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EU’s Court of Justice: Stem Cells Unpatentable If An Embryo Is Destroyed

Stephen Jenei — Tue, 25 Oct 2011 04:15:46 +0000

A process which involves removal of a stem cell from a human embryo at the blastocyst stage, entailing the destruction of that embryo, cannot be patented.

Last week the Court of Justice of the European Union issued a judgment in the case of Brüstle v Greenpeace e.V (Case C 34/10) in which it banned the issuing of patents for stem cells on ethical grounds. Mr. Oliver Brüstle is the holder of a patent for isolated and purified neural precursor cells produced from human embryonic stem cells used to treat neurological diseases.

The Federal Patent Court ruled that Mr. Brüstle’s patent was invalid in so far as it covers processes for obtaining precursor cells from human embryonic stem cells. On appeal, the Court of Justice (CJEU) was asked to interpret the concept of ‘human embryo’ which is not defined in Directive 98/44/EC on the legal protection of biotechnological inventions.

The purpose of Directive 98/44 is to establish a framework for the legal protection of biotechnological inventions. Article 6(1) provides that inventions must be considered unpatentable where their commercial exploitation would be contrary to ordre public or morality. Article 6(2)(c) of the directive cites the use of human embryos for industrial or commercial purposes as an example of inventions which are considered unpatentable.

The question is whether the exclusion from patentability of the human embryo covers all stages of life from fertilization of the ovum or whether other conditions must be met, for example that a certain stage of development be reached.

The case raised very interesting legal and ethical issues, in particular how the right to human dignity related to the dispute. Although a fundamental right under German constitutional law and jurisprudence, the right to human dignity has been recognized as an unwritten principle of EU law, and undoubtedly played a significant part in the outcome of this case.

The Court was asked “What is meant by the term “human embryos” in Article 6(2)(c) of Directive 98/44 ?” Directive 98/44 stipulates that patent law must be applied so as to respect the fundamental principles safeguarding the dignity and integrity of the person. The question then is what form, what stage of development of the human body, must be given the legal categorization of ‘embryo’.

The development from conception begins with a few totipotent cells, which each cell has the capacity to develop into a complete human being. The Court viewed totipotent cells as representing the first stage of the human body and must therefore be legally categorized as embryos.

The Court emphasized that whether that categorization must be recognized from before or only after implantation is irrelevant. This means that every totipotent cell, whatever the means by which it has been obtained, is an embryo and that any patentability must be excluded. This definition covers unfertilized ova into which a cell nucleus from a mature cell has been transplanted.

The Court felt that characterizing a totipotent cell as an embryo does not resolve the issue since an embryo quickly develops into a blastocyst made up of pluripotent cells, which can develop into all kinds of cells to form all the organs of the human body. These cells cannot develop separately into a complete human being. While the court felt that blastocysts as a whole must be categorized as an embryo, an individual pluripotent cells in isolation is not.

Most of the EU Member States take the view that pluripotent stem cells are not human embryos given that embryonic stem cells, taken in isolation, are no longer capable of developing into a complete individual. However, the Court said it is not possible to ignore the origin of this pluripotent cell. The pluripotent stem cell in the present case is removed from the blastocyst, which the removal will destroy. The argument is that patentability depends on the way in which it has been removed and the consequences of such removal .

In comparing the situation to prisoners killed in order to remove organs for trafficking, the Court reasoned that even though the claims under the patent did not specify that human embryos are used for the exploitation of the invention, when they actually are, the patentability of such an invention must be excluded.
While the Court agreed that inventions relating to pluripotent stem cells can be patentable if they are not obtained to the detriment of an embryo, the cells at issue are removed from the human embryo at the blastocyst stage and they necessarily entail the destruction of the human embryo. The Court held that Article 6(2)(c) must be interpreted that a human embryo applies from the fertilization stage to the initial totipotent cells and to the entire ensuing process of the development and formation of the human body, which includes the blastocyst.

The use of human embryos for therapeutic or diagnostic purposes which are applied to the human embryo and are useful to it is patentable, but their use for purposes of scientific research is not patentable.

The Court interpreted Article 6(2)(c) of Directive 98/44/EC on the legal protection of biotechnological inventions as an invention must be excluded from patentability where the application of the technical process for which the patent is filed necessitates the prior destruction of human embryos or their use as base material, even if the description of that process does not contain any reference to the use of human embryos.

The exception to the non-patentability of uses of human embryos for industrial or commercial purposes concerns only inventions for therapeutic or diagnostic purposes that are applied to the human embryo and are useful to it.

The holding and reasons of the case means that inventions making use of deposited cell lines which had originally been obtained by destruction of an embryo within the broad meaning of an embryo are not patentable. This applies even if the origin of the cell line is not part of the claim in question.

If you read the ruling as saying that any invention based on human embryonic stem cells is unethical and therefore cannot be patented, then the ruling will have major implications for the commercialization of stem cell-based technologies in the EU, especially if it fosters the idea that stem cell research is inherently immoral.

It will take several years for the European Patent Office, national patent offices and various courts to take up the issue and interpret the decision. In one view, companies may end up relying on keeping manufacturing processes a trade secret instead of relying on patents since the European Medicines Agency keeps data submitted for regulatory approval private for eight years and blocks others from using this information for two additional years.

While the decision could spur development of therapies since it could free up ES cell research from patent infringement, it could still prove to be harmful since the far-reaching decision bans patents on any downstream products using cell lines that required the destruction of human embryos for violating respect for human dignity.

Read the judgment (in English) here.

EPO Sees Double (Patenting)

Guest Barista — Wed, 02 Jun 2010 17:08:06 +0000

If an authority grants two patents for the same invention to the same applicant, that is double patenting. In most European states the law requires that one of the patents must cease.

Since it started, the European Patent Office (EPO) official view has been that it should not allow double patenting. The Guidelines for Examination explicitly state this. However, the governing European Patent Convention (EPC) makes no mention of double patenting.

A recent Technical Board of Appeal (TBA) decision, T 307/03, tried to find basis for the prohibition of double patenting in the EPC provision governing ownership of the invention.

The recent TBA decision T1423/07 rejects T 307/03 and confirms that the EPC gives no legal basis for any EPO prohibition of double patenting. The TBA decided there is nothing in the EPC explicitly prohibiting an applicant obtaining two patents for an invention, provided the applicant has a legitimate interest in doing so.

Consequences

This decision makes it more difficult for the EPO to refuse, on the grounds of double patenting, a divisional application to subject matter similar to that of the parent application.

However, the decision left open the possibility of refusing such an application if the applicant does not have ‘a legitimate interest’. We await the reaction of the EPO examiners with interest.

Please do not hesitate to contact us if you have any questions or if you would like further information.

Today’s post is by Guest Barista Matt Barton, a UK Chartered Patent Attorney and European Patent Attorney at Forresters in London.

Just a Reminder: EPO Fees Increase April 1

Stephen Jenei — Mon, 22 Feb 2010 19:23:08 +0000

The European Patent Office (“EPO”) recently announced that most of its fees will increase by between 5 and 8 per cent from April 1, 2010. A summary of the new fees is shown here.

What does this all mean to you?

If you know that you want to enter the European regional phase of a PCT application, you should do so before April 1 to save around 5% on the official fees due.

For example, a typical PCT application might have 35 pages and 15 claims, with the USPTO as the International Searching Authority (ISA). If that PCT application enters the European regional phase on or after April 1, the total official fees will be US4192. If it enters the European regional phase before April 1, the total official fees will be US3975 (saving slightly more than 5% in the official fees).

Exactly the same principle applies to filing a new European patent application directly at the EPO. It particularly applies to new divisional applications, where the savings on accumulated renewal fees can be considerable.
Therefore, if possible, you should file new European patent applications (particularly divisionals), and enter the European regional phase of PCT applications, before April 1.

For the first time in a number of years, the EPO is not introducing a new payment structure. The changes in fees will not change day-to-day practice, save for the need to pay higher official fees. Therefore, our previous practice advice, for example concerning minimizing the number of claims, still applies.

The major practice changes will arise from the changes in the rules on the filing of divisional applications. Please refer to our note on the changes relating to divisional practice. We expect that 1 October 2010 will be the deadline to file many divisional applications. We strongly recommend reviewing your portfolio of European patent applications now and filing as many divisional applications as possible before April 1 to save filing costs.

(via Forresters)

EPO: Dosage Regime Patentable Even If It is The Only Novel Feature

Stephen Jenei — Fri, 19 Feb 2010 22:38:02 +0000

The therapeutic use of that substance cannot be patented because that use is a method of treatment of a human or animal body by surgery, therapy or diagnosis which is practiced on that human or animal body.

Methods of treatment are regarded in Europe as not being capable of industrial application and are consequently not patentable. The Swiss Patent Office came up with the following solution in the early 1980′s:

“Use of compound X in the manufacture of a medicament for the treatment of disorder Y”.

Thus, the Swiss-type claim was born.

European patent application No. 94306847.8, “Nicotinic acid compositions for treating hyperlipidemi,” originally filed by Kos Life Sciences, Inc., now Abbott Respiratory LLC, was refused by a decision of the Examining Division on the grounds of lack of novelty under Articles 54(1) and (2) EPC 1973 and because it did not meet the requirements of Article 52(4) EPC 1973.

This decision was based on a Claim 1 which reads as follows:

“1. The use of nicotinic acid or a compound metabolized to nicotinic acid by the body selected from a group consisting of d-glucitol hexanicotinate, aluminium nicotinate, niceritrol, d,1-alpha-tocopheryl nicotinate and nicotinyl alcohol tartrate, for the manufacture of a sustained release medicament for use in the treatment by oral administration once per day prior to sleep, of hyperlipidaemia characterised in that the medicament does not comprise in admixture, 5-30% hydroxypropyl methylcellulose, 2-15% of a water soluble pharmaceutical binder, 2-20% of a hydrophobic component and 30-90% nicotinic acid.”

As set out in the decision under appeal, the Examining Division was of the opinion that the subject-matter of Claim 1 was anticipated by the disclosure in earlier documents, which contemplated the use of nicotinic acid for the manufacture of a sustained release medicament for use in the treatment of hyperlipidaemia by oral administration.

In that respect, the first instance, referring in particular to decisions T 317/95 and T 584/97, concluded that the feature of Claim 1 relating to a specific drug regime, i.e. once per day prior to sleep, reflected a medical activity excluded from patentability under Article 52(4) EPC 1973, which could not therefore be considered to represent a further medical indication from which novelty can be derived (points 27 and 28 of the Reasons).

The Board of Appeal held that the question whether medicaments for use in methods for treatment by therapy, where the only feature likely to confer novelty on the claim is a dosage regime, are patentable under Articles 53(c) and 54(5) EPC 2000 is an important point of law (decision T 1319/04, OJ EPO 2009, 36).

Under Article 53(c) EPC 2000 European patents may not be granted for methods for treatment by therapy or surgery of the human or animal body, neither may they be granted for diagnostic methods practiced on them. They may however be granted for medicinal products for use in such methods.

Already under the EPC 1973, to compensate for this exclusion, substances and compositions although already known in the art could nonetheless as such be patented for their first new and inventive use in one of these methods.

No express provision in the EPC 1973 allowed in contrast purpose-related product claims for second or further medical indications of known substances or compositions already used as medicines.

New Article 54(5) EPC contains an express permission of purpose-related product claims provided the new and inventive use of the substance or composition already known as a medicine be specific. However, the EPC does not give any definition of the precise meaning of this requirement that could encompass a new illness to be treated as well as the very disease that was already the object of a prior application, in which case the novelty of the use could be drawn from another distinguishing feature (e.g. different subjects to be healed or different modes of administration of the substance).

Therefore, the first sentence of Article 53(c) EPC, prohibiting patent protection of methods for treatment by therapy, is to be read and understood together with the provisions of its second sentence and with those of Articles 54(4) and (5) EPC respectively so that far from being mutually exclusive they are complementary.

By virtue of a legal fiction Article 54(4) and (5) EPC acknowledges the notional novelty of substances or compositions even when they are as such already comprised in the state of the art, provided they are claimed for a new use in a method which Article 53(c) EPC excludes as such from patent protection.

In such cases the notional novelty and following it the non-obviousness, if any, is not derived from the substance or composition as such but from the purpose the claimed substance or composition is related to, namely from its intended therapeutic use.

Swiss-type claims could be (and have been) considered objectionable as regards the question as to whether they fulfill the patentability requirements, due to the absence of any functional relationship of the features (belonging to therapy) conferring novelty and inventiveness, if any, and the claimed manufacturing process. Therefore, where the subject matter of a claim is rendered novel only by a new therapeutic use of a medicament, such claim may no longer have the format of a so called Swiss-type claim as instituted by decision G 5/83.

In Case Number: G 0002/08; Dosage regime/Abbott Respiratory LLC, the EPO Enlarged Board of Appeal decided that:

Question 1: Where it is already known to use a particular medicament to treat a particular illness, can this known medicament be patented under the provisions of Articles 53(c) and 54(5) EPC 2000 for use in a different, new and inventive treatment by therapy of the same illness?

Answer: Where it is already known to use a medicament to treat an illness, Article 54(5) EPC does not exclude that this medicament be patented for use in a different treatment by therapy of the same illness.

Question 2: If the answer to question 1 is yes, is such patenting also possible where the only novel feature of the treatment is a new and inventive dosage regime?

Answer: Such patenting is also not excluded where a dosage regime is the only feature claimed which is not comprised in the state of the art.

Question 3: Where the subject matter of a claim is rendered novel only by a new therapeutic use of a medicament, such claim may no longer have the format of a so called Swiss-type claim as instituted by decision G 5/83.

Answer:A time-limit of three months after publication of the present decision in the Official Journal of the European Patent Office is set in order that future applicants comply with this new situation.

EPO Enlarged Board of Appeal: Method Patentable By Disclaiming Unpatentable Step

Stephen Jenei — Thu, 18 Feb 2010 18:39:28 +0000

The EPO Enlarged Board of Appeal handed down its decision relating to the interpretation of the exclusion for patentability under article 53(c) EPC “method for treatment of the human or animal body by surgery”. Questions were asked to the Enlarged Board in a case about a medical imaging method, whereby a contrast agent was injected into the heart. The referring Board questioned whether this essentially diagnostic method involving a step consisting in a physical intervention was nevertheless excluded from patentability.

The appeal proceedings before the referring Board concern the appellant’s appeal against the decision of the Examining Division of 17 April 2003 refusing European patent application No. 99918429.4. The Examining Division decided that the claimed methods according to the requests then on file constituted diagnostic methods practiced on the human or animal body and thus were excluded from patent protection pursuant to Article 52(4) EPC 1973. Furthermore, the claimed methods comprised the step of administering polarized 129Xe as an imaging agent to a subject, either by inhalation or by injection. Insofar as the delivery of the imaging agent was done by injection, the claimed methods were excluded from patent protection pursuant to Article 52(4) EPC 1973 as involving a surgical step.

The application relates to magnetic resonance methods for imaging the pulmonary and/or cardiac vasculature and evaluating blood flow using dissolved polarized 129Xe. The imaging methods of the present invention may precede surgery or a drug therapy for treating pulmonary or cardiac vasculature problems. During surgery, they may provide real-time feedback for verifying success, for example surgically induced variations in blood perfusion. During a drug therapy, they may allow the effects of the drug to be determined.

The wording of claims 1, 11 and 17, underlying the referring decision reads as follows:

1. A method for MRI imaging the pulmonary and/or cardiac vasculature using dissolved-phase polarized 129Xe, comprising the steps of: positioning a patient in an MRI apparatus having a magnetic field associated therewith; delivering polarized 129Xe gas to a predetermined region of the patient’s body, the polarized gas having a dissolved imaging phase associated therewith; exciting a predetermined region of the patient’s body, having a portion of the dissolved phase polarized gas therein with at least one large flip angle RF excitation pulse; and acquiring at least one MR image associated with the dissolved phase polarized gas after said exciting step.

11. A method for deriving a spectroscopic signal representative of a blood volume or a blood flow rate of a patient, comprising the steps of: positioning a subject in an MR spectroscopy system capable of detecting spectroscopic signals in a subject having a pulmonary vasculature; delivering gaseous polarized 129Xe to the subject; dissolving a portion of the gaseous polarized 129Xe into the pulmonary vasculature having an associated blood flow path; exciting the dissolved portion of the 129Xe with an MR spectroscopy RF excitation pulse; and deriving a spectroscopic signal associated with the dissolved phase 129Xe representing a blood volume or blood flow rate.

17. A cardiac imaging method, comprising the steps of: positioning a subject having a cardiac blood flow path in an MRI system; delivering polarized 129Xe to the subject; dissolving at least a portion of the polarized 129Xe into the subject’s cardiac blood flow path; exciting dissolved polarized 129Xe in a target region along the blood flow path with at least one large angle RF excitation pulse; and generating an MR image associated with the excited dissolved polarized 129Ke.

The Enlarged Board answered the following questions:

Q. 1. Is a claimed imaging method for a diagnostic purpose (examination phase within the meaning given in G 1/04), which comprises or encompasses a step consisting in a physical intervention practiced on the human or animal body (in the present case, an injection of a contrast agent into the heart), to be excluded from patent protection as a “method for treatment of the human or animal body by surgery” pursuant to Article 52(4) EPC if such step does not per se aim at maintaining life and health?

A. 1. A claimed imaging method, in which, when carried out, maintaining the life and health of the subject is important and which comprises or encompasses an invasive step representing a substantial physical intervention on the body which requires professional medical expertise to be carried out and which entails a substantial health risk even when carried out with the required professional care and expertise, is excluded from patentability as a method for treatment of the human or animal body by surgery pursuant to Article 53(c) EPC.

2. If the answer to question 1 is in the affirmative, could the exclusion from patent protection be avoided by amending the wording of the claim so as to omit the step at issue, or disclaim it, or let the claim encompass it without being limited to it?

2a. A claim which comprises a step encompassing an embodiment which is a “method for treatment of the human or animal body by surgery” within the meaning of Article 53(c) EPC cannot be left to encompass that embodiment.

2b. The exclusion from patentability under Article 53(c) EPC can be avoided by disclaiming the embodiment, it being understood that in order to be patentable the claim including the disclaimer must fulfill all the requirements of the EPC and, where applicable, the requirements for a disclaimer to be allowable as defined in decisions G 1/03 and G 2/03 of the Enlarged Board of Appeal.

2c. Whether or not the wording of the claim can be amended so as to omit the surgical step without offending against the EPC must be assessed on the basis of the overall circumstances of the individual case under consideration.

3. Is a claimed imaging method for a diagnostic purpose (examination phase within the meaning given in G 1/04) to be considered as being a constitutive step of a “treatment of the human or animal body by surgery” pursuant to Article 52(4) EPC if the data obtained by the method immediately allow a surgeon to decide on the course of action to be taken during a surgical intervention?

3. A claimed imaging method is not to be considered as being a “treatment of the human or animal body by surgery” within the meaning of Article 53(c) EPC merely because during a surgical intervention the data obtained by the use of the method immediately allow a surgeon to decide on the course of action to be taken during a surgical intervention.

The entire opinion is here: Medi-Physics/Treatment by Surgery G107 Board Opinion