My thoughts on today’s hearing
Players past and present
Judge Hall-Magistrate Judge
Judge Andrews-District Judge
Judge Moore-Female Judge who seems to direct the discussion the most
Judge Albright-The guest judge from the Western District of Texas
Judge Lourie-Seemed to be the oldest judge sitting and participated the least but still had excellent input and questions.
Counselor Kelly representing Amarin
Counselor Hickman representing Hikma
4 areas where induced infringement was focused.
The Label which all sides have agreed the preamble was limiting but Amarin believes that there are other acts which causes the label to infringe indirectly
The Website which appears to have listed generic ab eqivalent Vascepa for the hypertriglyceride indication
The press releases which does NOT mention it is the generic AB equivalent but mentions that it is the generic equivalent of Vascepa
Statement from the original case where Hikma was aware of the sales of Vascepa at 919 million in sales yet the generic equivalent would only cover up to 25% of this amount but no mention of this. Appears that this may have been in the press releases also but I cannot be sure.
Judge Moore definitely came to bat for us. Her thinking is that we may not have enough discovery to overcome a summary judgement but at the 12b6 stage there is certainly enough evidence to plausibly conclude that this case move forward with discovery. One thing it appears that she erred on was on the website page it apparently has a statement from Hikma that their generic equivalent can be used for hypertriglyceridemia. She was stuck on the AB equivalent statement in small letters at the bottom of the page but if what Counselor Kelly is saying is true then this certainly is an act of induced infringement regardless of whether or not they have made a statement that their product is a generic AB Therapeutic equivalent. I don’t think she grasped that and just kept going to the press releases. Also it was clear that she had versed herself but wasn’t as clear as most here. When Counselor Kelly mentioned that we don’t list out all the steps for a generic infringement to be used for, he clairified that there are no different steps. She asked if generics also list 4g which he pointed her to the page to examine their label as also listed as 4g of IPE being taken. Basically you take 4g of generic if you have severe HTG and you take 4g of Vascepa if you have HTG. Simple as that. No other steps than throwing them back and drinking water. She then comment that then how is the label not infringing on which Kelly commented that both sides have agreed that the preamble on their label is limiting. I think in her mind she was seeing the injustice of generics having the same labeling instructions (except not for CVD) and thought silently, “How is this not infringing???” She was emphatic that at this stage the only thing that makes sense is this case moving forward as plausibly factual and lead to discovery.
Judge Albright-He also was very clear that, to paraphrase his words, the information presented should be decided by a jury and not by Judge Andrews at this stage. He later back tracked a little and said that maybe this case could have a summary judgement by Judge Andrews in which case it would be a appealed back to them at that level with a different set of directives to determine instead of whether case is plausibly factual and can be moved forward to discovery. Clearly he believes this case should move forward to discovery.
Judge Laurie-It was not as clear with him but he never mentioned anything from a positive note in the direction of Hikma that I could pick up. All his questions were for clarity which seemed to support also his belief that Amarin had a valid argument. I don’t see any reason he would have an apposing vote of this moving forward.
Counselor Kelly did an incredible job. He also pointed out that the website lists HTG as an indication which Judge Moore did not recognize and still seemed to not get by the end.
He successfully protected the label controversy so that if/when this goes to trial we also have this available where we can show that there were portions of the label which supported induced infringement in other areas. If he had just agreed that the label stand alone does not infringe in any way, we would have lost this ability later in the trial with Hikma arguing and pointing out our statement.
He kept bringing this back to GSK vs. Teva over and over and the similarities since this is the case where all the judges eyes are currently turned.
He kept his demeanor and answered every question I felt where it silenced the judges or at least their question was answered successfully.
He was clear and concise and built upon the foundation step by step explaining things well in the very limited time he had left.
Enough about my interpretation on the court hearing today.
Now my thoughts on this moving forward.
As Marjac mentioned, the remanded order will hold to a large extent how open or how handcuffed our hands will be.
If it returns back to Judge Andrews to open discovery, I personally wonder how much more information we can find through emails, etc. I am all but sure that Hikma has destroyed, deleted every last bit of information which condemns them. I know that this is illegal but there are few individuals and companies who wouldn’t destroy damning evidence to protect themselves if they know that they can get away with it. Not saying right but a reality.
I don’t know how much more information however that Amarin has. They may have much more information which can factually prove this beyond what they have shared so far.
The courts laid out ways for Hikma to possibly win on summary judgement but I am not so sure that the Judges’ ideas are as straightforward as they listed. Yes, Hikma can have expert witnesses on their side show that they would not be led to infringe on the extralabel indications but Amarin also can have expert witnesses swear that they would and have every day used drugs every day according to their understanding of websites, press releases and label instructions. THIS IS WHERE THE NEW LEGAL TEAM HAS TO GO THE EXTRA MILE AND GET THE FINEST OF FINEST EXPERT PHYSICIANS TO CONVINCE THE JUDGE AND THE JURY LATER IF IT GETS TO THAT POINT. We were very weak with this in the initial patent case and it was one of the crushing blows to our case.
Judge Andrews does not want to be the judge who opens up pandoras box IMO and create havoc with Section 8 and with generics. I truly believe that is why he found the weakest excuses to rule against us. I honestly believe this scares him and could effect his name as well as career and profession if he is that person. This assumes if our case is strong. I think with strong evidence he may not order a summary judgment in favor of Hikma because we will appeal it again and does not want the US Appellate Courts to possibly overrule him again. If the case is weak then I think he will rule with summary judgment and this will sink our chances. With a strong case before him though, he will allow this to move forward to a jury trial and wash his hands of this to a large extent directing the jury perhaps how to vote but not being able to make the final decision so to say.
If this goes to a jury then I can’t stress enough how important it is to talk to the level of the intelligence of the jurors. I’ve been on many juries and I am dumbfounded at times how certain jurors struggle with grasping certain concepts. I was on a drunk driving jury where the defendant was caught driving under the influence and rejected the testing outside of the car and waited over 2 hours before being forced to do the breathalizer and breathed a BAL over 2.0 (acceptable at that time was either 0.5 or 0.8 but can’t remember) and we still had one juror that said if I can’t seem him staggering around in front of me then I’m not going to vote that he was intoxicated. This is the mentality of individuals sometimes who make the jury. My point is that HTG and SHTG and patent law is extremely complicated and it will go over the head of most on the jury. Their mindset going in will be “I pay less for the generics when I get my medicine and the brand companies only want to make a lot of money.” We have to sympathize with them and even have them empathize with us by showing we are a one drug company who spent over 700 million dollars in research to develop a product in the hopes to save people from dying from a heart attack. The generics are the greedy demons who are using our product so they can get rich and destroy us and keep us from doing good. Basically our product is the same price as the generics and then somehow explain that Hikma can only use their product for people sick with this. We can use our product for not only those sick people but also these sick people. It will be confusing to the jury why the same product cannot be used on both. This is where hopefully we have a great analogy of some sort which explains that patents protect us so that we can get new lifesaving meds to the market and they put a timeline on them so that they will eventually expire and allow generics to compete over time.
These are just thoughts I’ve contemplated while working today.
I think the odds are still very much against us especially with Judge Andrews probably looking for ways to get rid of this case if possible but if discovery is very strong we may have a fighting chance.
As a side note the closing of April 15th will be the 30 day cut off where we will have to close above a buck to keep from getting the delisting notice.
Although extremely unlikely, a win against Hikma would raise our SP more than approval in any or all of governments of the EU would IMO.
Also, if we win expect lawsuits to come out of the woodwork against our CVD patents. It’s going to happen and is a given.
Finally, I am also worried about the ongoing lawsuit concerning monopolizing IPE supply. I don’t know how that will pan out but concerned.
But what do I know. Just random opinions.
AI
