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DR. MARTIN GRUND
PATENTANWALT / GERMAN PATENT ATTORNEY
EUROPEAN PATENT ATTORNEY
EUROPEAN TRADEMARK & DESIGN ATTORNEY
STACEY J. FARMER, Ph.D., J.D.
U.S. PATENT ATTORNEY
U.S. ATTORNEY AT LAW
SIBYLLA HUSTER
RECHTSANWÄL TI N / GERMAN ATTORNEY AT LAW
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IN COOPERATION W ITH:
DR. SABINE RIEMANN
PATENTANWÄLTIN / GERMAN PATENT ATTORNEY
EUROPEAN PATENT ATTORNEY
EUROPEAN TRADEMARK & DESIGN ATTORNEY
MATTHIAS W . SCHAEFER
PATENTANWALT / GERMAN PATENT ATTORNEY
EUROPEAN PATENT ATTORNEY
EUROPEAN TRADEMARK & DESIGN ATTORNEY
Published in “Bioscience Law Review”
Volume 9, Issue 1 (2006)
IS GERMAN UTILITY MODEL PROTECTION AVAILABLE FOR
BIOTECHNOLOGY INVENTIONS?
By:
Dr. Martin Grund, Dr. Erik Richly, and Dr. Stacey J. Farmer
Grund Intellectual Property Group, Munich, Germany
ABSTRACT
A German utility model (or ‘Gebrauchsmuster’) provides a quick and cost-effective means for
obtaining intellectual property protection for new technologies in the same way as a conventional
German patent. However, the German Utility Model Act, the body of law governing the issuance and
enforceability of utility models, expressly states that both methods and processes are excluded from
protection. Consequently, many practitioners have logically presumed that use claims are also
excluded, as these types of claims fall readily into the category of ‘method claims’. In two recent
decisions, the German Federal Supreme Court has defined what language constitutes a ‘method claim’
and how this exclusion should be applied. First, the Court held that a claim relating to the use of an
active substance in a therapeutic compound for a specific medical use may be a permitted claim
format. Notably, the court reasoned that a claim relating to the use of a known drug for a new
medical indication is more akin to an allowable product claim rather than a method claim. Second, the
Court held that this rationale only applies to pure method claims, while inventions having an
ambiguous nature are not per se excluded from utility model protection. Hence, any applicant wanting
GRUND INTELLECTUAL PROPERTY GROUP
to quickly secure an enforceable intellectual property right relating to a novel medical use for a known
substance should give serious thought to seeking a German utility model right.
Overview
A German utility model, like a German patent, affords intellectual property protection to technical
inventions that are new, involve an inventive step, and are susceptible of industrial application within
the territorial scope of Germany (per Section 1(1) of the German Utility Model Law, ‘UML’). Unlike
the process of securing a conventional patent right, however, the utility model is characterized by
several features that offer a relatively straightforward and cost-efficient way of securing protective
rights.
Typically, a utility model can be efficiently registered in only two to four months after the application
is filed with the German Patent and Trademark Office (GPTO); a period considerably faster than that
required to receive a patent grant, which typically takes several years. The speed of acquiring a German
utility model grant derives from the fact that upon filing and prior to registration, the GPTO merely
examines the basic formal requirements of the utility model application, including performing a prior
art search at the applicant’s request (upon payment of the official fee of 250 €) and generally involving
no formal substantive examination at all. This process thus offers an applicant a significant cost
advantage, as neither examination fees nor attorney fees for prosecuting the application are incurred.
However, as a utility model could conceivably be registered without having either novelty or inventive
step, verification of such requirements may be necessary via costly and time-consuming nullity or
infringement proceedings.
Worth considering is the notion that the utility model demands less stringent standards of patentability
compared to a German patent. Specifically, the inventive step standard as applied to a utility model
application requires only some indicia of inventive quality exceeding ‘purely handicraft skills’.
Likewise, the requirements for novelty of the invention are markedly different than those for a
German patent. In particular, the novelty analysis considers the prior art as comprising knowledge
that is made available to the public by means of a written description or by use in Germany.
Furthermore, any description or prior use of the invention by the applicant in the six month period
preceding the relevant priority date of the application will not be considered by the GPTO, thus
providing a kind of ‘novelty grace period’. Under these standards, the utility model may offer a mode
of intellectual property protection for subject-matter not otherwise fulfilling those requirements
applicable to the grant of a German patent.
According to Section 5 UML, a German utility model may be derived from any pending patent
application having legal effect in Germany, i.e. from a German, a European or an international patent
application (the latter two application types must designate Germany). An applicant may elect to
pursue a utility model from such a patent application up to two months after the application is
concluded (i.e. refused or granted), up to a maximum of ten years after the patent application filing
date. This 10-year time limit coincides with the maximum term of utility model protection. Also,
upon utility model application, maintenance fees must be paid to the GPTO to sustain the application,
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amounting to a total of 1090 €. Such fees are due at three, six and eight years from the filing date of
the utility model application (Section 23 (2) UML).
Exceptions from Patent Protection
A principal difference between the German utility model and the German patent is that, according to
Sec. 2(3) UML, no protection is available for any claimed method. An additional difference is based
on the implementation of the EU directive 98/44/EG (relating to the legal protection of
biotechnological inventions in Europe), which is reflected in amended Sec. 1(2) No. 5 UML, effective
28 February 2005, and states that no protection may be sought for biotechnological inventions using
the avenue of the German utility model.
However, recent jurisprudence provided by the German Federal Supreme Court has significantly
relaxed these rigid patentability exclusions by defining two notable exceptions, thus affording
applicants the possibility of including such subject-matter into a utility model application.
The Medical Use of a Substance may Constitute Proper Subject-Matter for a German Utility
Model
Claims relating to the medical use of a substance constitute, of course, conventional subject-matter in
patents worldwide. However, according to their plain wording, such claims have been traditionally
regarded (by the GPTO) as method claims and thus exempted from the scope of protection afforded
by a utility model pursuant to Sec. 2(3) UML.
Recently, the German Federal Supreme Court heard a case (X ZB 7/03) where a utility model
applicant sought protection for the use of serine/threonine-protein phosphatase inhibitors as a
medicament for the treatment of arteriosclerosis. After the GPTO had refused the application, the
applicant lodged an unsuccessful appeal with the Federal Patent Court, which confirmed the standing
practice of German patent law, namely, that:
Typical claims directed to a medical use are method claims, as they also comprise, apart from
the administration of the substance to the patient, means for its preparation for the use during
a therapeutic treatment, for example, its ready-made packing and labeling for the new
therapeutic use.
The Federal Supreme Court, however, did not follow this decision. Instead, the court held:
The subject-matter of [the above] method claim involves the suitability of a known substance
for a specific medical use and thus, ultimately, an intrinsic property of that substance. […]
Method claims of this type exhibit elements of product claims in any case (emphasis added).
Therefore, the Federal Supreme Court arrived at the conclusion that medical use claims do not
resemble method claims in the classical sense, and are therefore not properly captured within the
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exception of Sec. 2(3) UML. Consequently, this decision now provides an applicant with the
opportunity to seek the straightforward and cost-effective protection afforded by a utility model for
the medical use of a substance, wherein the substance can encompass biotechnological products
including proteins or peptides.
Biotechnology Inventions that are not Exclusively Directed to Biotechnology-related SubjectMatter may be Properly Protected by a Utility Model
With respect to the newly introduced exception relating to biotechnology-based inventions (found in
Sec. 1(2) No. 5 UML), the German legislature neglected to provide a precise legal definition of
“biotechnological invention”. Therefore, at present, an applicant is faced with some ambiguity when
determining what subject-matter actually constitutes a “biotechnological invention” and is thus barred
from the scope of protection afforded by a German utility model.
Section 1(2) No. 5 UML, as amended, now includes a reference to Sec. 1(2) of the German Patent
Law (‘PL’), which provides that patents may be granted for inventions consisting of or comprising
biological material. However, no actual definition of ‘biological material’ is offered by this provision.
Under Article 2 II (a) of the EU directive 98/44/EG, ‘biological material’ is defined as material
containing genetic information that is able to reproduce itself or to be reproduced in a biological
system. Yet, the exact scope of this definition remains unclear in practice. For example, are proteins
containing genetic information excluded from utility model protection?
The GPTO, aware of the vague implementation of the EU directive and without the guidance of
established case law, is presently focusing its efforts on the element of reproducibility in order to
define a feature directed to biological material. Accordingly, the GPTO excludes utility model
protection for DNA sequences, while permitting the inclusion features directed to peptides.
However, no formal guidelines on this practice currently exist at the GPTO.
An additional aspect of this analysis considers whether inventions that are entirely of a biotechnical
nature should be uniformly excluded, or whether – according to the definition of Sec. 1(2) PL
described above – the fact that biological material is merely somehow involved (e.g. a collagen-containing
cream or a protease-containing washing agent) should necessarily lead to a blanket rejection under Sec.
1(2) No. 5 UML, rather than just the exclusion of the biological feature itself.
Section 1(3) UML stipulates that the exclusion of biotechnological inventions should only apply to the
biotechnological ‘object’ itself, thus providing an indication that the latter presumption may be correct.
Another recent German Federal Supreme Court decision may be interpreted to confirm this result.
The Federal Supreme Court considered a case (X ZB 9/03) where a utility model applicant sought
protection for subject-matter comprising a mixture of method and product claims. The invention
belonged in the technical field of informatics and included claims directed to an electromagnetic signal
sequence suitable for transmitting over the internet, and included a computer program to be executed
on a remote computer.
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The German Federal Patent Court initially decided that the claimed signal sequence must be regarded
a method and thus must be excluded from protection according to Sec. 2 No. 3 UML. However, the
Federal Supreme Court reversed and held:
Sec. 2 No. 3 UML does not stipulate that only products having a stable material substrate
are suitable for protection by a utility model; in accordance with its wording it [Sec. 2 No. 3]
conversely stipulates that no utility model is granted for methods (emphasis added).
In other words, the German Federal Supreme Court concluded that the exception provided by Sec. 2
No. 3 UML, as is the case with most exceptions, must be narrowly interpreted and should only apply
to pure method claims, while inventions having an ambiguous nature are not per se excluded from
utility model protection.
By analogy to the holding of this decision, the exclusion of biotechnological inventions should
likewise be construed in a narrow manner, and should only apply to inventions strictly characterized as
pure biotechnological inventions at their core (within the above-described legal definitions) – for
example, a claimed DNA sequence. On the other hand, inventions having an ambiguous or hybrid
character and touching the field of biotechnology should not be affected by this exclusion.
Exemplary Biotechnology Inventions that may be Protectable Using a German
Utility Model
According to our analysis, the following examples may represent the kinds of biotechnological
inventions protectable by a German utility model: all types of peptides (including antibodies and
hormones), biotechnological inventions having an ambivalent character (for example, nucleic acid and
peptide arrays and beads for the isolation of nucleic acids), and any kind of pharmaceutical substance
involving biotechnological products, or the use of such products for a specified medical indication.
Consequently, exemplary subject-matter not suitable for protection by a utility model would thus
include: pure DNA sequences (for example, from sequencing projects), primers, plasmids, viruses or
bacteria.
To emphasize, such examples are based on the above-described recent Supreme Court decisions, the
holdings of which may not have been suitably incorporated into the guidelines currently used by
examiners at the GPTO.
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