The Doctrine of Equivalents: Examination of the Law in Spain
We share with you an interesting post which reviews the application of the Doctrine of Equivalents in Spain. It was written by Lisa Mueller, of the US firm Casimir Jones, in cooperation with our partners Jose Miguel Lissen and Francisco Bernardo. The article is originally published in Lisa’s blog Brics & Beyond
In many jurisdictions, the scope of protection afforded by a patent is defined by the claims of the patent as read either literally or under doctrine of equivalents. Infringement based on the doctrine of equivalents is generally not based on any statutory law but rather has been established via case law (e.g., Court decisions). The purpose of the doctrine of equivalents is to promote fair patent coverage so that trivial departures (e.g., variants) from the claim language cannot be used to avoid infringement. In this series, we will examine the law governing the doctrine of equivalents in Denmark, France, Germany, Great Britain, Italy, the Netherlands, and Spain.
Doctrine of Equivalents in Spain
In 1986, Spain joined the European Union and modernized its patent law, which was further updated in 2005. Today, Spain’s patent laws are fully in line with that of other European Countries and the European Patent Convention (EPC). This, together with Spain’s specialized Intellectual Property (IP) courts, which are mainly in Madrid and Barcelona, and its streamlined litigation procedures, makes Spain a reliable jurisdiction for the enforcement of patent rights.
In determining the scope of patent claims, Spanish Courts consistently apply Article 69 EPC and its protocol of interpretation, which has an equivalent under the Spanish patent law in Law 24/2015. While the extent of the protection conferred by a patent is determined by the claims, the description and drawings are also used. The claims are construed through the eyes of the person skilled in the art. Additionally, the new Spanish law specifies that elements equivalent to those specified in the claims must be considered (Article 68(3) Law 24/2015), a provision that mirrors Article 2 of the protocol of interpretation of Article 69 EPC.
Over the years, Spanish courts have developed and refined their own version of the doctrine of equivalents, often with an eye on the approaches taken by U.S., Great Britain and German courts.
In Spain, the doctrine of equivalents is applied in three different ways.
1. Using the double/triple identity test (based on the U.S. doctrine of equivalents approach). Under the double identity test, a variant is considered to be equivalent if it performs the same function that leads to be the same result. However, because this test may result in extending patent protection to new inventions that achieve the same result, the Spanish Courts often apply the “triple identity test” which requires the element have the same function, the same way of working and achieve the same result. The triple identity test was first applied in Spain in 1967 in a Supreme Court decision interpreting the Intellectual Property Act of 1929 (STS 1967), which includes a selection of decisions from the Courts of Appeals of Barcelona, Madrid, Zaragoza (which no longer decides patent cases) and Valencia. The double/triple identity tests are normal applied by the Spanish courts when analyzing the doctrine of equivalents in connection with non-complex mechanical patents.
2. Using the obviousness test. A modification in the way the triple identity test was applied by Spanish Courts beginning in 2005 (SAPB 2005, Annex II, SAPB 30_11_2005). Since this time, subsequent decisions by the Barcelona Provincial Court have applied this test in combination with the criterion of equivalency by obviousness (see SAPB 16-3-2011, SAPB 13_11_2009, SAPB 18_9_2006, amp SAPB 30_11_2005). This combination of using equivalency by obviousness in combination with the triple identity test is often referred to as the “obviousness test”. An example of how this test was applied in combination with obviousness was described by the Court of Appeals of Madrid (a specialized Court handling IP-related disputes) in a decision of September 27, 2013:
“In order to apply the doctrine of equivalents in an action for patent infringement, equivalence must not be analyzed in abstract. It is necessary to assess, on the basis of an element-by-element comparison, in case that the contested device does not reproduce any of the patented inventions’ elements, whether an insubstantial variant of that element has been used, the use of which would have been obvious for a person skilled in the art, as long as both elements performed the same function, in the same way and obtained the same result, taking into consideration the technical problem that the patent intends to resolve (hence the importance in these cases of the description); should this be the case, it is also essential that it would be obvious to the person skilled in the art that the variant with respect to some element observed on the contested device would fall within the scope of protection of the patent upon consideration of the context of the patent, that is to say, taking into consideration of the description and the drawings.”
The obviousness test has typically been considered by the Spanish Courts to be more appropriate when dealing with chemical and pharmaceutical patents.
3. Using the Catnic-Improver test. An improvement in the obviousness test which has also been applied by the Spanish Courts since 2005 is a variant of the Catnic-Improver test, which has been taken from the courts in Great Britain. The Catnic-Improver test applies the following three questions, consecutively:
i. Does the variant have a material effect upon the way the invention described in the patent works? If yes, the variant is outside of the claim. If no, go to ii.
ii. Would this (i.e., the fact that the variant had no material effect) have been obvious at the date of publication of the patent to a reader skilled in the art? If no, the variant is outside the claim. If yes, go to iii.
iii. Would the reader skilled in the art nevertheless have understood from the description and the claims that the patentee intended that strict compliance with the primary meaning of terms of the claims was an essential requirement of the invention? If yes, the variant is outside the claim.
With respect to the interpretation of the second question of the Catnic-Improver test, the Spanish Supreme Court has outlined, through a key judgment dated April 29, 2015 (STS 223/2015), that this question is to be assessed as whether a skilled person would have believed that there was a “very high probability” that the variant would work, and not just a “reasonable expectation of success (and likewise, not a 100% chance of success). In this judgment, the Supreme Court upheld the decision rendered by the Barcelona Appeal Court where it was decided that, in order to find the variant equivalent, the substitution had to be “predictable”, namely, “easy to see and understand”. The Supreme Court agreed with this approach.
After this 2015 Supreme Court decision, the Catnic-Improver test has been consistently applied by the lower Spanish courts that are competent to hear patent cases, such as the IP courts of Madrid and Barcelona, (which handle specialized appeals involving IP-related disputes), and the 15th Appeals Section of Barcelona.
Date by which Equivalence is assessed. When assessing the doctrine of equivalents in Spain, one question which often arises is what is the date by which equivalence is assessed? Is it the date of infringement? The priority date of the application? Date of publication of the patent? Unfortunately, the answer to this question is still unsettled in Spain. Some decisions implicitly refer to the date when the infringement occurs (especially those decisions which apply the double/triple identity test (but not the obviousness or Catnic-Improver tests). In contrast, other decisions (typically, those applying the Catnic-Improver or obviousness tests), refer to the filing/priority date of the patent application. Finally, other decisions refer to the date of publication of the patent.
Other principles to be applied under the doctrine of equivalents. In addition to the legal tests on equivalence discussed above, Spanish case law has established that the following principles must be followed when applying the doctrine of equivalents:
i. The analysis must be objective. The behavior/intention of the defendant is irrelevant.
ii. The all-elements rule applies. The patent and the alternative embodiment cannot be compared globally as a whole (as under an inventive step analysis), but rather, each element/technical feature must be individually compared against its allegedly equivalent alternative, infringement will only exist if all the features are present either literally or by equivalence.
iii. Prosecution history estoppel may apply, particularly in the context of the doctrine of equivalents. The patentee cannot claim as equivalent those elements which it explicitly and clearly excluded from the scope of protection during prosecution of the patent (Such behavior by the patentee would be inconsistent with its past position regarding the breath of protection, which is not acceptable in accordance with the principle of law “venire contra factum proprium non valet”, or “to come against one’s own fact is not acceptable”, based in the principle of good faith and the trust which has been placed in the patentee’s conduct.). However, in order for prosecution history estoppel to apply in Spain, the courts have emphasized that this waiver must be explicit and unequivocal, citing the Supreme Court judgment No. 366/12. Decisions, such as the landmark Olanzapine judgment of January 17, 2008 or the more recent decision from the Barcelona Court of Appeal (Section 15) dated May 13, 2019 have interpreted estoppel restrictively. Thus, the application of the prosecution history estoppel will very much depend on the facts and the context in which the patentee made his assertions regarding the scope of the claims.
Examples of some cases in the life science area involving the doctrine of equivalents are: Supreme court decisions STS 223/2015 (Lundbeck vs several generics companies), concerning a process to obtain escitalopram; STS 4270/2011 (CINFA et al. vs Eli Lilly), concerning an EP patent on olanzapine and processes for making it; or STS 4845/214 (Wyeth vs Germed) concerning patent litigation involving a sustained release formulation of venlafaxine. Some of the first decisions involving the application of the doctrine of equivalents in Spain in the area of pharmacy were rendered by the Barcelona Court of Appeal (Section 15), such as the decision of May 2, 2005 (Merck vs Liconsa) or June 7, 2005 (Merck vs Synthon), both concern a process to produce simvastatin.