Archive for June, 2011

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Danie Roy

Now that we’ve had a fun little break, we now return to your regularly scheduled prescriptions. Biologics were promised, and biologics will be served!

Seriously, something that actually warns customers that it smells like "heavily used gym socks" should not be sought out.

Now, I know the post is titled “new drugs,” but, the reality is, biologics have been around pretty much as soon as we figured out we could stick things in our bodies and we would suddenly feel better. The actual definition of a biologic is any medicinal product produced biologically rather than chemically. So, blood transfusions, ginger, insulin, organ transplants, even the notoriously odorous valerian root are all biologics. What I’m going to be talking about today, however, is new biologics: usually products targeted toward sicknesses in which the body is battling itself.

New biologics offer possible relief for people suffering from autoimmune diseases such as rheumatoid arthritis and psoriasis; anemia sufferers; even cancer patients. Such miracle drugs should be widely available, right?

Sadly, no. If you or someone you know suffers from rheumatoid arthritis, you know that these drugs make a world of difference to a rheumatoid arthritis patient. The before and after really is like night and day. The drugs are easy enough to get to, but they cost an arm, a leg, and your firstborn. There are no generics.

Why aren’t there any generics? Well, the blessing is also the curse. Because the drugs are produced through biological processes, they target the specific biological processes that cause disease. They’re also almost impossible to reproduce by other, similar methods because of the inherent uniqueness of processes. Never mind that undetectable differences in the products can be deadly.

“But patents are supposed to be enabling! How long until that runs out? I want cheaper meds!”

For that price, those better be solid gold.

Well… yes, patents are enabling. But that stuff is protected for 20 years from the application date. Usually you’ve got something shinier and newer by then. But, say we’ve got a patent expiring soon, such as the Enbrel patent. That’s supposed to expire in October 2012. A generic STILL probably won’t be available because bioequivalence is almost impossible to prove for a biologic, AND the United States law is horribly new and iffy. The infamous Patient Protection and Affordable Care Act of 2010 does allow for biologic generics to be manufactured… after 12 years of exclusive use for the original manufacturers.

Keep your fingers crossed, but don’t hold your breath.

The Law

Various Pharmaceutical Patent Expiration Dates

Further Reading from the FDA

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Danie Roy

I know I promised you all some more medical facts, but today, I’m going to take a break from the pharma IP and focus on something slightly less universally loved:  politics.

Apparently, Ms. Bachmann decided to use Tom Petty’s “American Girl” in her campaign, and, of course, Mr. Petty was greatly displeased. A cease and desist order was sent, which means that’s the last we’ll hear of the song on this campaign, or we’re about to bear witness to a glorious scandal.

I like where this train of thought is heading.

What I’m struggling to understand, however, is the logic behind this whole snafu. I mean, I get the point they are trying to make here, that Bachmann is an “all-American girl.” The logic is still fuzzy though.  I mean, yes, she is American and, yes, she is female, but I think after 28 kids you can stop calling yourself a “girl.”  Let’s pretend for a second that we’re buying the whole girl bit, but, even then, the choice of song could’ve been less depressing.  You’d think the campaign team grabbed the wrong “American Girl.”

Even assuming all of the above was completely logical, how hard would it be to get a license for use, or at the very least, ask nicely? With the millions of dollars spent on campaigning, you’d think that there would be room in the budget.

We’ll return to your regularly scheduled drug regimen when my brain has recovered from this.

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By Daniel Davidson

 When you hear the word racketeering you may think of the Gambino crime family, rum runners, or maybe the side project of the White Stripes front man, Jack White, The Racketeers, but I don’t think you would think of Lady Gaga.  In a recent lawsuit brought by a Michigan Law Firm, Lady Gaga, or should I say Stefani Germonatta, has allegedly been racketeering along with a few other entertainment companies through their sale of a wristband of which the entire proceeds were to benefit the victims of the Japanese Tsunamis.

In the proposed class action suit, the plaintiff, Caitlin DeMetsenare, claims the defendants kept some of the funds from the sales of the wristbands despite their claims that “all proceeds” would go toward the disaster relief.  The plaintiff’s eyebrow raised to the idea that maybe all the proceeds weren’t going to the relief when she was going to have to pay $3.99 for shipping and handling.

Among the causes of action include, violation of state consumer protection statutes, unjust enrichment, and the RICO Act (Racketeer Influenced and Corrupt Organization Act).  RICO originally was passed to prevent mobsters from being able to get away with murder because they ordered someone else to do it, they didn’t pull the trigger.  In this case, she didn’t kill anyone except for maybe a pocketbook. 

The plaintiff is asking for injunctive relief and several damages which include compensatory, consequential, statutory, punitive and treble.  I call this bad karma.  Cheers.

 


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Danie Roy

Earlier this week I posted an article giving a taste of some of the things I’d like to cover in the pharmaceutical IP world. Today, I’m going to explain how generics and patents relate, and how it effects your health and your wallet.

Most of us are familiar with generics.  They’re supposedly just as good as the brand name but cheaper.  I’ve heard some people insist that one particular brand or generic works better than another, but, aside from inert ingredient reactions, that just shouldn’t be true. Generics operate on the idea of bioequivalence, which means that the generic must be pharmaceutically equivalent and have the same bioavailability. Roughly speaking, pharmaceutically equivalent means that the doses of active ingredients should be the same, and bioavailability means that the same amount of the active ingredients should absorb into the bloodstream and work with the same efficacy.

Maybe in some sports, this could be breakfast.

The next thing I’m going to address is an apparently common misconception: “why does it take drug companies so long to invent generics??” For starters, generics aren’t actually invented per se. What actually happens is someone (or a team of someones) invents the original, brand-name drug, and gets it patented. There is a certain period of time that the brand-name drug gets the market all to themselves, but the second that time runs out, the patent enables other companies to produce the drug with different inert ingredients. Because of this, some drugs take longer to get generics than others. If the patent is challenged, like I mentioned last time, then the generic is available much quicker. If, however, a company manages to get a patent at the last possible second and is never challenged… it could be a long time before relief arrives.

Next time, I’ll talk about what a biologic is and why some meds may never get a generic version in Pharmaceutically Speaking, Part 3: New Drugs.

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By: Rene Dial

Is App Store a generic term?

Apple filed for the “App Store” trademark on July 17, 2008.  Sage Networks filed for a trademark to use the term “Appstore” in August 26, 1998 “providing computer software application hosting services by means of a global computer information network” but was abandoned in November of 2000.

Sage Networks is not in a fight with Apple.  I was just surprised to find an “Appstore” that predated Apple’s App Store.  If you take Apple’s word for it.  A quick search of the USPTO’s database found a number of businesses using the term Appstore by adding various names before it such as Rene’s Appstore.  Apple’s app store is not called Apple’s App Store it is just App Store.  In my mind it is kind of like using the term grocery store.  The only way to distinguish it is to call it by the name of the company that owns it.  For instance Publix’s Grocery Store or Winn Dixie’s Grocery Store.

According to a letter I found on TNW.com Apple is going after a small start up company called Amahi over their use of the name App Store on Amahi’s website.  Click here for a link to the letter found on TNW.  I can only imagine how many companies are out there using some variation of app store and I can only imagine how much money Apple is willing to spend to defend the mark.  Small start ups typically do not have the capital to take on these giants.  It usualy takes a titan to fight a titan.

Here comes our second titan to the ring, Amazon!  Now we finally get to see how much money and time Apple is willing to spend.  An Article on Bloomberg.com  says that Apple is currently in a court battle with Amazon for trademark infringement and to prevent Amazon’s registration of “appstore.”  According to the article it seems as though the judge in this case is set to deny Apple’s motion as they have not demonstrated real evidence of confusion.  Okay how many “app store/appstore(s)” can there be.  Are these companies really distinguishing their goods and services? 

Okay now for a little trademark 101.

According to the USPTO “A trademark is a word, phrase, symbol or design, or a combination of words, phrases, symbols or designs, that identifies and distinguishes the source of the goods of one party from those of others.”  Now when I say app store/appstore do you automatically think Apple?  Is Apple the only company that has an app store/appstore?  What draws the distinction of one app from another app?  Does Apple’s App Store distinguish Apple’s apps “of one party from those of others.”

I have a DVR that plays Netflix, news articles, Facebook and many other “apps.”  Apple does not come to mind when I click on an icon.  I do not think of Apple when my brother in law shows me the apps on his Droid smart phone.  If he shows me the Droid “app store” I do not think of Apple.  The only thing that distinguishes Apple’s apps from the other guys is that Apple’s apps are on Apple’s products.  I cannot buy a Droid app to place on an Iphone or an Iphone App to place on a Droid!  So how is the consumer going to confuse the “store” that their apps were purchased from.

According to (15 U.S.C. §1052) Section 2(e) of the Lanham Act states “No trademark by which the goods of the applicant may be distinguished from the goods of others shall be refused registration on the principal register on account of its nature unless it–… (e) Consists of a mark which, (1) when used on or in connection with the goods of the applicant is merely descriptive or deceptively misdescriptive of them…”  Is “app store/appstore” merely descriptive?

You be the judge.


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