The patent linkage battle that has been going on between Bayer (Bayer Corporation and Bayer Polychem(India) Ltd. and the Drug Controller General of India(DGCI) has finally been put to rest by the Supreme Court. On 1st of December, 2010 the Supreme Court upheld the decision of the Delhi High Court dismissing Bayer’s application challenging the DGCI’s order granting marketing approval to CIPLA to manufacture a generic version of a drug for which Bayer holds the patent.

Patent linkage refers to a system wherein the drug regulatory authority of a country refuses permission to a generic drug manufacturer to market and sell an already patented drug. This sometimes delays the entry of cheap and affordable generic medicines into the market.

Bayer had earlier challenged the decision of the Drug Controller General of India (DGCI) granting approval to Cipla Ltd. to market and sell a generic version of the Bayer’s patented drug, by filing a writ petition before the Delhi High Court. This petition was dismissed by the Delhi High Court in February 2010. The Hon’ble High Court based its ruling on the fact that there was a clear distinction between the patent system and drug regulatory system in India and that granting marketing approval to generic versions of patented drugs was completely in accordance with Indian law.

The Supreme Court dismissed the special leave petition filed by Bayer and confirmed the Delhi High Court’s decision dismissing Bayer’s application challenging the DGCI’s authority to grant marketing approval to generic versions of patented drugs. The division bench comprising of Justice A Alam and Justice RM Lodha based their decision on the finding that it was incorrect to say that the DGCI did not have the authority to grant marketing approval to generic versions of patented drugs. The Supreme Court further observed that the issue of injunction sought by Bayer was to be decided in a suit for infringement under the patents act by the Delhi High Court.

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The EPO’s Enlarged Board of Appeal has delivered its decision in two cases G 2/07 and G 1/08 by denying patents for essentially biological breeding processes. The decision was based on the interpretation of the term “essentially biological processes for the production of plants (or animals)” used in the European Patent Convention (EPC) to exclude such processes from patentability.

In the case G 2/07, the patent, EP 1 069 819,was filed by Plant Bioscience Ltd. and was opposed by Syngenta Participations AG (Basle/CH) and Groupe Limagrain Holding (Chappes/FR). It dealt with methods for breeding of certain broccoli plants allegedly having a cancer prevention effect. In the claimed process molecular markers were utilized for selecting specific hybrids. This was regarded as a routine step in modern breeding methods. In the other case G 1/08, the patent EP 1 211 926 was filed by Israeli Ministry of Agriculture and was opposed by Unilever N.V. (Rotterdam/NL). It dealt with breeding methods for tomatoes with a low water content, which are easy to process industrially. These tomatoes have come to be referred to as “wrinkled tomatoes”. The breeding process involved a step of allowing the fruit to remain on the vine beyond the point of normal ripening. Moreover, it included a screening step for determining the reduced fruit water content as extended by preservation of the ripe fruit and wrinkling of the fruit skin.

The Decisions passed by the European Patent Office (EPO) are challenged, before the Boards of Appeal of the EPO. The Enlarged Board of Appeal does not incorporate an additional level of jurisdiction. However, this board entertains cases only when the decision of the Boards of Appeal becomes inconsistent or when the question of interpretation of a significant point of law arises. The primary function of this board is to make sure that patent law under the EPC is applied uniformly and important points of law are interpreted correctly.

The questions referred to the EPO’s Enlarged Board of Appeal were:

• “Does a non-microbiological process for the production of plants consisting of steps of crossing and selecting plants fall under the exclusion of Article 53(b) EPC only if these steps reflect and correspond to phenomena which could occur in nature without human intervention?
• If question 1 is answered in the negative, does a non-microbiological process for the production of plants consisting of steps of crossing and selecting plants escape the exclusion of Article 53(b) EPC merely because it contains, as part of any of the steps of crossing and selection, an additional feature of a technical nature?
• If question 2 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?“

In its decision the EPO’s Enlarged Board of Appeal held that:

• A non-microbiological process for the production of plants which contains or consists of the steps of sexually crossing the whole genomes of plants and of subsequently selecting plants is in principle excluded from patentability as being “essentially biological” within the meaning of Article 53(b) EPC.
• Such a process does not 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, a step of a technical nature which serves to enable or assist the performance of the steps of sexually crossing the whole genomes of plants or of subsequently selecting plants.
• If, however, such a process contains within the steps of sexually crossing and selecting an additional step of a technical nature, which step by itself introduces a trait into the genome or modifies a trait in the genome of the plant produced, so that the introduction or modification of that trait is not the result of the mixing of the genes of the plants chosen for sexual crossing, then the process is not excluded from patentability under Article 53(b) EPC.
• In the context of examining whether such a process is excluded from patentability as being “essentially biological” within the meaning of Article 53(b) EPC, it is not relevant whether a step of a technical nature is a new or known measure, whether it is trivial or a fundamental alteration of a known process, whether it does or could occur in nature or whether the essence of the invention lies in it.”

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