03.01.18

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The European Patent Office (EPO) Should Lead the Way in Combating Patents on Nature and on Life

Posted in Europe, Patents at 7:03 am by Dr. Roy Schestowitz

Antibody

Summary: As the Office (EPO) grapples with patents on life, there are indications that these are anything but over

EARLIER this year the EPO (Office, not Organisation) said “no” to a CRISPR patent, i.e. to a patent on genome. This, by extension/extrapolation, may have meant the end of all such patents. We wrote about half a dozen posts about that alone because it was a major/historic decision. A year earlier the Organisation also said “no” to patents on plants and seeds. It was about time. The USPTO, for instance, mostly rejects CRISPR patents, which is just common sense.

Do humans now claim to have invented life and genetics? Is it actually an invention when artificially manipulated a little? Do we want to go down the route of monopolies on ‘code’ of life? Australia, according to this new report, has just decided that “gene patent claims remain patent eligible” (perhaps not too shocking given the incredible power CSIRO wields there).

“Claims directed to the correlation of gene sequences to a particular trait in cattle remain patent eligible subject matter,” said the above, “according to a ruling that has implications for the Sequenom/Ariosa case in Australia and also suggests a widening dichotomy between Australia and the US on gene-based patent eligible subject matter” (the US does this the right way).

If that wasn’t bad enough, a day or two ago we also saw CRISPR patents making a little rebound. This account said that the “European Patent Office Grants 2nd CharpentierDoudna Patent Covering CRISPRCas9 Gene Regulation Applications – CRISPRiCRISPRa Techniques Covered by the Patent are Quickly Being Adopted in Drug Discovery and nonTherapeutic R&D ERS Genomics,” linking to this statement we had spotted a day earlier or the night before [1, 2].

The EPO may have once again granted a patent on life. No opposition? We didn’t know that humans ‘invented’ genetics. From the press release: “ERS Genomics announced today that the European Patent Office (EPO) has granted Dr. Emmanuelle Charpentier, ERS Genomics’ co-founder, together with the University of California and University of Vienna, its second EU patent with very broad claims covering the use of CRISPR-Cas9 technology for gene regulation. The claims are directed to compositions and uses of a chimeric version of the Cas9 protein, most often associated with use in regulation of gene expression as opposed to direct editing of the genetic code itself. The patent covers uses in both cellular and non-cellular settings, including use in bacteria, plants, animals, and cells from vertebrate animals such as humans.”

Do we really wish to allow this in Europe?

Then came some more bad news. Life Sciences Intellectual Property Review (LSIPR) wrote the headline “EPO gears up to hear EpiPen patent opposition” — the outcome of which we have not yet seen.

For those who don’t know, EpiPen is now a truly evil ripoff (huge controversy around it in the US). Will the examiners realise the impact of their decision? It’s a matter of life and death (the latter for poor people mostly). These patents let them ban competition and then hike the prices as much as they wish (several orders of magnitude above production costs). According to LSIPR, a decision will have come by month’s end:

The European Patent Office (EPO) will hear an opposition against a patent covering Mylan’s EpiPen (epinephrine) at the end of March.

ALK-Abello, a Denmark-based pharmaceutical company that makes the Jext injector, opposed European patent number EP1,786,491 B, along with Merck, in November 2016.

Tim Powell, partner at Potter Clarkson, explained that claim 1 of the patent defines a number of “relatively conventional features” of an injection device, and a needle cover that is moveable between a retracted position (in which the needle is exposed for injecting) and an extended position in which the needle is shielded.

The Opposition/s Division ought to read up about the EpiPen controversy. There are many legitimate ethical matters associated with these patents.

And speaking of these sorts of patents, Novagraaf has just published “Can you protect dosage regimes in France?”

This too is about the EPO, at least partly:

The judgment of the Court of Cassation of 6 December 2017, in the case between TEVA and MERCK (patent owner), is the outcome of a long and complex affair concerning the nullity of the French part of the European Patent (EP) n°0724444 describing a dosage regime.

[...]

Since the decision of the Enlarged Board of Appeal G0002/08 of 19 February 2010, the European Patent Office (EPO) has admitted the patentability of so-called dosage regime claims: “Such patenting is […] not excluded where a dosage regime is the only feature claimed which is not comprised in the state of the art.”

Yesterday, as in most days, we heard from insiders who are concerned about decline of patent quality at the EPO. It’s now even lower than the USPTO’s..

Two days ago a site of patent maximalists, Watchtroll, wrote about § 103 in the US, alluding to patenting antibodies. To quote:

Under 35 U.S.C. § 103, a claim is not patentable if the “differences between the claimed invention and prior art are such that the claimed invention as a whole would have been obvious” to a person of ordinary skill in the art, before the effective filing date of the claimed invention. The U.S. Supreme Court set forth half a century ago a four-prong test to determine obviousness: (i) the scope and content of prior art, (ii) differences between claimed subject matter and prior art, (iii) the level of ordinary skill in the art, and (iv) objective evidence of nonobviousness, such as long-felt but unsolved need, failure of others, commercial success, unexpected results, and skepticism. Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966).

The USPTO will likely deny patents on antibodies (better known as immunoglobulin), but at the EPO nowadays it seems like nearly anything goes. Even naturally-recurring things like antibodies.

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