In 2015, the EPO Opposition Division upheld EP 138 after the appellant withdrew its opposition. In that connection, EPO held that Howell et al. and McLeskey in combination did not take away inventive step.
In a subsequent decision, in 2017, the EPO Opposition Division held EP 573 invalid for lack of inventive step and the Opposition Division noted in that connection that it disagreed with the conclusion reached in relation to EP 138, now holding that in combination with the knowledge derived from the articles by Howell et al. and McLeskey there was no inventive step.
The Maritime and Commercial Court held that the EPO decision regarding EP 573 must result in a material weakening of the presumption in favour of that patent being valid, and the fact that the decision had been appealed by AstraZeneca could not lead to a different assessment, even if the EPO appeal had suspensive effect.
This week in Munich, the European Patent Office (EPO) will hear a legal challenge filed by groups in 17 countries against an unmerited patent that allows US-based pharmaceutical corporation Gilead Sciences to charge exorbitant prices in Europe for the key hepatitis C drug sofosbuvir. The organizations Médecins du Monde (MdM), Doctors Without Borders/Médecins Sans Frontières (MSF), and Just Treatment are among the patient and treatment provider organizations* that challenged the validity of a Gilead patent on sofosbuvir on the grounds that it does not fulfill the requirements to be a patentable invention from a legal or scientific perspective. The groups today, once again, urged the EPO to rethink its decision that gives Gilead this monopoly. The EPO will hold a public hearing on September 13-14 to make a decision on the case.
If the patent challenge is successful, it would be a major step toward allowing the production and importation of affordable generic versions of sofosbuvir in Europe, protecting health systems across Europe from illegitimate financial burden due to excessive corporate pricing of this drug. The extremely high prices in Europe of newer hepatitis C medicines—called direct-acting antivirals, or DAAs—has led civil society organizations to investigate and subsequently challenge the monopoly status and legitimacy of such patents.
Barring the unlikely event that the Federal Circuit rehears en banc today's decision in Regents of the University of California v. Broad Institute, Inc. (or, even more unlikely, that the Supreme Court grants certiorari), the interference between the Broad Institute and the University of California/Berkeley is now concluded. The Court affirmed the Patent Trial and Appeal Board's decision (see "PTAB Decides CRISPR Interference -- No interference-in-fact"; "PTAB Decides CRISPR Interference in Favor of Broad Institute -- Their Reasoning") that there is no interference-in-fact between the Broad's twelve patents (the Federal Circuit citing U.S. Patent No. 8,697,359 as being representative) and one application-in-interference patent and University of California's pending application (Application No. 13/842,859).
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The consequence of this decision (assuming it is the final word) is that the status quo will remain: the Broad will maintain its extensive CRISPR patent portfolio and the University's patent application (reciting claims broader than the Broad's and encompassing CRISPR without regard to the cells in which it is practiced) should grant as a patent in due course. Under these circumstances, a third party wishing to practice the technology in eukaryotic cells (encompassing everything from yeast to man) would need a license from both the University and the Broad (absent the parties coming to an agreement on how their overlapping technologies will be licensed). This circumstance cannot fail to retard commercial adoption of the techniques, providing further impetus for some sort of co-licensing agreement between the parties to be forged.
In a closely-watched CRISPR patent case, the Federal Circuit says the PTAB did not err in concluding that Broad Institute’s claims would not have been obvious over the University of California’s claims