Health Care: Reform the Patent System

It should come as no surprise to anyone who has read my blog since its inception (that means you, honey) that I have issues with the patent system. Being a software developer, I've marveled at the absurdity of patents granted to the likes of IBM, Microsoft, Amazon, and others. Whether it's the GIF image format or Amazon's one-click idiocy or even the RSA's holding web security hostage, patents do more to undermine invention and progress in the software world than support it.

The same can be said of patents with regard to health care. In a previous post, I detailed how Aventis' games with Lovenox patents had a very direct effect on my family financially. Shortly thereafter, the FDA's treatment of Mylan Laboratories over a drug patent demonstrated an anti-consumer, pro-big-pharma, pro-patent attitude within the FDA, the gatekeeper for U.S. health care.

So, how would I fix it?

• Shorten Patent Duration: During the life of the patent system, we've gone from 14 years to 20 years while at the same time improving the technology required to create inventions. There's no reason to grant a 20 year monopoly on anything. I would argue that 7-10 years is a more appropriate duration in this day and age.



• Prohibit Patent Abuse by Pharmaceutical Companies: As I detailed in my Lovenox post, pharmaceutical companies frequently patent a compound upon initial discovery often times without any target condition. Once they create a drug and push through FDA approval, they then patent the final form of the drug, effectively extending the original patent by 20 years. They then use both patents to prevent generic competition. No matter how good they are at smoke and mirrors games, companies should only get one patent on an invention.



• Any Trace of Government Funding in an Invention Precludes Granting a Patent: Think about this one for a minute. Our government throws money at anything and everything through their earmark grants, especially health care. If someone develops an invention using our tax dollars, they should have no right to a patent on the invention. In fact, the work should be in the public domain. It's the only logical outcome of public funding yet it's the exact opposite of what we do.



• No Patent Without a Prototype: I know this might hurt some small inventors, but I don't believe patents should be granted unless a physical product exists. If you want to patent a flying car, fly the damn thing to the U.S.P.T.O. and let them take a look.



• Expire Patents Owned by Holding Companies: While the grandfather clause protects existing IP holding companies, we can change future patents to expire upon purchase by a company who is little more than a team of submarine patent lawyers. If there's no physical product, there's no reason for the patent to exist.



• Time Limits for Patent Lawsuits: If a product is on the market for at least 24 months without any objection from a company holding a patent on the underlying technology, that company cannot sue. Too many companies are using patents for leverage after their product failed in the market. Eliminate that option, but give them enough time to discover offenders.

DVD CCA vs. Kaleidescape

Slashdot reported the great news that Kaleidescape delivered a TKO to the DVD CCA in the case brought by the DVD CCA regarding Kaleidescape's media server business. If you've been reading long (yeah, like I have regular readers), you'll know I first blogged about the battle over 2 years ago. Unfortunately, the judge only decided this based on the fact that the contract was poorly worded and ommitted an important part of the Content Scramble System specification. This basically means that the DVD CCA just needs to modify its agreement to eliminate future media servers. I don't believe the article linked by Slashdot when it says more companies will enter the market.

MPAA Violates Copyright

This is just too funny not to post...

MPAA admits to unauthorized movie copying

The best part is that they cite fair-use because there is no monetary gain. And why can't I rip a DVD to a computer hard drive to play on my HTPC again????

DVD Copy Control Association Out of Control

The DVD Copy Control Association (DVDCCA) controls the gateway to any company wishing to build a product around playback of DVD content, specifically Content Scramble System (CSS) encrypted content. While DVD's can be created without CSS, most Hollywood movies employ the CSS technology in what they claim is an attempt to prevent copyright infringement. Consequently, a DVD player becomes largely useless without access to CSS encrypted content.

In truth, CSS does nothing to prevent copyright infringement. DVD's can easily be copied, CSS intact, and burned to new DVD media or distributed through the Internet. As long as the end user has a player capable of decrypgting CSS content, the bit-for-bit copy will work just as well as the original. The ultimate purpose of CSS licensing in the United States is to trample fair-use as defined by the Supreme Court.

So where are we today? While we can have iTunes happily playing iTunes Music Store purchased titles or even MP3's sampled from a legitimately purchased CD, the DVD CCA claims that we can't do the same with DVD content.

During the past couple of weeks, I've been setting up a MythTv system to provide a centralized music library, dvd library, Tivo-like functions, and a variety of other functions. In my research for that project, I stumbled onto Kaleidescape. Kaleidescape makes an absolutely incredible looking product for the sole purpose of building a DVD library. In fact, they're one of the few companies I've seen doing it. They even have a DVD CCA license to the CSS system.

So what's the problem? The DVD CCA SUED THEM!

Mark Cuban has it mostly right. Hollywood better get the message and change their ways or we'll find unencumbered content and technology. And, our democratically elected representatives better stand up and take notice, or they'll eventually find themselves without a job.

Somewhwere, someday a broadcast flag honoring Tivo will prevent a housewife from watching her recording of Days of Our Lives. It will be the beginning of the end for this kind of garbage.

Photo Copyrights

Someone please explain something to me. How can the Picture People and other studios like them justify claiming a copyright on pictures taken by their staff? And, how can Wal-Mart justify confiscating a Picture People print from someone attempting to scan a photo at their store?

Are these pictures artistic? No.

Did they have us sign a release like a normal model? No.

Did we pay them for the image? Yes.

So, how the hell do they expect to tell people they own it?

Our country is so ridiculously wrapped up in so-called "intellectual property" that we'll eventually sue ourselves into destruction. If I pay someone to take a picture of my child or my family, I damn well expect to own the rights to that image. If the law contradicts that premise, then the law is wrong and should be changed. Our elected officials (or should I say money grubbing whores) need to stop acting like proxies for big business financial interests and start doing the "right thing".

As If Patents Weren't Already Bad Enough

It was with great interest that I read a Reuter's story about Mylan suing the Food and Drug Administration (FDA) over granting Johnson and Johnson a patent extension on the drug Duragesic. Apparently, Mylan planned to bring a generic version of the drug to market before being cutoff by the FDA granting a 6 month patent extension.

Patent Extension...what the hell is that? A little Googling found the answer.

Apparently, the FDA and USPTO will grant drug companies patent extensions based on the amount of marketing time lost to the FDA's approval process for the drug. This sounds a lot like big drug companies in the pockets of our representatives.

Are there examples in any other field of similar laws allowing patent extensions? Where else does our government grant patent extensions when one of their bureaucracies delays a product to market?

DVT.net: The Warm and Fuzzy Front for the Lovenox Cash Cow

"Look honey, there's a commercial on television about a site for DVT treatment and prevention. What do you want to bet it's a thinly veiled advertisement for a certain pharmaceutical company that has tens of thousands of our hard-earned dollars?"

This may not have been the exact text of a one-sided conversation in our house a couple weeks back, but it conveys the basic idea.

DVT stands for Deep Vein Thrombosis. The media like to popularize the coined term "Economy Class Syndrome" as an alternative to DVT. Put simply...blood clots. Most DVT's appear during surgery, pregnancy, or long flights, but there are other potential causes such as medications (steroids, birth control pills), trauma, etc.

In 1993, my wife had a DVT that resulted in a pulmonary embolism (PE). Fortunately, she survived, and we found out she had a blood clotting disorder that could be triggered by a number of foods/medications. For the rest of her life, she will be on some kind of anti-coagulant to control the condition and decrease the possibility of another DVT/PE.

During and shortly after her hospital stay, the Doctors attempted to use Heparin to control the clotting. To their surprise, her condition did not respond well to Heparin therapy.

Most of the time, the anti-coagulant is Warfarin Sodium, better known as Coumadin. Coumadin has been around a long time starting out its life as a rat poison. Given that there are no patents encumbering its use, Coumadin is relatively inexpensive. Unfortunately, it is also difficult to manage, slow acting, sensitive to minor changes in Vitamin K, and teratogenic.

We were introduced to Lovenox 6 or 7 years later when she had to have minor, outpatient surgery. Unlike Coumadin, the pharmaceutical company Aventis still has patents on Lovenox, and they use them to their financial advantage charging around $100/day (on average) for the medication in the United States.

Some insurance companies will cover Lovenox, some won't. Some will cover it at the normal medication rate (90/10, 80/20, etc.), but others will classify it specially and cover it at a rate lower than other medications. This is fine for a one week dose due to outpatient surgery, but when you have to go on Lovenox for 2 years to attempt to have a child, it can be a real problem.

Needless to say, that's what we did. Originally, we were covered at 90/10 through Cigna. Of course, 10% of $3000/month is still a lot of money. When insurance time rolled around for her company, though, our insurance changed to Blue Cross Blue Shield (BCBS). Now, don't get me wrong. BCBS is about as good an insurance company as you can find, but my wife's company selected a plan that classified Lovenox at a 70/30 tier. Consequently, we had to cover 30% of $3000/month. At $1000/month for a year, it was all we could do to stay out of the red.

Now, back to Aventis...a few points:

• Lovenox Patents: The only remaining patents are 4,692,435 and 5,389,618. There are currently two generic manufacturers (Amphastar and Teva) trying to get approval from the FDA to create Lovenox generics. Aventis, as of August 2003, sued both, but they decided not to try to protect patent 435.
  
  
• Patient Assistance, according to Aventis in 2002, has such low income requirements that most Americans would not qualify. How many of you out there can add $300, $1000, or even $3000 per month to your expenses without a problem?
  
  
• During the two years my wife used Lovenox, we found a Canadian Pharmacy that would sell us Lovenox for 1/3 the cost of the drug in America. Given the dangers of not having Lovenox when needed, her Doctor's unwillingness to help, and the FDAs occasional crackdowns on medication shipments, we decided not to buy the drug in Canada.
  
  

So what does this have to do with DVT.net you ask? Did you not notice the little Aventis logo in the upper right corner of the site? Aren't they just the most helpful bunch you've ever met?

Don't get me wrong. I appreciate the work Aventis has done bringing Lovenox to market. In fact, Lovenox played a huge role in allowing us to have a child. The problem here is that Aventis demonstrates significant greed in its pricing and business tactics.

If over 100 million people have been treated with Lovenox as they claim, did it really need to cost $50 for each syringe in the United States?