Sci.Ev rjm Week 9 1 Today  60+ Minutes: Patent Expert Witness Prof. Jeff Bokor, Berkeley EE, tells about his experiences in the world of infringement litigation.  30+ Minutes: Alza, and what we can learn from it (patent law, strategy, etc.)  Next Week: No class, just meetings. Drop-in session Tuesday, 11/7, 3:45-5:45, room 95.  In the meantime: I’ll be looking over the claim charts, and outlines of SJ motions and expert declarations ( and, for the grad students, other writing of yours, only because I promised to, and not because you need help with writing, because in fact you are all stellar ) and will you with comments.

Sci.Ev rjm Week 9 2 Alza – Your Questions. My Answers. Your questions are all world class. Some things nobody touched on, that I want to remember to discuss: - TEACHING AWAY - What did Amidon recant? - How Alza’s Expert could have closed the holes in its proof. Also: from my answers at the end of the case: - Unexpected Results and Nexus - Other possible constructions of “deliver”

Sci.Ev rjm Week 9 3 Alza - Jeremy Patient Status is Necessary?: Why is it necessary to specify “the patient in need” in the patent claims? Isn't the function of the invention the same even if the patient isn't in need of treatment for incontinence? It seems like a very subjective thing to include in the claim itself. Possible answer: It's the Way You Use it That Matters: Sometimes drugs have multiple effects and there might be a non-obvious different patent to be made of using the same drug, say aspirin, for heart disease instead of pain. Yes, possibly these phrases help distinguish the claim over the prior art or were submitted to overcome a rejection for indefiniteness or something. One is in the preamble (so it ?? Doesn’t count); one is a ‘functional limitation.’ Adam and Fernando are going to address that issue, maybe, in their patent.

Sci.Ev rjm Week 9 4 Alza - Fernando Artisan v. Mylan: What is the clear error standard that the sentence mentions at the beginning of the discussion? When can it be used? It seems to me that once a court has decided something, it is extremely difficult to prove that there is the firm conviction that the court was in error. I don't have a guess for the answer a part from the fact that the proof of error has to be extremely convincing and definitive. The “definite and firm conviction that a mistake has been made” standard means that the appellate court shows some deference to the trial court. The “de novo” (as new) standard means that the appellate court just looks at all the evidence itself, regardless of any findings by the trial court. The former is for questions of FACT, the latter for questions of LAW.

Sci.Ev rjm Week 9 5 Alza – Ann Marie 2. Alza Question: Invalidity Prior Art Obviousness allows the combination of prior art whereas anticipation comes from a single source. Do parties tend to submit the same prior art under both an anticipation argument and an obviousness argument? And if they do, then wouldn't it make sense for the court to say if it's not invalid when we combine the prior art under obviousness, then it certainly won't be invalid with just the single piece of prior art? I feel like I must be forgetting something from patent law on this point. I would assume they'd argue both points for a particularly good piece of prior art but that it might make the anticipation argument look weaker if there is a fallback obviousness argument. You’re right, if the court found for PO on obviousness in light of the combination, it would usually say, and also of course the AI hasn’ met it’s burden of proof to show anticipation using one part of the combination. Here, of course, it’s saying the patent is INVALID. My guess is that the judges weren’t totally happy saying the Wong patent anticipated, by the way. Let’s discuss why.

Sci.Ev rjm Week 9 6 Alza - Angela B. Question about Alza: non-rigid test too subjective? The non-rigid "motivation-suggesting-teaching" test says "the motivation to combine need not be found in prior art references, but equally can be found in the knowledge generally available to [POSITA]". Since the levels of POSITA can be different at a given time, is this broad application of implicit suggestions too subjective that it would make the rule too difficult to be implemented? My guessed answer: Yes, it is somewhat of a judgment call. But there must be some articulated reasoning to ensure non-arbitrary decision-making. The suggestion test IS hard to apply, but those who love it think it’s better than nothing. Those who hate it think the opposite. Stay tuned for the KSR decision!

Sci.Ev rjm Week 9 7 Alza - Jason B. Alza Question Why did Alza waive a jury trial? This was probably because Alza is a major West Virginia employer and Alza figured it would fare better with a bench trial. Could be, although I think you mean Mylan, because Alza is based in Palo Alto or Mountain View. Other reasons to waive a jury trial: - the judge says we can do a bench trial tomorrow, or a jury trial in you (the litigator) had bad experience with juries and drug cases - ?? Note that if there is no jury, it means BOTH parties had to agree not to have a jury.

Sci.Ev rjm Week 9 8 Alza - Adam B. Question about Alza -Secondary Considerations? It was my understanding that secondary considerations usually played a major role in pharmacology patent trials. Nonetheless, the court only spends a few short lines discussing this issue in the opinion. Why didn't Alza provide more evidence in this vein, especially considering there was nothing that directly anticipated the claim? -Possible Response: There was not much evidence in the form of secondary considerations because of the nexus requirement or the product was not commercially successful. Could be, although I imagine the drug WAS successful if Mylan, a rather big generic, bothered to file an ANDA. Note that for CS, the PO can use the AIs success as well as its own! You’re right that the appellate decision brushes off 2Cs, and that seems odd. It may also be that Alza had page limit troubles with all the things it wanted to say, or messed up in what it included in the appellate appendix (I will explain what that is), so it couldn’t really argue much.

Sci.Ev rjm Week 9 9 Alza - Alvin [Alza vs. Mylan] Shouldn't Mylan's ANDA product infringe Alza's '355 patent under the Doctrine of Equivalents? I guess you would answer: No (is it because Mylan has proved it to be invalid?). I really think it should. It satisfies the triple identity test, i.e. it performs the same function, in the same way, and yields the same results. Right: if the patent is invalid it can’t be infringed, not literally, not by equivalence, not no how, not no way.

Sci.Ev rjm Week 9 10 Alza - Lisa B. Infringing an Invalid Patent If the Alza patent is declared invalid due to obviousness, why do the judges need to rule on the infringement issue? If the patent is invalid, there is nothing to infringe on. Possible answer: Maybe the obviousness argument only invalidates one claim of the patent, not the entire patent, so the justices can rule on infringement of other aspects of the patent. However, that doesn't really seem to be the case here. The Fed Cir for years thought just as you do: that they only had to rule on one of the two issues if it meant that AI won. The Supreme Court took them to task for that in Cardinal Chemical, saying that IT, not the Fed Cir was the final arbiter, and as a mere intermediate court, the Fed Cir had to decide all issues raised by the parties.

Sci.Ev rjm Week 9 11 Alza - Chrissy A. Alza Decision - Benchmarks for Infringement Why does the burden of proof lie on Alza to show that its drug would infringe on its own patent? They established the benchmarks for rates of release with the 355 patent, which I'm guessing must have used the in vitro and blood plasma data. Wouldn't their drug automatically infringe on their own patent by definition? My guess at an answer would be that they fudged the release rates in getting the patent and now they are stuck with their bad data. (Never lie to the PTO, right?) Alza doesn’t have to show that its claims READ ON its product, but here, because of the ANDA and the whole generic/proprietary drug regime, it should have long since figured out how to show this, so that it could slamdunk the case against the AI. (Look at 21 USC 505j, messy as it is…)

Sci.Ev rjm Week 9 12 Alza - Henry B. Alza question: Standard of review The crux of Amidon's testimony about obviousness seems to boil down to the one line in the Journal of Pharmaceutical Sciences article: "in general, the more lipophilic drugs were transported rapidly." Even though Alza pointed out an exception to this trend, the court accepted that this suggestion was sufficient enough to support motivation for combining references. I find it a little hard to believe that multi-million- dollar pharmaceutical companies invest funds into competing generics based on such minimal suggestions. My question is how much work the standard of review is doing in this case. Since obviousness is reviewed under the frustrating "law based on underlying fact" standard, the Federal Circuit can do whatever it wants with Amidon, and it decides to accept this relatively thin evidence of combining motivation. My guess is that your answer will be that the Federal Circuit purposely declares issues like obviousness to be issues of law, to preserve flexibility for setting patent policy the way it likes. No: anything with the myth of the POSITA is law, and maybe should be. (I give the judges more credit, and view them less cynically than other people you may have heard talk on the subject. In general, I think cynical answers are often wrong…)