Patents: patentability and validity 2003 developments
In the light of seemingly conflicting decisions last year, there is still uncertainty regarding the level of experimentation a skilled reader may employ in departing from the teaching of the cited prior art, and yet still anticipate the patent.
Dosing regimes unpatentable as methods of medical treatment
In our UK Patents Review 2001 we reported the Court of Appeal decision in Bristol-Myers Squibb v Baker Norton. In that case it was held that the patent for a dosing regime, whilst disguised as a second medical use claim by being drafted in “Swiss form”, was unpatentable as a method of treatment under section 4(2) of the Patents Act 1977. Similar considerations arose in 2003 in the case of Teva v Instituto Gentili & Merck. The patent-in-suit related to the use of alendronate for inhibiting bone resorption for treating osteoporosis. The use of alendronate for inhibition of bone resorption was known in the art and the claim, drafted in Swiss form, required administration of alendronate “in a unit dosage form which comprises about 70mg of alendronic acid or a pharmaceutically acceptable salt thereof, or alendronic acid active weight basis, according to a continuous schedule having a dosing interval of once-weekly”. The invention derived from the knowledge that patients receiving a dose of 70mg once a week would suffer less gastrointestinal adverse events than patients receiving 10mg once a day.
Jacob J expressed his reluctance at being bound by the decision in Bristol-Myers Squibb v Baker Norton and the necessary finding of invalidity therefore since the patent was directed to a method of medical treatment incapable of industrial application pursuant to section 4(2) of the Patents Act 1977. The Judge stated “I accordingly hold both patents invalid. I do so with some regret. Merck have only had a few years’ exclusive exploitation of alendronate. They must surely have had to make a very considerable investment and incurred considerable risk in bringing it to market and mankind is better off as a result. But the patent system does not confer monopolies on those who develop obvious or old products, even if they have never been exploited. A workable system for that might be a good idea, particularly in medicine and analogous fields”.
The Court of Appeal later in the year upheld Jacob J’s judgment for the same reasons although noted that the patentee had reserved the right to contend elsewhere that the decision in Bristol-Myers Squibb v Baker Norton had been wrongly decided.
Less risk of a Court failing to adopt the mantle of the skilled person when assessing obviousness from common general knowledge
In an assessment of obviousness, the Court will frequently adopt the guidance set out in the case of Windsurfing v Tabur Marine. The second step in the Windsurfing approach requires that the Court adopt the mantle of the skilled addressee of the patent-in-suit. In appealing the first instance decision in the case of SEB v De’Longhi, the applicant argued that the Judge had failed to adopt the mantle of the skilled addressee and cited the relevant paragraph of the judgment, “when obviousness in the light of the common general knowledge is concerned, the risks of failing to look at the problem through the eyes of the skilled person are perhaps diminished. There is no clearly defined starting point in the sense of a single publication”. Counsel for the Respondent submitted that these remarks were merely judicial comment that the Court may be less likely to fail to remember to look at the problem through the eyes of the skilled person in a case where the Court is looking to see if the invention is obvious in the light of the common general knowledge. The Court of Appeal agreed with these submissions and dismissed the appeal finding that the Judge had followed the Windsurfing approach, including the second step, in any event.
Test for novelty not whether two inventors have “in substance” reached the same invention
In the case of Synthon v SmithKline Beecham, the Court of Appeal gave consideration to the test for novelty and the requirement that there be an “enabling disclosure” in the cited prior art to anticipate a patent as derived from the authoritative cases of General Tire, Union Carbide, Hills v Evans and Asahi Kasei. The Court of Appeal in particular considered “the amount of deviation allowed by the skilled reader” in departing from the teaching of the prior art whilst still anticipating the patent.
The patent in-suit related to a pharmaceutical product (referred to as PMS) and a process for producing the same in crystalline form. Synthon started proceedings seeking revocation of the patent asserting it lacked novelty over their unpublished patent application. Section 2(3) of the Patents Act 1977 provides that unpublished patent applications may form part of the state of the art for the purposes of an attack based on lack of novelty – such unpublished applications may not, however, form the basis of an attack for lack of inventive step (see section 3 of the Patents Act 1977). Synthon’s unpublished application related to a very wide range of compounds, including PMS. The only mention of PMS in crystalline form, however, was in one example in the application. Experiments in the case demonstrated that the example was not repeatable so as to obtain crystalline PMS of the form claimed in SmithKline Beecham’s patent.
At first instance, Jacob J held that two inventors had disclosed the same invention at the same level of generality and that the patent was therefore lacking novelty. SmithKline Beecham appealed.
The Court of Appeal allowed the appeal. The Court stated that the Judge had incorrectly applied the law on novelty – “the test is not whether the two inventors have in substance reached the same invention. The comparison is between the claimed invention and the disclosure to decide whether in fact, not in substance, the disclosure makes the claimed invention available to the public”. The Judge was wrong to take “a broad view” of the disclosed content of the earlier application and to consider the issue at a level of generality that entailed ignoring “the slightest of differences” between the cited prior art and the patent in- suit. There was no room for a different approach to novelty in Section 2(3) cases to Section 2(1) cases and was therefore no legal basis for the Judge’s conclusion.
The test for novelty is well established in case law including the requirement set out in General Tire for “clear and unmistakable directions”. The crucial question is not whether the skilled reader would expect success from a modification to the process disclosed – rather there is a need for a clear and unmistakable disclosure in the prior art. On the facts the Synthon application provided no such clear and unmistakable directions to make PMS in the form claimed in the patent. The general teaching of the Synthon application did not mention PMS and it was only one of a number of compounds that were described by reference to formulae. The only specific reference was in an example that was unable to be repeated and that produced a different form of PMS. The first instance decision was thus set aside and the claim for revocation dismissed.
Use of ordinary skill in solving known problem without undue effort – the boundary between novelty, inventive step and sufficiency
The case of Synthon v SmithKline Beecham referred to above does not, however, entirely accord with the decision in SmithKline Beecham v Apotex, which also considered the test for novelty, on the grounds of the invention being an “inevitable result” of following the instructions in the prior art.
Pumfrey J stated that he considered the case of Synthon v SmithKline Beecham to be merely a particular application of the general principles of General Tire and not to establish any novel proposition. This perhaps explains why the two cases do not sit happily together. Pumfrey J cited the Court of Appeal decision in SmithKline Beecham v BASF which rejected the contention that the test for anticipation by a document in “inevitable result” cases was the same test as the “enabling disclosure” test for establishing sufficiency.
In cases where a skilled man is set a particular problem, such as repeating an experiment, and where this could be done in a number of ways, often one particular solution claimed in a patent will be alleged to be both anticipated and obvious. In SmithKline Beecham v Apotex, the Court stated that when considering such cases where the objections lie on the boundary between obviousness and anticipation, and where some of the solutions to the problem fell within the scope of the claim, then the claim should be held to be invalid. On the one hand the claim would be obvious – not as a whole, but rather in the particular techniques employed to perform the experiment. In addition, however, the claim may be anticipated, depending upon the level of experimentation required. In considering the level of experimentation that a skilled reader could perform whilst still anticipating the patent, the Court of Appeal in the BASF decision had commented that the alterations in that case had gone further than replication by a skilled addressee of the disclosure in the prior art example using his “ordinary skills”. There were also no “clear and unmistakable directions” as required by General Tire. Pumfrey J inferred from the BASF decision of Aldous LJ that had the alterations not gone “further than replication by a skilled addressee of the disclosure in example 1 using his ordinary skills” that there would have been anticipation.
Accordingly if, and it appears only if, one is dealing with a case where the skilled man is told what he is aiming for, and if in aiming for that objective he adjusts experimental conditions in a manner contemplated by the specification and with the normal exercise of skill and without undue effort, such adjustments are permissible and the specification will be an enabling disclosure and anticipate.
