|Brian Cordery sets the stage|
for second medical use
"use of a drug X in the manufacture/preparation of a medicament for the treatment of disease Y"EPC 2000 claims take the form of:
"Drug X for the treatment of disease Y"The European Patent Office's Technical Board of Appeal (TBA) have told us that these claims are not synonymous in scope (see T 1780/12 - University of Texas) and you cannot amend from one to another. Swiss-type claims have been outlawed since 2010, but there will still be Swiss-type claims kicking around until about 2035 (right around when Brian hopes to retire).
Last year was the most important year, so far, for second-medical use claims with Warner-Lambert's Lyrica (pregabalin) litigation undoubtedly the biggest case (see numerous Kat reports here). With the UK Court of Appeal hearing argument starting on 24 May 2016, it is hoped that there will be a decision before the summer break. Brian considers the Alimta (pemetrexed) case as potentially more interesting (see summary of decisions here). It concerns Eli Lilly's patent with Swiss-type claims to the use of pemetrexed disodium and Vitamin B12 for the treatment of cancer. Actavis sought to market a pemetrexed product but in a different salt form. However, when Actavis's product is reconstituted with saline pemetrexed and the alternative salt would be present in solution as separate ions and thus fall within the claim. The Court of Appeal considered that the reconstitution would be an act of infringement, as would be the administration to the patient. Brian noted that, contrary to the suggestions made in the earlier judiciary session, the English and the Germans are not always in harmony. In pemetrexed, the English court (Arnold J) granted a declaration of non-infringement (DNI), whereas the Germans did not. Both courts were reversed on appeal with the German court granting the DNI and the English court refusing it with respect to the indirect infringement claim. Both cases will be going to the Supreme Court. A third case to watch out for is Novartis's Aclasta (zoledronic acid) patent with Swiss-type claims for the use of zoledronic acid in a once-yearly i/v administration for the treatment of osteoporosis. The preliminary injunction was refused at first instance, granted by the Court of Appeal in January 2015 with a decision on the issue of direct infringement expected late Spring 2016.
Brian commented that perhaps Mr Justice Arnold (who has heard the Warner-Lambert and Lilly cases), is not looking at the claims from the right perspective. He suggested that you have to be purposive with these cases and identify the invention (see Eisai G5/83). Getting too bogged down on the "manufacture" element (literal) as opposed to the invention (purposive) is not the right way to go. Lord Justice Floyd in Lilly has adopted a purposive approach in relation to indirect infringement. In Warner-Lambert, Lord Justice Floyd suggested, also in relation to indirect infringement, that you could construe the claim as a multi-step process claim. Mr Justice Arnold has not. Is there a distinction to be drawn between the fact that Lilly concerns a reconstituted product and Warner-Lambert a white pill (so the focus is on the active manufacture)? Surely not - as such distinction is arbitrary. This is why the construction of a claim as a multi-step process claim could be preferred in that it avoids this arbitrary distinction, it is more in line with the purpose of the law and more closely aligns with the two forms of claim, while not abusing the language of the claim (see section 125 Patents Act 1977). But if the manufacture element is all important, then one has to look at what the manufacturer knows or could reasonably foresee about the intended use. This then potentially causes a myriad of enforcement difficulties.
While the courts are wrestling with the correct approach to these types of cases - both on construction and infringement - we are starting to see cause for optimism via non-legal routes. For example, tendering authorities splitting tenders between patented and non-patented indications.
|Sir Robin wants to make the payers pay|
|Ever the optimist, Mark Ridgway sees|
solutions on the horizon by way of
purposive construction of
second medical use claims
Mark Ridgway (Allen & Overy LLP) who co-led the Lyrica litigation in the UK on behalf of Warner-Lambert reminded the audience that whether a medical use patent can be effectively enforced has wider repercussions than just second medical uses, since first medical uses can also be affected. For example, if a first use is protected by a Swiss-type claim and a second use emerges that is unpatented, the patent on the first use is undermined if it cannot be enforced effectively and cross-label dispensing occurs. The incentives for drug discovery are thereby even more greatly reduced than in Sir Robin's example (there is a positive disincentive for a patentee to seek further authorized indications, as they could undermine the original). On a positive note, however, Mark observed that, in Sir Robin's example of where a doctor's publication is prior art, it will not always be the case that a medical report, which might be anecdotal, will render a patent obvious. In response to Brian's question as to whether Mark was optimistic that we are nearing a solution on second medical use, Mark stated that he was. After a very busy year in Europe's courts, Mark said, we have a clearer idea as to what can or cannot be done. Although there is not yet a consistent view as to how these claims will be construed, the courts across Europe will hopefully arrive at a sensible construction soon, since there needs to be a way of making these patents enforceable. However, Mark concluded, we will need to await the Court of Appeal to see how things develop.
|Jurgen Dressel's focus is on|
the patient - they must be
at the heart of the solution
|Judge Kalden points to Article 69|
as a potential solution to address
enforcement problems with
Rian stated that T-1780/12 is referred to a lot by the Swiss and Dutch courts as a process claim. The case was actually a case about double patenting. A Swiss-type claim was granted and then a divisional was granted with EP 2000 claims for exactly the same thing. The Examining Division refused to grant the claim because it related to the same subject matter. The Technical Board of Appeal said that the two are different claim formats:
"It is generally accepted as a principle underlying the EPC that a claim to a particular physical activity (e.g. method, process, use) confers less protection than a claim to the physical entity per se, see decision G 2/88 (supra, reasons, point 5). It follows that a purpose-limited process claim also confers less protection than a purpose-limited product claim. The scope of protection sought by the invention claimed pursuant the present main request is thus noticeably different from the scope of protection conferred by claims 1, 24 and 25 of EP1..."However, the Enlarged Board in G2/08 said that it seemed clear that no such difference was intended. The Enlarged Board referred to the preparatory document, which explained that the provisions filled a loop hole in the legislation. In particular, point 4 to the explanatory notes to MR/18/00 confirm the clear intention that:
"The new Article 54(5) EPC eliminates any legal uncertainty on the patentability of further medical uses. It unambiguously permits purposerelated product protection for each further new medical use of a substance or composition already known as a medicine. This protection is equivalent, as far as the further uses are concerned, to that offered by the 'Swiss type claim'. In contrast to previous Article 54(5), now Article 54(4) EPC, providing broad (generic) protection for use in a medical method for the inventor of such use for the first time, new Article 54(5) is expressly limited to a specific use. This limitation is intended to match as closely as possible the scope of protection to the scope provided by a 'Swiss type claim'."There is therefore a strong argument to construe Swiss-type claims as if they were purpose-limited product claims and therefore ignore the manufacturing element. In doing so, Rian explained, the right balance is struck between the legitimate interests of the patentee and legal certainty of third parties. Further it is consistent with Article 69 EPC and the Protocol. In Kirin Amgen, the House of Lords stated that the skilled person should be asked what the invention is that is being protected. You do this by construing the claim purposively. Since everyone knows that Swiss-type claims are a legal construct and understands what they actually doing - protecting medical use - Rian concluded that this is a potential solution.
|Marleen outlines a menu of remedies,|
but are any good enough?
|Christine finds the German remedies|
for second medical use limited, but
Dr Christine Kanz (Hoyng Rokh Monegier) stated that in Germany we had originally seen a tendency to look at marketing materials to assess whether a claim was being infringed. The situation in German had been very stable for a decade, Christine explained. The first Ribavin case in 2004 held that the only thing you can consider is the packaging material. If the materials do not mention the patented indication, then the defendant is not infringing. This would hold true even if patients that fell within the non-patented subgroup also fell within the patented subgroup. In the second Ribavin case in 2013, the Dusseldorf Regional Court held there was no infringement as there must be "a direct and specific link between the act of evident preparation" and the manufacture and distribution of the product. The link must "clearly urge the user to use the item in a patent protected way." However, the court held that you cannot consider marketing material to establish this link - promotional flyers and activities are irrelevant, as are actual prescriptions of the patented indication. Then the German Warner-Lambert case came along. The Warner-Lambert case showed us that maybe the whole issue cannot be solved by patent law alone, but also regulatory, social and medical law. In this case, generics participated in tenders for rebate agreements relating to the active ingredient, but the tenders were not restricted to the non-patented indications. The Regional Court of Hamburg held that the defendant was prohibited from entering rebate agreements without declarations that their pregabalin products could not be used for the treatment of the patented indication (neuropathic pain). The appeal is pending. Christine stated that she found the remedy the court granted quite limited in effect. The generic only has to tell the health insurers that they can only offer the non-patented indication. Then what? It does not go far enough. The tenders are still unlimited, although the generic may not win the tender if the health insurers are looking for someone who can supply throughout all indications. Warner-Lambert also found that unsatisfactory. They therefore started an action in the German tender courts arguing that tenders should not be unlimited, but should distinguish between patented and non-patented indications. The Court essentially agreed, saying that patent law should not stand behind social law - they have different objectives. This decision was confirmed by the Higher Regional Court of Dusseldorf in 2015. The lessons coming out of the German experience is that second medial use claims are not a matter that can be solved by patent law only, commented Christine. Do we really have to be careful with doctors on the subject? This matter does not impact the doctor's freedom of therapy. Its only about whose drug they prescribe. Why can't pharmacists see what the prescription is for, Christine asked. Christine concluded by stating that she is very optimistic about the future. 2015 saw good movement on a number of complex issues and 2016 will provide further clarification.
Steve Tepp from the audience then asked the question as to how product liability can be addressed if there is off label use and no way to ascertain what indication the product is being prescribed for. Dressel responded that to associate product liability with a specific drug with a specific manufacture would be a difficult issue and it is an issue. As a matter of principle, this would be a troublesome exercise as it depends on the country and, of course, has pharmacovigilance implications in terms of collecting and reporting patient data associated with the active ingredient. Cordery also pointed out that the issue of "cross-label" dispensing (which arises in relation to usage patents) is not the same as "off-label" use (which is where the product is not licensed for an indication at all). The two should not be confused.
|The second medical use panel looking forward to more clarity coming|
from the courts in 2016. But should we only rely on the courts for a solution?
The Amerikat was also struck by the purposive construction approach and its impact on enforcement. The argument for the approach keeps in mind the specific nature of the origins of Swiss-type claims - a legal fiction created to provide protection for new medical uses of known compounds. The "specific nature" language is also present in the Enforcement Directive. Recital 17 of the Enforcement Directive provides that:
"The measures, procedures and remedies provided for in this Directive should be determined in each case in such a manner as to take due account of the specific characteristics of that case, including the specific features of each intellectual property right and, where appropriate, the intentional or unintentional character of the infringement."