the unitary patent & uniform protection of biotech inventions · 1. the newly envisioned...

The Unitary Patent &

Uniform Protection of Biotech Inventions

Rob J. Aerts

Keygene N.V. (The Netherlands)

of 26 (September ‘14)

A combination of two elements:

According to the newly envisioned system (the “patent package”), a “European patent with unitary effect” is created that is granted for the combined territories of most Union Member States, while providing uniform protection

The patenting of biotechnological inventions in the Union Member States is governed by an instrument of Union law, the Biotechnology Directive [Directive 98/44]

Uniform protection and biotech inventions


Is for biotechnological inventions in the newly envisioned system the application of patentability requirements according to the Biotechnology Directive uniform indeed?

Or is for a European patent with unitary effect the application of Biotech Directive provisions dependent on the further fate after grant of the European patent with unitary effect?

Is in the new system the patenting of gene sequences, human embryonic stem cells and essentially biological processes always uniform, or is it influenced by the fate of the patent after grant?

* Aerts, R.J. (2014) EIPR 36(9), 584-587

Uniform protection and biotech inventions*


On the one hand, the Biotech Directive regulates biotech patenting within the Union

On the other hand, a European patent with unitary effect provides uniform protection

Thus it is suggested that under the new system, regarding the validity of a biotechnological patent:

under all circumstances application in a uniform manner is required of

Biotech Directive provisions for the patenting of gene sequences, human embryonic stem cells and essentially biological processes

Uniformity and biotechnological inventions


1. The newly envisioned European patent with unitary effect and uniform protection

2. Patenting of biotechnological inventions according to Union law

3. The present system within the Union is a hybrid system

4. The present hybrid system causes legal uncertainty with respect to patenting of biotechnological inventions

5. Is the newly envisioned system also a hybrid system?

6. Is there uniform protection of biotechnological inventions by European patents with unitary effect or is there also legal uncertainty?

Overview


The European patent with unitary effect

and uniform protection


Article 118 TFEU

The Union law-makers “shall establish measures for the creation of European intellectual property rights to provide uniform protection of intellectual property rights throughout the Union”

Unitary Patent Regulation 1257/2012

Unitary patent protection is established, which will “improve the level of patent protection by making it possible to obtain uniform patent protection in the participating Member States” [Preamble 4]

A right is conferred on the proprietor and it is provided that “the scope of that right and its limitations shall be uniform” [Arts 5(1) and 5(2)]

The legal basis: uniform protection


Patenting of biotechnological inventions

in the Union


European Patent Convention

Like for any invention, for a biotechnological invention the actual examination and grant of a European patent, and possible post-grant opposition procedure, is governed by the European Patent Convention

For harmonization purposes, Biotechnology Directive provisions on patentability criteria were taken over in literal wording into the European Patent Convention

The patenting of biotechnological inventions


1. Provision on the requirement for patentability of gene sequences

[Directive Art.5(3) ► EPC Rule 29(3)]

2. Provision on exclusion from patentability of uses of human embryos for industrial or commercial purposes

[Directive Art.6(2)(c) ► EPC Rule 28(c)]

3. Provision on exclusion from patentability of processes for the production of plants or animals that are essentially biological

[Directive Art.2(2) ► EPC Rule 26(5)]

The patenting of biotechnological inventions


1. Boards of Appeal of the European Patent Office are institutionally and judicially outside of the Union legal framework, and they have a distinct legal personality under international law [cf. CJEU Opinion 1/09, para. 71]

2. Being outside of the Union legal order, Boards of Appeal cannot take the place of courts of Union Member States, and - importantly - it is impossible for the Boards to refer questions on the interpretation of Union law to the CJEU [G2/06 (OJ EPO 5/2009, 306); cf. CJEU Opinion 1/09, paras 79, 80, 84, 85]

3. The European Patent Office acknowledges that it is a separate legal order, and that CJEU decisions are not legally binding on the European Patent Office, or the Boards of Appeal [T2221/10, r.38]

4. Boards of Appeal apply EPC law, and at most they can apply EPC law in the light of the Biotechnology Directive [EPC Art.23(3); T2221/10 of 4 Feb. 2014, r.38]

* Aerts, R.J. (2014) EIPR 36(2), 88-94

The EPC provisions are not Union law*


The present system within the Union is

a hybrid system


Court of Justice of the EU

X

EU National Courts X Boards of Appeal

of the EPO

The present hybrid system within the Union

Biotech

Directive


The present hybrid system causes legal

uncertainty with respect to biotech inventions


With respect to biotechnological inventions, there is no guarantee that decisions made by the two separate judicial systems, i.e. the Union judicial system and the EPC judicial system, result in similar conclusions

Two examples: Brüstle case and International Stem Cell Corporation case

Legal uncertainty caused by the hybrid system


In decision C-34/10 (Brüstle case), the CJEU elaborated on the definition of the term “human embryo” in Art.6(2)(c) of the Biotech Directive

[Brüstle v Greenpeace, C-34/10 ([2012] 1 CMLR 41)]

Subsequently:

The German Federal Supreme Court ruled that human embryonic germ cells are a source of human embryonic stem cells, and there was sufficiency of disclosure

[BGH X ZR 58/07 of 27 Nov. 2012, paras 23, 25, 26]

The Opposition Division of the European Patent Office ruled exactly in the opposite manner

[Decision on EP 1040185 of 28 June 2013, paras 29, 31, 33, 34]



Two UK patent applications by ISCC resulted in the referral by the UK High Court of a new question to the CJEU whether parthenotes are included in the term “human embryo” in Art.6(2)(c) of the Biotech Directive [ISCC v Comptroller, C-364/13]

The Advocate-General opined that they are not, and as such in principle are patentable subject-matter [Opinion of 17 July 2014]

However:

In contrast, the European Patent Office has meanwhile indicated its intention to reject the corresponding European applications, and it will not suspend proceedings pending the CJEU referral [EP 1948791, Com. of 21 Sep. 2012 and Com. of 16 July 2014; EP 2049043, Com. of 19 Dec. 2013]



Is the new Unitary Patent system

also a hybrid system?


The envisioned Unified Patent Court deciding on unitary patents is subject to obligations of Union law, it shall apply Union law and respect its primacy, and it is a court common to the participating Union Member States [UPC Agr. Arts 1, 20]

The Unified Patent Court shall cooperate with the CJEU and refer questions on the interpretation of Union law, and decisions of the CJEU are binding on the court [UPC Agr. Art.21]

Thus, when the Unified Patent Court examines the validity of a granted European patent with unitary effect and Union law is involved, it can or must refer questions to the CJEU

In contrast, when the European Patent Office investigates a granted European patent with unitary effect under opposition, it cannot refer questions to the CJEU on Union law

Also the new system is a hybrid system


Court of Justice of the EU

X

Unified Patent Court X Boards of Appeal

of the EPO

Also the new system is a hybrid system

Biotech

Directive


Is there uniform protection of biotechnological inventions by European

patents with unitary effect?


The Biotech Directive regulates the patenting of genes, human embryonic stem cells, and essentially biological processes

After grant of a European patent with unitary effect concerning a biotechnological invention:

Uniform and consistent patentability criteria should be applied to test the validity of the patent

The fate of the patent should be independent of testing its validity during an opposition procedure or during a procedure before the envisioned Unified Patent Court

It would seem uncertain whether this uniformity and consistency can be guaranteed

Uniform protection of biotech inventions?


The division of powers between European Patent Office judiciaries and Union judiciaries can result in opposite decisions, and this situation implies legal uncertainty

During an opposition procedure before the European Patent Office, claimed biotech subject-matter may be affected in a certain manner, while during a procedure before the Unified Patent Court the very same claimed biotech subject-matter may be affected in a different manner after appropriate referral of a question to the CJEU

Thus different and non-uniform criteria may be applied with respect to the requirements for patentability of biotechnological subject-matter

Uniform protection of biotech inventions?


Conclusion


1. Biotechnology is the only technical field for which Union law provides explicit substantive rules for the patentability, or the exclusion from patentability, of subject-matter

2. In the new system, after grant of a European patent with unitary effect, there still is incomplete control of the Union legal order over application of provisions of the Biotechnology Directive

3. Under these circumstances, it may be questioned whether uniform protection of patent rights as envisioned by the law-makers of Article 118 TFEU can be fully achieved

Conclusion


Thank you very much for your kind attention

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