Moot Spring 2023 Flashcards
3F Theme
This case is about not imposing a greater standard on inventors than that laid out in § 112 of the Patent Act
3F Roadmap
This Court should reverse the lower court’s finding under one of two theories
First – the patent does not expressly recite the upper end of the dosing range, but a POSITA would understsand that awakenate has an inherent upper limit
Alternatively – the specification adequately discloses to a POSITA how to arrive at this desired dose without undue experimentation
Under either theory -this court should reverse and remand
3F Inherency issue
– this Court in Fisher and Anderson established that unbound ranges are proper when a POSITA would understand the limits as inherent to the invention. Here, the invention is the treatment of a specific disease, with a single species of biologic that stimulates the nervous system, and recommended dosages of at least 100 mg without an upper limit.
But pharmaceutical stimulants of have inherent upper limits. A POSITA would know this, we know this, all people understand that the dose makes the poison. There are too high of doses that are lethal, too high a doses that are toxic, and too high a dose that creates side effects. In awakenate these side effects were due to overstimulation – which is intuitive.
Second, it is uncontroverted that awakenate can overstimulate-
Both experts agree that overstimulation occurs with awakenate. Dr Felton and Dr Hubert each say that awakenate was developed because prior drugs provided too much stimulation. Pg 11. “If you take too much at a time, of course it would stimulate. (pg7).
This alone demonstrates that a POSITA would understand that claim 10 is limited from between 100 mg to some amount that would overstimulate the immune system
The lower court below erred because it sided with Maleficent’s claims that there is no way to know the infringing dose when a range is not disclosed. The exact dose is not necessary – the fact that a POSITA would know it exists and is inherent to the treatment is sufficient. To say otherwise ignores this courts precedent and for these reasons this court should reverse and remand.
3F Intro to Wands Analysis
In the alternative, the patent is enabled because ascertaining this undisclosed range does not require undue experimentation.
Under a Wands analysis there are multiple factors that the court considers, though none are mandatory.
((1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims.)
Of these 8 factors only 5 were raised below – I will discuss them in turn
3F Wands analysis part I
First I will take two factors together – the amount of guidance in the speciation and the presence of working examples therein
The specification provided an adequate roadmap for a POSITA to practice the invention. The specification teaches three methods:
FIRST that an ordinary clinician can escalate the dosing and work with the patient to assess their individual needs and find the dose that works best for the patient;
SECOND the specification teaches that in vivo methods of extrapolating are known in the art and gives a specific in vivo example of rats, its gives the dosage that worked in rats, and gives a method to extrapolate that to humans. Thus values of 100 mg are expressly listed and values of 100 times greater are implied.
THIRD the specification teaches that in vitro methods are also possible
This is ample guidance for a POSITA to determine this range
The first two factors – the amount of direction and examples – was adequate to inform the public about how to reach the upper dosing range.
3F Wands Analysis Part II
The third factor – the predictability of the art – should also be resolved in three fairies favor
because the lower court improperly found in favor of Maleficent despite a factual dispute. While the field of biologics can be unpredictable, this is not contested – Dr. Hubert said that the methods used to actually determine these dosages ARE routine. This is contested by the other expert. Dr. Felton on page 10 of the record claims that animal model extrapolation QUOTE might not be proportional END QUOTE because of concentration difference. There are two issues here.
First, Dr. Felton is not giving examples of why awakenate cannot be extrapolated, but what MIGHT happen. This is conclusory. In ALCON RESEARCH this court held that expert testimony at trial must give actual examples – simply saying some factors may be an issue is concluslory and does not met the C&C evidence standard.
Second – in Alcon that expert testimony was AT TRIAL here the lower court relied on that testimony at SJ. Thus the court clearly did not weight all facts in favor of Three Fairies – SJ is not proper.
This factor should favor Three Fairies
3F Wands Part III
The FOURTH FACTOR – is the amount of experimentation required to practice the invention should also be resolved in 3F favor.
The court below erred on this factor. The court sided with Maleficents argument on PAGE 18 of the RECORD that QUOTE Maleficent relies on the testimony of its expert Dr Felton to show that the quantity of experimentation required is large”. The court goes on to say that it finds Maleficents position “more persuasive” on the final page. On Summary judgement – according to Rule 56 of the FRCP there must be no genuine dispute of fact but on page 8 the other expert states that a POSITA would “easily know the highest amount after some routine experimentation.” Because the court improperly resolved factual dispute in favor of the moving party – Summary judgemenat was improper
3F Conclusion
This court should THUS reverse and remand under one of two different theories – FIRST that stimulants like awakenate has known negative side effects at high dosages this constitutes an inherent upper limit OR second – that summary judgement was improper when the court below determined that
ascertaining this limit from the teachings of the patent
MAL - Theme
this is a case about weather inventors can ask the public to perform burdensome experimentation to practice aspects of the invention that the inventors themselves did not
MAL - roadmap
This court should affirm the lower courts answer to this question, no BECAUSE Claim 10 is not enabled under § 112 The reasoning is twofold:
First, there is not an inherent upper limit to the unbound range of claim 10
Second, it is further true that reaching the full scope of that claimed invention by determining this value would require undue experimentation under a Wands Factor Analysis.
Because the lower court properly found in favor on both of these points this Court should affirm their finding
3F - inherency
First, the inherency issue:
claim 10 cites a dosage range, but the undertermined upper end this range was not inherent. A POSITA at the time of filing would know the following facts are uncontroverted from expert testimony and the intrinsic record:
-Awakenate is a (central nervous system) CNS stimulant
- Similar stimulants for treatment of this syndrome had failed because they had either overstimulated the nervous system (Three fairies expert appx 007)
- Or other treatments had not stimulated the nervous system at all (placebo-Three Fairies expert Appx 007) and it was not known why
Given this set of facts,
Conclusion
A POSITA would not find the therapeutically effective value inherent because stimulants were commonly used but never correctly dosed in the art — as this court held in MagSil – a POSITA must be able to obtain the values within the range for the invention to be enabled
MAL - Wands transition
Since this value is not inherent, the key inquiry is whether determining it required undue experimentation.
We say that it does.
Under a Wands analysis there are 8 factors this court has laid out, although not all were raised in the court below and none are mandatory
((1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims.)
Of these 8 factors only 5 were raised below – that the quantity of experimentation when weighed against the breadth of the claims given large given the amount of direction given the scant examples and the unpredictability of the art.,
