Archive for February, 2010

Hearing fixed for “Broccoli” and “Tomatoes” cases before the EPO Enlarged Board of Appeal, G 0002/07 and G 0001/08

Monday, February 22nd, 2010

Post from Paul Cole

The EPC prohibits patents for essentially biological processes and the referred questions relate to the degree and nature of human technical intervention, which is necessary for that provision not to apply.  Case G 0002/07 “Broccoli” concerns EP-B-1 069 819 Plant Bioscience Limited  which has been opposed by Syngenta Participations AG and Groupe Limagrain Holding, referring decision T 0083/05. The patent relates to methods for producing new Brassica plants, in particular broccoli, with elevated levels of anticarcinogenic glucosinolates. The claimed method involves the selective, molecular marker assisted breeding of “double haploid” breeding lines of broccoli with wild Brassica oleracea species.

Case G 0001/08 “Tomatoes” concerns EP-B-1211926 State of Israel Minister of Agriculture and is opposed by Unilever NV, referring decision T 1242/06.

The two cases have been consolidated in view of the similarity of the issues raised.

The hearing is to take place in Munich on 20 and 21st July 2010.

Yes, Judge Michel, There have been some WDR Appeals!

Monday, February 22nd, 2010

During oral argument before the Fed. Cir. in Ariad v. Lilly, as reported by Patently-O, the government attorney was pressed for specific evidence that a separate WDR “is necessary for USPTO to perform its examination function”, e.g., that it serves a practical function. Chief Judge Michel was quoted thusly:

“I can’t remember ever seeing a patent office rejection that was based only on the failure of written description. I’m not saying there aren’t any, but the flow of cases that come through this court at three or four hundred a year, it is exceedingly rare that the patent office hangs its case on written description. I can’t remember a single case.”

The government’s attorney, Mr. Freeman, couldn’t either. To the contrary, those of us in the prep/pros trenches should be able to recall a few that made it to the Fed. Cir. from the Board, “based only on the failure of written description.” It took me five minutes in my not-very-well-organized WDR file to locate In re Wallach, 378 F.3d 1330 (Fed. Cir. 2004)(“Without amino acid sequence, or with only partial sequence, a nucleic acid molecule’s structures cannot be determined and the WDR is consequently not met.”); In re Alonso, 88 USPQ 1849 (Fed. Cir 2008)(Claim to use of any Mab to human neurofibrosarcoma to NFS based on one example fails WDR.) and Capon v. Eschhar and Dudas, 418 F.3d 1349 (Fed. Cir 2005)(Claims based on combining known gene fragments do not per se fail WDR. Remanded for evaluation of support for generic claims). In re Alton, 76 F.3d 1168 (Fed. Cir 1996) is bit more aged, but it is oft-cited for the proposition that it is error to disregard factual evidence relating to the adequacy of the WD in a specification. These are not obscure decisions – their impact is/was not “minuscule” and, to top off the irony tank, Judge Michel was on the panel that decided Alonso and Alton.

Can any one else add to this list (remember, failure to meet WDR must be the ONLY issue on appeal from the Board)?

Sustained release fluvastatin formulations – The UK Court of Appeal opinion in Activis UK Limited v Novartis AG [2010] EWCA Civ 82

Friday, February 19th, 2010

Post from Paul Cole

Sometimes a decision as to obviousness hinges on a single short point. In Graham v John Deere, the tipping point testimony was during cross-examination of the witness for the patentee, when he said that the allegedly inventive feature made no significant difference to the operation of the device. Once that evidence had been given, the outcome was inevitable, and references to Thomas Jefferson, though decorative, were mere dicta.

The controversy concerning the fluvastatin sustained release patent EP-B-0948320 (UK) falls into the same category. The patent was based on the premise that fluvastatin was so water-soluble that it was difficult to devise a sustained release formulation. Claim 1 as amended read:

A sustained release pharmaceutical composition comprising a water soluble salt of fluvastatin as active ingredient and being selected from the group consisting of matrix formulations, diffusion-controlled membrane coated formulations and combinations thereof, wherein the sustained release formulation releases the active ingredient over more than 3 hours.

The tipping point fact was that fluvastatin was not of such extreme water-solubility as to give rise to the difficulties alleged. After that had been established, the whole basis for patentability collapsed, as explained concisely by Jacob L.J. at the conclusion of his opinion, which also contains an implied warning that although it may be appropriate to rely on an earlier decision for a rule of law, the facts on which that earlier decision was reached are of little relevance:

Once the obstacle put forward in the Patent against being able to make a sustained formulation was shown to be illusory, then a sustained release formulation is obvious. You might get better efficacy or fewer side effects, but you would certainly get better compliance. In Pozzoli terms the only difference between the prior art and the claim is the idea of making a sustained release formulation. For that there was a technical motivation and no difficulty, real or apparent.

The PSA [problem-solution analysis] gives the same answer. What is the objective problem? Why that which the patentee himself stated – to produce a sustained release form of fluvastatin. Was the solution obvious? Yes, any of the standard methods for such formulations would clearly work: there is no reason why they would not.

There is no need and it would be wrong to re-formulate the problem as suggested by Mr. Meade. This is not a case where some prior art unknown to the patentee has turned up. Nor is it right to reformulate the problem as one of looking for better medical effects when that was not the problem as seen by the patentee or to reformulate the solution as having found such effects when the patentee has not promised any.

In the latter respect this case is quite unlike the case, relied upon by Mr. Meade, about a sustained release form of oxycodone recently considered by this court, Napp v Ratiopharm [2009] EWCA Civ 252, [2009] RPC 539. Oxycodone was, until the patent, known as a minor weak opiod generally administered, to the extent that it was administered at all, as a co-drug. The slow-release form transformed it, as the patent said, into a serious alternative to morphine – something that was wholly unexpected. Of course the invention was non-obvious.

The upshot is that I would uphold the decision of the Judge. Unlike him, however, I do not think the case was finely balanced. Once the basis of the Patent was proved illusory there was nothing left to save it.

Jacob L.J.’s opinion contains a lengthy discussion of the respective approaches to inventive step of the UK courts under Windsurfing/Pozzoli and of the EPO approach using PSA which may be valuable to students and has been praised as “a tutorial in the law of obviousness”. Readers may recall John Mortimer’s fictional barrister Rumpole, who knew little law, but was an expert on bloodstains and used his instinct for tipping point facts with devastating effect in the cases for which he was responsible. No magic touchstone is to be found either in the USA under Graham/KSR or in the UK under Windsurfing/Pozzoli because in both jurisdictions after certain mandatory preliminary enquiries the issue has to be decided on a case by case basis according to the evidence and without the distortion introduced by preconceptions in the mind of the decision-maker. The legal background is only a guide as to the appropriate enquiries to be made and what matters is the evidence as to the tipping point facts, of which in the present case there was only one.


Friday, February 19th, 2010

The Enlarged Board of Appeal of the EPO issued a decision on February 19th (G02/08), that Swiss-form claims will no longer be permitted as a way to claim a “second medical use” of a bioactive agent – “The use of compound x to prepare a medicament to treat condition y”. Rather, the form of “first medical use” claims is to be used: “[Known compound x] for use in [treating condition y].” (First medical use claims are simply: “Use of compound x for treatment of condition y” – in older applications, first medical use claims often appear simply as “Use of compound x in medical therapy,” but this form is often deemed objectionably vague these days.)

The decision is not retroactive, and will apply only to applications having a priority date three months after the Decision is published in the Official Journal of the EPO (which has  not yet occurred). Thanks to Marks & Clerk UK for getting the word out so quickly.