Sunday, January 11, 2009

Unfortunately "but we infringed only because their product is inferior" and "if you don't allow us to infringe patients will suffer" don't work....

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In case you are wondering what we are talking about here, we are dealing with Acumed Vs. Stryker. Once you are done here, you can easily tell that a few people who will not be mentioned here (yeah, right) need to go back to law school and pay attention this time around...

Let us see, all this could also be clubbed under "Much Ado about a screw" (and no, don't you start getting any ideas about the slant of this post :p ).

Medical device companies suing the other's head off is not new. As I have blogged here before, Medtronic and Kyphon were at each other's throats till their marriage ended like one of those kisses between the boy and girl who fight till they fall for each other in one of those corny high school musicals. And, you know who actually made money in all that Medtronic Vs. Kyphon madness.

Some industry veterans I have come to know and respect told me ages ago that the "Big Boys" would come down on smaller start ups with teams of lawyers and run them over. Mind you, Acumed is no small company. On their website, they boast of an enviable 90,000 square foot manufacturing facility and the ability to call themselves a global company - rightly so.

However, this particular judgment is not about a match of purse sizes. It is a pithy lesson on what you should know about patent laws, infringement and other intellectual property issues.

"Infringe first, settle later" is a strategy, but a really bad one. If someone in your company is suggesting you go down this path, you know what you might want to ....

I like reading Dennis Crouch's Patently-O. Reading the blog gives you a good picture of various IP issues and is much more cost effective than all those business school case studies you could buy. That said, Acumed Vs. Stryker is a good one for medical device related IP struggles between companies.

As one of the commenters in the Patently-O posting has questioned, "Why not use a different screw?", as a development team or a business you might have to consider various strategies, including:

1. Hiring a good law firm. Listen to them and watch for pitfalls in strategies and implementation. After all, you are paying an arm and a leg sometimes to get the work done.

2. Do appropriate due diligence. Some "clever" lawyers have suggested don't even look at prior art, lest you might have to testify about it in court - well, that's just stupid. When was the last time you had an absolutely spontaneous idea about which you had hitherto never read or heard of...

3. If something looks like it could come back and hurt your company, it probably will. So, pay attention to your IP Strategy? Do you have one? Is it good? Are there people in your company who think "IP Strategy" is just hogwash - maybe something turned them off?

Now, on to what happened in this case. If you read the other blog, it talks about the "4-factor test for injunctive relief" . What is that?

Take a look at this document:

The plaintiff must demonstrate that:

1. It has suffered irreparable damage
2. Remedies available at law are insufficient to repair the damage (a monetary damage of a few million dollars is a good remedy)
3. Considering the balance of hardships between the plaintiff and the defendant, a remedy in equity is warranted, and,
4. Public Interest would not be caused a disservice by a permanent injunction


The blog also keeps mentioning "eBay". Where does "eBay" head into all this?

Read this:

The idea is that in 2006, the Supreme Court declared that whenever the district or federal courts consider a permanent injunction against the defendant, they have to perform the "4-factor test for injunctive relief" on a case by case basis.

eBay and Acumed Vs. Stryker Deadline

If you have been keeping your head above the water on this one so far, you would realize that Acumed sued Stryker in 2004, and the district court came back with a permanent injunction for a decision.

Based on the "eBay" decision handed down by the Supreme Court, the Federal Court dismissed the injunction judgment and sent it back to the district court.

Following a lot of huffing, puffing and blowing, the District Court has once more awarded permanent injunction in this case.

"Licensing Agreements and Permanent Injunctions"

This is probably the most exciting hair-splitter for the legal folks arising out of this case. Read this:

Let's go back to our friends MercExchange and eBay. Originally, the problem was that MercExchange existed only to patent "stuff" i.e., business methods and license them out to companies actually "practicing the inventions". In short, to use a derogatory sense, MercExchange is a "patent troll".

So, the jury handed down a permanent injunction while the district court turned it down stating that since MercExchange solely existed to license out patents, it could not suffer irreparable damage from infringement.

To muddle this, the Federal Circuit agreed with MercExchange and stated that "infringement does not exist only for those who practice" and reinstated the original infringement decision.

The Supreme Court decided that they do not want to be left out of all this fun, and decided to jump in. And then like the inscrutable parent, it scolded everyone around.

It first said, yes "just licensing without practicing" can be bad, but what would "Universities, individual inventors and others like them do"?

Then it came back and downloaded the now oft-repeated "four factor test for permanent injunction" - with the note that courts could still make "rare" excpetions.

Sadly, it appears that the "Big Boys" of eBay were able to walk back to the district court and prove that MercExchange still did not suffer irreparable damage. It all depends on whether or not you like trolls and whether or not you are or you respect the "individual inventor".


It's been a long night, so let's recap - Acumed did suffer irreparable damage as has now been proved many times over. A strong IP strategy is necessary, and a stronger defense strategy is also necessary:

1. Claiming that you infringed on someone else's patent after you deduced that their product resulting from the patent is "inferior" to yours, is basically, admission of guilt.

2. Claiming that now that you have infringed anyway and have patients to treat (and retrofit with squeaky hips - no that's not going away, not for Stryker or those who have to live with noisy hippiness), that calls for "damage to public interest" is just ridiculous.

Still want to say "Much Ado about a screw"?

Thursday, January 08, 2009

Congratulations old people of the Supreme Court - your "get out of jail free card" called preemption is live and kicking....

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...patients where it really hurts!!!

We now have a perfect system to circumvent any need for accountability or justice. We can watch patients die or be put through unnecessary morbidity by firms without any need for worry, whatsoever.

I am not talking only of Medtronic mind you - this article refers to their cases that were dismissed. Very recently, Stryker also walked away from any responsibility from similar cases filed in Colorado.

The FDA is dead and useless for all practical purposes, and the only lawmaker who even seems to know anything about all this is of course, Grassley, but that is almost plain hypocrisy since it is the Republicans who appointed the Supreme Court Justices and cheered the industry on to weaken regulation on any and every kind.

We do have only God (who created us 6,000 years ago alongside the dinosaurs by the way) to thank for the continued existence of the FDA - given President Bush's propensity to allow "free" markets and deregulation even when everything fails.

However, I do not trust the Democrats to stand up for, against or with anything. Even with 39 senators, Republicans can hold the Senate to ransom because Democrats are chronically weak, aimless and never in charge. Moreover, their focus is to bring in their grandchildren to inaugural ceremonies of every sort, and Obama is focused on "diversities of opinion" at the expense of the people who voted for him and stood by him.

Meanwhile, in other parts of the galaxy - companies do recalls, fail to sell products of any remarkable quality and are now well protected!!!

Apparently, the FDA is thrilled that there were "fewer" clinical trial rule violations in 2007 (that may be because they are all waiting 6 months to a few years before feigning knowledge of breaking the law!)

Read about it here:©id=F24E6520-7502-4050-9A02-DDC0053774B5

Sigh! Watch this space for continue sad and bleak revelations on the fruits that preemption will bear.

Meanwhile, an infamous stent manufacturing "power house" medical device company whose stock is worth less than fodder, just acquired a company in Ireland - this after laying off hundreds of well meaning employees and unloading assets over the last month.

Irresponsibility, seems to be the backbone of 21st century medical device manufacturing...

Oh, happy new year, by the way.