EPO overturns plant biotech patents

A nature.com blog post: “Controversial plant biotech patents overturned” talked about the important news about the EPO recently overturning two controversial patents for broccoli and tomato varieties, varieties that were produced using conventional breeding techniques. Genetic markers were used to breed the desired traits. Nature say:

“According to EU law, biological processes for the production of plants or animals are not allowed to be patented. But the law regards marker-assisted selection as a technical process, and therefore patentable. The broccoli and tomato patents were awarded on this basis…

…After years of appeals and hearings, the cases reached the EPO’s Enlarged Board of Appeal, its highest level of jurisdiction. In a ruling on 9 December, the board agreed with industry that the patents covered the whole selection and breeding process and therefore should not be allowed…

..This decision does not affect the patentability of inventions or technical steps such as genetic markers”

The news was also reported on the EPO site “No European patents for essentially biological breeding processes”

“The EPO’s Enlarged Board of Appeal has now rendered its decisions in the so-called “broccoli” (G 2/07) and “tomato” (G 1/08) cases, bearing on the correct interpretation of the term “essentially biological processes for the production of plants (or animals)” used in the European Patent Convention (EPC) to exclude such processes from patentability.

The Enlarged Board of Appeal is the highest instance in the EPO’s judiciary and, as all other Boards of Appeal of the EPO, acts in full independence of the Office in carrying out its duties. Its task is to ensure a uniform application of the patent law under the EPC.”

For more info:

“The battle of the broccoli and tomatoes”

“Broccoli and tomato patents – European Patent Office“

The battle of the broccoli and tomatoes

I believe that the entire agricultural and biotechnology community is looking forward to learning about the outcomes of last week’s hearing at the European Patent Office (EPO) Enlarged Board on whether marker-assisted selection is a biological breeding process or a technical method and therefore patentable. 

At stake are two patents: Patent EP 1069819, which the EPO granted in 2002 to Plant Bioscience Ltd., on a method for selectively increasing the level of a potentially anti-carcinogenic substance in broccoli plants; and Patent EP 1211926 granted to the Israeli Ministry of Agriculture in 2004 on a method for breeding tomatoes with reduced water content. Both patents have been challenged respectively by Syngenta Participations AG and Unilever N.V. on grounds of invalidity: the selection method was essentially a biological and not a technological process and thus not patentable.

Both Syngenta and Unilever referred to the Board the following questions:

1.         Does a non-microbiological process for the production of plants consisting of steps of crossing and selecting plants fall under the exclusion of Article 53(b) of the European Patent Convention (EPC) only if these steps reflect and correspond to phenomena which could occur in nature without human intervention?

2.         If question 1 is answered in the negative, does a non-microbiological process for the production of plants consisting of steps of crossing and selecting plants escape the exclusion of Article 53(b) EPC merely because it contains, as part of any of the steps of crossing and selection, an additional feature of a technical nature?

3.         If question 2 is answered in the negative, what are the relevant criteria for distinguishing non-microbiological plant production processes excluded from patent protection under Article 53(b) EPC from non-excluded ones? In particular, is it relevant where the essence of the claimed invention lies and/or whether the additional feature of a technical nature contributes something to the claimed invention beyond a trivial level?

In answering the above questions the Board will analyze and apply article 53(b), trying to establish:

“…. whether marker-assisted selection is a biological breeding process or is a technical method and therefore patentable”.

The problem comes from a tension created between article 53(b) of the 1973 EPC which excludes (or exempts) from patentability plant or animal varieties and essentially biological processes for the production of plants and animals and Directive 98/44 article 3(2) which states that:

 “biological material which is isolated from its natural environment or produced by means of a technical process may be the subject of an invention even if it previously occurred in nature”.

Article 3(2) is controversial because, as Dr Van Owervalle points out:

“a distinction has to be made between the natural phenomenon discovered by the researcher and the invention resulting from the searcher’s work after the discovery of a natural phenomenon”.

To complicate the matter further, the broccoli and tomato patents do not protect only the method used to identify the anti-carcinogenic substance and water content, but also the plants selected and produced by this method.

So would the patents breach or contradict article 53(b) of the EPC?  Will the patents grant a monopoly (even if only for 20 years) over the plants themselves, with potentially negative consequences for independent farmers and consumers as DW-World states?  According to Christopher Then of Greenpeace, the only way this tension and complexity can be resolved is by simplifying the patent system and clarifying the bans on what can be patented.  The protests taking place in Germany are around the patentability of new varieties of plants which should not be allowed as “they belong to all humankind”. 

 In my opinion the key point is whether the patents do really extend to the plants themselves or are limited to the technical method used to identify certain elements in the plants.  If the applicability of such inventions is the use of the method for the production of the specific modified plant, then a ban should be imposed. What is clear is that if developing countries adapt or, even worse, translate our already confusing standard to their patent systems, nothing good will come out of it! Carlos Correa, Director of the Centre for Interdisciplinary Studies on Industrial Property and Economics Law, at the University of Buenos Aires, believes that this is perhaps a good opportunity to review the system and says that:

“Changes are visible not only in Europe, but also in the US where healing has started and the patent system is being given a second look after years of ever-extending patenting”.

We will see….a decision is likely to be taken only towards the end of the year…

If you want to read more about this issue, please refer to the following documents: http://www.epo.org/about-us/press/backgrounders/history.html; http://www.droit-technologie.org/actuality-1175/the-directive-98-44-ec-for-the-legal-protection-of-biotechnological-in.html.

Post written by Francesca Re         Manning of CAS-IP

Monsanto Technology, the European Court of Justice and Roundup Ready Soybean

This is a continuation of a saga involving Monsanto and the scope of their European patent for Roundup Ready soybeans.  Full details of this saga can be found on the links in this post but, in a nutshell from the IPKat:

“Argentina, the world’s third-biggest soybean exporter after Brazil and the US, is one of the few countries where Monsanto does not hold a patent on the herbicide-resistant seeds. However, a ruling that Monsanto’s European patent is enforceable would let it block those imports.”

Read the full article from IPKat, “Soy far, soy good” for Argentine importers” including the European Court of Justice AG’s (Advocate General) Opinion (in French with an interpretation).

The Bloomberg article (referenced by IPKat) “Monsanto May Lose Bid to Halt Argentinean Soy Imports (Update2)” said:

“The European patent for the trait that makes soybeans resistant to some herbicides doesn’t extend to soy meal made from the patented seeds, Advocate General Paolo Mengozzi of the European Court of Justice said in a non-binding opinion today….

…Monsanto said it was “disappointed” by today’s outcome and will wait for the court’s final decision. Rulings tend to follow within six months of an opinion.”

We’ll be revisiting this news within 6 months then!

The devil is in the differing-detail for the European Patent Office

Despite that many say that patent law within the European Union is reasonably uniform, there are still strong differences which go to the root of the matter.  In a recent hearing, Ranger Services Ltd’s application (BL O/362/09) of 17 November 2009, the applicant challenged the guiding principle that the European Patent Office (EPO) had applied in evaluating the existing prior art.  The EPO took its decision on the basis that proof had to be “beyond reasonable doubt”.   The applicant claimed that in the UK a patent is a matter of civil law and thus decisions ought to be taken on “the balance of probabilities”, not on “proof beyond reasonable doubt” which applies only in criminal matters.

Regardless of the fact that the evidence was not strong enough even if the “balance of probabilities” had been applied, this is a great case which illustrates how much EU Member States need to do to ensure a uniformed and consistent patent-granting regime.

Post written by Francesca Re Manning, consultant to CAS-IP

The final chapter in the “Enola” case has closed

We have been impatiently waiting for the moment we can finally, finally consider the “Enola” matter laid to rest.  That moment has now come….  Please see link to a news release from CAS-IP.

Picture by Neil Palmer, CIAT.

The U.S Court of Appeals for the Federal Circuit (CAFC) dismissed the claims of the original “Enola” patent in July 2009.  See our blog entry on the news.  However, shortly afterwards POD-NERS petitioned for a panel rehearing, arguing that the panel had misapplied the court’s obviousness precedent.  Today we received word that the POD-NERS petition for rehearing was denied on the 16th September 2009.

From this experience, it is clear that information and research results produced by public organisations such as the CGIAR should be clearly and easily accessible to patent examiners.  The examiners at the USPTO describe great difficulty in finding printed material about yellow beans during the patent examination process.  On re-examination however, a previous publication on some yellow beans served as ‘legal’ prior art in this case.  Together with information on gene typing that was submitted by CIAT scientists it was possible to clearly show that certain yellow beans and Enola were in fact the same.

This highlights the legal and practical utility of making publications more widely accessible, and directly through the databases accessed by patent examiners.

One such step CAS-IP, ICRISAT and CIAT have been involved in is an initiative to put publications in front of patent examiners. Under a Memorandum of Understanding executed with the EPO, publications are periodically uploaded onto the EPO’s own Non-Patent Literature database.  This is the in-house database that EPO examiners use.  This ensures that prior art searches will immediately include research results and information published by centre scientists (see our blog post explaining the initiative).   CAS-IP is pressing forward to facilitate having other Centers and public agricultural institutes sign up to this program.  In addition, CAS-IP is working with other patent offices such as the US Patent and Trademark Office, (USPTO), and ICRISAT is working with the Indian Patent Office to find additional means for easy ways to provide patent examiners with information.

Finally, back to “Enola” — congratulations to CIAT, and to all those who were involved (including CAS-IP) an the effort that only annulled the “Enola” patent, but also raised awareness which could help avoid this kind of misappropriation of public goods in the future.

Getting the word IN. Defensive publishing in the CGIAR

http://www.cas-ip.org/projects/cgiar-centre-publications-as-prior-art/

Intellectual property management within the context of public research organisations is as much about ensuring access and it is about protecting rights.  Back in 2005 CAS-IP initiated a partnership between the European Patent Office (EPO) and ICRISAT, with a view to ensuring the publications produced by ICRISAT would be easily accessible to patent examiners, and thus qualify as “prior art” and therefore minimizing likelihood of becoming patented by 3rd parties.

Had this option been available to USPTO then perhaps a situation like the Enola bean case could have been avoided.

This forms part of a wider scheme of ‘defensive publication’ http://www.cas-ip.org/ip-agriculture/ip-primer/defensive-publication/

Hanumanth B. Rao, the IP Manager for ICRISAT said:

“The collaboration was initiated primarily to complement the Board approved policy in making ICRISAT’s IPRs  as prior art… Endorsing the CAS-IP novel approach, the CGIAR Genetic Resource Policy Committee(GRPC) has recommended in its meeting held in Rome on 23-25 April 2007 that Centers should be encouraged to incorporate their publications in databases used by patent examiners.  Accordingly, CIAT, the other CGIAR Center has signed a similar agreement with the EPO in Feb 2009.  ICRISAT would also like to initiate collaborations with Patent and PVP Offices in India based on these experiences.”

For more information about this please visit the lead link http://www.cas-ip.org/projects/cgiar-centre-publications-as-prior-art/

“simple patent protection does not apply anymore”

http://www.ag-ip-news.com/GetArticle.asp?Art_ID=7065&lang=en
This was a quote from Jean-Noël Durvy, Acting Director Innovation Policy – DG Enterprise and Industry, European Commission, Brussels.  He said this during an opening speech at the European Patent Forum 2009.  According to the lead link from an interesting news agency called “Ag-IP-News” he went on to outline some of the new challenges to the IP system presented by the world of digital technologies.

I am trying to see if there are any papers etc available from this event now it has taken place –if there are then I will post an update with details.