Unethical consideration of living subjects
Claudia Seitz, pointed out that while regulatory data protection would in theory allow generic companies to conduct its own clinical studies during the data exclusivity period, the declaration of replication of clinical trials with human subjects unethical, and animal law prohibited animal studies that did not lead to new insights. So replication of clinical studies was only impractical for economic reasons.
IoT IBM states
Alsech Staehelin, IBM, explored the data protection implication of the Internet of healthcare/things. Using massive amount of data from connected devices to improve health healthcare. Partially an advertisement of IBM’s Watson data analytics and insight service, the presentation gave a taste of things to come for pharmaceutical companies. As Alsech points out “the internet of healthcare” will finally enable much hyped personalized medicine. We must also keep in mind “anonymized” data is often fig leaf. Confronted with most important question whether access to data becomes more important with patent protections, Alsech said that in IoT world the value of patents was in controlling the inoperability of devices. Patent owners owning standard essential patents could reap outsized rewards for patents that was not necessarily from legal point of view. IBM sought to comply with many rules of law that may be involved, or whether a kind of ‘meta-law’ evolved that was called a global standard.
Simon Hirsbrunner, explained the influence of EU law on licensing agreement in Non-EU country, mainly Switzerland. EU law applies to agreements entered into parties in third countries if the agreement influenced the EU market. Simon noted the “blind-spot” of TT-BER, as they only relate to agreement concluded for production purposes. He also noted that it is worthwhile to read the question was posed whether an agreement that obliges licensee to challenge the validity of the licensed patent in arbitration, at the exclusion of state courts, violates the prohibition of non-challenge clauses by the TT-BER. No clear answer was found ,that the answer turns on whether the arbitration award obliges the patentee to formally revoke the patent, thereby removing barriers to entry for all market participants, or whether the award only holds that the patent is to be considered invalid between the parties. In the former case, I do not see a violation of the TT-BER, in the latter case, probably so, because a potentially invalid patent still is on the register(s) and has anti-competitive effects).
A Comparative Analysis
Dary Lim, took a comparative analysis of Genetech and Kimble vs. Marvel Entertainment, exploring the limits of maxim, “no patent, no royalties”, and he likes to build bridge between people and ideas. Genetech basically holds that paying royalties for patent the license does not practice or that is invalid is not in violation of EU competition law provided the licensee can terminate the agreement at any time with reasonably short notice.
Kimble, the inventor of Spiderman web shooting toy, entered into an agreement with Marvel that settled a breach of contract and the patent infringement case. According to the agreement, Kimble was entitled to a royalty of 3% on all sales of toys by Marvels, and beyond the term of the patent. The US Supreme Court felt bound Brulotte vs. Thys Co. which provides that no royalties must be paid after expiration of the patent.