All Case Law Flashcards
Synthon BV v SmithKlein Beecham [2006]
Is the invention novel? Enabling disclosure.
Enabling disclosure consists of two separate requirements which to be satisfied if an objection of lack of novelty is to succeed:
> Prior disclosure
> Enablement
Asahi Kasei Koygo [1991]
Enabling disclosure.
The skilled person required not only the formula of the chemical compound but also the means by which the compound could be produced.
Bristol-Myers Squibb Co. v Baker Norton Pharmaceuticals [2001]
Enabling disclosure.
Lecture given by the patentee’s Director of Research before the priority date on use of the drug Taxol to treat ovarian cancer amounted to ‘enabling disclosure’.
Lecture contained ‘clear and unmistakable’ directions to carry out what was being claimed in the patent.
Windsurfing International Inc v Tabur Marine (GB) Ltd [1985]
Novelty and Use.
Prior use held to anticipate plantiff’s patent and patent declared invalid.
Booms of sailboard differed slightly in that they were straight (whereas those of the plaintiffs were curved), but while in use, there were flexible enough to end like those of the plaintiffs.
Merrell Dow Pharmaceuticals v Norton Healthcare [1996]
Novelty and (secret) Use.
A patent for a substance which had been produced naturally before the application of the process was invalid.
The patent was invalidated after the discovery that the effect was produced naturally from an acid metabolite.
Patent infringement does not require that one should be aware that one is infringing: ‘whether or not a person is working [an] .. invention is an objective fact independent of what he knows or thinks about what he is doing..’.
Dosage Regimes/ABBOTT RESPIRATORY [2010]
Novelty - use of known substances for new purposes.
Where it is already known to use a medicament to treat an illness, Art.54(5) EPC does not exclude that this medicament may be patented for use in a different treatment by therapy of the same illness.
Such patenting is also not excluded where a dosage regime is the only feature claimed which is not comprised in the state of the art.
Actavis UK Ltd v Merck & Co [2008]
Novelty - use of known compounds for new purposes VS evergreening.
Patentability of new dosage regimes are not allowed.
Mobil Friction Reducing Additve G2/88 [1990] EPOR 73.
Non-medical uses of known products and novelty of purpose patents.
Patent application for a friction reducing additive for motor engine lubrication oils.
Prior use? a prior US patent disclosed use of the same compound as a rust inhibitor additive for motor engine lubrication.
Problem: friction-reducing property inherent in, but not explicitly described by, the prior claim. Mobil had not invented a new product or process, but had merely discovered something new about an old product or process.
EPO Enlarged Board of Appeal: The word ‘available’ carries with it the idea that, for lack of novelty to be found, all the technical features of the claimed invention in combination must have been communicated to the public or laid open for inspection.
How to tell if infringing? Is customer inhibiting rust or reducing friction by using?
PLG Research v Ardon [1995]
Inventive step
Patent should only be granted to meritorious inventions.
Intention is to distinguish inventions from mere ‘workshop improvements’.
The public should not be prevented from doing anything which was merely an obvious extension or workshop variation of what was already known at the priority date.
Raychem Corp’s Patents [1998]
Inventive step: Common General Knowledge
The Common General Knowledge is the technical background of the notional man in the art against which the prior art must be considered.
It is not limited to material he has memorised and has at the front of his mind.
It includes all the material in the field he is working in which he knows exists, which he would refer to as a matter of course if he cannot remember it and which he understands is generally regarded as sufficiently reliable to use as a foundation for further work or to help understand the pleaded prior art
Alcan/Aluminium Alloys [1995]
Inventive step: EPO approach
EPO Board sees no legal basis for imposing on the organs of the EPO one particular method for the assessment of inventiveness under Article 56 EPC, where that Article has left the methods open. Thus the problem and solution approach ought to be considered as one among other possible approaches, each of which has its own advantages and drawbacks.
Pozzoli SPA v BDMO SA [2007]
Inventive step: UK approach
(1) Identify the notional ‘person skilled in the art’. Identify the relevant common general knowledge of that person.
2) Identify the inventive concept of the claim in question or, if that cannot readily be done, construe it.
3) Identify what, if any, differences exist between the matter cited as forming part of the ‘state of the art’ and inventive concept of the claim or the claim as construed.
4) Viewed without any knowledge of the alleged invention as claimed, do those differences constitute steps that would have been obvious to the person skilled in the art, or do they require any degree of invention?
Haberman v Jackel International Ltd [1999]
Inventive step can be simple.
Mrs. Haberman had the patent for the ANYWAYUP Cup, a trainer cup for toddlers.
▪ The plaintiff’s cup had a valve fitted to the lid, which would open when the baby sucked
and close when it stopped, thereby solving the problem of leakage.
▪ The defendants produced and launched a rival product ‘Super Seal’.
▪ In an action for infringement, the defendants claimed that the plaintiff’s patent was
invalid on the grounds of ‘obviousness’.
▪ Laddie J found that, even although the invention only involved a ‘very small and simple
step’, it was sufficiently inventive to deserve the grant of a patent. The invention had
solved a problem to which many had sought a solution, that is, leakage in infant trainer
cups.
Generics (UK) Ltd v H Lundbeck
Determining Obviousness.
The question of obviousness must be considered on the facts of each case. The court must consider the weight to be attached to any particular factor in the light of all the relevant circumstances.
These may include such matters as the motive to find a solution to the problem the patent addresses, the number and the extent of the possible avenues of research, the effort involved in pursuing them and the expectation of success.
MedImmune Ltd v Novartis [2012]
Determining Obviousness - obvious to try?
‘‘One of the matters which it may be appropriate to take into account is whether it was
obvious to try a particular route to an improved product or process. There may be no
certainty of success but the skilled person might nevertheless assess the prospects of success
as being sufficient to warrant a trial. In some circumstances this may be sufficient to render
an invention obvious. On the other hand, there are areas of technology such as pharmaceuticals
and biotechnology which are heavily dependent on research, and where workers are faced with
many possible avenues to explore but have little idea if any one of them will prove fruitful.
Nevertheless they do pursue them in the hope that they will find new and useful products. They
plainly would not carry out this work if the prospects of success were so low as not to make
them worthwhile. But denial of patent protection in all such cases would act as a significant
deterrent to research.
Conor v Angiotech [2008]
Determining Obviousness: Reasonable expectation of success.
‘the notion of something being obvious to try was useful only in a case where there was a
fair expectation of success. How much of an expectation would be needed depended on the
particular facts of the case.”
Novartis AG v Generics
Determining Obviousness: Reasonable expectation of success.
- What is a reasonable or fair expectation of success will again depend upon all the
circumstances and will vary from case to case. Sometimes, as in Saint Gobain, it may be
appropriate to consider whether it is more or less self-evident that what is being tested ought
to work. So … simply including something in a research project in the hope that
something might turn up is unlikely to be enough. But I reject the submission that the court can only make a finding of obviousness where it is manifest that the test ought to work. That
would be to impose a straitjacket on the assessment of obviousness which is not warranted by the statutory test and would, for example, preclude a finding of obviousness in the case where
the results of an entirely routine test are unpredictable.
Cellular proliferate disorders/ONCOLYTICS
Determining Obviousness: Reasonable expectation of success.
In Cellular proliferative disorders/ONCOLYTICS, the Board stated that a
reasonable expectation of success ‘implies the ability of the skilled
person to predict rationally, on the basis of the knowledge existing before
a research project is started, the successful conclusion of the project
within acceptable time limits’.
Teva UK Ltd v Leo Pharma A/S [2015]
Determining Obviousness: Reasonable Expectation of Success.
The Court of Appeal disagreed with the lower court that found a combination patent to be
obvious on the basis of the ‘obvious to try with a reasonable expectation of success’ doctrine.
Reversing the decision, Jacob LJ held that the result of the combination was unpredictable.
The patents concerned two well-known compounds, calcipotriol and betamethasone, which
were previously used individually in the treatment of psoriasis. These two compounds were
claimed in combination with a known solvent called Arlamol E.
Jacob LJ held that choosing a particular solvent was inventive. He noted that ‘identifying a
non-aqueous solvent which would actually work to produce a stable ointment, was not easy’
and that ‘[f]inding one was a research project’. The reason for this is that ‘there was no
sufficient expectation of success. Yes, a particular candidate might work, but it was far from
certain that it would’.
Generics (UK) Ltd v. Daiichi [2009]
Determining Obviousness: Unexpected results.
The Court of Appeal stated that ‘Levofloxacin is not just twice as active as ofloxacin (which
might be expected)’, emphasising the unexpected and surprising high solubility of the
enantiomer* as compared to its racemate ofloxacin. The Court of Appeal concluded that
‘[o]nly a curmudgeon would say there was no invention here’.
Dyson Appliances Ltd v Hoover [2001]
Inventive Step: Prejudices of the industry
Dyson invented a bagless vacuum cleaner, whose use of cyclones rids the air of dirt. Before the
priority date no vacuum cleaner manufacturer had commercially sold or proposed a bagless
vacuum cleaner.
According to Sedley LJ:
89. The vacuum-cleaner industry was functionally deaf and blind to any technology which
did not involve a replaceable bag. The fact that the handicap was entirely economically
determined made it if anything more entrenched. The industrial perception of need was
consequently, in the judge’s happy coinage, bagridden. It is entirely in accordance with what we
know about innovation that this commercial mindset will have played a part in setting the
notional skilled addressee’s mental horizon, making a true inventor of the individual who
was able to lift his eyes above the horizon and see a bag-free machine’.
Human Genome Sciences v Eli Lilly & Co [2012]
Industrial application.
Held that in relation to a new protein and its encoding gene, it was sufficient that the applicant demonstrate a ‘plausible’ or ‘reasonably plausible credible’ use.
In this case because the protein was part of the TNF ligand superfamily of cytokines (which acted as treatments for inflammation and immune responses) it was sufficient to assign that same role to this
new member of the family (even when no wet trials had been conducted to establish the link)
The patent had to demonstrate a real possibility of exploitation - the absence of experimental activity of the protein was not fatal; a plausible use could suffice.
Biogen v Medeva and Kirin Amgen
Sufficiency/Insufficiency.
Under Biogen the question to ask is:
Whether the claims cover other ways in which they might be delivered, ways which owe nothing to the teaching of the patent or any principle which it disclosed.
Product-by-process claim towards a DNA molecule which could express the antigens of the Hep B virus in a host cell.
The breadth of a claim must not exceed the contribution to the art. However, where the claim is to a product which was previously unavailable, the product itself is the technical contribution to the art. Thus it is only necessary to show one way of making it to gain protection for the product itself regardless of how it is made.
Generics (UK) v Lundbeck
Sufficiency of Disclosure
This case concerned a product patent that disclosed only one way of producing the claimed compound.
It was confirmed that for product claims one method of manufacture disclosed in the patent specification will be sufficient, and that neither the UK patent law nor the EPC require that the product claims must disclose all methods of producing the patent.