df-mp - News
As part of our service for our clients, we provide information regarding the latest developments in intellectual property
law as well as noteworthy news about our law firm.
df-mp – IP News
A Blow to Broad Medical Use Claims from Technical Board 3.3.10?
In a recent decision (T 1063/06) Technical Board of Appeal 3.3.10 ruled that a Swiss-type claim relating to the "use of compounds which are capable of stimulating soluble guanylate cyclase independent of the participation of the heme group of the enzyme for the preparation of a medicament for treating cardiovascular diseases such as angina pectoris, ischemia and cardiac insufficiency" is to be considered as a "reach-through" claim that does not fulfill the requirements of Article 83 EPC (sufficiency of disclosure).
The Board argued that the claim at stake referred to a problem without providing a solution thereof (i.e., a desideratum), which would cover future inventions. However, so the Board, the Applicant could only achieve protection for what he has invented, i.e., protection could be obtained only for the actual contribution to the art which would not be an undue limitation for the Applicant, but justified given the circumstances. Patent protection was in accordance with the EPC seen by the Board not to serve the purpose of reserving an unexplored field of research, but of protecting actual results of successful research as a just reward for making them publicly available.
The Board went on to argue that the formulation of a chemical compound as a desideratum comprised all compounds having the property indicated in the claim (i.e., stimulating soluble guanylate cyclase independent of the participation of the heme group of the enzyme). However, in the absence of any guidance in the application as to which compound is to be chosen and without having available common general knowledge, the skilled person could only rely on trial and error experimentation in testing arbitrarily chosen compounds as to whether they have the required property. This, however, would be an undue burden.
This decision should certainly be taken into account by Applicants when drafting new second medical use applications aiming for broad claims. Furthermore, this decision may also have an impact on broad functionally defined compound claims.
The practice of filing European divisional applications will fundamentally change
as of 1 April 2010
Presently, divisional applications can be excised and filed from a (parent) EP-application as long as the parent application is pending. An application is pending until the mention of grant of a patent is published in the European Patent Bulletin. Accordingly, divisional applications can be filed at any time prior to the grant of the parent application (so-called voluntary divisional applications).
This practice, however, will change. In its "Raising the bar" project, aiming at improving overall quality and enhancing legal certainty while ensuring that legitimate rights and expectations are fully served, the EPO will fundamentally change the practice of filing European divisional applications. In its paper CA/145/08, the EPO criticizes the abuse of divisional applications which have been used to achieve a "duplication" of the proceedings. As an example, the EPO argues that an Applicant may file a(n identical) divisional application the day before the oral proceedings, i.e. before any refusal might occur. If refusal ensues in the oral proceedings, instead of appealing against the negative decision of the examining division, the Applicant simply pursues the divisional. Moreover, even if an appeal is filed and the refusal is confirmed by the Board of Appeal, this procedure allows the Applicant to have the same technical content examined again. The Applicant can repeat this tactic over and over again.
Accordingly, in a major announcement affecting the ability of Applicants to file divisional applications, the EPO's Administrative Council has adopted a new Rule (EPC Rule 36) as of 1 April 2010 which severely restricts the ability to file voluntary divisional applications.
New Rule 36 EPC will constrain Applicants in filing divisional applications in two ways.
Firstly, divisional applications can only be filed prior to the expiry of a time limit of 24 months from the Examining Division's first Communication in respect of the earliest application (i.e. parent application) for which a Communication has been issued.
As recently clarified by the EPO, the "First Communication" will be a communication under Article 94(3) EPC or, where appropriate, a communication under Rule 71(3) EPC (indicating the intention of the Examining Division to grant a European patent). Neither the Communication under Rule 161/162 EPC nor the notification of the search opinion will cause this 24-month period to start.
In addition, as a further measure in its "Raising the Bar" project, the EPO will insert a new Rule 70a EPC which invites Applicants to correct any deficiencies noted and to amend the description, claims and drawings within a given time limit (usually 2-months).
Likewise, the EPO will amend Rule 161 EPC accordingly so that Applicants are invited to take into account deficiencies mentioned during the PCT-phase in the Written Opinion of the ISA (Chapter I) or, if applicable, in the IPRP (Chapter II) within a time period of 1-month.
If Applicants were to neglect this invitation, their opportunities to later amend the claims may be limited in view of the forthcoming amendments to Rule 137(4) EPC. In particular, in its paper CA/PL 14/08 the EPO proposed to amend this Rule such that, inter alia, the Applicant's right to amend the application of his own volition after receipt of the Examiner's first Communication is shifted to the procedural stage of response to the opinion accompanying the European search report, or, where applicable, the WO-ISA or the IPRP.
Secondly, given the circumstances that a Communication has issued in which the Examining Division has objected that the earlier application does not meet the unity requirements governed by Article 82 EPC, Applicants are provided with a time limit of 24 months to file divisional applications as a reaction to the non-unity objection (so-called mandatory divisional applications) that is calculated from the date of the Communication.
There will be transitional provisions which extend the time limit for filing divisional applications based on applications pending on the date of entry into force of the revised rules on 1 April 2010.
Specifically, the EPO proposes that:
- if the time limits for filing divisional applications as governed by new Rule 36 EPC have expired before the date on which the new rule enters into force, a divisional application may still be filed within six months as from that date;
- if they are still running on the date on which the new rule enters into force, they will continue to do so for not less than six months.
The amended version of Rule 135 EPC will apply to these transitional periods, i.e. the aforementioned periods will be excluded from further processing, but susceptible to re-establishment.
In sum, the change in the divisional practice will force Applicants to carefully consider their future prosecution strategy and to already at this point of time evaluate their patent portfolio as to whether there is a need to file divisional applications in view of the rather short duration of the transitional period.
Should you have any questions to these upcoming changes in the divisional practice before the EPO, please feel free to contact us.
German Federal Supreme Court Refines Novelty Test in Chemical Cases in Lilly's "Olanzapine" Case
The Federal Supreme Court (FSC) had recently decided to annul the German Federal Patent Court's earlier decision to revoke the German part of Eli Lilly's European patent EP 454 436-B1 to Olanzapine (Zyprexa®) in a hearing held on December 16, 2008. The eagerly awaited written decision is now available
here.
In summary, the "Olanzapine" decision of the FSC is remarkable in that it
- explains the correct test for novelty and puts the FSC's previous decision "Elektrische Steckverbindung" ("Electrical Plug-in Connector") into the context of chemical cases;
- abandons the previous concept of the "Fluoran" decision that a general chemical formula is to be construed as disclosing all individual compounds falling within its scope and brings German patent law and practice in the chemical area into line with the EPO approach, which acknowledges anticipation only where a particular compound is the inevitable result of a prior art process, or is disclosed in an "individualized" manner
- cites with apparent approval EPO case law regarding novelty of stereoisomers, thereby indicating that it would likely follow the EPO's general approach also in this specific area of chemistry; According to the FSC, the evaluation of whether or not the subject matter of a patent is anticipated by a prior art document requires determining the entire content of that document. What is decisive is which technical information is disclosed to the skilled person. In this regard, the concept of "disclosure" is the same as that applied in other areas of patent law. It is wrong to ask in which specific form the skilled person may practice a more general teaching of a document, or how s/he might amend that teaching. The decisive question is rather what the skilled person understands the content of the (general) teaching of the document to be.
- yet seems to view the EPO's "problem-solution" approach with some reservation.
In the following, the reasoning of the FSC is discussed in more detail.
According to the FSC, the evaluation of whether or not the subject matter of a patent is anticipated by a prior art document requires determining the entire content of that document. What is decisive is which technical information is disclosed to the skilled person. In this regard, the concept of "disclosure" is the same as that applied in other areas of patent law. It is wrong to ask in which specific form the skilled person may practice a more general teaching of a document, or how s/he might amend that teaching. The decisive question is rather what the skilled person understands the content of the (general) teaching of the document to be.
According to the decision, this principle has already been previously expressed in the case law of both the FSC and the Boards of Appeal of the EPO by emphasizing the importance of evaluating what can be "directly and unambiguously" derived from a given document.
The decision notes that this approach towards novelty is not in conflict with the concepts developed by the FSC in the earlier "Elektrische Steckverbindung" ("Electrical Plug-In Connector") case. In that case, it was held that the disclosure content of a document encompasses information so obvious to the skilled person studying it with a view towards the actual meaning of the terms used therein (rather than the mere literal wording) that it is immediately evident to her/him, thereby extending the disclosure content to what the skilled person automatically infers from the document. The use of the term "obvious" in "Elektrische Steckverbindung" might at first sight indicate that equivalents are included. However, according to the FSC the additional reference in that decision to what the skilled person would infer from a document makes clear that -- rather than including equivalents -- the issue is to make sure that indeed all information which the skilled person obtains from studying the document is taken into account. In this regard, the FSC explicitly emphasizes (e.g., in the second headnote of the decision) that a supplementation of the teaching of a document based on the skilled person's general knowledge (e.g., with conceivable variants and developments of the document's teaching or with conclusions drawn therefrom) is not appropriate and goes beyond the document's disclosure content.
According to the FSC, these principles apply equally to the area of chemistry, including the disclosure content of a structural chemical formula. The disclosure of a structural or other general formula does not generally amount to a disclosure of the individual compounds falling within its scope. As far as any deviating concept might be derivable from the earlier FSC decision "Fluoran" (which was still rendered under the old German Patent Act of 1968, and which was considered binding by the German Federal Patent Court in the first instance of the Olanzapine case) such concept is no longer adhered to by the FSC for the application of the presently applicable law. Only in cases where the skilled reader automatically infers an individual compound from a document in the sense explained above (e.g., because s/he knows it as the embodiment of the disclosed more general formula that is commonly used in practice) is that individual compound considered to be disclosed by the document.
The FSC decision expresses the belief that the above approach towards novelty is in line with the case law of the UK High Court and of the EPO. In this regard, the FSC inter alia cites with approval EPO case law on the novelty of stereoisomers (e.g., decision T 296/87 (Enantiomers/HOECHST; OJ EPO 1990, 195)) and explains that a particular compound should be considered anticipated only by disclosures that describe the compound as the inevitable result of a prior art method or in a specific, i.e., "individualized" form.
Applied to the facts of the "Olanzapine" case the FSC denied anticipation by a prior art scientific paper (Chakrabarti et al.), since Olanzapine was considered to be merely one of twelve compounds that the skilled person would understand to theoretically fall within the general formula disclosed therein. Olanzapine was, however, not disclosed in an individualized form. Since it was not apparent that the skilled reader of Chakrabarti et al. would automatically infer this compound from the disclosure content of the document in any other way, novelty vis-à-vis this reference was acknowledged. The same conclusion was reached in respect of other documents which the plaintiffs had relied upon to support a lack of novelty.
The considerations in the FSC's Olanzapine decision regarding inventive step (which was also acknowledged) are likewise of interest. In particular, the FSC notes that the evaluation of inventive step from the point of view of a "closest prior art" document (again Chakrabarti et al. in this case) may carry the risk of applying hindsight, since only in retrospect would it be clear which prior art is indeed the closest to the invention and how the inventor could have proceeded from there to arrive at the claimed solution. According to the FSC, the concept of the "closest prior art" cannot take away the fact that the skilled person would first have had to make the choice to start from Chakrabarti at all, thereby limiting the choices to be made to arrive at the invention. These comments seem to indicate a certain reservation regarding the "problem-solution" approach practiced by the EPO in the evaluation of inventive step, which approach is very focused on selecting a "closest prior art" document as a first and very decisive step. This is consistent with German commentary opinion where the EPO's "problem-solution" approach is considered to be at risk of producing results arrived at in hindsight.
Enlarged Board of Appeal renders decision in G 2/06 "WARF/Thomson stem cell application"
The EPO's Enlarged Board of Appeal (EBA) has recently handed down its decision G 2/06 concerning the patenting of human embryonic stem cells and thus answered the questions referred to them by Board of Appeal 3.3.08 in the context of the appeal proceedings in the so-called WARF application.
In essence, the EBA answered a first question referred to them to the effect that Rule 28(c) EPC (Rule 23d(c) EPC1973) applies to all pending patent applications, including those filed before the entry into force of the Rule (September 1, 1999). Rule 28(c) EPC prohibits the grant of patents in respect of biotechnological inventions concerning, inter alia, the uses of human embryos for industrial or commercial purposes.
Also, the EBA answered a further question which was deemed to be the heart of the matter referred to them to the effect that Rule 28(c) EPC forbids the patenting of claims directed to products which, as described in the application, at the filing date could be prepared exclusively by a method which necessarily involved the destruction of human embryos, even if this method is not part of the claims.
Specifically, the EBA made it clear that the provisions of Rule 28(c) EPC cannot be carved out by the mere fact that the use of human embryos is not explicitly claimed. Indeed, the EBA pointed out that Rule 28(c) EPC refers to "invention" in the context of its exploitation. Accordingly, one has to look at the technical teaching of the patent application as a whole as to how the invention is performed. Thus, clever and skillful drafting of claims cannot avoid the patenting prohibition governed by Rule 28(c) EPC if the application as a whole teaches that only by destroying human embryos, the claimed embryonic stem cells can be obtained.
Furthermore, the EBA answered another question to the effect that technical developments which were publicly available only after the filing date of an application in question and which would enable obtaining human embryonic stem cells by means other than destroying human embryos cannot retrospectively change the fact situation that at the filing date, it was necessary to destroy a human embryo in order to obtain embryonic stem cells. Consequently, in such a situation the application in question would still violate the requirements of Rule 28(c) EPC (and hence, Article 53(a) EPC).
The above being said, the meaning of the "use" of human embryos for industrial or commercial purposes as recited in Rule 28(c) EPC has not been explicitly addressed by the EBA. In fact, the EBA solely discussed the situation where the destruction of human embryos is necessarily involved in the context of the "use" recited in Rule 28(c) EPC. The EBA did not provide an interpretation on what is embraced by the "use" of human embryos for commercial or industrial purposes in the sense of Rule 28(c) EPC. Neither did the EBA provide an opinion on the patentability in general of inventions relating to human stem cells or human stem cell culture.
If the term "use" as recited in Rule 28(c) EPC were to be construed broadly as embracing any manipulation of a human embryo, human embryonic stem cells that can only be obtained by such manipulation would not seem to be patentable.
However, it is meanwhile known that embryonic stem cells can be obtained from human embryos without destroying them. Accordingly, if the term "use" as recited in Rule 28(c) EPC were to be construed narrowly, i.e., as being limited to the mere destruction of a human embryo, it may still be possible to patent human embryonic stem cells obtained from embryos without destroying them. Yet, this interpretation does not seem to be likely.
Specifically, in view of Article 53(a) EPC which prohibits patents for inventions the commercial exploitation of which would be contrary to "ordre public" or morality, it seems the term "use" is not likely to be construed narrowly, i.e., as being limited to scenarios where the human embryo is necessarily destroyed. Rather, it may have to be more broadly construed as meaning any use of human embryos for industrial or commercial purposes, including obtaining stem cells without destroying them. Indeed, the possible damage to the human embryo caused by such a process could already be seen as being contrary to "ordre public" and morality pursuant to Article 53(a) EPC, leading to the refusal of the application as a whole, or at least the claims objected to.
In sum, the EBA specifically answered the question deemed to be the heart of the matter referred to them without providing further comments extending beyond that question. The EBA thereby provided guidance under which circumstances a patent on human embryonic stem cells cannot be obtained, i.e., if the destruction of human embryos is necessary for obtaining such cells. However, the EBA's decision provides only limited guidance as to what may still be patentable in this area of technology.
Accordingly, there are still some open questions which require clarification. Perhaps, a similar scenario as in the diagnostic cases may arise that after the issuance of a first EBA decision, another referral reaches the EBA.
What are the practical implications of the EBA's rulings?
As Rule 28(c) EPC is applicable to any patent application filed before the entry into force of this rule, claims directed to human embryonic stem cells per se will likely be objected to as violating Rule 28(c) EPC.
Accordingly, it seems it is presently difficult to obtain patent protection for human embryonic stem cells, at least assuming the term "use" as recited in Rule 28(c) EPC is broadly interpreted by the EPO, which we believe is a likely scenario. Even if the claimed human embryonic stem cells can be obtained without destroying an embryo, and even if Rule 28(c) EPC were narrowly construed as being limited to scenarios where the embryo is necessarily destroyed, it would still appear difficult to obtain claims encompassing so-obtained stem cells in view of the provisions of Article 53(a) EPC.
Consequently, one would then also have to exclude human embryonic stem cells from the scope of the claims by way of a disclaimer which, even without literal support, should be allowable in view of the EBA's decisions G 1/03 and G 2/03, ruling that non-patentable subject matter may be excluded by virtue of a(n undisclosed) disclaimer.
However, the exclusion of human embryonic stem cells for ethical reasons may have implications both for substantive issues such as enablement and, again, for ethical reasons. In fact, if the human embryonic stem cell is essential to the invention and cannot be substituted by or credibly extrapolated to a non-human embryonic stem cell, enablement issues may arise.
Nevertheless, it still appears to be possible to patent human embryonic stem cells which can be obtained by means and methods without the use of human embryos. Yet, if so-obtained cells are not distinguishable from already known stem cells by defined physiological or biochemical parameters, they would not be considered novel and/or inventive.
The decision of the EBoA can be found here.
Bill for the Modernisation of German Patent Law
On October 15, 2008 a bill was agreed upon by the Federal Government to simplify and modernise patent law in Germany. The new law is yet to be ratified by the German Parliament ("Bundestag"). The aim of the changes to the law is to simplify the filing of patents and trademarks and to shorten court proceedings, particularly in patent nullity proceedings. The main points of the bill are summarised in the following:
Reform of Patent Nullity Proceedings: In the future, the Federal Patent Court ("Bundespatentgericht") must inform the Parties of the relevant questions to be discussed at the oral hearing and offer them a possibility to make supplementary submissions. A deadline for filing such submissions will be enforced to guard against new evidence being unexpectedly introduced in the oral proceedings.
Reform of Appeal Proceedings: The task of the Federal Supreme Court ("Bundesgerichtshof") will be limited in the future to deciding whether the law has been correctly applied by the Federal Patent Court. The filing of further facts or evidence will be possible only in exceptional cases. The Proprietor can no longer make amendments to the patent in order to defend the patent in the nullity appeal proceedings.
Modernising the German Employee Invention Law: The process for employee inventions will be simplified by the introduction of the so-called "Inanspruchnahmefiktion" (i.e., the invention is deemed to have been effectively claimed by the employer). This means that all rights in the employee invention will be automatically transferred to the employer after 4 months and in return, the employee has a claim to a renumeration.
Changes to the Law relating to the charges for registering a patent ("Patentkostengesetz"): The cost of submitting patent applications electronically is reduced to encourage people to do so. The filing fees will furthermore depend in part on the number of patent claims. Both measures are an attempt to reduce the workload at the DPMA and to avoid backlog.
Changes to the Trademark Law: In opposition proceedings, older marks that have not been registered will now be considered. This measure is introduced to remove the previously existing inequality in the treatment of these marks. Furthermore, it will also be possible to commence second instance proceedings (Beschwerde) in place of further first instance proceedings (Erinnerung). International trademarks may in the future be filed in English or French.
