Occasionally, we talk about problems with big pharma companies and how they sometimes hinder innovation. There are lots of ways to develop new drugs, and apparently plenty of people out there are willing to ingest experimental drugs for fun (and then maybe eat other people's faces). Here are just a few examples of some innovative folks doing some chemistry.

• Underground chemists are making synthetic versions of recreational drugs that are technically legal to possess and sell. This has been going on for years, but recently, there have been increasing political efforts to make these "chemically-similar" drugs illegal. [url]
• Amateur scientists are working on all kinds of crazy biological experiments and ideas such as rewriting the DNA of an acorn so that it grows into the shape of oak furniture. The zombie apocalypse might not come from a megacorporation, but from biology experiment gone wrong in a garage... [url]
• Albert Hofmann discovered LSD had interesting effects in the 1940s, and he said that it spoke to him: "Don't give me to the pharmacologist, he won't find anything." And lots of people have tried LSD since, including Steve Jobs and Aldous Huxley. [url]
• To discover more interesting science-related stuff, check out what's currently floating around the StumbleUpon universe. [url]  

By the way, StumbleUpon can recommend some good Techdirt articles, too.

We've been covering the Prometheus Laboratories v. Mayo Labs case for a few years now, as it was a key case involving whether or not you could patent basic medial diagnostics -- i.e., can you patent basic science and limit doctors from doing such science without paying up. Tragically, in a series of decisions, the appeals court (CAFC) twice ruled that diagnostics are patentable, and we were particularly concerned that the oral hearings in the Supreme Court on this case seemed very narrowly focused. Of course, as we noted at the time, the oral hearings can be a red herring, as rulings often have little (if anything) to do with what is said during the oral hearings. This appears to be one such case.

Instead, it looks like we got a reasonably good (not great, but definitely pretty good) ruling from the Court effectively rejecting the concept of patenting basic medical diagnostics as laws of nature that are not patentable. It's always a good sign when Supreme Court IP case rulings are written by Justice Stephen Breyer -- as he remains the one Supreme Court Justice who seems to consistently, and instinctively, understand how excessive intellectual monopolies can cause much more harm than good. In this case, Breyer wrote the decision which, thankfully, was actually a unanimous decision, rejecting Prometheus' patents, and reiterating that laws of nature are not patentable.

In particular, the steps in the claimed processes (apart from the natural laws themselves) involve well-understood, routine, conventional activity previously engaged in by researchers in the field. At the same time, upholding the patents would risk disproportionately tying up the use of the underlying natural laws, inhibiting their use in the making of further discoveries.

Breyer's opinion is pretty clear and easy to read and makes some important points:

If a law of nature is not patentable, then neither is a process reciting a law of nature, unless that process has additional features that provide practical assurance that the process is more than a drafting effort designed to monopolize the law of nature itself. A patent, for example, could not simply recite a law of nature and then add the instruction “apply the law.” Einstein, we assume, could not have patented his famous law by claiming a process consisting of simply telling linear accelerator operators to refer to the law to determine how much energy an amount of mass has produced (or vice versa). Nor could Archimedes have secured a patent for his famous principle of flotation by claiming a process consisting of simply telling boat builders to refer to that principle in order to determine whether an object will float.

One nice aside: the ruling also rejects the US government's own brief in the case, which effectively suggested that we get rid of the rule that laws of nature can't be patented, and instead just focus on whether or not the claims are new and non-obvious. As Breyer wrote, this "risks creating significantly greater legal uncertainty, while assuming that those sections can do work that they are not equipped to do."

Finally, at the end, Breyer highlights the costs and benefits of patents and how the arguments that more patents automatically lead to greater innovation is simply not the case:

Patent protection is, after all, a two-edged sword. On the one hand, the promise of exclusive rights provides monetary incentives that lead to creation, invention, and discovery. On the other hand, that very exclusivity can impede the flow of information that might permit, indeed spur, invention, by, for example, raising the price of using the patented ideas once created, requiring potential users to conduct costly and time-consuming searches of existing patents and pending patent applications, and requiring the negotiation of complex licensing arrangements. At the same time, patent law’s general rules must govern inventive activity in many different fields of human endeavor, with the result that the practical effects of rules that reflect a general effort to balance these considerations may differ from one field to another....

In consequence, we must hesitate before departing from established general legal rules lest a new protective rule that seems to suit the needs of one field produce unforeseen results in another. And we must recognize the role of Congress in crafting more finely tailored rules where necessary.

All in all this is a good ruling. It's a little limited in suggesting that you could patent diagnostics that go further rather than just "drafting" on a natural law, but this is definitely a big step in the right direction. And as Patently-O notes, it's likely that this ruling will mean that the appeals court will now also be told to go back and re-evaluate its awful decision saying genes are patentable in the Myriad Genetics case. Hopefully, this ruling is a clear statement that not only are diagnostics not patentable, but genes aren't patentable either. If that's true it will be a huge boost to research in the biotech field, which won't be held back by expensive restrictions and tollbooths.

Of course, that's not the story you hear from the patent maximalists, who are arguing that this is horrible for the biotech community because it will mean fewer patents. But that ignores all of the good this does in making it easier to do research, to share results and lead to more real innovations built on basic laws of nature and facts, rather than locking up that knowledge.

The garage startup occupies a mythic place in the technology world, with famous examples ranging from HP to Google. On the basis that if it worked for computers, it might work elsewhere, Rob Carlson wants to try it for biotech startups:

if we want to maintain a healthy pace of innovation in biological technologies, it makes sense that we will need to foster a profusion of garage biotech labs.

For those worried about the safety implications of synthetic biology labs springing up all over the place, he points out:

the emerging model of community labs (Genspace, Biocurious, etc.) is a good foundation to build on. The FBI already has a program in place to engage these labs. And as it turns out, the President has already signed a document that states garage biology is good and necessary for the future physical and economic security of the United States.

Those community labs mentioned are non-profit, which underlines an interesting divergence from the prototypical garage startups:

Not for profit and community engagement is definitely the way to go. I think most medium to large U.S. cities could support at least one community biotech lab.

That makes sense, since it would allow a collaborative, open source approach to developing this new area. That's not the only difference from the classic garage startup; Carlson thinks that garages might not actually be the best place to locate them:

I suggest that, following the recent model of installing Fab Labs and Hackspaces in public libraries, the USG should encourage the inclusion within libraries and other underused public spaces of community biotech labs. There are endless benefits to be had from following this strategy.

Maybe; but what would it mean for the great garage startup tradition?

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We're getting closer and closer to creating designer life forms. People can almost build a single-celled organism from scratch, so we're not too far away (in terms of logical steps, not time) from intelligently designing our own little creatures someday. Instead of a "grey goo" nightmare, maybe we should be more worried about a "green goo" disaster. Here are some quick links to research that might lead to this unexpected biotech revolution:

Dolly the sheep has been revived again. Clones created THREE years ago in secret? Yah, nothing wrong with that at all.... [url]

Solar-powered hornets! Okay, these were discovered, not designed -- but it's just a matter of time before mad scientists start creating other solar-powered insects. [url]

Scientists have made bacteria with genes that can be used as logic circuits. Will Moore's law apply? Probably not, but self-assembled, exponential growth of a biological "chip" would be kinda cool. [url]

A mouse with two fathers still needs a mother to be born. But apparently, the rodents can be made with two genetic fathers or two genetic mothers. Weird family trees ensue. [url]

A human lung on a chip could lead to more "organ on a chip" developments. Great, now we can all breathe easier. :) [url]

Patent defenders often claim that patents are necessary because top venture capitalists would never invest without patents. And yet, we keep pointing to examples of some of the best venture capitalists in the business who are quite skeptical of patents. For the most part, those have been limited to software patents, but Brad Feld seems to have jumped the hurdle to recognizing it's not just software patents that are the problem, and is digging into the research on how much patents have held back innovation in lots of other fields as well (Brad: if you want a list of more such research, let us know...). He's written up a post about some upcoming research concerning patents in the biotech field, where he explains how patents are hindering innovation in that field as well by scaring off research into certain areas:

Regularly, patent advocates tell me how important patents are for the biotech and life science industries. However, there apparently is academic research in the works that shows that patents actually slow down innovation in biotech. The specific example we discussed was that there is increasing evidence that when a professor or company gets a patent in the field of genetics research, other researchers simply stop doing work in that specific area. As a result, the number of researchers on a particular topic decreases, especially if the patent is broad. It's not hard to theorize that this results in less innovation around this area over time.

I can't wait to see the final results of that study, as it would fit in well with a few other studies that have found similar results.

Apparently, a bunch of big biotech firms feel that the patent monopolies they already have over certain drugs aren't enough, and they are demanding Congress enact laws that also stamp out any competition from similar drugs (known, back here in the real world, as competitors). You would think that after centuries of understanding how bad monopolies are for the market that the gov't wouldn't kowtow and simply hand over such things -- but it is. Of course, the biotech firms already have patents, so it's questionable why they also need an additional gov't granted monopoly period to block out "biosimilar" drugs, other than the fact that they don't like competition.

They claim, of course, that they need this exclusivity to recoup their costs in developing the drug. However, the deeper you look at the details, the less true that really is in practice. Much of the really core biotech work is done under gov't grants anyway, and often at research institutes. These private firms pick up the trail later in the game in a lot of cases -- but still get full patent rights. The actual cost of developing these things has been massively overstated, often lumping in marketing costs to R&D. It is true that clinical trials are crazy expensive and a huge burden on biotech and pharma companies, but that's a separate issue. There are numerous proposals about ways to take the clinical trial burden expense away from pharma. Lumping those mandatory gov't induced expenses into basic R&D is misleading. Furthermore, even in the face of competition, time and time and time again, we've seen that the original provider still commands a large and noticeable premium, from which it can easily recoup its costs. This is nothing more than blatant monopoly rents with a Congress too clueless about basic economics to resist.

TorrentFreak alerts us to the latest in a long line of research that highlights just how damaging the intellectual property system has been to innovation. This isn't new, of course. We've been pointing to tons of research on this subject for years, but it's great to see some more to add to the pile. And this isn't just a couple of folks with an opinion either -- but a seven year study, involving a large interdisciplinary team of folks examining all aspects of intellectual property, with the main focus being on the biotech industry. The report hits on a few key themes we've highlighted over the years:

The current era of intellectual property is waning. It has been based on two faulty assumptions made nearly three decades ago: that since some intellectual property (IP) is good, more must be better; and that IP is about controlling knowledge rather than sharing it. These assumptions are as inaccurate in biotechnology – the field of science covered by this report – as they are in other fields from music to software.

The full report is a good read. It's well researched and documented, and points out that listening to IP lawyers alone, or just looking at IP laws is a huge mistake in analyzing the overall impact of IP:

An analysis of IP laws alone gives a distorted understanding of how IP facilitates innovation and dissemination. Such an analysis must be complemented by an understanding of business and governmental practice as well as the public and private institutions and entities that create, grant and govern IP.

There's plenty more in the report, and it's all footnoted, and some of the additional research is new to me and will be fun to explore over the next few weeks.

However, while the report's description of the problems is dead on, the report runs into trouble when it gets to the "and what do we do about it" section. It talks a lot about "new IP" which is vaguely defined, and involves a lot of wishy-washy statements about trust and collaboration and openness. It basically suggests that a bunch of different parties all have to start acting differently but doesn't necessarily explain why or how that will work. That seems... difficult, and a tad idealistic. This is really too bad, given how solid the earlier part of the report is. It's almost as if the group putting together the report saw all the problems, but couldn't come up with really concrete solutions. That's unfortunate, given that plenty of folks have shown real world examples of how the system can work just fine by simply removing IP from the equation, and watching the business models that result. Overall, this is an excellent addition to the literature in looking at the problems, but comes up short when it gets to the solutions side of the discussion.

There's definitely been a lot of talk lately about how biotech is the industry that's got the most promise to be "the next big thing." Whether you agree with that or not, it seems that some high schools want to prepare the next generation of students for biotech jobs, so they're actually offering biotech as a high school class. What may be most interesting here is the connection between the schools and actual biotech companies. This isn't just about learning about biotech, it's about interacting with companies in the space and understanding the business side of biotech, rather than just the technology (er... and biology). The hope, obviously, is to help make sure the next great biotech breakthroughs come from American companies -- and the best way to do that, supporters of these programs believe -- is to get high school kids thinking about and excited about biotech opportunities. Still, while it's surprising that there isn't more pushback (at least the article doesn't note any) about corporations reaching directly into high school classrooms, it seems like a reasonable thing to do in such an emerging area. A standard curriculum won't be all that useful in a rapidly changing arena -- and connecting with companies who are on the bleeding edge is likely to be a lot more educational in the long run anyway.