Sufficiency Flashcards
Eli Lilly & Co v Human Genome Sciences Inc [2008]
“The key elements of this requirement which bear on the present case are these:
(i) the first step is to identify the invention and that is to be done by reading and construing the claims;
(ii) in the case of a product claim that means making or otherwise obtaining the product;
(iii) in the case of a process claim, it means working the process;
(iv) sufficiency of the disclosure must be assessed on the basis of the specification as a whole including the description and the claims;
(v) the disclosure is aimed at the skilled person who may use his common general knowledge to supplement the information contained in the specification;
(vi) the specification must be sufficient to allow the invention to be performed over the whole scope of the claim;
(vii) the specification must be sufficient to allow the invention to be so performed without undue burden.”
Key terms: UK sufficiency
Aldos J, Mentor Corp v Hollister [1991]
“[It] requires the skilled man to be able to perform the invention. Such a man is the ordinary addressee of the patent. He must be assumed to be possessed of the common general knowledge in the art and the necessary skill and expertise to apply that knowledge. He is the man of average skill and intelligence, but is not expected to be able to exercise any invention…Further, in circumstances where the art encompasses more than one technology, the notional skilled person will be possessed of those technologies which may mean that he will have the knowledge of more than one person.”
Key terms: who is reading the specification
Types of insufficiency
(i) Classical insufficiency
(ii) Biogen insufficiency/excessive claim breadth
(iii) Insufficiency by ambiguity
Classical insufficiency
the invention cannot be performed without undue burden
Biogen insufficiency/excessive claim breadth
the invention cannot be performed across the whole range without undue burden (so can be performed in part)
Insufficiency by ambiguity
the skilled person would not know whether he or she is working the invention or not
Standard’s Brand’ Patent [1981]
When must the specification be sufficient?
Traditionally it had to be sufficient at the time of publication (as that was when the disclose was made available)…
(this is now incorrect)
Biogen v Medeva [1997]
When must the specification be sufficient?
Must be sufficient at the date of filing (as no matter can be added thereafter).
Monsanto v Merck [2000]
“It has never been the law that the claim must be co-existence with embodiments specifically disclosed by the patentee in his specification. Protection limited in this way would in all probability be illusory”
Key terms: Degree of sufficiency
Edison and Swan Electric v Holland (1889)
“in describing in what manner the invention is to be performed the patentee does all that is necessary, if he makes it plain to persons having reasonable skill in doing such things as have to be done in order to work the patent, what they are to do in order to perform his invention. If…they are to do something the like of which has never been done before, he must tell them how to do it, if a reasonably competent workman would not himself see how to do it on reading the specification”
Key terms: Degree of sufficiency
Mentor Corp v Hollister [1991]
“Patent specifications need not set out every detail necessary for performance, but can leave the skilled man to use his skill to perform the invention. In so doing he must seek success. He should not be required to carry out any prolonged research, enquiry or experiment. He may need to carry out the ordinary methods of trial and error, which involve no inventive step and generally are necessary in applying the particular discovery to produce a practical result”
“The test to be applied for the purposes of ascertaining whether a man skilled in the art can readily correct the mistakes or readily supply the omissions, has been stated to be this: Can he rectify the mistakes and supply the omissions [without] the exercise of any inventive faculty? If he can, then the description of the specification is sufficient. If he cannot, the patent will be void for insufficiency”
Key terms: Trial and error, correction of errors
Plimpton v Malcolmson (1876)
“You must not give people mechanical problems and call them specifications”
Key terms: Degree of sufficiency
Electric Lamp v Marples Leach (1910)
Stating an incorrect theory for why the invention works does not invalidate the patent unless the theory makes the specification misleading.
Key terms: correction of errors
(for example) Novartis v Johnson & Johnson [2010]
The English courts are now increasingly looking to apply the “undue burden” test of the EPO
Key terms: UK correction of errors
Biogen v Medeva [1997]
Thus if the patent has hit upon a new product which has a beneficial effect but cannot demonstrate that there is a common principle by which that effect will be shared by other products of the same class, he will be entitled to a patent for that product but not for the class, even though some may subsequently turn out to have the same beneficial effect… other hand, if he has disclosed a beneficial property which is common to the class, he will be entitled to a patent for all products of that class (assuming them to be new)even though he has not himself made more than one or two of them.’
“the specification must enable the invention to be performed to the full extent of the monopoly claimed. “
Key terms: UK Biogen insufficiency, excessive claim breadth
