Seminar 19 - 20: Competition Law Flashcards
What is the key framework for competition law in the pharmaceutical sector under EU law?
Articles 101 and 102 TFEU prohibit anti-competitive agreements and abuse of dominance, aiming to balance innovation with access to affordable medicines.
What is a “pay-for-delay” agreement in the pharmaceutical sector?
A pay-for-delay agreement involves originator companies paying generic manufacturers to delay market entry, extending monopoly profits and delaying price reductions from generic competition.
What is the test for potential competition under Article 101 TFEU?
The generic manufacturer must have a firm intention and inherent ability to enter the market, and entry barriers, including patents, must not be insurmountable.
What constitutes a “restriction by object” under Article 101 TFEU in pay-for-delay cases?
A restriction by object occurs if value transfers incentivize generics to delay market entry, preventing competition on the merits.
What factors are assessed for a “restriction by effect” under Article 101 TFEU?
Evidence must show that the agreement appreciably delayed generic entry, preserved monopoly pricing, and impeded price reductions from independent generic competition.
How is dominance assessed under Article 102 TFEU in the pharmaceutical sector?
Dominance is assessed by defining the market, focusing on product substitutability (functional and economic), and determining if the company has significant market power (e.g., 50%+ market share).
What are examples of abuse of dominance in the pharmaceutical sector?
Misusing regulatory frameworks (e.g., AstraZeneca case), disparaging generics (Hoffmann-La Roche case), and excessive pricing (e.g., Pfizer and Flynn case).
What is the Akka test for assessing excessive pricing under Article 102 TFEU?
It involves evaluating price-cost excessiveness and unfairness, either in itself or compared to competitors, considering the economic value of the product or service.
What was the outcome of the Generics (UK) Ltd v. CMA case regarding pay-for-delay agreements?
Settlement agreements delaying generic entry were deemed restrictions by object and effect under Article 101 TFEU. The agreements were found to maintain monopoly pricing and harm competition.
How does the AstraZeneca case define abuse of dominance in regulatory frameworks?
Abuse includes misleading patent offices to extend SPCs and deregistering marketing authorizations to block generic entry and parallel trade.
What was the significance of the Hoffmann-La Roche case on disparagement?
The case established that disseminating misleading information about a competitor’s product to favor a higher-priced alternative constitutes a restriction of competition by object.
How is the concept of substitutability applied in defining the market for Article 102 TFEU cases?
Substitutability includes functional (same therapeutic need) and economic (cross-price elasticity) aspects to determine competition between products.
What did the Lundbeck case clarify about pay-for-delay agreements?
The case confirmed that agreements involving payments to generics to delay market entry restrict competition by object, even if patents are involved.
What were the findings of the Servier case on pay-for-delay agreements?
Servier’s agreements were deemed restrictions by object and effect under Article 101 TFEU, and its cumulative exclusionary strategy was considered an abuse of dominance under Article 102 TFEU.
What is patent clustering, and how does it impact competition?
Patent clustering involves filing large numbers of patents around a product to create a “patent thicket,” complicating generic entry and delaying competition.
What factors influence excessive pricing cases in the pharmaceutical sector?
Factors include price-cost differences, comparator benchmarks, socio-economic impact, and justifications like innovation or unique market circumstances.
What are examples of excessive pricing cases involving off-patent drugs?
Cases include Napp (morphine), Aspen (anti-cancer drugs), Phenytoin (anti-epilepsy), and CD Pharma (oxytocin), where prices were raised significantly without economic justification.
Can excessive pricing tests be applied to patented drugs?
While most cases focus on off-patent drugs, applying excessive pricing tests to patented drugs is under discussion, considering innovation and market exclusivity factors.
How does the Akka/LAA case define comparator tests for excessive pricing?
Prices in one market are compared with prices in other markets or regions using objective, verifiable criteria like purchasing power parity (PPP), assessing significant and persistent differences.
What are the implications of excessive pricing for competition law enforcement in the life sciences sector?
Excessive pricing undermines access to affordable medicines, particularly in essential markets, prompting regulatory focus on balancing innovation incentives and consumer protection.
