Article 53 EPC: Exceptions to patentability

Text of Article 53 EPC

In plain English

Article 53 removes three groups of inventions from protection even when they are new, inventive and technical.

Article 53(a) covers inventions whose commercial exploitation would be contrary to ordre public or morality. A national ban is not enough on its own. For biotechnology, Rule 28(1) lists specific cases: processes for cloning human beings, processes for modifying the human germ line, uses of human embryos for industrial or commercial purposes, and certain modifications of animals that cause suffering without substantial medical benefit.

Article 53(b) excludes plant and animal varieties and essentially biological processes for producing plants or animals. Sexual crossing of whole genomes followed by selection is essentially biological, even with a technical step added to help it (G 2/07 and G 1/08). Since 1 July 2017, Rule 28(2) also excludes plants and animals obtained exclusively by such a process, and G 3/19 accepted that, except for patents granted before that date and applications filed before it that are still pending. Microbiological processes and their products stay patentable.

Article 53(c) is the exclusion most drafters meet. Methods of treatment by surgery or therapy, and diagnostic methods practised on the body, are excluded; products for use in those methods are not. That is why a new drug or a new medical use is claimed as “compound X for use in treating disease Y” (Article 54(4) and (5)) rather than as a method of treatment.

The boundaries come from the Enlarged Board. A method is excluded as surgery if it includes an invasive step that is a substantial physical intervention, requires professional medical expertise and carries a substantial health risk even when done properly (G 1/07). A diagnostic method is excluded only if the claim includes the diagnosis for curative purposes, the preceding steps that are constitutive for it, and the specific interactions with the body (G 1/04). Who carries out the steps does not matter.

Key decisions

• G 1/04 (Diagnostic methods) : A diagnostic method is excluded only if the claim includes the deductive diagnosis itself, the constitutive preceding steps and the specific interactions with the body; the presence of a doctor is irrelevant.
• G 1/07 (Treatment by surgery/MEDI-PHYSICS) : A claim with a single invasive step of the kind described is excluded as surgery; the exclusion can be avoided by disclaiming that embodiment if the claim still meets the EPC.
• G 2/08 (Dosage regime/ABBOTT RESPIRATORY) : A further medical use defined only by a new dosage regime can be claimed as a purpose-limited product under Article 54(5), and Swiss-type claims are no longer allowed for such inventions.
• G 2/06 (Use of embryos/WARF) : Rule 28(c) forbids claims to products that, at the filing date, could be prepared only by a method necessarily involving the destruction of human embryos.
• G 2/07 and G 1/08 (Broccoli and Tomatoes) : Crossing whole genomes of plants and then selecting plants is an essentially biological process, and adding a technical step to assist those steps does not change that.
• G 3/19 (Pepper) : Plants and animals obtained exclusively by an essentially biological process are excluded, but not in patents granted, or applications filed, before 1 July 2017.

Common objections

Method of treatment claim (Article 53(c))

Reformulate as a product for use (“Composition Z for use in treating…”), as a non-therapeutic method if the effect is genuinely cosmetic, or as a device claim. The Guidelines let the examiner do this reformulation in the Rule 71(3) text where the meaning is clear.

Surgical step in an imaging or monitoring method

Delete the invasive step, start the claim after it, or disclaim the surgical embodiment under G 1/07, provided the remaining claim is clear and supported.

Plant claimed with an essentially biological origin

Show that the claimed trait was introduced by a technical process such as genetic engineering, and claim it that way, or rely on the pre-1 July 2017 transitional rule where it applies.

Drafting and prosecution tips

• Draft the medical claim set from the start as purpose-limited product claims and device claims; keep method-of-treatment wording out of the claims.
• For diagnostics, define the steps carried out on a sample outside the body. In vitro steps are not “practised on the human or animal body”.
• Embodiments in the description that fall under Article 53 have to be removed, reworded or marked as outside the claims before grant (Guidelines F-IV, 4.3).