Posts Tagged ‘pharmaceuticals’

Pharmaceutically Speaking, Part 8: Biosimilar Now!

Sunday, 25 September, 2011 23:27 Written by Danie Roy 0 Comments

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!

Pharmaceutically Speaking, Part 3: New Drugs

Thursday, 30 June, 2011 14:44 Written by Danie Roy 0 Comments

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

What is Patentable?  A Brief Background on Bilski and Where We Are Now.

Monday, 16 November, 2009 18:04 Written by Mark Malek 5 Comments

Gravatar Iconby Mark Malek

Oral arguments before the United States Supreme Court In re Bilski were held on November 9, 2006.  This case has been closely watched by the patent community because it can have some serious ramifications as to the type of subject matter that is patentable.  The patent application filed by Bernard Bilski and Rand Warsaw is directed to a method of hedging risks in commodities trading.  The Examiner issued a final rejection, noting that the invention was not directed to patentable subject matter, pursuant to Section 101 of Title 35, United States Code.  Pursuant to 35 U.S.C. § 101, to be patentable, an invention must be directed to a “new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof.”

The Applicants appealed the Patent Office’s decision to the Federal Circuit.  The en banc Federal Circuit upheld the PTO’s decision and noted that patentable subject matter does not include “laws of nature, national phenomena, or abstract ideas.”  The court went on to reiterate the “machine or transformation test” with respect to patentability.  More specifically, patentable subject matter must be tied to a particular machine or apparatus, or it must transform a particular article into a different state or thing.  Using that test, the Federal Circuit found that the method of hedging risks in commodities trading did not meet the requirements for patentability.

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Why are patents so important?

Friday, 09 October, 2009 07:31 Written by Mark Malek 2 Comments

Gravatar Iconby Mark Malek

light bulbPatent rights are derived from the U.S. Constitution.  Many people mistakenly call patents rights a monopoly, but that isn’t exactly accurate.  Patent rights are not a true monopoly, as the Government does not grant you a right to make something.  Instead, the right granted allows the patent holder to exclude others from making, using, selling or offering to sell the invention that is protected by the patent.  In most cases, i.e., utility patents, that right lasts for 20 years from the date the application is filed.  For simplicity, I will not get into the patent term adjustments or other patent rights that may not last as long as the utility patent rights, e.g., design patents.

The patent system is intended to reward innovation.  Any inventor out there that has tried to bring their product to market knows how long it takes and the cost involved in bringing their invention to market.  Even the simplest of inventions can cost tens of thousands of dollars to bring to market.  This is true when it comes to mechanical inventions, but especially true in the pharmaceutical industry.  We always hear critics that vilify the pharmaceutical companies say that their drugs shouldn’t be so expensive because it only costs a penny to make each pill.  That’s not exactly accurate.  Sure, pill number 2 – 10,000 only costs a penny each, but that first pill had a cost in the millions (and sometimes billions) in research and development costs.  An often-cited research study on the subject put the number north of $800 million in 2003.  Shouldn’t any inventor that has put forth the time to develop their invention be allowed to recover their costs and profit from their innovation without others merely copying them?  The answer to that question is obvious.

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SUNDAY, FEBRUARY 05, 2012

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