Summary of C-IP2 2022 Fall Conference - Panel 1: How Well Does the Antitrust Approach Fit the Biopharma Space?

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00:00:00 - 01:00:00

The panelists at the C-IP2 2022 Fall Conference discuss how well the antitrust approach fits the biopharma space. They talk about how the goals of antitrust law have changed over time, and how the law now embraces intellectual property rights. They also discuss how the law can be difficult to apply in the biopharma space, and how the Supreme Court's decision in American Apparel has compromised the risk of loss that patent holders might face.

00:00:00 The antitrust approach to addressing potential abuses in the pharmaceutical industry is not necessarily a perfect fit, as the industry is in many ways unique. However, the panelists discussed important aspects of the drug development process, including how clinical trials work and the high failure rate of candidate drugs.
00:05:00 The panel discusses how the antitrust approach fits the biopharma space, highlighting the importance of strong and reliable patent protections. Pharmaceutical companies have invested more than one trillion dollars in research and development of new medicines since 2000, and IP and the potential for recovering the cost of a product's success could allow companies to move forward with such long-term risky investments.
00:10:00 The first panel of this conference discusses how well the antitrust approach fits the biopharma space, specifically with respect to patent disputes and biosimilars. The panel argues that while antitrust law can be used to address anti-competitive behavior, such legislation has been introduced in Congress that would create a presumption of anti-competitive effect, which could put a thumb on the scale for the FTC.
00:15:00 This 1-paragraph summary discusses how changes to the pharmaceutical innovation system, introduced in the 1980s and 1990s, have had a significant impact on drug development and competition. The author cites research that suggests pharmaceutical innovation is important and that changes to the system can have a significant impact on the development of new drugs.
00:20:00 The speaker discusses how increasing generic competition has had a negative impact on early stage pharmaceutical development, with a decrease in the flow of innovative activity. The speaker argues that this evidence justifies the claims made in a recently published paper.
00:25:00 The speaker discusses how the antitrust approach to drug development may not be the best fit for the biopharma space. They introduce the C-IP2 2022 Fall Conference, where they will be discussing how well the antitrust approach fits the biopharma space. They use data from the Pharma Projects data set to measure the number of compounds in the pre-clinical OR phase, one stage of the drug development process. They define a pharmaceutical Marketplace as being an ATC two-digit category and focus on the ATC two-digit level of disaggregation to give a sense of what that is. They use data from the NIH's ndti database to measure scientific opportunity or technological opportunity in a drug domain. They face a key inferential problem: it is difficult to determine whether the rise in generic market share or research productivity is responsible for the decline in innovation. They propose that firms research productivity in a particular pharmaceutical domain in order to attempt to determine causation.
00:30:00 This 1-paragraph summary of the video discusses how antitrust law embraces intellectual property rights and how this impacts the biopharmaceutical space. The author notes that while antitrust law does protect intellectual property rights, it also embraces competition and encourages innovation. The author also notes that while the answer to the question of whether the antitrust approach fits the biopharmaceutical space is yes, it is also yes because antitrust law encourages competition.
00:35:00 The first panel of the C-IP2 2022 Fall Conference discussed how well the antitrust approach fits the biopharma space. The panelists discussed the importance of intellectual property rights, antitrust principles, and the problem of antitrust enforcement policies not embracing intellectual property rights.
00:40:00 The antitrust laws are intended to prevent harmful competition, but they can be difficult to apply in the biopharma space because of the close relationship between patent holders and generic manufacturers. The Supreme Court rejected the FTC's argument that the patent would not have to be at issue in order to find harm to the market, and the case ultimately resulted in lower prices for patients due to the extended patent licensing negotiations between the patent holder and the generic manufacturer.
00:45:00 In this video, panelists discuss the Supreme Court's decision in American Apparel, which allows companies to pay off patent holders in order to avoid patent litigation. The panelists say that this decision compromises the risk of loss that patent holders might face, and that it is an anti-competitive effect only if it goes one way - in other words, the risk that the generic might win is ignored. The panelists also note that this decision vindicates the Chief Justice analogy.
00:50:00 This video discusses how the antitrust approach fits the biopharma space, and how the goals of the law have changed over time. The panelists discuss how the institutional pressures on the antitrust enforcers will keep them trying to limit the powers of intellectual property rights (IPR).
00:55:00 The speaker discusses how money is a potential problem in settlements between patent holders and generic manufacturers, and how this can be justified in certain cases. The speaker also points out that the Supreme Court has primarily focused on the money aspect of settlements, which may be problematic in some cases.

01:00:00 - 01:35:00

The panelists discuss how the antitrust approach fits or does not fit the biopharma space. They note that there is less going on in this space, less patents being produced, and that the main question is whether or not the changes are micro or generic. The panelists also discuss how the antitrust approach is constrained by data, and that when a big result is observed, the bias and data against the researcher is often strong, leading to a huge result that may look big but is actually biased.

01:00:00 The panel discusses how well antitrust law fits the biopharma space, with particular emphasis on the FTC's concerns about consumer benefits that can be derived from multiple manufacturers of a particular product. They also discuss the challenges of defining the market in a way that preserves competition.
01:05:00 The panelists discuss the rarity of monopolies in the biopharma space and the challenges of obtaining data on drug competition. They note that while technology has improved, research costs have also increased, making it more difficult to study the dynamics of drug competition.
01:10:00 The panelists discussed how well the antitrust approach fits the biopharma space, with particular emphasis on the impact of generic competition. They noted that the antitrust approach is constrained by data, and that when a big result is observed, the bias and data against the researcher is often strong, leading to a huge result that may look big but is actually biased.
01:15:00 The panel discusses how the antitrust approach does or does not fit the biopharma space, focusing specifically on the impact of generic competition on pharmaceutical firms. They note that while patents are valuable for protecting innovation, they may not be as valuable when generic competition arises. The panel also discusses how research into tools used in small molecules research and development may decline due to a lack of funding.
01:20:00 The panel discusses how the antitrust approach fits the biopharma space. They note that there is less going on in this space, less patents being produced, and that the main question is whether or not the changes are micro or generic. Gary Posner, a former government employee, says that the legislative and administrative bodies should focus on the consumer's big-picture concerns, rather than just academics. The litigator notes that there has been an increase in small molecule-oriented startups and machine learning being used to find early-stage drugs.
01:25:00 The speaker discusses the pros and cons of antitrust law in the biopharma space, and offers alternatives if it is seen as not fitting. He believes that if there are trust principles that work, antitrust should be used rather than letting the market run amok.
01:30:00 The panel discusses the level of aggregation when looking at antitrust violations, and Professor Brandstetter argues that looking at the two digits of the patent number may be capturing something else besides just the strength of the patent pattern. The panel then discusses whether lawyers should read papers from A to Z before making decisions.
01:35:00 The panel discusses how well the antitrust approach fits the biopharma space, and discuss how economics does not play a role in real-world settlements.