potential to impose high costs on society without providing substantial benefits. If a patent regime cannot avoid the grant of such patents, or does not provide instruments to remove them from the register, the negative effect may stifle innovation instead of encouraging it. In 2008, in consideration of these problems, the government of New Zealand introduced a Patents Bill. This Bill is the culmination of the government's review process, which started in the late 1980s. The aim of the Bill is to update New Zealand's patent law in order to bring it in line with international practise and to reduce the costs to society arising from invalid and overly broad patents. The provisions of the Bill cover all principal aspects of the patent regime: standards of examination and procedures, challenges on the grant of a patent, and provisions for updating the regulatory regime for patent attorneys. This dissertation focuses on analysing how the quality of New Zealand's patents could be enhanced using the knowledge and experience of third parties. Because the current examination standards may allow the grant of overly broad patents, this dissertation analyses specifically which changes in the examination procedure could help prevent the grant of "bad" patents without overburdening the resources of the IPONZ. In the next step, the dissertation analyses third-party instruments under the current patent system and under the Patents Bill 2008, proving that neither approach by itself would be sufficient to bring about an effective patent reviewing system for New Zealand. The approach under the current system is too expensive and has the potential to delay the granting procedure, whereas the approach proposed by the Patents Bill 2008 limits the influence of third parties before the grant of a patent to such an extent that most patents may remain in the register. The overall aim of this dissertation is to suggest a new approach that includes aspects of both of the others in order to find a balanced solution and an optimal fit for the specific needs of New Zealand.</p>

The disclosure function of the U.S. patent system: evidence from the PTDL program and extreme snowfall

Are retail investors using uncurated disclosures in form of patents for their investment decisions? This study uses the investment decisions of retail investors and variation in the local availability of patent information to answer this question. The variation comes from changes in the locations of U.S. Patent and Trademark Depository Libraries over time. I find a strong increase in the local trading volume of stocks after the release of a patent in counties that have easier access to patent information. In addition, trades made by retail investors with easier access to this information yield higher returns, compared to trades made by other investors. These results indicate that disclosures of the U.S. Patent and Trademark Office facilitate the dissemination of patent information to retail investors. Furthermore, these results suggest that retail investors complement traditional curated disclosures with uncurated disclosures in form of patents.

The Patent System, Assistive Technologies, and the Developing World

Although many assistive devices are created in advanced economies, the developing world has been responsible for numerous creative solutions. Despite this, according to the World Intellectual Property Organization (WIPO), the clear majority of patenting activity in this field occurs in developed countries. Developing countries, which generate comparatively few issued patents, engage in significant innovation using forms of creativity that are not rewarded under the Global North’s patent standards. Developing nations can respond to this circumstance through a number of mechanisms. One is to modify the existing patentability standards to capture more types of creative endeavors. Such an approach should be considered thoughtfully, as the patent system has the potential for both positive and negative consequences for developing nations. Alternatively, nations can adopt other forms of incentives (such as grants or other rewards) to encourage the development of new assistive technologies for their domestic creators.