I have a really hard time with this issue.
On one hand I find it really outrageous to patent naturally occurring things, like genes, hormones, or proteins. Still at the same time work done on these things are VERY labor intensive with very expensive tools needed, so the cost of isolating a gene, or identifying a protein (or lack thereof) in a disease is VERY expensive.
I will say that I fall SLIGHTLY into the free-market capitalist side of things. I know on a larger scale genetically modified organisms are patented, such as genetic models of lab animals, or hybrid plants for agriculture. You cook up these organisms in your lab, you have a right to a patent, as its your labor, and your intellectual property.
Further let’s say you have a disease which is a result of a lack of proteins being produced in your body. Well once this cause is discovered you’d naturally want a supply of these proteins as well as a bio-available delivery method to restore yourself to health. You’re GOING to need industry for that. The academic world doesn’t much care for patents, but they also don’t have the infrastructure to actually treat patients on any scale with their discoveries. Once a discovery is made its now time for industry to produce a viable product and create enough of it to treat the population. This is expensive, and they should indeed be paid for their labor, just like the people who built your car should be paid for their troubles.
Also another thing that gets me on the side of patents is that they aren’t invincible. I had a nasty headache the other day. I reached for some CVS brand ibuprofen, and it cleared right up. Notice I didn’t say Pfizer Advil brand pain killer!
Patents expire, and to further pick on Pfizer, that big company has been downsizing for about a decade now as its big blockbuster drugs such as Lipitor and Viagra have expiring patents and therefore generic drugs can be sold by other companies who did none of the research or development. They will still make SOME money on the sale of these drugs (I should see if my wife wants to do a post on generic drugs, as she is a strong believer that name-brand drugs are safer and better due to the fact that the generics are simply reverse engineered and contain different inactive ingredients meaning there will be subtle differences between how the drugs work in your body, and side-effects they produce) but the market share will take a serious hit from cheaper off-brand medications being sold.
So even if a gene or protein is patented it will be available to the entire US after a number of years.
Of course all of this is seen through my libertarian rose-colored glasses, as well as the fact that I have indeed worked in the pharmaceutical industry.
What do you all think on this?
I don’t think genes (etc.) are patentable. For one thing, they don’t fall into the broad interpretation of patentable subject matter SCOTUS described in Diamond v. Chakrabarty as “include anything under the sun that is made by man.” Genes do not qualify (and seem more like Morse’s attempt to patent an abstract idea (in his case, communication via electromagnetic force over long distances) that the Supreme Court did not allow in O’Reilly v. Morse). Certainly not to the same extent as Chakrabarty’s invention of a bacterium that could break down components of crude oil. No bacteria like that exist in nature, and so it qualified as “made by man.”
I’m sure Myriad has some proprietary process it uses to deal with the genes. Provided that process is sufficiently novel, that process itself could be patented. Now, if it is not patentable (either because someone has already invented the process, or because it consists of an already invented process that the company only improved upon in obvious ways), Myriad does have a problem.
Also, and this is just to nitpick the video, but if a soft drink company patented its secret recipe, the recipe wouldn’t be secret. When you patent something, it is disclosed to the public as part of the process (the public disclosure is part of the give-and-take between the patentee and society in exchange for the right to exclude others from making/selling/etc. the patented invention), and after 20 years, anyone would be able to use it. Coca-cola didn’t patent its secret recipe. It’s a secret and is locked in a safe that only two people have the combination to (KFC treats the Col.’s original blend of herbs and spices much the same way).
Bottom line: under the current patent law, I don’t think genes themselves are patentable, unless the inventor actually makes enough changes to an existing gene to create a gene that does not occur in nature. Congress is of course free to include “genes” as a category of patentable invention by amending the code, but I don’t think that’s likely.
“I should see if my wife wants to do a post on generic drugs, as she is a strong believer that name-brand drugs are safer and better due to the fact that the generics are simply reverse engineered and contain different inactive ingredients meaning there will be subtle differences between how the drugs work in your body, and side-effects they produce”
Since my husband has specifically called me out on this, I would like to clarify my viewpoint on generics. Generics have a place in the market and they are clearly more affordable so I support them (and have taken them). BUT, you need to be an informed patient to understand if a generic is right for you and the disease you are trying to treat.
First thing to note, generic drugs have to be compared against the brand name drug in a bioequivalence study (clinical study comparing generic to branded drug). The generic formulation has to meet bioavailability criteria of 80-125% of the branded product within 90% confidence intervals. This is a good thing and ensures that the generic company doesn’t just make placebo and try to market it as being as effective as the branded drug. The caveat to the acceptance criteria for bioequivalence is for diseases where there is a narrow therapeutic index. A way to think of a narrow therapeutic index is that you have a narrow window for the systemic drug concentration in your body to be effective (too little and you don’t have efficacy, too much and you could have unwanted side effects or toxicity). In this case, subtle differences between the generic and brand names could be noticeable by the patient. Other differences between brand and generic that might impact the patient could be allergies to various inactive ingredients such as dyes, inks, coatings, etc. A final difference is that not all generics are the same. Once a brand drug is off patent, there are usually multiple companies to bring a generic version of the drug to the market. All generics are compared to the brand, but not necessarily to each other. When you pick up your generic prescription at the local pharmacy and notice that it looks different from the last time you had this drug, it could be your pharmacy has contracted to purchase from a difference source of the generic drug.
Having said all of this, I think generics are fine for most things, but you just want to be careful if you have a narrow therapeutic index for your disease. Go save yourself some money if you can, but be smart!