Archive for September, 2011

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Danie Roy

Some of you may remember when I wrote on patenting all the immunization schedules ever. Turns out that the really ridiculous patents just didn’t end there. Apparently, there is actually a patent that is broad enough to claim even thinking about the patented treatment. If you need a minute to reread that and let it sink in, go ahead. I needed a few minutes myself.

Prometheus Lab v Mayo is going all the way to the Supreme Court. Apparently, the method patent at hand involves administering the drug thiopurine, checking a patient’s blood for how much got absorbed into the body, and adjusting the dose accordingly. Someone please tell me how this didn’t get a 103 rejection and a look of disapproval.

I made this face when I read about this patent.

For those slightly less acquainted with medical issues, a lot of medications, especially those used in the treatment of autoimmune disorders (like thiopurine is), need to be closely monitored. The amount of the drug actually absorbed by and used in the body is critical for proper treatment. The problem is, everyone’s body is different, so different doses are necessary for different people.

Take a look at cyclosporine, for example. That drug has been around since the early 80′s and blood levels and adjustments are made in much the same manner. Take any other immunosuppressant, new or old, and it’s the same deal. One should conclude that it would be OBVIOUS to to use this method for any given immunosuppressant, or even a slightly unpredictable drug, for that matter.

What is killing me is that the Supreme Court is going to be deciding the issue of whether or not this is a valid method patent, and looking to Bilski. Am I missing something? The issue here shouldn’t be whether this passes the machine-or-transformation test (or any other test that can be reasonably used), but whether this should have issued as a patent in the first place. Lives actually do hang in the balance here, so I can understand Mayo’s frustration.

I can only hope the Supreme Court makes the right decision.

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By Daniel Davidson

As if her dress that she wore to the 2010 MTV Video Music Awards spoiling because of a lack of refrigeration wasn’t enough, Lady Gaga is having to deal with unruly fans stealing the goodwill of her trademark.  Recently, a three panel committee of the National Arbitration Forum decided that the fan was not unruly enough to constitute the shutdown of www.ladygaga.org.

 

Stefani Germanotta, the holder of three trademark registrations for “Lady Gaga” decided that a fan page dedicated to her was infringing upon her trademark and was registered in bad faith. 

 

According to the Uniform Domain Name Dispute Resolution Policy of ICANN, if a domain name dispute arises, a complaint must meet three elements:

(i) the domain name is identical or confusingly similar to a trademark or service mark in which the complainant has rights; and

(ii) the domain name Registrar has no rights or legitimate interests in respect of the domain name; and

(iii) the domain name has been registered and is being used in bad faith.

By looking at the first two elements, Lady Gaga has a legitimate complaint against the domain name holder.  There is always a kicker though.  To cap her complaint, the Gaga had to show that the domain was registered in bad faith.  This element, she did not prove.

In the panel’s opinion, they found that the owner of ladygaga.org is providing the star with free publicity, the domain was registered in 2008, shortly before her release of her first single “The Fame”, and the domain’s owner also doesn’t use the site for profitable reasons.  Ergo, no bad faith was found.

 

 With all that, the panel decided against the bouffant singer and has allowed the super fan to keep the site.  Cheers.

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I have a thick beard, and I need to shave every day. I also have sensitive skin. When I shave, I cut my face, and I bleed. Clients and co-works (I assume) don’t want to see this nastiness. It’s gross, but there’s not much I can do about it. I have to shave because, at the moment, I do not want a beard. Long ago, I started shaving at night.

Pay up!

I still get nicks and cuts, but it mostly heals by morning. I’ve never met anyone else who does this. I’m thinking I should patent the idea: “Shaving at Night to Avoid Grossing People Out”. I’ll draw little pictures and a flow chart, and then I’ll sue anyone who infringes on my brilliance. Now that I’ve shared that, let’s focus on the AIA, and one of its better subparts.

Under a provision in the America Invents Act (“AIA”), patent on a strategy for reducing, avoiding or postponing taxes are disallowed. Yep. Shifting assets up, down, and all around is no longer patentable, no matter how many trusts, partnerships, or offshore accounts you set up. But it wasn’t as obvious to lawmakers as it should’ve been.

Years ago, the Wealth Transfer Group, a Central Florida law firm, actually from beautiful Altamonte Springs (home of the worst eyesore on I-4) patented “a strategy that involved funding so-called grantor retained annuity trusts or GRATs with nonqualified stock options.” (source) Precisely what a GRAT is neither here nor there. Needless to say, it’s a tool to avoid or defer taxes. The Wealth Transfer Group holds the patent for it – just one of the more than 161 tax patents which have already been awarded by the U.S. Patent and Trademark Office (167 more are pending).

When a man used the GRAT method without license from the Wealth Transfer Group, he got served. Not by the IRS, mind you, but by the patent-holding law firm.

Now, most people never heard of GRATs, but lawyers in the field use them all the time. A patent on them seemed so ridiculous that it was paid no heed. But it was enough that the Wealth Transfer Group received a settlement from the tax-avoiding man referenced above. Such business method patents “are designed to protect a unique process or series of steps for executing a service or business strategy.” (source)

I can see the allure of patenting such a practice. Just think, each time someone shaves at night, I could sue for treble damages, attorneys’ fees, and royalties! Now, I just need the right defendant (here’s to hoping the wealthy have thick beards and sensitive skin).

The courts will decide what effect, if any, the AIA will have on already-issued or pending tax loophole patents. But I think we can agree that even in a widely-maligned (and rightfully so) law, this was a good call.

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Danie Roy

By now, most of you know about my fascination with pharmaceutical IP. One of the topics that came up before was that of biologics, and how impossible it was for most biologics to go generic. Well, today, I may have very good news.

To recap: biologics are as old as dirt and the cutting edge of medicine. A biologic is any medicinal product produced biologically rather than chemically. It’s old as dirt because, pretty early on we realized “treat X with Y to feel better” and “Y” could be as simple as “eating a leaf.” It’s the cutting edge of medicine because it’s being used to target specific biological processes that cause diseases or the horrendous symptoms of those diseases. For the new biologics, think of it as biological damage control when your body is WAY out of whack.

I’ve previously mentioned that it’s very difficult to get a biologic to go generic even after it goes off-patent. The reason for this is that patent protection is not equivalent to FDA approval, and FDA approval for generics requires bioequivalence or biosimilarity.

The rules of bioequivalence govern how most generics are made: same active ingredient, substantially similar amounts of that ingredient absorbed in the body, and different inactive ingredients. Biosimilarity is the term that seems to be used for the newer biologics.

The reason bioequivalence is difficult to attain for a biologic is that a biologic is, by definition, biological. Minute, undetectable differences can be fatal. It really doesn’t take much. Even changing one little thing changes the whole medicine. There isn’t really an “inactive ingredient” to play around with. A biosimilar, on the other hand, accomplishes a similar effect to the original medication without being the same.

The EU already has a system governing the production and use of biosimilars. The good news from up top? We might just be about to get a system of our own. Sometime between now and Christmas, the FDA will (finally) issue guidelines. Expect an update when that happens.

Just what I had on my wish list!

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By Rene Dial

Last week I explained the possibility of losing your trademark for becoming generic by misusing the mark and that the trademark registered should be the trademark used.  This week we will look at putting the public on notice by using the ® symbol and discuss Microsoft’s guideline’s when using trademarks associated with their products.

 Registration of your mark with the USPTO allows use of the ® symbol and using the ® symbol has a few advantages.  One of the main advantages is placing other businesses on notice that you are out there and have a registered mark.  When a business searches the registry for a possible conflict your mark should come up.  Also, if your mark is registered and the owner of a conflicting mark attempts to register their mark the examiner should uncover the possible conflict and refuse registration of the conflicting mark.  Registration could possibly save you thousands of dollars from future litigation.  That alone is reason enough to register. The ® symbol simply places the public on notice that you have indeed registered your mark with the USPTO and that you have legal remedies available to you should they decide to infringe your mark.  This is a very valuable tool that has certain legal advantages and remedies should someone infringe your registered mark especially the presumption of your mark’s validity.

 Below is a list from the USPTO that sets out some of those advantages. 

  • constructive notice to the public of the registrant’s claim of ownership of the mark;
  • a legal presumption of the registrant’s ownership of the mark and the registrant’s exclusive right to use the mark nationwide on or in connection with the goods and/or services listed in the registration;
  • the ability to bring an action concerning the mark in federal court;
  • the use of the U.S registration as a basis to obtain registration in foreign countries; and
  • the ability to file the U.S. registration with the U.S. Customs Service to prevent importation of infringing foreign goods.

Microsoft is a trademark savvy company.  They police their marks and make sure the public is on notice that the marks belong to Microsoft.  Small business owners should take heed and apply some of these principles and guidance to their marks.

When referring to Microsoft software and products, apply the appropriate trademark symbols in accordance with the list of current Microsoft trademarks.

The common way to set trademarks apart from other words or nouns is to capitalize the product name and use the appropriate trademark symbol and appropriate descriptor. You may also underlining, italic type, or bold type for the name.

Include an attribution of Microsoft ownership of the trademark(s) in the credit notice section of your documentation or advertisement. Follow this format:

  • ·Microsoft, Encarta, MSN, and Windows are either registered trademarks or trademarks          of Microsoft Corporation in the United States and/or other countries.
  • Microsoft trademarks identify specific products and services. Do not refer to applications, services, or hardware devices that work with Microsoft products incorrectly. For example, do not refer to products or services that work with the Windows operating system as “Windows applications,” “Windows services,” or “Windows hardware.” If necessary, these types of products can be referred to by their relationship to the Windows operating system by inserting the word “based” between the name Windows and the type of product designed to work with Windows.
  • Microsoft trademarks should never be used in the possessive or plural form. They should be introduced as a proper adjective followed by an appropriate descriptor.

 Next week we will continue our walk through the proper use of trademarks and look at Apple’s guidance as to how to use their marks.  Until then have a great weekend!


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