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Abbott’s HIV/AIDS Drug Patents Challenged by PUBPAT


Written by Gene Quinn
President & Founder of IPWatchdog, Inc.
Patent Attorney, Reg. No. 44,294
Zies, Widerman & Malek
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Posted: September 6, 2010 @ 4:21 pm
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About 4 weeks ago The Public Patent Foundation (PUBPAT) announced that it had formally asked the United States Patent and Trademark Office to reexamine eight patents held by Abbott Laboratories (NYSE: ABT) relating to the HIV/AIDS drug ritonavir, which is marketed by the Chicago, Illinois pharmaceutical giant under the name brand Norvir. According to PUBPAT, as it requested reexamination it submitted previously unforeseen prior art proving that the patents should not have been granted. Time will tell whether the reexamination requests are granted, but I am skeptical about the prospects for invalidating patents on drugs, particularly important or blockbuster drugs. I also question whether anti-patent do-gooders in the biotech and pharma space are really causing more harm than good through attempts to bust patents on blockbuster drugs.

The challenged patents are U.S. Patents Nos. 5,541,206, 5,635,523, 5,648,497, 5,674,882, 6,037,157, 6,703,403, 7,148,359, and 7,364,752, which are the eight patents listed in the FDA’s Orange Book for the 100mg ritonavir tablet approved on February 10, 2010.  According to their own press release, PUBPAT acknowledges that the tablet is heat stable and does not need to be refrigerated like prior versions of the drug.  They seemingly make the argument, although not directly, that because this makes it much more convenient for patients it is unfair to charge prices sufficient to recoup R&D and a premium to make the speculative R&D reasonably profitable for investors. Of course, the fact that the drug is extremely convenient for patients is not a reason to invalid the claims, and in fact is likely a compelling reason why the patent claims cover a truly novel and nonobvious innovation.



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The very fact that PUBPAT admits in its own press release this fact about the tablet being heat stable and not require refrigeration makes me suspicious of the reexamination request. If the patents ought not to have issued covering a first of its kind heat stable HIV/AIDS drug then why hadn’t any other drug maker come up with a heat stable pill previously? It kind of makes you wonder, doesn’t it?

At least some of the charges raised by PUBPAT include attempts to prove that certain claims are obvious and should have never issued. The fact that no one has previously done something similar doesn’t mean as a matter of fact or a matter of law that an invention is nonobvious, but it can be persuasive evidence of nonobviousness and entitlement to a patent. The obviousness inquiry requires one to consider the claimed invention, the scope of the prior art and the level or ordinary skill in the art, which will inform the decision-maker whether it would have been obvious to combine one or more references to produce the claimed invention. So-called secondary considerations of obviousness are also required to be considered, and these secondary considerations, which are sometimes referred to as objective indicia of nonobviousness, provide a reality check. For example, how could anyone say in an intellectually honest way that an invention that addresses a long well known problem is obvious? If it were obvious and the problem was appreciated and well defined over a long enough period of time it would stretch the imagination to characterize the now present solution or invention as being obvious enough that it was already believed or understood to be in the public stores of knowledge.

So exactly how is a first of its kind heat stable HIV/AIDS drug obvious? That is a good question indeed. It beats me to think of any way that such a revolutionary and important advance could be viewed as obvious in any intellectually obvious way. Of course, the requests for reexamination filed by PUBPAT start out by explaining that the patents are causing public harm and that “American men, women and children suffering form HIV/AIDS are entitled to access the best pharmaceutical treatments available without undeserved patents making those treatments either too expensive or too limited in supply.” See, for example, Reexam Request re: 7,364,752; other Reexam Requests available at PUBPAT Ritonavir HIV/AIDS Drug Patents.  This has absolutely nothing to do with the granting of a reexamination request, and is pure grandstanding. The question the Patent Office will answer is whether the evidence submitted suggests there is a substantial new question of patentability. Nevertheless, the grandstanding does suggest the real motive, which is to kill the patents so that generics can manufacture this revolutionary HIV/AIDS treatment for virtually free.

I would rather not get involved in a strict numbers debate regarding exactly how much it costs to go from discovery to market for a new drug. The industry says the number is somewhere between $900 million to $1 billion and the opponents would have that number be substantially less. I have heard estimates of $100 million, $300 million and $400 million. Whatever the actual number is can we at least all agree that it is a LOT of money? Of course we can, and anyone who doesn’t agree is just fooling themselves and ignoring financial and regulatory realities. Discovering new drugs and seeing them all the way through to market is an extremely expensive proposition and will only be undertaken when an acceptable rate of return can be obtained.  So if you like new drugs that treat disease, including life threatening diseases, then you must be pro-patent because without a strong patent system we will get less, not more, of those treatments and cures we so desperately want.

The statistics I have seen suggest that 10% of drugs are blockbusters, 10% make a little money, 10% break even and 70% lose money. Whether you want to accept those numbers or not, can we also agree that the overwhelming majority of new drugs never make it to market, or make it to market and make little or no money? With the fall out rate due to drugs not showing the promise thought possible it is not at all a stretch to ask for everyone to accept that most drugs never make it to market. Those drugs that never make it to market and the ones that do and lose money eat up financial resources for the pharmaceutical industry just the same as the ones that do make money.  This makes it all the more critical for the pharmaceutical industry to make as much as they can on the truly revolutionary blockbuster drugs they develop.

Can we also all agree that pharmaceutical research and development is extremely speculative in nature? Just look at how many drugs fall out in Phase 1 trials, how many fall out in Phase 2 trials and how many fall out in Phase 3 trials.  There are even drugs that make the market and then are removed for various reasons.  Also look at where pharmaceutical companies make their money; it is from a hand full of drugs usually. On top of that companies like Pfizer for years now have been in the news because they have and will continue to have important blockbuster drugs come off patent. They knew that years in advance and were researching and developing away and were not coming up with all that much that seemed exciting for a very long while. You simply can’t say we are going to invent a blockbuster pharmaceutical drug and do it on command. You need to do a lot of hard work, come up with some breakthroughs and then a little luck never hurts, and may in fact be required. This stuff is difficult science and then even more difficult application of the science so as to not harm those taking the drugs, something the FDA is extremely interested in.

Now I ask you whether those who seek to take down pharmaceutical patents so that the drugs can be made available for practically nothing are doing more good than harm? I suggest the clear answer that they are doing far more harm than good. Sure, it would be wonderful to have revolutionary drugs for practically nothing the minute they are approved for the market, but why would any pharmaceutical company ever again spend the many hundreds of millions of dollars to take a drug to market ever again? The answer is they simply wouldn’t. So if you prevent the pharmaceutical companies from making money then you are guaranteeing they will go out of business and if they are out of business it will be impossible for them to come up with further important blockbuster drugs. See, that logic wasn’t so hard to follow… was it?

I am also sick and tired of hearing the “we already paid for the research” argument.  That is naive to an extraordinary level.  The argument is that the federal government has funded early stage research that leads to something that is of keen commercial importance and, thus, it should be freely available to everyone.  If you believe that rational please raise your hand — of course right after you remove your head from the sand firmly planted around it!  Federally sponsored research and development plays a critical role in many industries, but it is simply factually inaccurate to believe that anything that is forthcoming from federally funded research is ready for commercialization on the market.  Universities, for example, make scientific breakthroughs.  They do not go through the FDA process and they do not engage in the translational research that is required to move from scientific discovery to commercial product.  So you are believing a lie if you think that federally funded research is capable of filling the need for translational research required to get to market.  You are also living a lie if you think the US government has enough money to invest in such research.  Newsflash — thanks to out of control spending we are broke!

Now I am not advocating bad patents, and if the patents are bad then they shouldn’t issue; my beliefs on that have not changed and are well documented. It is, however, hard to imagine that the revolutionary first of its kind heat stable HIV/AIDS drug is or will be determined to be obvious, and it is difficult for me to believe the claims will be determined to be anticipated because they are identical to what is in the prior art. This is because unlike any other area of innovation the pharmaceutical, and perhaps the biotech, industry really only care about extraordinarily narrow claims. The claims that matter are the ones to the specific formulation that gets FDA approval, so extremely narrow claims can be tolerated without a second thought. That’s because all they need to do is prevent the generic drug makers from making exactly what is approved. If the generic drug makers want to make something similar but not the same then who cares? They won’t because they would have to go through and fund the rigorous FDA review process because what they want to make is not the same as what is already approved. That is why PUBPAT wants to invalid the patents, because they cover the specific drug approved and if the patents fall then generics can swoop in and make the drug relying on the hard work and extraordinarily expensive work done by Abbott to get through the FDA regulatory process.  Talk about free-riders!

The reality is the generics and those who seek to bring down pharmaceutical patents that cover FDA approved drugs are interested in only a couple things. First, some are just straight out anti-patent and would rather see the entire patent system disappear, which is naive in the extreme. Second, there are others are not necessarily anti-patent but they want the pharmaceutical giants to fund all the research, development and the FDA regulatory review through at least 3 phases of trials so that they can copy all that work and sell the drug for pennies on the dollar. Of course generics can sell drugs for pennies on the dollar, they don’t innovate! All they do is copy! Is that what the patent system is supposed to promote? Is that what the Constitution says and what our founding fathers wanted? No. Innovators are to be rewarded and copyists are to wait until exclusive rights expire.

I am like everyone else.  I like paying less for prescription drugs and am thankful when a generic is available.  Unlike many, however, I do not begrudge paying for an on-patent prescription drug because I am just thankful the drug exists and know that in a few years it will be available for next to nothing.  So in exchange for allowing market exclusivity for a few years, which is usually less than 12 years the pharmaceutical case, we get the benefit of the drug immediately and then have to pay pennies on the dollar once the patent expires.  That is perhaps one of the best trade-offs of all time, and the fact that there are some who would rather punish big pharma and consequently not have the drugs (or as many) in the first place is perplexing.

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Posted in: Biotechnology, Food & Drug Administration, Gene Quinn, IP News, IPWatchdog.com Articles, Patents, Pharmaceutical, Reissue & Reexamination

About the Author

is a Patent Attorney and the founder of the popular blog IPWatchdog.com, which has for three of the last four years (i.e., 2010, 2012 and 2103) been recognized as the top intellectual property blog by the American Bar Association. He is also a principal lecturer in the PLI Patent Bar Review Course. As an electrical engineer with a computer engineering focus his specialty is electronic and computer devices, Internet applications, software and business methods.

 

31 comments
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  1. the hiv aids story is being rewritten – http://www.HouseofNumbers.com – more info and videos at http://www.youtube.com/hivquestions

  2. @Gene

    The challenges are the checks and balances that are more important then control and profit. I support such action, and I don’t believe because some entity just dreams up a patent application that it was done in a vacuum only by them.

  3. Gene, you’re missing the point here. If we cut open the pharmaceutical companies, we can get all the drugs at once!

    Seriously though, don’t confuse PUBPAT’s dubious and clearly self-defeating motivation with the actual legal basis of their request for reexam. From a practical standpoint, a requester needs both a factual basis for alleging invalidity and a motivation to bring same to the attention of the PTO. The two don’t need to be the same thing.

    Activists always feel the need to appeal to people’s emotions, and perhaps say a little too much sometimes. Still, once you get through the BS hippie protest rant at the top, the request does include some lengthy allegations of abandonment, anticipation, and obviousness. If those allegations are true (I haven’t read them), should we care that they were brought to the PTO’s attention by a “reexam troll”?

  4. INANE-

    I wouldn’t care if they were brought by a reexam troll, but I still think we should question whether this is for the greater good as these reexam trolls always allege. I say it is not. Perhaps what I am saying is that there should be some kind of exclusivity period for approved drugs even if a patent is invalid. Not really sure, I need to think that through a lot more, but I am happy to throw it out there for debate. Thoughts anyone?

    I also think it is unrealistic to think that patent claims that cover a drug of such importance and that is really revolutionary could be considered to be obvious. This is bolstered by the fact that these claims, and all pharma claims really, are quite narrow in scope. At least the claims that are most beneficial are quite narrow.

    -Gene

  5. anti-bad patent do-gooder (aka New Here)-

    First, I prefer your old handle better, but do like the pun.

    Second, I really don’t know what to say because I am not sure I follow you. Could you elaborate?

    -Gene

  6. “Second, I really don’t know what to say because I am not sure I follow you. Could you elaborate? ”

    Gene it seems you have a problem with the PUBPAT challenge if I follow you right ?
    It seems to me in the U.S.A. the Law says nothing about people whom, make such challenges are “do-gooders” ? Please provide a reference if I am wrong.

    A problem if there is in fact prior art and these patents grants, were wrong ? Because no one’s work is done in a vacuum, so does it really make people anti-patent to want to make sure that the patent system is working as it should ? Or should they just let it go and have the system working for a select few ?

    Once again, the challenges are the checks and balances that are more important then control and profit., and are not the privilege of only those pro-patent as i once again believe the Law doesn’t say that ?

  7. “I am also sick and tired of hearing the “we already paid for the research” argument. That is naive to an extraordinary level. The argument is that the federal government has funded early stage research that leads to something that is of keen commercial importance and, thus, it should be freely available to everyone. ”
    The only research that is legally protected is the ‘invention’ part, which I would think generally comes in the early stages, particularly in regards to pharmaceuticals. We don’t give patents for clinical trials, getting FDA approval, or marketing. My personal feelings are that Bayh-Dohl doesn’t give enough to the public, and I would contend that projects with significant* funding have already utilized a more direct federal system of motivation, and that utilizing another federal system of motivation is double dipping.

    “Perhaps what I am saying is that there should be some kind of exclusivity period for approved drugs even if a patent is invalid. ”
    That doesn’t seem to be in line with our laws. Again, patents are given for the invention, and if there is no invention, then there is nothing that can be protected. You might be able to squeeze out a separate potection from the commerce clause, but there aren’t many signs that the pharmaceutical industry is hard up for money anyway (I think the record industry has actually had a lower success rate than the 70% losses that you mentioned for the entirety of its existence).

    *significant would probably be defined as greater than a certain sum or percentage determined by another party. I don’t have numbers to throw out, and they would probably be dependent on a variety of factors

  8. even if a patent is invalid.

    No. that makes a mockery of the patent system.

    because I am not sure I follow you.
    A rose by any name…

    My personal feelings are that Bayh-Dohl doesn’t give enough to the public,

    No surprise there, given that “the public” deserves everyone’s individual authorship and inventions, right?
    /off sarcasm

  9. “No surprise there, given that “the public” deserves everyone’s individual authorship and inventions, right?”
    If the party in question publicly disclose them, the law says that eventually we do.

  10. I still think we should question whether this is for the greater good as these reexam trolls always allege. I say it is not.

    Well, of course do-gooders always allege that. And of course they allege it for reasons that have absolutely nothing to do with patents. Even a competing drug company would only be requesting reexam for its own economic gain, and is that any more noble? I fully expect the PTO to completely ignore that entire section of the request, just as any sane examiner would if you went on for five pages in an office action response about how your invention was so wonderful for society because it treats AIDS or something.

    Personally, I’m willing to consider a reexam “for the greater good” whenever it raises a serious and legitimate question as to patentability. That’s why the reexam procedure exists, and why it doesn’t actually require any demonstration of interest or standing. It benefits the public to have good patents granted promptly and bad patents invalidated, and that means conducting as thorough an examination as we can reasonably conduct – but also knowing when to stop.

    Think of it as due process for patents. Even people who are obviously serial killers get due process. You know, provided they’re from here.

  11. Bobby – the key words are “law says that eventually “.

  12. @Blind Dogma
    Yes. I am not saying that our law requires it be completely freely available instantaneously, although I question giving temporary protection and federal funding to the same party for the same project because both resources are used for the same purpose. Bayh-Dole places some restrictions on researchers, but I personally don’t think they go far enough, at least when ‘significant’ federal funding is involved. Perhaps the rules should be lighter for ‘insignificant’ roles in federal research, but I think if federal funds were a major driving force in an invention, then the public should be able to freely utilize it.

  13. “but I think if federal funds were a major driving force in an invention, then the public should be able to freely utilize it.”

    Bobby,

    That was view before Bayh-Dole was enacted, i.e., no “give aways” of invention rights developed through government-sponsored research. As a result, prior to Bayh-Dole, few, if any, inventions developed through government-sponsored research that could be “freely utilized” ever made it to commerical reality. That’s not speculation, but based recognized fact.

    Also, even with significant government funding of that research, it takes private sector dollars to bring that research to commercial reality. Government is simply not in the business of commercializing technology. That’s why Bayh-Dole favors private ownershp of inventions developed from government-sponsored research, to encourage commrercialization of that technology.

  14. “That’s not speculation, but based recognized fact.”
    My understanding was that there wasn’t a unified government policy, but anyway, do you have any good independent studies on the matter, particularly one with controls for other growth in the industries receiving funding, and the changes in how much federal funding was given? If the growth isn’t horribly different than the portions of the industry without federal funds or is more strongly tied to the amount of funding received than the change in policy, then the efficacy of the act could be vastly overestimated, and there very well could be other factors involved as well.

    “Also, even with significant government funding of that research, it takes private sector dollars to bring that research to commercial reality”
    Perhaps true, but patents cover invention, not commercialization. If you initially developed a drug, and Bristol-Myers Squibb took that drug and got it FDA approved, it would be you that would hold the patent, regardless of the resources BMS spent. While costly, there isn’t any innovation in clinical trials.

  15. Even beyond the point that EG makes, that same quote seems to conflict with your stated viewpoints that the public should be able to freely utilize any invention – after all, in your world, these rights are taken from the public to begin with, are they not?

    But back to the critical word – now broaden your vision to inventions in general and focus on the timing. Use Step Back’s point from the other thread and realize that each of us are tryign to point out a subtle nuance to you (and that nuance deals with that word that you dread, that word that strikes fear into your co(ld) heart).

  16. Bobby,

    Your comments at 14 show that you continue to filter information through your dogma filter. You seem to find it impossible to accept the notion of capitalism intermixed with the concept of property and ownership. Those words must chill your spine.

  17. @Blind Dogma
    “that same quote seems to conflict with your stated viewpoints that the public should be able to freely utilize any invention – after all, in your world, these rights are taken from the public to begin with, are they not?”
    They are taken from the public, but there is at least a theoretical possibility for this taking of rights to be justified if the terms are rights. The social contact is based largely on the idea of waiving rights for a net benefit.

    “Your comments at 14 show that you continue to filter information through your dogma filter”
    Because I have skepticism on a claim with no given evidence or that a claim or that I think that patents cover inventions?

    “You seem to find it impossible to accept the notion of capitalism intermixed with the concept of property and ownership”
    Capitalism, property, and ownership can all happen without federal funding or government granted monopolies.

  18. “do you have any good independent studies on the matter, particularly one with controls for other growth in the industries receiving funding, and the changes in how much federal funding was given?”

    Bobby,

    Here’s one recent article that discusses the impact of Bayh-Dole (before and after): http://www.bepress.com/ndsip/reports/art6/ .

    Here’s what the article says was true before and after Bayh-Dole (note cites to an AUTM report):

    Before Bayh-Dole, the government held title to about 28,000 patents.27 Fewer than 5% of these (approximately 1,400 patents) were licensed to the industry sector. According to the AUTM report, 4,783 new licenses were executed during FY 2004, on top of the 27,322 licenses already active. The licenses generated an income of U.S.$1.385 billion.

    As to the licensees and the exclusivity pattern of the new licenses, 8% were executed with start-ups (91% of which were exclusive), 58% with small companies (41% exclusive), and 34% with large companies (65% exclusive). Since 1980, some 4,500 startup companies have been formed, with a survival rate of nearly 59 percent. Compared to that for the venture capital industry overall, this survival rate is fairly high.

    In the interest of full disclosure, this article also notes the difficulty in attributing impact, including increases in patenting, due to Bayh-Dole:

    Nevertheless, the rise in overall patenting may be attributed to other factors: biotech patenting was much stimulated by the 1980 U.S. Supreme Court decision in Diamond v. Chakrabarty which allowed the patenting of living organisms. Moreover, the establishment of the Court of Appeals for the Federal Circuit (CAFC) in 1982 strengthened the enforcement of patentholder’s rights and served as an incentive for patenting. Finally, the increase in total research expenditure (U.S.$ 41,245 billion in FY 2004) is partly responsible for the overall increase in nonprofit patenting.

    Like any piece of legislation, as this article points out, Bayh-Dole has also caused “a number of unintended consequences, affecting inter alia the shift from basic to applied research, conflicts of interest, free flow of information, the rise in tuition fees in spite of universities’ huge royalty income, the contribution to the
    creation of anti-commons and the pricing of drugs developed with federal funds.”

    Here’s what this article concludes about Bayh-Dole:

    By changing the ownership of governmental-sponsored inventions, the U.S. government aimed to increase industrial exploitation of federally funded research. Owing to its success in encouraging the licensing of federal inventions, the Bayh-Dole Act is widely viewed as an effective framework for federal technology transfer. There have been a number of empirical studies on the unintended effects of this piece of legislation, with mixed results. Since many factors influence today’s situation in patenting and R&D, it is difficult to assess the extent of Bayh-Dole’s actual impact.

    In spite of the debate on the unintended effects of the Act, many countries have considered adopting a similar strategy in their innovation policies. Japan, Canada and Germany,55 for example, have passed similar legislation. However, governments need to bear in mind that comparable regulations may not be as successful, since the outcome will be affected by the standard of research and the local business environment.

    Again, the impact of Bayh-Dole has its pluses and minuses. But what is quite clear from this article (and the empirical facts it mentions) is that, before Bayh-Dole, government owned of inventions were minimally licensed and that means minimal commercialization of such inventions. I stand by my prior statement: “prior to Bayh-Dole, few, if any, inventions developed through government-sponsored research that could be “freely utilized” ever made it to commerical reality. That’s not speculation, but based recognized fact.” Government simply isn’t in the business of commercializing technology.

  19. Bobby,

    Let me also clarify that I don’t agree with this article when it says Bayh-Dole has caused or affected the following: “free flow of information, the rise in tuition fees in spite of universities’ huge royalty income, the contribution to the creation of anti-commons and the pricing of drugs developed with federal funds.” Information, as does academic research, still “flows” in spite Bayh-Dole or patenting (most academics can and do publish their research results). Also, suggesting any connection between Bayh-Dole and a “rise in tuition fees” because universities somehow are unable to capitalize on so-called “huge royalty income” is absurd. As others have pointed out, the “anti-commons” argument is absolutely unproven and won’t stand up under critical scrutiny. And saying that the “pricing of drugs developed with federal funds” is impacted in any significant way by Bayh-Dole doesn’t give enough credit to the impact of how much it currently costs to secure FDA approval for those drugs.

  20. Bobby says: “Capitalism, property, and ownership can all happen without federal funding or government granted monopolies.”

    That is simply false. In a world where some innovations, particularly those in the biotech and pharma fields that we want most, costs billions of dollars to develop and take to market is is naive on an almost unbelievable level to think that innovation can occur without “government granted monopolies” or in other words “patents.”

    Bobby, you need to do some basic research on free-riders and the generic pharmaceutical industry. Generic pharma innovates nothing. They copy wholesale and sell for pennies on the dollar because they do not research, develop or fund the onerous FDA process.

    Please keep your comments real. It is not helpful to blindly ignore reality.

    -Gene

  21. The rights of the patentee are not “taken from the public”. The public was never able to practice the invention, because the invention was not known to the public before its invention and disclosure by the patentee.

    People who challenge drug patents on principle are missing the very important point that many things would not be invented at all if they could not be patented, and nowhere is that effect more significant and apparent than in the pharmaceutical industry.

  22. @IANAE
    The rights are taken from the public. WIthout patents, anyone who knows how to make an invention could make an invention, or independently figure out how to make an invention, make it and possibly instruct others. Patents work by suppressing this ability temporarily when an approved patent is disclosed, with the theory being that doing this will result in greater disclosure, greater research, and thus more usable knowledge available to the public in the long run.

    @Gene
    Capitalism, property, or ownership don’t need scientific progress in the medical field to happen, so that’s not even relevant to my point.

    Also, the argument about patent has never been that ‘progress won’t occur’, but rather that ‘progress won’t occur as fast.’ The heavy regulations of FDA approval do create a high cost on the industry and eliminate the first mover’s advantage, creating some disincentives for creating new drugs. However, even with these disincentives, it is unreasonable to argue that no new drugs would make it to market, just significantly fewer at worst. That makes the question not drugs vs. no drugs, but X new drugs per year vs. Y new drugs per year, and the effectiveness, cost, and availability of said drugs in a system with or without patents.

    Generic pharmaceuticals do escape the costs of developing new drugs, but their availability is incredibly important to the welfare of society, both domestically and in developing countries. Being able to pick up aspirin for practically nothing quite possibly has a greater effect on society than every single drug protected by patents today combined.

  23. WIthout patents, anyone who knows how to make an invention could make an invention, or independently figure out how to make an invention, make it and possibly instruct others.

    Sure, but without patents “anyone who knows how to make the invention” is “nobody”. Rewrite your sentence with “nobody” in it, and see the difference it makes.

    Put another way, the set of things the public can actually do is in no way diminished by the grant of a patent. Nobody can point to a thing they could do before that they can’t do after, except as invalidating prior art.

  24. Generic pharmaceuticals do escape the costs of developing new drugs, but their availability is incredibly important to the welfare of society, both domestically and in developing countries.

    This is just nuts. How many generic pharmaceuticals have created their product from scratch? Talking about the importance of their availability while remaining ignorant of what is required to get the product in the first place in complete nonsense.

    The more this Bobby speaks, the dumber we all become.

  25. @IANAE
    You are ignoring important factors. Inventors aren’t likely to just sit on a useful invention. They will generally attempt to utilize it, and by utilizing it, they will most likely create something that someone in the public can at least partially reverse engineer. If they won’t, they would probably opt for using trade secrets instead. Also, you are ignoring the independent invention factor. If someone else would have figured out how to do the same thing during the exclusivity period, they would have been able to do this and fell into the set of “anyone who knows how to make the invention”, but patents mean they can’t do something they would have otherwise done.

    Taking rights from the public is a negative, but it doesn’t by itself mean that patents are bad. Even the best institutions virtually all have significant negatives. Acknowledging the positive and negative must be done before you can fairly evaluate an institution, and extensively evaluating the patent system would be a great tool for big improvements in policy.

  26. Bobby-

    You say: “it is unreasonable to argue that no new drugs would make it to market, just significantly fewer at worst.”

    Please provide proof. I am anxious to learn which companies would spend the $1 billion required to innovate and take to market knowing they will never be able to recoup given that day one generics would copy them and sell for pennies on the dollar.

    Everyone… and I do mean EVERYONE… who objectively considers the financial and market realities knows you are wrong.

    You say: “[1] Generic pharmaceuticals do escape the costs of developing new drugs, but their availability is incredibly important to the welfare of society, both domestically and in developing countries. [2] Being able to pick up aspirin for practically nothing quite possibly has a greater effect on society than every single drug protected by patents today combined.”

    I inserted the [1] and [2] so we can discuss. With respect to [1], I completely agree. With respect to [2], you are nuts!

    Of course generics are incredibly important to the welfare of society. Neither I, nor anyone with any credibility suggests doing away with generics. Even the biotech and pharma industry do not suggest that, and acknowledge the vital role generics play for socieity. That is the EXACT reason to have a patent system though. Without a patent system and the ability to recoup costs and make a profit there would NEVER be any drugs for generics to copy. So generics provide tremendous social benefit after the patent expires specifically because there was a discovery in the first place. Kill the discovery and you kill the generic, it is that simple.

    Your statement about aspirin is really stupid. I know that is inflammatory, but there is no other way to describe it. There are hundreds or perhaps thousands of life saving, life altering drugs on patent. In a matter of years they will be off patent and free to be copied by generics. Is is asinine to pretend that any one drug that is off patent is as valuable as all those, or even several of those, that are still on patent. You are factually wrong and you display either the height of intellectual dishonesty or total ignorance.

    Generics do not invent, they copy. If there is nothing to copy there is nothing to benefit society. This cycle is exactly what patents promote, and exactly what they are intended to promote. The fact is that do-gooders like you want to do away with the patent system and want to demand that drugs be available immediately. Well Mr. Do-Gooder, what are you doing to help those suffering and dying receive generic drugs that could save their lives and dramatically improve the quality of their lives? Why focus on the patented drugs when there are hundreds and thousands off patent that would cure disease?

    -Gene

  27. Inventors aren’t likely to just sit on a useful invention. They will generally attempt to utilize it, and by utilizing it, they will most likely create something that someone in the public can at least partially reverse engineer.

    Of course. But the only reason they bother to do any of that for a product that can be reverse engineered is because they were granted a patent in the first place. None of the technical knowledge associated with that invention would have been available to the public but for the patent.

    It’s a somewhat idealistic view of patents, but it holds pretty true for pharmaceuticals.

    And yes, I am glossing over the possibility of independent invention, but I don’t believe that’s a common enough occurrence for it to be central to this debate, particularly for pharmaceuticals. It’s also highly speculative and virtually impossible to quantify, and one could even argue that the resources it costs to independently invent a patented drug are better deployed elsewhere once the public knows it’s already been invented. You know, unless the market decides we need a thousand different drugs for ED more than we need a first cure for cancer.

    Taking rights from the public is a negative, but it doesn’t by itself mean that patents are bad.

    Exactly. The exclusive patent right is supposed to benefit the public on balance. We’re happy to trade off the public’s right to make something the public had no idea how to make, in exchange for instructions on how to make it.

  28. @Time to stop
    Actually, aspirin didn’t get a patent in Germany, where it’s modern form was created by Bayer, although it did get some patents elsewhere. The smallpox or polio vaccines were not patented, either, and smallpox is the only virus that humanity has successfully eradicated. There was a patent on penicillin, but not by the man who invented it.

    @Gene
    “Please provide proof. I am anxious to learn which companies would spend the $1 billion required to innovate and take to market knowing they will never be able to recoup given that day one generics would copy them and sell for pennies on the dollar.”
    There are drugs that make more than they cost to get to market even after they go generic, and some statistics suggest that more is spent on marketing and promotional samples than actual research. Different models of development could arise to deal with the high costs of getting a drug to market, possibly even significantly lowering the clinical costs. Also, billionaires get sick sometimes too. ;)

    On aspirin, you have to consider that helping a lot of people a little can be more powerful than helping a few people a lot, and if you pay attention to Bayer commercials, you’d know that aspirin can help save you from a heart attack, which I believe is the single biggest killer in the world today. I don’t have any statistics and there are different ways to measure it, but patented drugs can only help those who need the drug and can afford it, so if you are weighing the positive effects they have on the world, it’s not hard for just a portion of generics to carry more a good deal more weight than what’s patented today. Aspirin alone may be a stretch, but I only said “quite possible”, which doesn’t seem to be bolder than Jefferson’s claim voicing healthy skepticism of the patent system altogether when he said “it may be observed that the nations which refuse monopolies of invention, are as fruitful as England in new and useful devices.” I’m not even saying that patented drugs are inherently bad, but trashing generics is just uncalled for. I would be interested in the possibilities of some alternatives, such as perhaps requiring compulsory licensing with reasonable caps for patented pharmaceuticals. This could potentially get drugs out to a much wider audience while still giving an adequate degree of insurance that companies will get a return on research investments.

  29. The smallpox or polio vaccines were not patented, either, and smallpox is the only virus that humanity has successfully eradicated.

    The smallpox vaccine was essentially the related naturally-occurring cowpox virus. It’s as close to an accidental discovery as one could have in the pharmaceutical industry, and it’s no wonder Jenner couldn’t get a patent.

    The eradication of smallpox has more to do with smallpox itself and the WHO than with the patentability of the vaccine. Smallpox occurs only in humans, so it can be controlled by treating only humans. Compare and contrast malaria, which you can’t really eliminate without also hunting the mosquito to extinction (which wasn’t as easy as people expected). Also, the WHO was instrumental in the widespread distribution of the vaccine throughout the world. Most vaccines aren’t well distributed in poorer or more remote countries, so even diseases like polio that are unheard-of in the Western world (due only to ongoing vaccination) are still common in other places. Probably because polio isn’t quite as horrific a disease as smallpox.

    The polio vaccine is a weakened or inactivated polio virus, which is also pretty close to a mere discovery and would not be easily patentable.

    There was a patent on penicillin, but not by the man who invented it.

    Penicillin was discovered, not invented. It occurs naturally, and was known as a folk remedy even before Fleming’s discovery. There’s a reason we don’t grant patents on such things – they’re not very motivating for the Penicillium bacteria.

  30. Penicillin was discovered, not invented. It occurs naturally, and was known as a folk remedy even before Fleming’s discovery. There’s a reason we don’t grant patents on such things – they’re not very motivating for the Penicillium bacteria.

    There was an article recently about Penicillin enhanced Nubian Beer (I’m serious – read it) brewed between 350-550 AD. I know a lot of people who would have loved to help test it :)

  31. Ganz toller Post! Ich bin ganz gespannt auf weitere Artikel dieser Art.