There has been some interesting recent activity to report from the highest appeal bodies of the European Patent Office (EPO) and the US judiciary, i.e. the Enlarged Board of Appeal (EBA) and the US Supreme Court respectively...
Firstly, turning to the EPO, there is more fallout to report from the recent G 1/24 decision of the Enlarged Board of Appeal (EBA), which we reported here, and here (in which the EBA confirmed that the description and drawings of a patent specification should always be taken into consideration when determining the scope of the claims for the purposes of assessing patentability). As we anticipated here, a new EBA referral has now been made (G 1/26) from appeal case T 873/24, regarding whether/how decision G 1/24 applies to the assessment of added matter (Article 123(2) EPC) and extension of subject matter in divisional applications (Article 76 EPC).
In the new G 1/26 referral, a ratio of chemical elements (titanium and nitrogen) is specified in claim 1 of the patent in suit as granted, EP3587104, without units, and the parties (patentee and opponent) are in disagreement over what kind of ratio this means:
ArcelorMittal (the patentee) argues it clearly refers to a weight ratio — i.e. comparing the weight of titanium to the weight of nitrogen. They argue this is clear from the rest of the claim and from standard industry practice.
POSCO (the opponent) argues that it is not clear which type of ratio is meant. It could be read as a molar ratio, as well as a weight ratio, and because the original patent application only ever described the latter, the claim as granted contains unallowable added subject matter.
In its deliberation, the Board found that different appeal boards across the EPO have been applying three different approaches to this type of problem — specifically, how much the patent's description may be used to interpret the meaning of the claims :
Restrictive approach — The description is used only to identify who the "skilled person" is and what their general knowledge would be. Under this approach, if the claim wording could mean multiple things, all technically sensible readings must be considered. In this case, this would mean the claim fails because a molar ratio reading is not disclosed in the original application.
Middle approach — The description is consulted more broadly, but features from the description cannot be read into the claim to narrow or broaden it. Under this approach too, the claim would likely fail for the same reason.
Holistic approach — The claims and description are read together as a unified whole. Under this approach, because the description only ever discusses a weight ratio and gives an explanation tied to that specific meaning, the claim would be interpreted as referring to a weight ratio — and would therefore pass the "added matter" test.
Because these three approaches lead to conflicting results, the Board decided to refer three groups of questions to the EBA:
On admissibility — Can a Board refer a question to the EBA simply by showing that the question arises naturally in the case, and it is reasonable to deal with it next, or must the Board first rule out all other possible outcomes?
On claim interpretation — Does the primacy of the claims prevent features found only in the description from being "read into" a claim? Or is claim interpretation a holistic process combining the claims, description, and drawings together?
On added matter — When checking whether a patent amendment adds new subject-matter, must every technically possible interpretation of the claim language be originally disclosed? Or is it enough that only the interpretation established by reading the patent as a whole is disclosed?
This referral raises a number of questions. Will the EBA admit the referral (given that it does not seem to meet the required criteria, hence the first referral question)? If the proprietor wants the ratio to mean a ratio by weight then why don't they just amend the claims to state this? It is established law that the correct interpretation of a claim is that which the skilled person would understand from the claim's own wording, having consulted the description, the drawings, and in view of the common general knowledge. The parties to proceedings will advance particular interpretations that are advantageous to their respective positions, and it is the job of the Board of Appeal, the Court, etc., to decide which interpretation is correct. Thus, in this case, isn't it the responsibility of the Board to decide what the claim means and consequently determine whether the claim has basis in the ((grand)parent) specification as filed? Is the Board merely passing the buck by making an unnecessary, and possibly inadmissible, referral to the EBA? G 1/24 - the gift that keeps on giving.
Turning to the USA, there is good news for generic pharmaceutical manufacturers from the Supreme Court, which in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc., No. 24-889 has reversed the Federal Circuit and held that a generic drug manufacturer's FDA-compliant skinny label, combined with routine marketing statements describing its product as a "generic version" of the brand-name drug, does not state a claim for active inducement of patent infringement under 35 U.S.C. § 271(b).
Amarin makes a branded drug called Vascepa (icosapent ethyl), which was originally approved to treat high blood triglycerides (the "SH indication"), and was later approved for a second, more lucrative use: reducing cardiovascular risk in patients already taking statins (the "CV indication"), for which second use Amarin held patents.
Hikma, a generic manufacturer, sought approval to sell a generic version of Vascepa for the first, unpatented SH indication, using a so-called "skinny label", i.e. a label that deliberately carves out the patented second CV indication.
After Hikma launched its generic, Amarin sued for "induced infringement", claiming that even though Hikma's label only mentioned the unpatented use, Hikma's other communications — press releases calling the product "generic Vascepa," references to Vascepa's total sales (driven mostly by the patented CV use), and its website — effectively encouraged doctors and pharmacists to prescribe the generic for the patented cardiovascular use as well.
The trial court dismissed Amarin's claim, saying that nothing Hikma said amounted to actively encouraging the patented use. The Federal Circuit reversed the decision, holding it was "at least plausible" that a doctor could read Hikma's statements as an instruction to prescribe the drug for the patented use.
The Supreme Court unanimously reversed the Federal Circuit in a 9–0 opinion written by Justice Jackson. The Court held that Amarin failed to state a viable legal claim because it did not plausibly allege that Hikma actively encouraged the infringing use.
The Court decided that it is not enough to show that a doctor could read Hikma's statements as instructions to infringe — Amarin needed to show that Hikma actually took affirmative steps designed to encourage the patented use. The Court found that Hikma's statements had "obvious alternative explanations" — for instance, Hikma was legally required to use labeling nearly identical to Amarin's, and calling itself "generic Vascepa" was standard industry practice. Citing Vascepa sales figures in investor-facing press releases was too remote from any encouragement of a specific medical use to count as inducement.
The Court clarified that inducement need not be "express" — a company can implicitly encourage infringement — but that any encouragement, whether implicit or explicit, must be "clear" and "affirmative".
Thus, brand-name drug companies cannot sue generic makers for patent infringement in the USA based merely on speculation about how third parties (doctors or pharmacists) might interpret routine marketing statements. The decision makes it harder for branded manufacturers to block generics that have lawfully carved out patented uses from their labels, and reinforces the "skinny label" pathway that allows cheaper generic drugs to reach patients sooner for non-patented indications, without the generic company facing costly infringement litigation over its standard communications. Generic manufacturers can describe their products using ordinary industry terminology — such as calling them "generic [brand name]" or citing publicly available sales data — without that alone crossing the line into patent inducement, so long as they are not actively directing anyone towards the patented use. The decision also has wider implications for induced infringement in general.