09.12.18

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Patents on Life at the EPO Are a Symptom of Declining Patent Quality

Posted in Europe, Patents at 2:53 am by Dr. Roy Schestowitz

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Summary: When even life and natural phenomena are deemed worthy of a private monopoly it seems clear that the sole goal has become patenting rather than advancement of science and technology; media that’s controlled by the patent ‘industry’, however, fails to acknowledge this and plays along with privateers of nature

THE legal certainty associated with US patents is very low. That’s because the USPTO spent decades granting truly dubious patents. The EPO‘s patent quality problems threaten to do the same to European Patents (EPs).

Earlier this year the EPO’s Opposition Division rejected a patent on life, causing Broad Institute to panic. Are patents on life itself still worth anything? Are EPs on CRISPR without merit? That opposition suggested so.

Yesterday Kluwer Patent Blog wrote about a test at a Danish court, i.e. outside the EPO itself, noting that a couple more EPs may be meritless:

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.

Yesterday we also spotted a couple of announcements from Doctors Without Borders/Médecins Sans Frontières (MSF) International [1, 2], taking stock of an opposition with the following statement:

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.

Public interest or the Commons play a role here, irrespective of patents on nature/life/biology.

Going back to Broad, whose controversial EPs may be thrown out by the Boards of Appeal, Patent Docs wrote about it this week in relation to Regents of the University of California v Broad Institute, Inc. (Patent Docs is in general a loud proponent of patents on life, as this latest post by Bryan Helwig reminds us again). To quote:

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).

[...]

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.

Broad Institute’s case was also mentioned by Managing IP yesterday. Michael Loney wrote about how CAFC is backing PTAB as usual:

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

Our view is that all CRISPR patents need to be voided. Life is not an invention. Where does Managing IP stand on this matter? Ellie Mertens’ (Managing IP) summary says: “How can reproductive technologies be protected when they relate to natural processes? Is a human gamete or embryo a “human organism” in terms of patent law?”

Why is this even a question? Why entertain the patent ‘industry’ in trying to answer such questions? The utter insanity of trying to patent life itself — and after much lobbying succeeding at it — just comes to show the great influence of money. It’s no secret that large firms with patents in these domains buy politicians to shield their patents from PTAB.

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