by Mike Masnick
Wed, Feb 6th 2013 11:57pm
by Leigh Beadon
Thu, Nov 8th 2012 12:02pm
from the no-quid,-no-quo dept
Today, in a ruling from the Supreme Court of Canada, Pfizer lost its Canadian patent on Viagra as the result of a long-fought battle with rival pharmaceutical manufacturer Teva, which sought to make a generic version of the popular drug. Though the patent was not set to expire until 2014, Teva argued (and the Supreme Court agreed, though lower courts had rejected the argument) that it was in fact never valid in the first place, because it was written in such a way as to obscure the information that is required disclosure in a patent:
P holds Patent 2,163,446 for the use of a “compound of formula (I)” or a “salt thereof” as a medicament for the treatment of erectile dysfunction (“ED”). The patent’s specification ends with seven cascading claims for successively smaller ranges of compounds, with Claims 6 and 7 relating to a single compound each. Only sildenafil, the subject of Claim 7 and the active compound in Viagra, had been shown to be effective in treating ED at the time of the patent application. Although the patent includes the statement that “one of the especially preferred compounds induces penile erection in impotent males”, the patent application does not disclose that the compound that works is sildenafil, that it is found in Claim 7, or that the remaining compounds had not been found to be effective in treating ED.
The patent application did not satisfy the disclosure requirements set out in the Patent Act, R.S.C. 1985, c. P‑4 (“Act”). The patent system is based on a “bargain”: the inventor is granted exclusive rights in a new and useful invention for a limited period in exchange for disclosure of the invention so that society can benefit from this knowledge. Sufficiency of disclosure lies at the very heart of the patent system, so adequate disclosure in the specification is a precondition for the granting of a patent.
The ruling goes back to this all-important concept a few times: without disclosure, there can be no patent. It's good to see the court making this a central point, because pharma companies are notorious for attempting to twist the patent system so they get virtually perpetual monopolies on their drugs, while still shrouding their research and manufacturing methods in as much secrecy as possible. In the US, Pfizer had a similar showdown with Teva over generic Viagra starting in 2010, in which Pfizer won using a second patent that didn't cover the active compound in Viagra itself, but rather the marketing of it as an erectile dysfunction drug. Thus, even though the core patent on the drug expired this year, Pfizer will likely retain a monopoly on it until 2019. This is in stark contrast to the UK, where the patent on using the drug to treat ED was invalidated for obviousness way back in 2000—but Pfizer still dominates the market there thanks to related patents on manufacturing methods.
Basically, Pfizer uses any method it can think of to prevent its patents from ever expiring and benefiting the public the way patents are supposed to, including writing disclosures that obscure the necessary facts. The Supreme Court was having none of it—rather than letting Pfizer retroactively fix the disclosure, or coming up with any kind of partial remedy that allowed them to retain the patent, the ruling correctly states that patents must be a deal between two sides to function, and thus the patent is (and always has been) invalid:
Although s. 27 does not specify a remedy for insufficient disclosure, the quid pro quo underpinning the Act leads to the conclusion that deeming the patent invalid is the logical consequence of a failure to properly disclose the invention and how it works. If there is no quid — proper disclosure — then there can be no quo — exclusive monopoly rights.
There is no question that sildenafil’s utility had been demonstrated as of the time of filing of the patent application. This takes the invention out of the realm of sound prediction. As to the delay of 13 years between the filing of the patent and the challenge, the relevant question is whether the disclosure was sufficient as of the date of filing, so the delay is inconsequential.
This is a big victory for Teva and a major blow to Pfizer's Viagra empire, which is slowly crumbling around the globe. It's also likely to lead to even more illegal cross-border pharma sales, and even more of everyone's favorite email spam advertising online Canadian pharmacies—but that's another story.
by Mike Masnick
Thu, Apr 5th 2012 6:11pm
from the ah,-patents dept
That's a bit of interesting background for the fact that the Italian antitrust authority recently found drug giant Pfizer guilty of abusing antitrust law in the country to try to delay or block competition from generic drugs. According to the report linked here, Pfizer was specifically called out on two points:
1. the artificial extension of the Xalatan patent in Italy by means of: a) the application of a divisional patent; b) the validation of the divisional patent in Italy; c) the application for an SPC in Italy; d) the application for pediatric extension; andPfizer is expected to appeal, and the blog post linked here (from law firm DLA Piper) suggests that it has a decent chance of having the original ruling reversed. But, really, that's quite a change in just a few decades. From being a leader in the market -- often by building on the ability to produce generics -- to one where cheaper generics (which help keep people healthy in a more affordable way) are aggressively blocked from the market by activities of giant multinational pharma companies.
2. the start of litigations aimed at discouraging or increasing the costs for the marketing of latanoprost generic products in Italy.
by Mike Masnick
Fri, Feb 24th 2012 5:46pm
from the not-cool dept
The latest is the news that tonight (as we post this), a bunch of big companies who employ some of the key lobbyists supporting the extreme nature of TPP... are hosting a fancy, expensive dinner in Washington DC. The dinner is sponsored by the US Chamber of Commerce, Philip Morris, Chevron, PhRMA, Microsoft, Pfizer, Amgen, Dow Chemical, among others... and the ambassadors from the TPP countries will all be in attendance (though we've heard, but don't have confirmation, that Australia just pulled out after realizing how bad this looked).
The next round of TPP negotiations take place next week in Australia, so it's nice that the corporate interests pushing an extreme version of the agreement get to wine and dine all of the key negotiators at an expensive and closed off dinner in DC, huh? Public interest groups? They just found out about the dinner today and (as you might expect) really aren't welcome.
What's amazing to me is how incredibly tone deaf the USTR and the US government is to how this appears. The USTR is negotiating a massive agreement that will change IP laws in pretty significant ways which clearly could favor some of these large companies. And just days before they're set to negotiate... they're letting some of the biggest special interests supporting an extreme vision for TPP buy them a fancy dinner? Even if you can believe that they're not actually influenced by this, do they not realize just how bad this looks?
by Mike Masnick
Wed, Nov 16th 2011 6:55am
A Look At The Testimony Given At Today's SOPA Lovefest Congressional Hearings... With A Surprise From MasterCard
from the they-said-what-now? dept
First up, the most troubling of all: Maria Pallante, the Register of Copyrights (aka, Head of the US Copyright Office). She should be here to defend the public and to make sure that massive regulatory capture by a couple of stagnant industries doesn't happen. But, that's not how the Copyright Office rolls. Instead, her testimony is basically the US Chamber of Commerce's key talking points (perhaps not a surprise, since the main lobbyist at the US Chamber who's in charge of shepherding this bill into law only recently worked at the US Copyright Office). If you had hoped for some reasoned argument about pushing back on the massive excesses of SOPA and the broad definitions, you're not going to get it from Pallante.
It is my view that if Congress does not continue to provide serious responses to online piracy, the U.S. copyright system will ultimately fail. The premise of copyright law is that the author of a creative work owns and can license to others certain exclusive rights – a premise that has served the nation well since 1790. Congress has repeatedly acted to improve enforcement provisions in copyright law over the years, including in the online environment. SOPA is the next step in ensuring that our law keeps pace with infringers....In other words, the successful tech industry should be hindered and shackled because my friends in Hollywood are too clueless to adjust their business models. Really?
The response provided by SOPA is serious and comprehensive. It requires all key members of the online ecosystem, including service providers, search engines, payment processors, and advertising networks, to play a role in protecting copyright interests – an approach I endorse. Combating online infringement requires focus and commitment. It should be obvious that we cannot have intermediaries working at cross-purposes.
SOPA is also measured. It appropriately provides much broader tools and flexibility to the Attorney General than it provides to copyright owners. This is a sound policy choice at this time. The Department of Justice has experience fighting online infringers, will use resources carefully, must exercise prosecutorial discretion in bringing actions, and must plead its case to the court and obtain a court-issued order before proceeding. Put another way, while the copyright industries are extremely important (and certainly a point of pride with respect to the U.S. economy), SOPA recognizes that many sectors rely on, invest in, and contribute to the success of the Internet.Almost none of that is accurate. It is not measured. It is vague, broad and dangerous. The Justice Department's "experience" going after infringers has been to take down websites with no notice based on false info from copyright holders... and then to threaten those who seek to appeal with criminal charges. This is not "using resources carefully," it's government sponsored censorship.
It is for this reason that SOPA puts only limited tools in the hands of copyright owners, and provides the Attorney General with the sole authority to seek orders against search engines and Internet service providers. This is not to say that we should not continue to assess Internet piracy and the impact of SOPA or whether additional measures or adjustments may be needed. Indeed, SOPA assigns ongoing studies to the Copyright Office and the Intellectual Property Enforcement Coordinator for these very purposes. But I do think SOPA provides the right calibration at this time.First off, the "limited tools" include the ability to completely cut off funding to any website based solely on accusations. Perhaps I learned a different language from Pallante, but that's hardly "limited."
Furthermore, how the hell can she say that this is "the right calibration," when even she admits this issue has not been studied yet? The bill is completely "shoot first, measure later," with no details on how it's effectiveness -- or harmfulness -- will be measured.
As with any legislation, SOPA deserves and can only benefit from a robust discussion. As the Committee works to further improve and refine the bill, I know it will fully consider a variety of perspectives and suggestions, including from my fellow witnesses. This said, I believe that Congress has a responsibility to protect the exclusive rights of copyright owners, and I urge the Committee to move forward with this in mind.Yes, a robust discussion that leaves out nearly everyone opposed to the bill, and only allows a single party -- one easily dismissed -- to speak about concerns on the bill. A robust discussion that leaves out public interest groups, despite Copyright's entire purpose being for the benefit of the public. This is a shameful bit of testimony from the Head of the Copyright Office, and one that guarantees her a tarnished legacy in her role.
From there, she goes on to defend the US blacklist of sites the Attorney General decides are dedicated to infringement by (1) repeating the US Chamber's debunked talking points, (2) praising ICE's highly questionable domain seizures, which are currently being litigated (a fact she conveniently ignores) and (3) quoting (of course) Floyd Abrams, leaving out that he was paid by the MPAA to give that opinion. Even worse, she quotes the really questionable part of his claim:
It also bears repeating that injunctions are not at odds with the First Amendment. As noted First Amendment scholar Floyd Abrams has observed, they are "a longstanding, constitutionally sanctioned way to remedy and prevent copyright violations."This is true, but highly misleading. Injunctions are allowed against those infringing. But that's not what SOPA is about. SOPA is about issuing injunctions on innocent third parties. That's what we're concerned about. And for Pallante to ignore that point is really unfortunate.
She then goes on to defend the private right of action to kill off websites based on a single accusation. She claims, laughably, that because the private right of action only leads to injunctions, rather than monetary rewards, there's little incentive to abuse. Wait. Is Ms. Pallante totally ignorant of the past decade plus of the DMCA? The DMCA takedown process also is basically about blocking content and not about monetary relief, and yet it's widely abused, with some estimates suggesting that over 30% of DMCA takedowns are questionable. The problem with SOPA (totally ignored again) is that unlike the DMCA -- which targets the specific content -- SOPA will kill off entire sites.
Even more stunning: rather than suggesting that such abuses may come from copyright holders sending bogus takedowns, she worries instead that payment processors and ad networks may ignore such takedowns -- and hints that if anything, the bill may need refinement on that front. Whoa. It's like an alternative universe where everything is mirrored. Again, we know what happens. We have the less draconian DMCA already and see how widely it's abused. And we see that those who receive takedowns generally abide by them.
Speaking of the DMCA, she pretends -- totally against the text of the actual bill -- that nothing in SOPA will impact the DMCA. This is hilarious. Why would anyone use the DMCA to take down a specific piece of content when they can now kill off an entire site using SOPA? Amusingly, she points to the fact that payment providers and ad networks face no monetary liability under SOPA... but ignores that just two paragraphs above, she was hinting that perhaps the law should be changed to include such liability to make sure they comply. This is the ultimate in cynical, obnoxious politics. Put in that one clause that makes you able to pretend something is reasonable (no monetary punishment!) and then be ready to remove that the second the bill is in place.
Finally, she talks about how "pleased" she is that SOPA turns streaming into a felony. Apparently Pallante would prefer people no longer stream videos any more. Has she even used the internet? Amusingly, she cites YouTube as an example of a legal source for streaming... ignoring the fact that under SOPA, YouTube likely wouldn't have even existed. It's as if she doesn't even understand the bill she's supporting and what it will do to the technology world.
And people wonder why so many Americans think copyright law is a joke? Perhaps they should look at the Copyright boss.
Next, we've got MPAA VP Michael O'Leary. His testimony is really worthy of having been written in Hollywood, seeing as it kicks off with a tearjerker of a story about the poor, poor stunt coordinator, "who depends on the residual payments he earns to help support his wife and three children between productions." Of course, the rest of the world doesn't get to sit back and get a check for work they did in the past, but actually has to keep working to support their families. Of course, how much do random key grips, stunt coordinators and boom mic operators (the favorites for these multi-millionaires to exploit in this kind of way) really make from residuals? It's a lot less than these kinds of testimonies suggest.
O'Leary continues to pull at heart strings, by trying to rope all sorts of other businesses into the movie and TV industry including (I'm not joking) the dry cleaners that serve the cast and crew on location. Apparently, without movies, dry cleaners go out of business. Think of the poor dry cleaners!
by Mike Masnick
Tue, Nov 15th 2011 5:51am
from the what-are-they-afraid-of dept
Why is the Judiciary Committee so afraid to hear the concerns of the wider internet industry?
The five "pro" speakers are the Register of Copryights, someone from the MPAA, someone from Pfizer, someone from MasterCard, and someone from the AFL-CIO. The choice of MasterCard is deliberate, since Visa is against the bill -- because Visa recognizes that supporting a bill that requires them to cut off customers based on accusations of infringement is going to be a huge burden, and one that isn't good for their own customers.
Furthermore, the "one" against SOPA is going to be Google. This is a strategic choice, because the pro-SOPA folks know that Google is easy to dismiss on this topic, because they'll claim (not accurately) that Google just wants to profit from infringement. Google is already under a lot of scrutiny in Congress, and so it makes it much easier for pro-SOPA supporters to say that "ah, the only opposition is Google." And, yet, that's not true. Companies throughout the tech and internet industries have expressed concerns. Facebook, Twitter, Mozilla, eBay and over 160 startups have all come out against the bill. This isn't "just a Google issue." This is an issue of the entertainment industry trying to change the fundamental legal and technical framework for how the internet has functioned -- and in doing so, creating tons of liability and compliance costs for the part of the economy that is growing and has been creating jobs. Just because Hollywood is jealous, doesn't mean that they should get to use Congress to punish the industry that's doing well.
Either way, it's quite stunning that the Committee has decided to go so far in stacking the deck, and it shows just how unwilling they are to hear the real concerns about the bill.
by Tim Cushing
Wed, Jul 6th 2011 9:21am
from the our-regional-sales-rep-will-help-you-gather-your-data dept
Some more drug company ugliness has surfaced in a report published in the Archives of Internal Medicine. Examining documents uncovered during the Franklin v. Pfizer case, researchers came across details of a marketing ploy disguised as a Phase IV trial of gabapentin, a drug used for treatment of seizures and neurological pain:
"The Study of Neurontin: Titrate to Effect, Profile of Safety (STEPS)" study was a so-called seeding trial, in which the stated objective was to assess the safety and efficacy of gabapentin, but the actual aim was to increase prescribing of the drug by duping the very physicians recruited to conduct the "trial," according to three medicolegal consultants involved in litigation against the drug's manufacturer.In addition(!) to the data tampering, exclusionary tactics, unethical recruitment practices and low-level bribery, the researchers also found that Parke-Davis' (a subsidiary of Pfizer) own internal documents referred to STEPS as "a marketing strategy" and that the trial's findings were secondary to "increasing market share in new prescriptions":
In the STEPS trial, Parke-Davis recruited 772 physicians to prescribe Neurontin (gabapentin) and titrate the dose upward in patients whose partial seizures were not completely controlled by other drugs. The drug company purposefully recruited "site investigators with little or no clinical trial experience [and] provided insufficient training," and limited enrollment to about four patients per investigator.
The study design was uncontrolled and unblinded, and its rigid titration protocol led to the exclusion of 87% of the study subjects. One institutional review board that twice rejected the STEPS application to be conducted at their medical center stated that "the entry criteria and outcome measures are too vague to allow any scientific conclusions to be reach[ed]." Parke-Davis sales representatives collected and recorded individual subject data. In a clear example of data tampering, they not only attended epilepsy patients' office visits (under the guise of "shadowing" the clinician), but also actively promoted the use of Neurontin and blocked the use of competing medications, particularly lamotrigine (Lamictal), at those visits. They also rewarded participating investigators with free lunches and dinners.
"Mr. Krumholz and his coauthors clearly demonstrate that the true intent of seeding trials is to introduce a new product and induce clinicians to use it," according to Dr. G. Caleb Alexander. As others have noted, "Deception is not just an incidental part of a seeding trial, but rather the very success of the trial depends on such deception, since few institutional review boards, investigators, clinicians, or patients would willfully participate in a study with marketing objectives and little or no scientific value," Dr. Alexander wrote in commentary accompanying the report.When contacted about its ethics breach (an understatement along the lines of the "Titanic's hull breach"), Pfizer spokesman Christopher Loder responded with a canned response that he quite possibly copied right off Neurontin's (gabapentin) promotional pamphlet:
"Neurontin is an important FDA-approved medicine that physicians have prescribed to treat millions of patients safely and effectively. Neurontin has been widely studied for more than 2 decades and there is an extensive body of publicly available literature on its safety and its use."True that, I suppose. But at this point you can add "as well as a growing body of publicly available literature on its unethical testing procedures and another in a long series of black eyes for the pharmaceutical industry" to the end of that little blurb any time you want, Chris. "Now" would be good.
by Mike Masnick
Fri, Apr 9th 2010 2:37pm
from the jacking-up-the-price-on-known-medicines dept
However, Jamie Love points us to the news of a new report that found that the Indian patent office has gone against this law and issued such patents quite frequently and, no surprise, the main recipients are among the world's largest pharma companies, including Pfizer, Novartis and Eli Lilly. Is it any wonder that they've all been pushing to dump sections 3(d) and (e) all along? Remember, pharma patents are not about drug discovery, but about jacking up the prices on drugs.
by Mike Masnick
Thu, Apr 8th 2010 7:47am
How Pfizer And The US Gov't Set Up A Fake Subsidiary To Take The Brunt Of Lawsuit Over Falsely Marketed Drugs
from the don't-you-feel-healthy-now dept
The FDA approved Bextra only for arthritis and menstrual cramps. It rejected the drug in higher doses for acute, surgical pain. Promoting drugs for unapproved uses can put patients at risk by circumventing the FDA's judgment over which products are safe and effective. For that reason, "off-label" promotion is against the law.Where the story gets scary is in what happened when all this came out. Federal officials announced a criminal case over this, but they didn't actually sue Pfizer directly. Instead, they sued a (not kidding) subsidiary of a subsidiary of a subsidiary of a subsidiary of Pfizer, which was basically set up just take the brunt of this lawsuit:
But with billions of dollars of profits at stake, marketing and sales managers across the country nonetheless targeted anesthesiologists, foot surgeons, orthopedic surgeons and oral surgeons. "Anyone that use[d] a scalpel for a living," one district manager advised in a document prosecutors would later cite.
A manager in Florida e-mailed his sales reps a scripted sales pitch that claimed -- falsely -- that the FDA had given Bextra "a clean bill of health" all the way up to a 40 mg dose, which is twice what the FDA actually said was safe....
Internal company documents show that Pfizer and Pharmacia (which Pfizer later bought) used a multimillion-dollar medical education budget to pay hundreds of doctors as speakers and consultants to tout Bextra.
Pfizer said in court that "the company's intent was pure": to foster a legal exchange of scientific information among doctors.... But an internal marketing plan called for training physicians "to serve as public relations spokespeople."
According to court documents, Pfizer Inc. owns (a) Pharmacia Corp., which owns (b) Pharmacia & Upjohn LLC, which owns (c) Pharmacia & Upjohn Co. LLC, which in turn owns (d) Pharmacia & Upjohn Co. Inc. It is the great-great-grandson of the parent company.But it was only that last one, Pharmacia & Upjohn Co. Inc., that was sued -- and the report also notes that this company just happened to be set up the same day that Pfizer and federal officials worked out a deal for it to plead guilty -- even though it, as an entity, hadn't done anything.
Why did they do this? Well, if Pfizer itself had been found guilty then it would be barred from Medicare and Medicaid, and prosecutors figured it would effectively close down Pfizer -- and Pfizer was deemed "too big to fail" like that. Why? I have no idea. If the company really did have to close down, it seems likely that others would have picked up the company's various products -- and perhaps done so without putting people's lives at risk.
Really, the problem here is the way the entire system is set up. The FDA requires expensive and involved clinical trials. This is very good, because we want to make sure that any drugs actually do what they're supposed to do, and don't have serious side effects or cause even worse problems. But, the system is currently set up so that the pharmaceutical company itself is in charge of paying for and running those clinical trials, which creates two very problematic situations. First, it gives the company all sorts of incentives to fudge the results or to pretend the results said something different than they really did (see the example above, or Merck with Vioxx) and second, it contributes to the "expense" that a drugmaker can claim comes from developing a new drug, which is part of why it demands patent rights. But if you break out the costs of the clinical trials, the marketing-hidden-ad-development-costs, and the amount of research that's actually funded by gov't grants -- you find that pharmaceutical firms really aren't spending nearly as much as they claim. A big part of the issue is the clinical trials, and that's leading to all sorts of questionable behavior. In the past, some have suggested that such trials should be conducted by the gov't, rather than by the pharma companies themselves. While I'm not sure that's the answer, it's pretty clear that the existing system is not working, if our end goal is to make people healthier.
by Mike Masnick
Fri, Oct 10th 2008 11:23am