News

Amendments to the rules of European divisional application – October 2013

On October 18, the Administrative Council of the European Patent Office (EPO) has announced an amendment in the rules for divisional applications.

Amendements to rule 36 PPC entered in force in 2010 allowed the filing of divisional applications up until the time of 24 months after the first Communication from the Examining Division.

Said amendments did not have the desired effect of reducing the number of divisional application and the Administrative Council has decided on the following changes effective April 1, 2014:

As of April 1, 2014 it will be possible to file a divisional application for as long as the parent application is still pending. This rule will be in force for any application (still) pending on April 1, 2014.

The EPO will introduce a progressive fee for divisional applications of divisional applications (so-called second or later generation applications). The precise details of the new fee will be made public at a later date.

New Zealand Patents Bill – August 2013

New Zealand Patents Bill was finally passed by its Parliament on 28 August 2013.
The most important points are the following:
General points
Examination criteria will be extended to include absolute novelty and inventive step (currently, the criteria include local novelty and no inventive step – although inventive step is a ground for opposition/revocation!).
No extension of term for pharmaceuticals.
Computer programs
(1) A computer program is not an invention and not a manner of manufacture for the purposes of this Act.
(2) Subsection (1) prevents anything from being an invention or a manner of manufacture for the purposes of this Act only to the extent that a claim in a patent or an application relates to a computer program as such.
(3) A claim in a patent or an application relates to a computer program as such if the actual contribution made by the alleged invention lies solely in it being a computer program.
Thus New Zealand has taken an approach which is similar to that in Europe.
Methods of medical treatment and diagnosis
Methods of medical treatment which were considered not patentable as being contrary to morality, are considered now in specific exclusions:
– An invention of a method of treatment of human beings by surgery or therapy is not a patentable invention.
– An invention of a method of diagnosis practised on human beings is not a patentable invention.
Again, these exclusions will be familiar to European practitioners.

Syngenta case: limitation or extension?

Syngenta is the proprietor of European patent EP 90300779 filed on 25 January 1990 and issued March 23, 1994. Syngenta filed on September 28, 2009 a request to limit the scope of claim 8 of the French part of this patent to add to claim 8 the indication that the claimed composition further comprises a second active compound selected from a large list of compounds of various nature and functions.
The Director General of INPI ruled that this request does not constitute a limitation of the patent claims, but focuses on a different product that does not fall within the scope of previous claims.

The judgment of the Court of Appeal of Paris on 7 September 2011 rejected the appeal by Syngenta on the grounds that the decision of the Director General of INPI was justified because the limitation to a list of possible combinations did not precise composition as mentioned in the initial claim 8, but had the effect, on the contrary, to add a new active ingredient selected from a large list, offering in reality a considerable scope for new combinations.

The Court of Cassation quashed the judgment on March 19, 2013. Referring to Article 69 EPC and Article L.613-24 of the Code of Intellectual Property, the Court held that the Court of Appeal did not check “if the subject-matter of the amended claim was not directly and unambiguously disclosed in the description of the patent as granted. “

However, the Supreme Court has not ruled on the question of whether the addition of this feature was a limitation or extension.
However in that case the Supreme Court suggests that for SPC, it will be possible to obtain an SPC for a combination of active ingredients with reference to a basic patent wherein said combination is only described but not claimed.

Austria: First ratification of the Agreement on a Unified Patent Court – August 2013

The first member states have signed the Agreement on the Unified Patent Jurisdiction (UPJ) February 19, 2013, namely: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Portugal, Romania, Slovakia, Slovenia, Sweden, United Kingdom.
Spain and Poland have not signed the Agreement.

On 26 June 2013, the public consultation on the rules of procedure of the Unified Patent Court has been launched. It is open for written comments from stakeholders and other interested parties. Interested parties are invited to send their comments until October 1, 2013 only to secretariat@unified-patent-court.org.

The Preparatory Committee includes entry into force in early 2015.

In a press release, the Foreign Ministry of Austria has communicated that Austria has deposited its instrument of ratification of the Agreement on a unified patent Court on August 7, 2013. However, the original optimistic hopes of the EU Commission that the first patents with unitary effect might be granted in April 2014 will not become reality. This would have required that by November 2013 at least 13 States including the United Kingdom, France and Germany would have ratified the Agreement. At present, bills are pending in France and the United Kingdom, whereas the legislative process has not yet started in Germany due to the imminent end of the legislative period.

Further information on the site http://www.unified-patent-court.org/

Annual Report 2012 of the EPO: a record year!

2012 was another record year at the European Patent Office. Patent filings and grants reached their highest levels ever in our 35-year history. See the following link.

G 2/13 – july 2013

The following questions are referred to the Enlarged Board of Appeal for decision :

1. Does a non-microbiological process for the production of plants which contains the steps of crossing and selecting plants escape the exclusion of Article 53(b) EPC merely because it contains, as a further step or as part of any of the steps of crossing and selection, an additional feature of a technical nature?

2. If question 1 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?

Myriad – June 2013

The Supreme Court of the United States has just partially reversed, in its decision of June 13, 2013, the proceeding decision of the United States Court of Appeals for the Federal Circuit dated on August 16, 2012.

It is to be reminded that Myriad is the owner of a number of patents relating to an isolated DNA from BRCA1 or BRCA2 genes, mutations of which can dramatically increase an individual’s risk of developing breast and ovarian cancer.

Contrary to the opinion of the United States Court of Appeals for the Federal Circuit, who considered that isolated DNA as cDNA was patent-eligible, the Supreme Court of the United States holds that “a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated”.
According to the Supreme Court, identifying and separating a gene from its surrounding genetic material is not an act of invention.

In fact, the Supreme Court considers that Myriad did not create or alter any of the genetic information encoded in the BRCA1 and BRCA2 genes. Nor did Myriad create or alter the genetic structure of DNA.

However, the Supreme Court affirms that cDNA is patent eligible because it is not naturally occurring.

By the way, relating to Myriad’s argues based on PTO’s practice, the position of the Supreme Court is that: PTO’s practice was not “a sufficient reason to hold that isolated DNA is patent-eligible.”

What would be the consequence of this decision?
Other than the loss of monopoly for Myriad in the Unites States, this decision partially leads to medical and research public domain restoration while reaffirming the patent-eligibility of laboratory genetic constructions.

What will happen in other country, especially in Europe?
The article 5.2 of Directive 98/44 on the legal protection of biotechnological inventions and corresponding articles in national law (L611.18 in France) or European law (R29(2)EPC) will always be applicable?

http://www.supremecourt.gov/opinions/12pdf/12-398_1b7d.pdf

Parliament approves the regulation on the unitary patent – Decembre 2012

The European Parliament in Strasbourg adopted December 11, 2012 the two draft regulations on the creation of a unitary patent.

This system is expected to reduce the costs of protecting inventions in Europe and interest in particular research centers and SMEs.

The European patent with unitary effect or unitary patent valid for the 25 participating states (Spain and Italy are not members of this agreement) is based on two regulations, one of creating the instrument, and the other language regime for the new patent (three official languages German, English and French). The European Patent Office (EPO) is responsible for issuing and managing unitary patents.

Moreover, a unified patent litigation system has been established under an international convention establishing the Unified Court (UPC), a specialized tribunal with a first and appeal instance with exclusive jurisdiction in respect of the infringement and unitary patent validity.

The unitary patent must now be formally adopted by the EU Council and the European Parliament.

The first unitary patent applications may be filed as soon as the legal provisions for both the unitary patent and the UPC will come into force. The agreement establishing the UPC should be signed February 18, 2013 and will enter into force once thirteen Member States of the European Union (EU), including France, Germany and the United Kingdom have ratified the package. The EPO plans to approve the first unitary patent in 2014.

The unitary patent will provide legal protection for inventors in 25 EU Member States through a single administrative process. He co-exist with national patents and European patent with which it shares the legal basis and the granting proceeding (as defined in the European Patent Convention), from which it differs only in the post- delivery part: within the unitary patent system, the EPO will also be in charge of a centralized administration of the patent, the collection of annual fees and their distribution to Member States participating in the EU.

The fact that the unitary patents will be treated as a single patent no longer requiring to be validated (including translation) or administered at the national level in each state should lead to massive savings in terms of time and cost. This should make Europe more attractive for investors and innovation and bring on an equal footing with its competitors in Asia and the United States.

The Myriad case – September 2012

In its decision of 16 August 2012, in the Myriad case, (http://www.cafc.uscourts.gov/images/stories/opinions-orders/10-1406.pdf), the Court of Appeals for the Federal Circuit United States concluded that the compositions of man-made materials, including isolated DNA molecules, and screening methods that implement them are likely to be protected by a patent, if they satisfy the other criteria of patentability. In contrast, the Court upheld the decision of the District Court decision in the case v Mayo. Prometheus (http://www.supremecourt.gov/opinions/11pdf/10-1150.pdf) regarding the non patentability of diagnostic methods.

The Prometheus case – September 2012

In the case Mayo v Prometheus, (Mayo Collaborative Servs. V. Prometheus Labs., Inc., 132 S. Ct 1289 (U.S. 2012), the Supreme Court of the United States focused on the eligibility of claims to diagnostic methods.

The main claim of the challenged patent concerned a method of optimizing therapeutic efficacy for treatment of an immune-mediated disease gastrointestinal disorder comprising:
a) administering a drug providing 6-thioguanidine to a subject having said immune-mediated disease gastrointestinal disorder; and
b) determining the level of 6-thioguanidine in said subject
wherein:
o a level of 6-thioguanidine in red blood cells below a first threshold indicates a need to increase the amount of said drug for a new administration and
o a level of 6-thioguanidine in red blood cells higher than a second threshold indicates a need to reduce the amount of said drug for a new administration.

According to the Supreme Court, these claims include “laws of nature, natural phenomena and abstract ideas” which are not patentable. The Court concluded that:
a) the “administering” step simply refers to doctors who treat patients and already use thiopurines to treat these autoimmune diseases,
b) the “determining” step covers any method used to calculate the levels of metabolites, all of these methods are well known in the field and
c) the “wherein” clauses simply inform the doctors of the existence of laws of nature and, in addition, they trust them to take said laws into account when treating the patient and
d) even in combination, these steps do not add anything significant that goes beyond the sum of their parts individually.

Thus, when invention resides in the discovery of a natural phenomenon, simply integrate the application of this natural phenomenon to a standard method of diagnosis consisting in removing a sample and making the necessary analysis to compare its result to the rule of the natural phenomenon is not sufficient to confer the said invention usefulness required by section 101 of the U.S. patent law.

The decision of the Court undoubtedly creates uncertainty about the patent claims to methods of diagnosis and in the area of personalized medicine. Moreover, it affects both patents already granted and the applications filed under examination for which amendments to the claims can be considered. For future applications, it will be necessary to describe methods with more practical implementation to support an acceptable claim. Following this decision, the USPTO has issued draft guidelines for patent examiners regarding the Prometheus case (see this link).