Tuesday, 25 October 2016

New EPO Enlarged Board referral: does the gold standard apply to a bitten apple?

If claim 1 of your application or patent encompasses subject matter in the prior art, you have to do something about it. Usually this means limiting the claim using subject matter found from somewhere in the application as filed. If the prior art only counts under Article 54(3) EPC, you only have to make the resulting claim novel. Any amendment though has to comply with Article 123(2) EPC, in that it must not contain subject-matter which extends beyond the content of the application as filed. A usual way of limiting a claim would be to add a narrowing feature, making something in the claim more specific. Sometimes though, the only option is to disclaim a part of the invention by explicitly stating that a certain portion is excluded.
"Gold bitten apple" by Teodor Dukov 

The Enlarged Board in G 1/03 decided disclaimers that did not have basis in the application as filed were in some cases allowable, but only where a disclaimer was required to: i) restore novelty over an A54(3) document; ii) restore novelty over an "accidental" prior art document, where anticipation was "so unrelated and remote that the person skilled in the art would never have taken it into consideration when working on the invention"; or iii) disclaim subject matter that was excluded from patentability for non-technical reasons. This allowed disclaimers to be made that would otherwise fall foul of A123(2), but only in quite limited circumstances.

A further Enlarged Board decision in G 2/10 related to disclaimers, but instead to those that were disclosed in the application as filed. The Board did, however, state that the test to be applied is "whether the skilled person would, using common general knowledge, regard the remaining claimed subject-matter as explicitly or implicitly, but directly and unambiguously, disclosed in the application as filed" (point 4.5.4 of the reasons). This test was, according to G 2/10, the generally accepted "gold standard" for assessing any amendment for compliance with A123(2) EPC.

The question then arises whether the gold standard must also be applied to the type of undisclosed disclaimers that would otherwise be allowable under G 1/03. This situation has arisen in the appeal case, T 437/14, for which a decision has recently issued. The Board has decided to refer the following questions to the Enlarged Board (which will presumably be numbered G 1/16) to decide the issue:
1. Is the standard referred to in G 2/10 for the allowability of disclosed disclaimers under Article 123(2) EPC, i.e. whether the skilled person would, using common general knowledge, regard the subject-matter remaining in the claim after the introduction of the disclaimer as explicitly or implicitly, but directly and unambiguously, disclosed in the application as filed, also to be applied to claims containing undisclosed disclaimers?

2. If the answer to the first question is yes, is G 1/03 set aside as regards the exceptions relating to undisclosed disclaimers defined in its answer 2.1?

3. If the answer to the second question is no, i.e. if the exceptions relating to undisclosed disclaimers defined in answer 2.1 of G 1/03 apply in addition to the standard referred to in G 2/10, may this standard be modified in view of these exceptions?
The issue in this case related to a claim to a range of chemical compounds, in which two disclaimers were introduced during opposition and appeal proceedings. These disclaimers were made to confer novelty over two cited documents, but there was no specific basis in the application as filed for them. Following the test in G 1/03, the Board concluded that the disclaimers did meet the accidental disclosure test, and that the resulting claim was novel, inventive, sufficient and clear. The only question remaining was whether the gold standard mentioned in G 2/10 should also be applied. In some previous cases only G 1/03 was applied, while in others the gold standard was used, resulting in an inconsistency that needed to be resolved.

In the Board's view, applying the gold standard of G 2/10 regarding A123(2) would result in the disclaimers not being allowable for the case in point (point 10.2 of reasons). The disclaimers would only be allowable if either only the G 1/03 standard was to be applied to disclaimers due to accidental disclosures or if some modified form of the gold standard test was to be applied.

The Board gave a simple example to illustrate their reasoning. If one takes a bite out of an apple, what remains is recognisably no longer the same apple as the original one. Even though it is still an apple, the apple with the bite taken out of it cannot be regarded as explicitly or implicitly, but directly or unambiguously, "disclosed" in the original apple (point 8.1 of the reasons). The strong suggestion from the Board therefore is that the test in G 1/03 alone is not enough.

Thankfully I do not have to deal with chemical cases where these kinds of issues most often arise, which is largely due to the way that chemical compounds are often very broadly defined in claims. It has, however, always struck me as a bit odd that an amendment could be made to a claim that had no basis at all in the application as filed. I wonder whether the Enlarged Board will think it odd as well that such a decision could have been made, and set aside G 1/03.

Thursday, 13 October 2016

Sofosbuvir EP opposition - an update

As I reported in February last year, Gilead's European patent EP2203462B1 to sofosbuvir (Sovaldi) was opposed by various organisations, the first of which was MĂ©decins du Monde (MdM). Their main reason for opposing the patent seemed to be that Gilead was charging a high price for the drug, which is effective for treating Hepatitis C. The opposition has recently concluded, following oral proceedings earlier this month. A press release issued on October 5th indicated that MdM's opposition was partially successful, and that "the quality of the patent was weak". Details of how exactly the patent fared as a result of the opposition were, however, missing, except for a mention that "the patent extended beyond the content of the patent application as filed" (suggesting an Article 123(2) issue). Another report from IP Watch did not provide much in the way of further illumination, and as yet there has been no word from Gilead or the EPO on the outcome.

The decision and minutes of the oral proceedings have not yet appeared on the EP register for the case, and are unlikely to do so for some time. It can, however, be inferred from what has already been said, and in particular a document that has appeared on the register, what actually happened.

In their preliminary opinion, issued on January 28, 2016, the opposition division indicated that claim 1, corresponding to the racemate (shown here), had been specifically disclosed in the application as filed. Claims 2 and 3, however, which were directed to the enantiomers (or diastereomers - see the comment below), did not appear to be disclosed. Whether the disclosure was sufficient to disclose the enantiomers was something that was due to be discussed at the oral proceedings.

Gilead filed a large number of auxiliary requests, the first of which had a set of claims that had been amended to define the enantiomers instead in terms of the slow and fast eluting isomers obtainable by a specific method that was disclosed in the application. The clue that this succeeded at oral proceedings is this document, issued shorty after the proceedings, that contains amendments made to the summary of the invention, and indicating that this corresponds to the first auxiliary request. This shows that claims 2 and 3 have been removed from the application, clearly indicating that claim 1 survived, but that the specific claims to the enantiomers did not.

As a result, the patent seems to me to have survived pretty well, and not really limited in any substantial way. It will, of course, be irritating to Gilead that the specific claims to the enantiomers have gone, but the patent as amended would still protect the drug. Reports (such as this one, for example) that suggest generics may be able to enter the market sooner than expected, therefore seem to be a bit wide of the mark.

UPDATE 3/11/16: The grounds for the decision have now appeared on the EP register. As expected, claim 1 to the racemate stands, and the claims to the enantiomers/diastereomers have gone.