TAKE ACTION FOR LOWER DRUG COSTS! HELP SPREAD THE WORD
Consumer Catalyst has launched a social media campaign to raise awareness about how sketchy ‘Pay-for-Delay’ deals hurt consumer health! Join the discussion on twitter and share your story, using the hashtag:
Stop the #RxRacket!
Pharmaceutical companies are colluding to keep drug prices high – and taking that money right out of your pocket.
Did you know drug companies have made more than 160 secret, back-room deals that
Have kept 100 generic drugs or more off the market for years
Drive up the cost of each drug by an average of $3,000 a year
Keep all of our prescription costs high, while divvying up the spoils!
Right now, the Supreme Court is currently deliberating over whether these back-room deals are legal – but we know they’re wrong. Since 2005, as many as 142 different generic drugs have been unfairly kept from consumers, according to government reports. Delaying the launch of a generic drug lets the drug companies make bigger and bigger profits, while patients are stuck footing the bill, or going without the medicines they need.
The Supreme Court heard arguments by the drug companies, and fortunately Justices Kagan and Sotomayor raised consumer concerns – but the Court did not hear the perspective of the thousands of Americans unable to afford their medications. That’s because most people don’t even know that these deals are costing consumers thousands, and our health system billions of extra dollars, each year!
Help us raise awareness of this #RxRacket. The public deserves to know how this decision will affect us all – how thousands of Americans are being forced to choose between skipping their medications or going into credit card debt, just so that drug companies can make even more profit. Not to mention, how health care costs for everyone have gone up, because insurers pay most of these higher costs!
Whatever the Supreme Court decides, help spread the word, so we can help make sure that these deals come to an end, once and for all.
Target drugs:
If you have taken Cipro, Provigil, or Androgel, you have definitely paid more because of a pay-for-delay settlement. And according to legal experts, it is very probable that many drugs including blockbuster drugs like Lipitor, Plavix and Nexium — have been delayed by pay-for-delay deals.*
We need you to tell everyone you know that this is happening, and help gather and share the stories of people you know that have been negatively impacted.
Share these posts on Twitter, using the hashtag #RxRacket, and ask others to share their stories too. And follow us at @postscriptrx.
Join our community on Facebook to keep up with the campaign and join our email list of impacted consumers by sharing your story.
You can find all the information you would ever need about this issue on our Pay-for-Delay info page. Please also feel free to add your thoughts on this #RxRacket in the comments, below.
Thank you for helping us protect your right to affordable medicine!
*The Full List – Drugs Likely to Have High Prices from ‘Pay-for-Delay’ Deals:
Adderall XR, Aggrenox, Altace, Arthrotec, Caduet, Carbatrol, Clarinex, Comtan, Duac, Effexor XR, Eloxatin, Ethyol, Femcon Fe, Fentora, Flomax, Lipitor, Lamictal, Levaquin, Lexapro, Loestrin-24 Fe, Loprox, Lotrel, Lybrel, Namenda, Naprelan, Nexium, Niaspan, Niravam, Olux, Opana ER, Ortho Tri Cyclen Lo, Oxytrol, Plavix, Propecia, Razadyne, Razadyne ER, Rythmol SR, Sinemet CR, Skelaxin, Solodyn, Stalevo, Tricor 145mg, Vanos, Vfend, Wellbutrin XL (150 mg), Xopenex, and Zantac!
As we discussed here last week, the U.S. Supreme Court is currently deliberating over whether pharmaceutical companies can collude to reap $3.5 billion a year in excess profits from American patients. Named FTC v. Actavis (and informally referred to as “The Androgel Case”), this case addresses whether it was legal for a brand name company to pay its generic competitor to delay generic Androgel from coming to the market. Why does this matter to you? Because the generic is up to 10 times cheaper than the brand name drug and Androgel is not the only brand name drug where a generic has been delayed. As Columbia University professor Scott Hemphill puts it, “[A] pay-for-delay settlement transfers wealth from consumers to drug makers, in the form of continued high pharmaceutical prices, with brand name firms sharing a portion of that transfer with the generic firm.”
The decision in this case would have far-reaching impact on the price of at least 140 different drugs whose costs have remained high because of such back-room deals. Since the Court heard oral arguments in the case last Monday, the Washington Post, Boston Globe, and smaller newspapers such as Sonoma County’s Press Democrat have all come out in agreement with us: these payments have to stop. Why?
The financial burden of monthly out-of-pocket drug costs has forced millions of Americans without drug coverage to cut back on taking their drugs or delay other health care. Even if you have insurance, co-pays for a brand name drug whose generics have been blocked can be a significant hardship—and your insurance company pays more, too. For example, the price of the drug Provigil skyrocketed from $300 a month in 2007 to over $1,000 per month in 2010 because in 2005 and 2006, Provigil’s manufacturer, Cephalon Corp. paid $136 million to four different generic drug companies to delay generic Provigil for 6 years—while Cephalon made more than $3 billion on U.S. sales of Provigil. In response, many insurers stopped covering the drug, forcing consumers onto Cephalon’s new drug “Nuvigil,”which many consumers reported to be less effective.
Meet two patients whose lives were turned upside down by the pay-for-delay deals that kept generic Provigil off the market:
Tanna
A state librarian in Fayetteville, MI, Tanna has been taking Provigil for more than ten years to treat idiopathic hypersomnia, a disease causing excessive sleep. Her son has narcolepsy, a related disease. When Tanna’s son first received his diagnosis, he was on Provigil as well, but Tanna’s insurance company forced them both to switch to Nuvigil. Neither of them could tolerate the drug and her son successfully switched to an ADHD drug for his symptoms, but Tanna has tried everything and Provigil is the only drug that works for her.
Much of Tanna’s suffering ended after she was diagnosed and prescribed Provigil. She has obtained her Master’s in Library Science and is able to work – as long as she takes her medicine.
While Tanna says Provigil has given her life back, its high price exacted a toll in return. Instead of decreasing with time, Tanna’s copay more than doubled from $35 a month in 2005 to $75 a month in 2009.
“If ten years ago, someone told me the percentage of my salary I’d be paying a month in health-related costs now, I’d say they were crazy,” Tanna said.” We’ve managed to pay our bills, but I have no savings, no safety net. We’ve done what families do – we’ve used credit cards. There’s no way I can ever think of retiring, but I always wanted to work, so I guess I’m getting my wish.”
While her doctor promised there would be a generic version of Provigil in2008, she has only seen the price reduced in the past three months (her copay is now down to $12 a month).
Tanna knows the Supreme Court decision will greatly affect everyone who relies on prescription drugs.
“If they [the drug companies] win this case then they can do whatever they want. Forever,” she said. “We’re screwed.”
Karen
Prior to Karen’s diagnosis with multiple sclerosis (MS), she barely took an aspirin. In the eight years since her diagnosis, Karen, a busy mother of three, has relied on Provigil. Unfortunately, while Provigil gives Karen the energy she needs to function, it is prohibitively expensive. A resident of Clarkston, MI, she served as a worker’s compensation administrator at a major automobile company until her MS forced her to stop working in 2005. When Karen stopped working, she had two mortgages and three young children. As she discussed with Ed Silverman on Pharmalot, between 2007 and 2010 the price Karen paid for Provigil more than doubled, from $7.26 a pill to $16.87 a pill (with her insurance company paying half). During this time, she was unable to afford her prescription in addition to her normal household expenses, either skipping doses or splitting pills to reduce costs.
In 2011, Karen had a major MS relapse. While crippled by fatigue, she was overwhelmed by the price of Provigil – she could not afford to continue paying for her medicine out-of-pocket, so she had to stop taking it, despite her doctor’s recommendation.
Since a generic version of the drug was released in October of last year, Karen has been able to take her full dose and pays only $16 every three months. The release of generic Provigil and its lower cost has enabled Karen to lead an active life, spending more time with her family, volunteering at church and even hosting a Japanese exchange student.
The Rest of Us
Tanna and Karen are not alone – if you’ve paid for Androgel, Augmentin, BuSpar, Cardizem, Cipro, K-Dur, Nolvadex (tamoxifen), or Provigil, it is almost certain you’ve paid too much because of pay-for-delay deals based on records from the FTC and other lawsuits. Legal scholars and experts also suspect (the documents are secret) that pay-for-delay agreements have delayed generic versions of nearly fifty more drugs, including Lipitor, Plavix, Nexium, Zantac, Effexor XR, Lamictal Cipro, Adderall XR*, Wellbutrin XL (150 mg), Provigil*, Altace, Niaspan, Nolvadex (tamoxifen), Caduet, Zantac and many others (see full list in box).
If you have paid for one of these drugs in the last few years, you too might have been fleeced by a pay-for-delay agreement that kept a generic off the market. Please share your story with us, like Tanna and Karen did, and join them in the fight to stop these unfair deals, once and for all.
Khadijah M. Britton, JD, Program and Policy Associate
Drugs Likely to Have High Prices from Pay-for-Delay
Second Circuit takes a pass on reviewing the legality of pay-for-delay settlements
A negative court decision before the Second Circuit this week underscores the importance of passing federal legislation to ban ‘pay-for-delay’ settlements in order to preserve access to affordable, quality prescription drug benefits. At issue is the drug industry practice of paying off generic competitors of expensive brand-name drugs to delay access to low-cost generics. See our earlier blogs here and here.
On Tuesday, the Second Circuit issued a decision on the legality of pay-for-delay settlements concerning the drug Cipro that dealt a blow to consumer advocates and consumer protection attorneys challenging these collusive agreements in court. The decision rebuffed the Federal Trade Commission, the Department of Justice, and a group of State Attorneys-General, all of whom asked the Court to re-evaluate an earlier precedent from 2005 that allowed such ‘pay-for-delay’ settlements.
While the attorneys ponder whether to appeal the case to the Supreme Court, the importance of a legislative solution to this problem becomes even more clear.
Current legislation before the U.S. Senate proposed by Senators Herb Kohl (D-WI) and Richard Durbin (D-IL) would create a presumption that any drug patent settlement that exchanges a payment in return for an agreement to delay bringing a generic to the market is a violation of anti-trust law. The bill gives the FTC the tools to challenge such settlements. However, it still allows the drug companies to prove that a settlement is not a collusive agreement, but a legitimate effort to avoid the time and costs of litigation.
Why is a ban on pay-for-delay settlements important? Since 2005, Congress has responded to concerns about potential collusion by requiring the drug industry to file any settlement of patent litigation concerning a generic drug under seal with the FTC. Since 2004, the FTC has reviewed these settlements, and found that an increasing number of ‘pay-for-delay’ sweetheart deals have been made since the courts started to allow them in 2005. Last fiscal year, a record 19 such pay-for-delay deals were made. By the nine month mark of this fiscal year on June 30, the record was broken, with 21 new pay-for-delay settlements.
These settlements have prevented billions of dollars in possible savings, by preventing generic drugs from being available. At a time when consumer advocacy groups like AARP are documenting exhorbitant price increases for brand-name drugs, generic drugs are the best solution. Another recent report found that every 2% increase in generic use saves Medicaid $1 billion a year.
The FTC, which reviews these agreements, reported in January 2010 that $20 billion dollars in annual brand-name drug spending was being insulated from generic competition by pay-for-delay sweetheart deals. Then, in July, the FTC reported that new pay-for-delay deals were shielding another $9 billion in drug spending from market competition.
How does this impact consumers? The FTC reports that pay-for-delay settlements keep a generic drug off the market for an average of 17 months. The FTC estimates that being forced to take a brand-name drug costing $300 per month, instead of a generic costing $30, would increase a consumer’s health cost by $4,590 over that 17-month period. Drugs that cost more, or that have longer delays, will cost even more.
If a robust, competitive market is to play a role in our new health care system, shielding nearly ten percent of all annual brand-name drug sales from market competition will only allow drug company price increases to continue depleting more and more of our health care resources, while putting more patient care at risk.
In a brief filed with the court, the AMA and AARP described having access to a generic drug improves the quality of patient care:
The price of a brand drug can be prohibitive for uninsured patients who do not have help covering the cost of their prescription drugs. Even for those patients who are insured but who are on fixed or limited incomes, having a generic option is often the difference between having access to a health care treatment and not having any treatment option at all.
And the lawsuit filed by PAL member AFSCME District Council 37in 2006 is challenging the pay-for-delay settlements concerning the drug Provigil, used to treat narcolepsy. This lawsuit has revealed how the lack of competition reduces patients’ quality of life or quality of care when an insurance company refuses to pay for a high-cost brand-name drug. A pastor from Ohio reports that after
paying almost $17,000 in annual premiums for my family [health insurance plan, l] ast year, I was paying around $650/month [for Provigil. I]t now costs me $852/month. That is out of pocket money I have to come up with until later in the year when I reach my deductable and I can enjoy a few months of only paying $60/month. I cannot describe to you how much stress and difficulty this has caused for me and my family the last several years. As you can imagine, with my income, I often cannot afford to refill my prescription. I often take 1/2 or 3/4 of my dosage on days I know I won’t be driving much so I can delay getting a refill. But I do a lot of driving for my work, so I am forced to spend lots of money I don’t have just so I can be safe driving.
To find out how you can support legislation to prevent these pay-for-delay settlements, please contact us!
Baker’s main point is that we have accepted the current system of using the incentive of a patent to spur research and development as inevitable and natural. It brings to mind the saying “the fish are the last ones to notice the water.” It’s vital to remember that there’s nothing natural or inherent about that system, however.
This is the system that has brought us more than 8 prescription drugs for heartburn, and more than 4 for erectile dysfunction, but no meaningful new treatments for diseases that are true scourges of humanity, like malaria and tuberculosis. Other systems might work much better at creating incentives to develop treatments, particularly for these neglected diseases that affect millions of people who happen to have the rotten luck to live in poor countries rather than in the U.S. where TV ads work to convince us all that we have restless leg syndrome, insomnia, and toenail fungus.
It’s telling that although all of the presidential candidates have talked about the greed of pharmaceutical companies, none have even dared to mention, let alone question, the conventional wisdom about how we develop drugs.
Baker offers a variety of proposals, such as increasing the budget for the National Institutes of Health, running all clinical trials through the NIH, etc. Publicly-funded medical research has a vital role to play — and we need to make sure that we don’t pay twice for drugs and medical treatments that are developed with public funds — once when we pay for the research, and again when we are forced to pay exorbitant prices for the drugs that result from that research. The discovery of Abbott Laboratories’ [NYSE:ABT] HIV/AIDS drug Norvir was made possible by an NIH research grant, yet that didn’t stop Abbott from quintupling the price of the drug. [PAL member SEIU Health & Welfare Fund is a plaintiff in an ongoing class action lawsuit against Abbott for this price increase. See more about that case here.)
Some highlights of the truthout.org piece:
The most remarkable part of this story is we do not even have a public debate on how we finance drug research. The United States is currently spending almost $250 billion a year for prescription drugs. If drugs were sold in a competitive market, without government-imposed patent monopolies, we could save close to $200 billion a year. The $200 billion in higher drug prices buys a bit less than $25 billion a year in pharmaceutical research, according to the Congressional Budget Office. Paying $8 in higher drug prices for $1 in research does not seem like a very good deal.
Furthermore, as economists who don’t work for the drug companies will tell you, the huge markups created by patent monopolies are an invitation to corruption. When a drug company can sell a drug for $500 that costs it $4 to manufacture and distribute, it has an enormous incentive to mislead doctors and the public about the safety and effectiveness of the drug. And, when the drug company performs the research on the drug, and controls the dissemination of research findings, they also have the ability to act on this incentive.
Under the current system, we should not be surprised to find drug companies conceal evidence that their drugs might be ineffective or even harmful. Given the structure of the incentives that the government has created, we should be surprised if drug companies are not dishonest.
There are many different alternatives to patent monopolies for financing drug research. In fact, the US government already spends $30 billion a year on biomedical research through the National Institutes of Health. Virtually everyone, including the drug companies, agrees this government-funded research has been extremely valuable…
We should be having a serious national debate on the relative efficiency of the current patent system and various alternative mechanisms for financing drug research. Unfortunately, the drug companies are so powerful that few politicians are even willing to consider alternatives. In fact, the drug companies are so powerful that few media outlets would even print a column suggesting alternatives. In fact, the drug companies are so powerful that few economists would ever consider researching alternative mechanisms.
Dearest Readers: From time to time, it is our pleasure to bring you posts here on the Prescription Access Litigation blog written by guest bloggers. Our latest guest blog entry is by Sarah Rimmington of the consumer advocacy group Essential Action.
It’s safe to say that most Americans are blissfully unaware of negotiations that just recently went on at the World Health Organization (WHO) in Geneva to address how pharmaceutical research & development (R&D) can benefit the literally billions of people in developing countries who lack the resources (money) to pay for prescription drugs that in many cases cost more for a single pill than many of those people earn in a day, or even longer. The issue has been conveniently ignored by the mainstream media in the United States, despite the role that American drug companies play in opposing an agenda that would bring access to medicines to many of the world’s poorest people.
We here at the Prescription Access Litigation blog tend to cover only prescription drug issues here in the U.S. (and there’s plenty to cover just in this country, mind you). But occasionally we want to use our modest blog to call attention to issues outside the borders of the U.S. The pharmaceutical market has become truly a global market, with more and more clinical trials being conducted abroad, and more and more of our drugs being produced abroad, so we here in the U.S. couldn’t ignore these global issues even if we wanted to.
Without further ado, let me turn to Sarah Rimmington, for her report on the WHO’s recent negotiations and what they mean for the issue of access to medicines for the developing world:
On May 3, representatives of more than 100 nations finished what was supposed to be the final round of talks at the World Health Organization (WHO) in Geneva. These talks were meant to spur a medical research and development (R&D) system that works for the developing world.
The WHO Intergovernmental Working Group on Public Health, Innovation and Intellectual Property (IGWG) was set up in 2006 to develop a plan to promote new medical research and development (R&D) mechanisms to serve the twin goals of promoting innovation to meet the particular needs of developing countries, and ensuring that important medicines are accessible to people in the developing world, regardless of their income.
Despite difficult and incomplete negotiations, delegates to the IGWG took an important first step by agreeing to explore some common sense measures to promote developing country-focused innovation that does not compromise access to medicines.
Patent monopolies result in high prices
Why are R&D incentives that promote innovation plus access (“I plus A”) so important? The current patent monopoly-based system of R&D has proven inefficient at advancing a needs-driven public health agenda. This is true for rich countries as well as poor, but the situation is much worse in poor countries. This has nothing to do with the ethics of Big Pharma. It is how the system is designed. (For more information on the challenges faced by developing countries under the current R&D system, refer to this report.
The current corporate sector system of R&D is driven by the prize offering of a patent monopoly. Patents are not worth much if they offer monopolies on sales to a population that — no matter how large — has little buying power. And if the prize incentive is too small, it will not induce R&D, no matter how much it may be needed as a public health matter.
Here’s what this means in practice: Developing countries comprise 80 percent of the world’s population but amount to only 13 percent of the global market for medical products. A review by Doctors Without Borders of new drugs introduced between 1975 and 2004 found that of 1,556 new drugs put on the market, only 21 were for “neglected diseases” — diseases endemic to developing countries
It is also the case that the products developed to treat diseases that occur in all countries whether rich or poor (such as cancer, heart disease and HIV/AIDS) are often not appropriate for conditions in developing countries. For example, not enough R&D is invested in creating products that do not require refrigeration, an important feature for products to be used in countries with warm climates and unreliable electricity.
The value of the patent monopoly is based on the holder using it to profit maximize as a monopolist. It is therefore no surprise that companies holding patent monopolies charge high prices. This is what the patent enables. High prices are an increasing problem in rich, developed countries, but the brand-name pharmaceutical industry’s current pricing model — which commonly runs into the thousands of dollars a year for a single medicine, and may involve charges of more than $100,000 — leaves new medicines completely out of reach of the vast majority in developing countries.
Spurring developing country-focused innovation plus access
The WHO IGWG was set up to create a global strategy and plan of action focused on advancing developing country-focused innovation that also ensures the fruits of the innovative process are available to the people that need them.
Public health experts and advocates encouraged IGWG delegates to embrace this mandate and examine systemic approaches to support R&D that do not rely on patent monopolies or the prospect of charging high drug prices as a reward, and to identify mechanisms to make the fruits of R&D widely accessible. See statements by Essential Action and Doctors without Borders.
There are a lot of good ideas, large and small, about how to do this. Notably at the IGWG talks that ended on May 3, Bolivia and Barbados put forward a series of concrete proposals for non-patent prizes to incentivize R&D, with the resulting products to be made immediately available in generic form at competitive prices. The prize proposals focus on incentivizing several priority health needs of developing countries, such as the development of a diagnostic test for tuberculosis, new treatments for Chagas disease, and priority medicines and vaccines. The countries were hoping that the final strategy that came out of the negotiations would reference the proposals as examples of the types of initiatives that countries should examine when implementing new R&D strategies for developing countries.
There is no guarantee that these types of prize funds would work in creating innovation where now there is none or much too little. But they are interesting and provocative proposals that, in keeping with the mandate of the WHO talks, concentrate on health problems specific to developing countries.
Progress and setbacks in Geneva; one more year for bold action on R&D
The good news out of Geneva is that countries came to consensus on several important issues. These include an agreement to explore R&D incentives like prizes, and to encourage future discussions of an R&D Treaty, which would involve agreement that all countries should have to contribute to global R&D, or at least participate in the R&D system, but that there should be differential obligations based on degrees of wealth.
The bad news out of Geneva is that despite this progress, much work remains to be done to promote R&D models that will work for the developing world. IGWG delegates did agree to create a working group on financing for R&D. But one concern is that the draft strategy does not specifically reference the importance of examining the Bolivia and Barbados proposals — as well as proposals that may be developed by other countries – and that the new working group will not look at such proposals.
Another concern is that because of resistance from developed countries such as the United States, the EU, and Canada, consensus was not reached on concrete proposals to actually implement the urgently needed new incentive mechanisms. A significant amount of negotiating time was lost debating core principles such as the role of patents in creating barriers to access to medicines, and the importance of promoting the use of already-agreed to flexibilities available under international trade law to promote access to affordable generic medicines where patent protections remain a problem. A number of these issues remain unresolved and will be the subject of further talks, to take place at a later date and concluded by May 2009. For more information on the recently concluded talks see comments from Doctors without Borders and Knowledge Ecology International.
Of course, it is hard not to wonder if pressure from the brand-name pharmaceutical industry – which is based in rich countries and which along with its allies remains ideologically committed to opposing any tinkering with patent monopolies – influenced the disappointing outcomes at IGWG. Industry is concerned that tinkering in the case of health problems related to developing countries will eventually threaten the patent monopoly system in the rich world, or interfere with its ability to expand sales to the wealthy in middle-income countries.
But it’s not too late. WHO member countries have another year to finalize the R&D agreement that comes out of the IGWG process; they must be encouraged to use this time wisely by taking concrete steps to advance experiments with new institutional arrangements to promote the complementary public health objectives of innovation and access. It is time to ignore those who would subordinate public health to patent veneration or commercial concerns, and enact bold solutions that have the potential to benefit us all.
For more information on the World Health Organization R&D talks see:
Last week, we here at PAL joined 11 other consumer and public interest organizations in filing a amicus curiae (“friend of the Court”) brief in the case of Tafas / GSK v. Dudas et al. Details are below. PAL believes that manipulation of the patent process by pharmaceutical companies has a detrimental effect on consumers’ access to prescription drugs. The brief was written by the Public Patent Foundation, a member of the PAL coalition.
Consumer and Public Interest Groups Back New U.S. Patent Rules That Would Curtail Abusive Behavior By Applicants
ALEXANDRIA, VA – December 20, 2007 – A coalition of consumer advocacy and public interest groups today filed legal papers supporting new U.S. Patent Office (USPTO) rules that would curtail abusive behavior by patent applicants and improve patent quality.
In a friend-of-the-court brief filed in U.S. District Court in Alexandria, VA., the groups urged that an injunction blocking the proposed rules be lifted and they be implemented immediately.
The proposed new regulations ask applicants to justify the need for more than two continuations per application and to assist the USPTO in performing initial technological research on applications that contain an excessive number of claims.
The groups joining in filing the Public Interest Amici brief are: The Public Patent Foundation (“PUBPAT”), Computer & Communications Industry Association (“CCIA”), AARP, Consumer Federation of America (“CFA”), Essential Action, Foundation for Taxpayer and Consumer Rights (“FTCR”), Initiative for Medicines, Access & Knowledge (“I-MAK”), Knowledge Ecology International (“KEI”),Prescription Access Litigation (“PAL”), Public Knowledge (“PK”), Research on Innovation (“ROI”), and Software Freedom Law Center (“SFLC”).
“The public interest overwhelmingly supports the USPTO’s Final Rules for at least two significant reasons,” the brief said. “First, they will enable the USPTO to curtail abuses of the patent application process made by those patent applicants who seek to pervert the system to gain an unfair advantage. Second, the Final Rules will help the USPTO
improve patent quality, which is a critical issue for ensuring the patent system benefits the American public.”
The new rules were to have been implemented by the patent office on Nov. 1, but were blocked by suits brought by drug maker GlaxoSmithKline and inventor Triantafyllos Tafas.
Under current rules which allow unlimited continuations, USPTO examiners who have repeatedly rejected an application often face an endless stream of continuation applications that “may well succeed in ‘wearing down the examiner’, so that the applicant obtains a broad patent not because he deserves one, but because the examiner has neither the incentive nor will to hold out any longer,” according to professor Mark A. Lemley of Stanford Law School and Kimberly A. Moore, now a Circuit Judge on the U.S. Court of Appeals for the Federal Circuit.
Pharmaceutical companies are most likely to use continuations in order to help them keep monopolies over their drugs. According to the publication Nature Biotechnology, from 1995 to 1999, 41% of drug patents issued were based on continuations. In contrast only 22% of the patents issued in mechanical engineering were based on continuations.
The consumer and public interest groups’ brief said the new rules would:
– Curtail abuse of continuation applications and unlimited claiming,
– Help the USPTO improve patent quality, and
– Increase patent office efficiency.
The legal papers, available below, also noted that while briefs filed opposing the new rules claimed they were acting in the “public interest”, in fact they represented the narrow interests of patent holders and patent attorneys.
“Congress has intentionally implemented a patent system that balances the incentives provided to patentees with the benefit to the public of the disclosure and ultimate dedication of the resulting inventions to society,” the consumer groups said. “Thus, the public interest lies in an efficiently functioning patent system, not one that is subject to abuse and manipulation.”
The consumer and public interest groups said that despite having various missions and activities, they are united in their belief that patent law and policy should be crafted to ensure that it benefits the public interest. They “firmly believe that the Final Rules would significantly advance both the general public interest and the specific aspects of the public interest that they each separately exist to represent. Thus, the Public Interest Amici have united in this brief to express a single voice in support of the Final Rules.”
Papers Filed By Public Interest Amici Curiae, Public Patent Foundation et al., in Tafas / GSK v. Dudas et al.
Below is a new trailer for the documentary, Money Talks. The documentary is a companion to the independent feature film, Side Effects, which stars Katherine Heigl, of Grey’s Anatomy fame.
“This 50-minute documentary was created to give an in-depth, academic perspective on the questionable marketing tactics of the pharmaceutical industry, and features the commentary of investigative journalists and medical professionals including Dr. John Abramson, author of Overdosed America, and Prescription Access Litigation Project Director, Alex Sugerman-Brozan. Other notable interviewees include Dr. Bob Goodman of Columbia University, founder of the ‘No Free Lunch’ program, and Dr. Jerome Hoffman of UCLA Medical School.”
Today, Pharmalot has an item about a dispute between AstraZeneca and Pharmac, New Zealand’s drug buying agency, over a cardiovascular drug called Betaloc.
Pharmac medical director Peter Moodie had this to say about AstraZeneca’s patent tactics — a quotation that could easily apply to numerous other brand name pharmaceutical companies’ manipulation of patents to forestall competition:
“Pharmaceutical suppliers must realise that when a patent runs out, other suppliers will enter the market and it is not acceptable to hold patients to ransom for commercial gain in such an unethical way. It is not acceptable for AstraZeneca to gamble with the lives of acutely ill patients in order to protect itself from competition.”
The Public Patent Foundation (“PubPat”) is a member of the PAL Coalition. PUBPAT is a not-for-profit legal services organization that represents the public’s interests against the harms caused by the patent system, particularly the harms caused by undeserved patents and unsound patent policy.
Below is a release they issued on Wednesday, reporting that the US Patent & Trademark Office has granted each of PUBPAT’s requests to review four key HIV/AIDS drug patents held by Gilead Sciences, Inc. PUBPAT alleges that there was “prior art” that the Patent Office did not review when considering the patent applications. Prior art “constitutes all information that has been made available to the public in any form before a given date that might be relevant to a patent’s claims of originality. If an invention has been described in prior art, a patent on that invention is not valid.” (Wikipedia entry on prior art)
KEY HIV/AIDS DRUG PATENTS TO BE REVIEWED BY U.S. PATENT OFFICE: Prior Art Submitted by PUBPAT Raises Substantial Doubt Regarding Validity of Gilead Sciences Claims
New York, NY — July 18, 2007 — The Public Patent Foundation (“PUBPAT”) announced today that the U.S. Patent & Trademark Office has granted each of PUBPAT’s requests to review four key HIV/AIDS drug patents held by Gilead Sciences, Inc. (NASDAQ: GILD). The patents relate to the drug known generically as tenofovir disoproxil fumarate (TDF), a key weapon in the battle against HIV/AIDS. Gilead markets TDF in the United States under the brand name VIREAD and as a part of its ATRIPLA combination product.
Roughly 40 million people worldwide are infected with HIV/AIDS, including more than 1.2 million Americans. The U.S. Food and Drug Administration will not allow anyone other than Gilead distribute TDF in the United States because Gilead claims the four challenged patents give them the exclusive right to do so.
“Every person suffering from HIV/AIDS has a right to get the best medical treatment science can offer, without any unjustified impediments placed in their way,” said Dan Ravicher, PUBPAT’s Executive Director. “This includes Americans infected with HIV/AIDS, who are entitled to the best pharmaceuticals possible without undeserved patents making them exorbitantly expensive.”
In its March filings challenging the patents, PUBPAT submitted prior art that the Patent Office did not review before granting the patents to the Foster City, California, biopharmaceutical giant. PUBPAT also described in detail how the prior art invalidates the patents. The Patent Office has now found that PUBPAT’s filings indeed raised “substantial questions” regarding the validity of each of the four Gilead Sciences patents. Having granted PUBPAT’s requests to review each of the patents, the Patent Office will now turn to deciding whether they deserve to exist or not.
“We are very pleased that the Patent Office has agreed with us that there are indeed significant questions about the validity of the Gilead patents on TDF,” said Ravicher. “This is a very strong first step towards ending the harm being caused to the public by Gilead’s use of those patents to prevent anyone else from offering TDF to HIV/AIDS patients in the United States.”
The Gilead Sciences TDF patents challenged by PUBPAT now being reviewed by the Patent Office are U.S. Patents No. 5,922,695, 5,935,946, 5,977,089 and 6,043,230. Gilead has applied for similar patents on TDF in other countries throughout the world, including India, where they have received fierce opposition by non-profit AIDS patient groups.
More information about the reexaminations of the four Gilead Sciences TDF patents challenged by PUBPAT, including copies of the official Office Actions issued by the Patent Office granting PUBPAT’s four requests for reexamination, can be found at http://www.pubpat.org/gileadhivaidsdrug.htm
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