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[mjkleko]

Hi all, while I would like law to be in my future, I am yet a freshmen in college, so pardon any of my ignorance,

In doing some research of pharmaceutical drugs, I have found that essentially the market revolves around patents and rights of exclusivity to prevent the production of generics and maximize market gain.

However, I know little about patent terms.

After digging around the web a bit, I came across this site, as well as this thread from a while back..

http://www.intelproplaw.com/ip_forum/index.php?topic=3736.0

It seems that term getting bandied around is 20 years. Is this correct? Not to assume it is, or assume that it isn't, I would just like to be sure. And does anyone know where I could get a refernce for this number?

Also, after browsing the FDA's Orange Book (http://www.fda.gov/cder/ob/), I had some questions as how to identify the patents correct expiration dates. For instance, let's look at Lipitor, one of the top pharmaceutical drugs, pulling in $8.661 mil. in revenues in 2006. Alright, so you pull up Lipitor and it gives you a screen showing the different applications of the drug in this case, 4 pills of different sizes (10mg, 20mg, 40mg, 80mg). Clicking on the first pill, you learn the approval date was on Dec. 17th, 1996, that it is not a referenced listed drug (RLD), and on the next page you find "patent data" that gives a list of expiration dates for several different patent numbers, yet all the same application numbers and product numbers, seen here http://www.accessdata.fda.gov/scripts/cder/ob/docs/patexclnew.cfm?Appl_No=020702&Product_No=001&table1=OB_Rx

Now do these dates (and subsequent patent numbers) reflect different filings for the original patent application, like extensions or what not? And if the approval date was Dec. 17th 1996 and the first "expiration date" is Sept. 24th 2009 with the last being Jul. 19th, 2013, then that certainly doesn't maintain the 20 year patent term that was discussed in the thread previously mentioned.

Does anyone know a decent place for me to get an understanding of basic pharmaceutical patent terms and the application process? I'm not trying to get a patent or anything, simply just trying to figure out how to interpret expirations for individual drugs.

Also, I was wondering if someone could possible help me interpret the term Reference Listed Drug (RLD). The FDA defines it in their preface as;

A reference listed drug (21 CFR 314.94(a)(3)) means the listed drug identified by FDA as the drug product upon which an applicant relies in seeking approval of its ANDA.

FDA has identified in the Prescription Drug Product and OTC Drug Product Lists those reference listed drugs to which the in vivo bioequivalence (reference standard) and, in some instances, the in vitro bioequivalence of the applicant's product is compared.  By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart.  Such variations could result if generic drugs were compared to different reference listed drugs.  However, in some instances when listed drugs are approved for a single drug product, a product not designated as the reference listed drug and not shown to be bioequivalent to the reference listed drug may be shielded from generic competition.  A firm wishing to market a generic version of a listed drug that is not designated as the reference listed drug may petition the Agency through the Citizen Petition procedure (see 21 CFR 10.25(a) and CFR 10.30)....

(article cut off due to word limit on post)
 

So is this essentially saying that a drug that is not a Reference Listed Drug cannot be generically reproduced and that those that are must be done so in accordance with rules for bioequivalency of the drug, ie. it must be essentially the same drug if it wishes to market itself as a generic of the brand name? And in Lipitor case, does this mean that the 10, 20, and 40mg applications are protected from being generics, while the 80mg application (which is a RLD) can be freely reproduced and sold in America?

Thank you ahead of time for any all iput/evaluation/interest, every tidbit is greatly appreciated.

Max K.

[Wiscagent]

US patents GENERALLY expire 20 years after their date of application.

But just to keep things interesting, there are exceptions that can extend or shorten that time period.  The extensions most often relate to (i) the patent office taking a long time to process the application and (ii) delays related to getting FDA approval to test or market a drug.  The shortened periods typically relate to a patent that is a result of a series of applications, wherein one application builds on a prior application.

All these rules are rather complex and can interact in various ways.