Importation of Prescription Drugs: A Bad Idea
“Reimportation” of prescription drugs is back as an issue, but only because Democrats seek to distract from the effort to repeal and replace Obamcare, according to Politico. By importation we refer to the ability of American consumers to buy their prescription drugs from overseas rather than from domestic sources, and particularly to large-scale importation, such as US drug distributors sourcing their drugs from overseas.
There has always been some cross-border traffic on pharmaceuticals, as drug prices in Canada can be cheaper than in the US. But the Medicare Part D prescription drug benefit, which came into effect in 2006, has significantly reduced this traffic by making prescription drugs available to seniors at more affordable prices.
There’s a reason why such importation is illegal today under most circumstances, and that’s because of safety. The rate of counterfeit drugs in other countries is staggering, and the only way to keep the counterfeit problem from infecting the US drug supply is through the rigorous inspection and supply-chain regime maintained by the FDA. And the FDA has repeatedly told Congress that it cannot guarantee the safety of drugs entering the US from other countries such as Canada, since it does not inspect those facilities. And when the FDA has been permitted to inspect overseas facilities, the results haven’t been encouraging, such as the extensive and discouraging history of the FDA with Indian pharmaceutical manufacturer Ranbaxy.
Some on the free-market side of the political spectrum argue that importation of prescription drugs is simply a matter of “free-trade,” which at least up until the last few months has been a persuasive argument when presented to Republicans. But, as professor Richard Epstein notes in an IPI publication noted below, importation of prescription drugs is actually a perversion of free trade, in that it rewards other countries for their price controls and socialized medicine systems, rewards them for their disregard for the patents of American drug companies, and would likely create shortages of much needed drugs in poor countries as their drug supply was diverted back to the US. Read More >>
Larry Lessig: All "property" is imaginary
Larry Lessig is a well known critic of intellectual property protection, such as copyright and patents. But Larry has always claimed to believe in the basic idea of intellectual property; he just thought it all needed to be "reformed," by which he always seemed to mean "rendered impotent."
Well, a couple of days ago, Larry made a little Freudian slip on Twitter. Or perhaps it was entirely intentional. Regardless, it's instructive.
October 7, 2016Read More >>
When Academics Try to Silence Debate
The policy problems with FCC Chairman Tom Wheeler’s set-top box proposal are many—the majority of which have nothing to do with set-top box competition issues—from consumer privacy to cybersecurity to energy consumption. But the concern that seems to have resonated the most is the proposal’s brazen disregard for copyright—constitutionally enshrined intellectual property rights that help provide the foundation for American creativity and the cultural and economic benefits they bring our nation.
Wheeler's proposed rule would force pay-TV providers to transmit copyrighted content to third parties without obtaining the consent of the copyright holders, allowing the third parties to appropriate that content for their own commercial benefit and undermining the ability of programmers to create television and film content in the first place.
Almost from the moment Chairman Wheeler announced his set-top proposal, it has been teetering over an abyss in the face of near unanimous opposition, including from small and large programmers, civil rights groups, television and film unions, individual creators, more than 180 Democrats and Republicans in the House and Senate, and a bipartisan triumvirate of Chairman Wheeler’s own fellow commissioners. Read More >>
The Moral and Logical Vacuity of the Anti-Patent Crowd
Now, any clown can come up with an example of a bad patent. Priti has the nerve, however, to use Sovaldi as her example, which is where we are going with all of this.
What is Sovaldi? Sovaldi is a CURE for Hepatitis-C. It’s a revolutionary medicine. First you had Hep-C, and you suffered and you died early. Now, with Sovaldi, you can be cured of Hep-C.
I emphasize this because, before Sovaldi, the critics of the pharmaceutical industry were bashing the industry because it allegedly was focusing on lifestyle drugs for the rich West rather than trying to cure the diseases that plagued millions of people. Greed rather than trying to actually cure diseases. Then Sovaldi comes along and inconveniences their argument.
But you’ve got to hand it to Priti. She has nerve—almost certainly more nerve than you or I have. Because Priti can write something like this:
“We have evaluated Gilead’s patent portfolio and found that, based on US and international patent law, Gilead does not deserve any of its 27 patents for Sovaldi. Both the base and secondary patents for the drug are based on old science and commonly known techniques.”
Really? So there’s no cure for Hep-C. Someone invests millions of dollars and years of expertise and actually manages to invent a cure for Hep-C, but they’re not entitled to a single patent for such a revolutionary invention? Read More >>
Venture Capitalists and Copyright: Smug Alert!
HBO’s “Silicon Valley” has built a successful show satirizing the real Silicon Valley’s hubris and worst excesses. Many of the funniest moments follow the struggles of the protagonists with various venture capitalists who have invested in their business (Russ Hanneman anyone?). VCs – or “Angel Investors” – are the demigods of Silicon Valley. Their decisions can make or break companies. As such, they hold a special place in tech circles and their opinions are given a lot of deference.
It’s this VC worship that likely led Silicon Valley-backed intellectual property skeptic advocacy group Engine to commission a 2014 survey of investors (and law firms that advise them) concluding VCs may be less likely to invest in “digital content intermediaries” (firms like YouTube) if the company were exposed to legal risk for copyright infringing content on their sites.
The notion that investors account for legal liability as they choose their investments isn’t insightful or new. And the idea that a VC might choose not to invest in a new business built on facilitating access to unlicensed copyrighted content shouldn’t be either.
This “innovation at all costs” mentality, which seems to fuel the Engine report, reminded me of a 2013 Wired article discussing Silicon Valley’s “threadbare nature of digital exceptionalism.”
The undue emphasis placed on entrepreneurship, combined with a limited view of who “counts” as an entrepreneur, functions to exclude entire categories of people from ascending to the upper echelon of the industry. And the ideal of authenticity privileges a particular type of self-presentation that encourages people to strategically apply business logics to the way they see themselves and others.
New Xfinity TV App Demonstrates Irrelevance of FCC's "AllVid" Rulemaking
One argument against the FCC’s recently announced “AllVid” plan to regulate and “open up” the video set-top box is that set-top boxes are NOT a natural monopolistic platform that must be regulated by government in order to allow competition – in fact, set-top boxes are on the verge of being phased out and replaced by a variety of innovative new options. Apple TV, for instance, is an example of innovative new hardware for video access. But even a look at Apple TV lets you quickly see the real future of video access – apps. Put simply, in the normal course of innovation responding to consumer demands, set-top boxes are being replaced by apps on smart TVs, mobile and streaming devices. There may never be a better example of government regulation being behind the pace of innovation.
And today, Comcast announced its Xfinity Partners Program, which will allow Comcast customers to access their Xfinity content through a variety of devices and platforms using an Xfinity TV Partner app. Samsung and Roku have already joined the program, which means Comcast customers simply won’t need a set-top box if they own one of the new Samsung or Roku devices featuring the Xfinity TV app.
Seeing Comcast join the impressive number of over-the-top video providers who allow access to their content through apps demonstrates that the FCC’s AllVid rulemaking is not a response to a problem in the marketplace. The FCC has also done no economic analysis whatsoever to justify its scheme. Nevertheless, the FCC is pushing the Allvid scheme very aggressively with shortened timeframes for comments and public input. One has to wonder what, exactly, is the FCC trying to accomplish? And why the rush?
Meanwhile, industry continues at the speed of innovation while the FCC regulates looking backward. Read More >>
The TPP, Conspiracy Theories and Click-Bait
Die-hard opponents of free trade and intellectual property have plainly stated their intention to wage a smear campaign against the largest trade agreement in history, the Trans-Pacific Partnership (TPP). Their transparent and tone-deaf tactics have been lampooned as one-sided and overly simple, but still they strain to create fear and anxiety among consumers and users at every opportunity. This, despite mounting fatigue and annoyance from their own supporters. For example, Redittor “binarybandit” posted:
I've seen EFF doing this lately with the TPP bill. They've been using fear mongering to make people believe that they're seriously gonna go to prison for making a free mod for a game, or that it's gonna destroy the internet somehow. People are eating it up though.
Right on cue, the latest effort to invent controversy centers on a breathless EFF conspiracy theory – government lawyers have secretly expanded the scope of penalties for copyright infringement during a technical review of the TPP text by changing the word “paragraph” to the word “subparagraph” in a footnote.
To be fair, it is true that this change means the footnote only applies to one part of the paragraph, and that does actually make a difference. The paragraph at issue sets out rules for calculating and applying remedies for criminal theft of intellectual property, and the footnote allows countries to ignore those rules, except for more significant cases. The change means only the last part can be ignored (except for more significant cases), not the whole paragraph. Sensing an opportunity, the EFF pounces insisting there is “no rational basis” for the change. Let’s examine that.
The very first obligation in the paragraph — where the footnote no longer applies — is that the punishment should fit the crime. In the precise terms of the agreement, countries must provide “Penalties that include sentences of imprisonment as well as monetary fines sufficiently high to provide a deterrent to future acts of infringement, consistent with the level of penalties applied for crimes of a corresponding gravity.” Now, if the footnote applied to this requirement, it would be saying that in lesser cases, the punishment doesn’t have to fit the crime and doesn’t have to provide a deterrent. Would that make any sense to you?
Exceptions & Limitations Harm the Creation of Culture in Developing Countries
I’ve just discovered the International Authors Forum (IAF), and I’m in love.
For one thing, IAF features prominently on their website and in their materials the critical text of Article 27 of the Universal Declaration of Human rights, which states:
Everyone has the right to the protection of the moral and material interests resulting from any scientific, literary or artistic production of which he is the author.
It drives the CopyLeft and Access to Knowledge folks crazy that the key international human rights document includes intellectual property rights as a basic human right. Yes it does. They try to reconstruct the sentence sometimes to make it sound like it means the opposite of how it is written, but they’re wrong.
I’ve tried to make some hay over the years with this fact, not only writing about it, but also getting physically accosted by activists at a WIPO meeting where I dared to read out the text of Article 27 during an IPI intervention (more here). Ah, memories.
Anyway, the International Authors Forum has a great document [PDF] on their website where authors from around the world including developing countries explain how expanding copyright exceptions and limitations would be harmful to their attempts to produce cultural products in their own markets. It’s worth your time. Read More >>
Another Voluntary Agreement to Reduce Online Piracy
We’ve often argued that a combination of government enforcement and private voluntary agreements is necessary to reduce illegal online theft of copyright materials [ex here and here]. Everyone in the online world has an interest in ensuring that a complete array of rich content is easily accessible online, but that requires a healthy Internet environment, which means the rule of law predictably applies in the online world as well as it does in the analog world. That the online community resists the idea that piracy is a “killer app,” either for Internet adoption or for selling advertising.
And it’s entirely consistent with America’s long tradition of civil society and free association for voluntary agreements among Internet players to be a big part in creating this healthy internet ecosystem. That’s why it’s been cheering to see several recent examples of voluntary agreements designed to reduce online piracy.
Last week Donuts—the world’s largest Internet domain name registry and the registrar of the new .MOVIE domain extension, announced that it has entered into an agreement with the Motion Picture Association of America (MPAA).
Essentially, infringement notices from MPAA to Donuts will be treated with high priority, and MPAA’s notices will have a presumption of credibility, so long as MPAA provides sufficient information to Donuts. That information includes:
- A statement that the MPAA is authorized by its members to submit the referral;
- Detailed description of the clear and pervasive copyright infringement occurring on the domain (e.g., sample URLs, screen shots);
- Non-exhaustive identification of the law(s) being violated and a description of why the copyright infringement violates the specified law(s);
- Statement that, prior to sending the referral, the MPAA alerted or attempted to alert the registrar of record and hosting provider, including a description of the response received, if any, from registrar and hosting provider and an explanation of why such responses failed to mitigate the infringement;
- Statement that the referral is submitted with a good faith belief that the information contained therein is true and accurate; and
- Confirmation that the referral was subject to careful human review and not submitted solely based on automated Internet scanning or scraping services.
This is more than enough information to guard against the concerns of copyright critics that such takedown notices are sometimes used nefariously to suppress legitimate content.
IPI commends Donuts for its willingness to work cooperatively with content owners to reduce online piracy. We’ve not simply reproduced the entire agreement in this blog entry, but the agreement is a robust model for other registrars and operators to follow, and we hope further such voluntary agreements are in the offing. Read More >>
GIPC Releases International IP Index, 4th Edition
On February 10th the Global Intellectual Property Center (GIPC), a project of the U.S. Chamber of Commerce, released the fourth edition of its International IP Index. The Index is a mapping and ranking of the climate for IP-based innovation in the 38 economies around the world that account for nearly 85 percent of global GDP.
There is a ranking, of course, because people (and governments) like lists. And while the rankings easily lent themselves to highlighting on social media, the great value is the nation-specific discussion of changes in country policies that have improved their IP climate, and nation-specific discussion of gaps and areas for improvement. For instance:
- Malaysia is noted for improvements in its IP climate, and its participation in the Trans-Pacific Partnership (TPP) will result in further improvement in its IP policies.
- Israel’s 2014 patent reforms, including data protection for pharma-related clinical data and patent restoration for biopharma.
- But several European countries, including Switzerland, Sweden, Poland and Italy, are noted for lax efforts at combatting online piracy.
- The BRICs (Brazil, Russia, India, China) are noted for continuing to tie IP protection to concessions on market-access and for an overall policy of using weak IP protection as a means of trying to favor their own domestic interests.
- Even the U.S. is faulted for weak enforcement against trade secrets theft. < Read More >>
How's PTAB Doing?
Curious how PTAB's going?
PTAB is the Patent Trial and Appeal Board, which was created in the America Invents Act (AIA) patent reform bill in 2012. The idea was to find a quicker way to find and invalidate patents that should not have been issued.
Of course, PTAB has turned into many things, including a means for hedge fund short sellers to make a quick profit by shorting a stock and then challenging patents held by that company. I'm guessing creating a new way to manipulate the stock market for profit isn't quite what the patent reformers had in mind.
But apparently it's worse than that. Here's Gene Quinn's view from his IP Watchdog blog:
The Redline case, like so many others, shows just how much of a wild west inter partes review is at the Patent Office. PTAB judges do not implement the rules and laws uniformly, and joke is being made out of due process. Why? Because these proceedings need to be completed within 12 months, so the PTAB cuts corners and simply doesn’t believe they can offer the process that patent owners, and increasingly petitioners, deserve. This is making post grant proceedings seem more like a kangaroo court or some hang ’em high court right out of a Clint Eastwood western.
Lovely. Read More >>
Grading the Trans-Pacific Partnership
Derek Scissors of AEI published a paper back in December containing his analysis of the Trans-Pacific Partnership (TPP) agreement, which at some point one assumes will be submitted to Congress by President Obama.
Scissors is a free-trader who recognizes the need for such agreements in the absence of an effective WTO trade liberalization process. Based on several of his written pieces, Scissors 1) thinks the TPP as negotiated is distinctly better than no TPP, 2) is disappointed that the U.S. didn’t work harder to get a better deal, 3) thinks we should still try to fix the TPP within the framework of the existing parties to the agreement and, if that doesn’t succeed 4) we should fix the TPP at the cost of dropping countries that refuse to go along with the proposed fixes.
Earlier in November of 2015 Scissors wrote:
If this cannot work, free traders should not abandon the TPP. The next step would be to shrink the number of participants in the first round.
Scissors recognizes that the business community is pretty solidly behind the TPP as an improvement the status quo.
Here at IPI, we’ll be writing a lot more on the TPP as the debate begins in earnest. But for now I wanted to highlight the fact that Scissors’ disappointment with the TPP do not stem from the most popularly criticized and controversial sections of the agreement, the intellectual property and agriculture sections. His chief criticisms are with the sections having to do with state-owned enterprises (SOE) and with the excessive number of exceptions that were granted to countries to simply not conform to the agreement in particular areas. It would have been far better to allow those countries longer phase-out times for those domestic considerations rather than simply granting them a carve-out from trade liberalization.
The strength of Scissors’ paper is how handily he rebuts the most commonly voiced arguments against the TPP. In particularly, as you might guess, I’m interested in his comments on the intellectual property section, which he grades at a B+. Read More >>
Carrots, Sticks, and Straw Men
“An abundance of ideas” is the stated organizing principle of the Copia Institute, a new think tank “from Mike Masnick and the team behind Techdirt.” But their latest paper, “The Carrot or the Stick?: Innovation vs. Anti-Piracy Enforcement,” offers no new ideas. The paper purports to demonstrate that anti-piracy policies are ineffective and, alternatively, that introduction of legal online content distribution platforms correlates with a reduction in theft. As such, enforcement regimes should be abandoned in lieu of “innovation.”
What if the answer to Hollywood’s concerns about piracy actually come from Silicon Valley? What if the best way to reduce piracy is to let innovation flow, and to provide better services that reasonably respond to consumers and their entertainment needs?
But as Masnick surely knows content creators already make their works available on an abundance of legal online distribution services. Indeed, there are over 400 licensed video services and 98 licensed music services worldwide, and digital books, magazines, newspapers, photos and other works are ubiquitous.
Instead, Masnick offers a straw man argument, as no one is arguing that enforcement is the only solution to online theft. Indeed, in the real world, rights holders are pursuing voluntary, market based solutions amongst good faith stakeholders to combat piracy. For instance, the five largest ISPs and the content community created the Copyright Alert System to educate users about infringing activity and help guide them to legal alternatives. And the advertising industry recently announced the formation of the Trustworthy Accountability Group, which will help advertisers ensure their valuable brands don’t appear on websites dedicated to theft, thereby helping to take the profit out of piracy while at the same time protecting their good names. Further, recognizing that rights holders should ask of themselves what they ask of others, the MPAA launched wheretowatch.com, a search tool that helps connect consumers with particular movies or shows of interest to them among so many options.
Shkreli's Stupid Pricing Move Vindicates Rather Than Indicts Pharmaceutical Markets
Let's Get Real about What's Fair in TPP Copyright Provisions
Last year I was invited by Bill Watson of the CATO Institute to make the case as to why it is critically necessary for U.S. negotiators to insist on strong IP provision in our trade agreements. Intellectual property-intensive industries account for about two-thirds of U.S. exports – it would be malpractice for our negotiators NOT to work to prevent foreign theft of American innovation.
(I think I got the better of my fellow panelists at that event—you can watch it and judge for yourself.)
The TPP negotiators are in Atlanta this week trying hard to work through the last few, toughest issues, and Bill is back at it again, this time arguing that the United States should not only allow, but in fact demand broad exceptions to copyright in the laws of our TPP trading partners. This again proves what I said last year – that the TPP debate is not really about trade, it’s about people who want weaker intellectual property rights. (Bill was kind enough to reference this piece of mine in his, which is always nice.) Ok, so let’s have that debate.
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