The Connecticut Attorney General is suing McKesson Corp., the nation’s largest pharmaceutical distributor, on allegations it illegally inflated wholesale drug costs for many brand-name drugs, including Lipitor and Prevacid.
Genzyme Corp. spent $640,000 lobbying the federal government in the first quarter on matters such as on patent-reform legislation and bills that would allow generic drug companies to sell cheaper copies of biotech drugs, according to a disclosure form.
Blogger J. Matthew Buchanan has opened the doors to his new firm, Buchanan Intellectual Property Office LLC (BIPO), along with a new website Effective IP.
The US Patent and Trademark Office has published what’s being dubbed as the iPhone Patent, a 371-page whopper that covers Apple’s handheld multi-touch UI paradigm in excruciating detail. Days until the arrival of the second coming: 10.
Efficacy Brands has come out with chewable, cherry-flavored dextrose tablets, Obecalp (placebo spelled backward), which are being sold as a placebo for parents to give their kids. This should go a long way in promoting a drug-free nation.
The ABA has paired with Justia.com, a legal information portal, to create a search engine covering all of the 1,800-plus blogs in our directory — including Patent Baristas. Blawg Search is like Google for lawyers.
MedImmune and Genentech have announced that they reached a settlement regarding their patent lawsuit over MedImmune’s best-selling drug Synagis®, which is used to prevent respiratory infections in infants. “The parties advise the court that they have reached a settlement,” according to a telephone conference recorded on the docket in the U.S. District Court for the Central District of California.
Lawyers had wanted to see this fight continue in light of the interesting legal questions raised — and the pure amusement value — but litigants tend to not want to continue suits just to please lawyers.
The settlement follows a Supreme Court decision last year that allowed MedImmune to sue in an attempt to overturn a Genentech patent while MedImmune continued to pay royalties to use it. Medimmune, Inc. v. Genentech, Inc., et al. (S.Ct. No. 05–608). The patent, U.S. Patent No. 6,331,415, covers a technology that uses cell cultures to manufacture human antibodies. MedImmune said Genentech had illegally obtained the patent by conspiring with a British biotech company.
Earlier, the Supreme Court ruled that licensees would have a chance to get out of bad license deals by challenging the validity of the underlying patents. The case is about whether a company must stop paying royalties on a patent license to challenge the validity of the patent. MedImmune is paying licensing fees to Genentech for an antibody technology used in Synagis, while at the same time challenging Genentech’s patent in court.
In an 8-to-1 decision, the Supreme Court ruled that MedImmune could sue Genentech for patent infringement even though MedImmune continues to pay fees to Genentech to use the disputed technology to develop the drug Synagis.
Genentech argued that MedImmune had no case since it was not seeking an interpretation of its present contractual obligations since (1) there is no dispute that Synagis infringes the Cabilly II patent, thereby making royalties payable; and (2) because while there is a dispute over patent validity, the contract calls for royalties on an infringing product whether or not the underlying patent is valid.
The Court didn’t buy this since MedImmune “disputes its obligation to make payments under the 1997 License Agreement because [petitioner’s] sale of its Synagis product does not infringe any valid claim of the [Cabilly II] Patent.” App. 136. The Court also felt that the phrase “does not infringe any valid claim” (emphasis added) cannot be thought to be no more than a challenge to the patent’s validity, since elsewhere the amended complaint states with unmistakable clarity that “the patent is . . . not infringed by [petitioner’s] Synagis product and that [petitioner] owes no payments under license agreements with [respondents].”
MedImmune had said it would vigorously pursue its case in the lower court and Genentech said it remains confident in the validity of the patent. They must have received their lawyers’ bills in the meantime.
“Let every nation know, whether it wishes us well or ill, that we shall pay any price, bear any burden, meet any hardship, support any friend, oppose any foe to assure the survival and the success of liberty.”
~ John F. Kennedy
In Memoriam
Welcome to the Memorial Day Edition of Blawg Review. I’m not a big flag-waver — out of fear that heart-felt remembrance can often lapse into misplaced jingoism. So, I was reluctant to fill in at the last moment for the Memorial Day edition after Prof. Mirko Bagaric at Moral Dilemma had a work conflict. And while Memorial Day would seem to be all about shopping — if you go by the number of ads in the paper — it is a day worth special reflection in a time of war. I offer this Review with respect for all who have fought and died for our freedoms.
On Memorial Day we honor our war dead and one of the greatest ways we can show our respect is to pledge to uphold our own constitution and laws, to pledge that there will never be wars for erroneous and misleading reasons; to pledge no more killing except for the ultimate defense of our country and our freedoms. Thus, it is appropriate that a group of lawyers should hold this day special. With great humility, I have to admit that I cannot hope to meet the standards set by previous Memorial Day Blawg Reviews (Crime & Federalism, Blawg Review and Biker Law) but I will pledge to uphold the respect the day deserves.
Originally called Decoration Day, there are many stories as to the beginnings of Memorial Day, with over two dozen cities and towns laying claim to being the birthplace of Memorial Day, but Memorial Day was officially proclaimed on 5 May 1868 by General John Logan, national commander of the Grand Army of the Republic.
The “National Moment of Remembrance” resolution asks that at 3 p.m. local time, for all Americans “To voluntarily and informally observe in their own way a Moment of remembrance and respect, pausing from whatever they are doing for a moment of silence or listening to Taps.
Constitutional Rights
While our rights and freedoms are defended by the military, they do not derive from them. Our rights and freedoms are granted to the people by the people under our Constitution (for extra points, try your hand at the U.S. Constitution quiz by the INS). That’s not true in many other countries in the world; witness Myanmar and China, as AmeriCaresmakes its first shipments into Chengdu.
Denise at Life, Law and Gender offers reactions to the decision of the California Supreme Court in the “In re: Marriage Cases” as well as a reflection on the death of Major Alan Rogers, who died in Iraq while shielding two other soldiers from the blast of an exploding IED. Alan was a gay officer and his country required him to lie in order to serve.
Sujit Choudhry at the University of Toronto Faculty of Law Blog looks at the Significance of Khadr where the Canadian Court Court held that he has a constitutional right to the disclosure of the interrogations conducted by Canadian officials in Guantanamo Bay, some or all of which were shared with American authorities. Also, see Lyle Denniston at SCOTUSblog regarding Canada Court denounces U.S. detentions.
The Volokh Conspiracy why the conservatives care so much about the courts – a survey found that 44% of Republicans picked naming judicial appointments as the top political issue compared to just 7% of Democrats. The hypothesis is that most high profile Supreme Court constitutional law decisions have considered whether to ban practices embraced by conservatives rather than whether to ban practices embraced by liberals. Mentioning abortion, school prayer, gay rights, flag burning and the death penalty, Volokh believes that a victory for the conservative side means that the political process is left unaltered while a victory for the liberal side means that the court intervenes and mandates that the majority preference — the generally conservative view — is out of bounds. I’m not sure how the end of slavery, women’s suffrage and desegregation would play into that equation.
When the Supreme Court decided Twombley (effectively raising pleading standards in the context of an antitrust case), the Drug and Device Law blog predicted that the decision would ultimately apply to all substantive areas.
Deborah Pearlstein at Slate’s legal blog notes that, according to Defense Secretary Gates, we’re stuck in Gitmo till ’09. Why? Gates says there are about 70 detainees who the DoD has cleared for release, but their home countries won’t take them back, or would take back but then release them (presumably against the DoD’s wishes).
What the Funny…Patents, operated by the guys at Rethink(IP), show how U.S. Patent 6,130,946, filed on Oct. 23, 1936, did not issue until Oct. 10, 2000 (some thirty one years after the inventor passed away) due to a secrecy order. The inventor, William F. Friedman, is considered by many to be the father of American cryptology and the application was withheld for national security reasons. [via]
Global Perspectives
China Esquire notes that “America calling for a ban on Chinese imported… bodies?!” Note, this isn’t just a ban on Chinese plastinated bodies. It’s a ban on all such imports. So, it’s not an anti-China matter. However, that we’ve gotten to a society that would even need to ban such a parade of corpses is remarkable.
The ACLU Blog of Rights presents its first symposium, Torture and America. It is shocking that, in the United States, we would even have to convene such a symposium to discuss our nation’s use of torture.
Land of the Free
Not everyone is convinced our freedoms remain intact. Some Silicon Valley folks are looking to create a permanent, quasi-sovereign nation floating in international waters. What I don’t understand is: Why go for Waterworld? Why not just buy a small island from a nation willing to part with it as sovereign territory?
David Giacalone at f/k/a touches many with his Memorial Day haiku. And asks everyone to save fuel by driving no more than 55 over the Memorial Day weekend.
Tsan Abrahamson reported that Harley-Davidson has prevailed in a trademark infringement claim concerning the term “scarecrow.” Now if they can just lock down “tin man” and “cowardly lion”, they’ll be all set.
That’s a wrap for Blawg Review #161. If I’ve missed some great posts, leave a link in the comments section below. Blawg Review has information about next week’s host, China Law Blog, and instructions on how to get your blawg posts reviewed in upcoming issues.
______
WE SHALL KEEP THE FAITH
We Shall Keep Oh! you who sleep in Flanders Fields,
Sleep sweet – to rise anew!
We caught the torch you threw
And holding high, we keep the Faith
With All who died.
We cherish, too, the poppy red
That grows on fields where valor led;
It seems to signal to the skies
That blood of heroes never dies,
But lends a luster to the red
Of the flower that blooms above the dead
In Flanders Fields.
And now the Torch and Poppy Red
We wear in honor of our dead.
Fear not that ye have died for naught;
We’ll teach the lesson that ye wrought
In Flanders Fields.
LegalZoom, co-founded by Robert L. Shapiro of People v. O.J. Simpson fame, is a do-it-yourself website for getting legal documents but not legal advice. But, of course, this raises the question: if they’re not giving you legal advice, what is it you’re getting for your money? Well, it appears you get some forms filled out with your specific information.
They claim to take your information and insert this into the proper forms but I have difficulty seeing how that can’t lapse into legal advice. Often, what information is inserted in which box comes down to making a legal judgment call. Caveat: the site claims that before you submit your order, a LegalZoom professional (but not a lawyer) will review the answers you provide on the questionnaire for consistency, completeness, spelling and grammar so presumably there is some check on how you filled in the blanks.
Two new services by the company are filing of patent and trademark applications. These services include:
Patent filings are divided between provisional patent applications, design patent applications and utility patent applications. I’m not sure lay inventors will fully appreciate the differences between these types of applications.
Under provisional patent applications, the site assures you that you will:
Receive immediate “Patent Pending” status and secure a priority filing date for a full 12 months. A Provisional Patent protects the way your invention works and how it’s used. It’s a quick and inexpensive way to protect your machine, manufactured item or business process.
Would everyone understand all the implications of provisional applications? I’m not so sure. Provisional applications sound nice but can be a dangerous step if entered into without proper guidance. Even the USPTO offers a laundry list of cautions about their use:
Provisional applications are not examined on their merits.
It is recommended that the disclosure of the invention in the provisional application be as complete as possible. In order to obtain the benefit of the filing date of a provisional application the claimed subject matter in the later filed non-provisional application must have support in the provisional application.
A provisional application automatically becomes abandoned when its pendency expires 12 months after the provisional application filing date by operation of law. Applicants must file a non-provisional application claiming benefit of the earlier provisional application filing date in the USPTO before the provisional application pendency period expires in order to preserve any benefit from the provisional-application filing.
The section on utility patent applications describes a different approach:
First, Claim Your Idea using LegalZoom’s Patent Pending Service. Before you commit to filing your patent, you can receive immediate “patent pending” status for your invention along with key materials and services needed to prepare your patent application.
Next, File Your Patent using an Attorney Service Package. An attorney will reference your LegalZoom materials and work with you directly to draft and file your patent application. You’ll enjoy expert patent attorney services and consultation for a fraction of the typical cost.
I’m not sure how you get immediate “patent pending” status for your invention before you even “commit to filing your patent.” Using the words “patent pending,” or any word importing that an application for patent has been made, when no application for patent has been made, or if made, is not pending, is subject to penalties under 35 U.S.C. 292. I’m also not sure it’s really a big selling point that it is endorsed by Bill O’Reilly but I’ll leave that to others.
The Patent Pending Service does include a “Provisional Application for Patent,” a comprehensive (their word, not mine) search for prior patents and a preliminary review and assessment by a patent attorney. See caveats on provisional filings above. The bottom line is simple: if the disclosure in the provisional is not adequate to support the invention, no priority date will be obtained.
Then again, the site does have lots of disclaimers like:
Furthermore, the legal information on this site is not legal advice and is not guaranteed to be correct, complete or up-to-date. Because the law changes rapidly, LegalZoom cannot guarantee that all the information on the site is completely current. The law is different from jurisdiction to jurisdiction, and is also subject to interpretation by different courts. The law is a personal matter, and no general information or legal tool like the kind LegalZoom provides can fit every circumstance. Therefore, if you need legal advice for your specific problem, or if your specific problem is too complex to be addressed by our tools, you should consult a licensed attorney in your area.
Interesting. So, I guess you can’t assume anything they do for you is correct. I’m not endorsing or recommending for or against anything here, I’m just offering that this site does exist. I will tell you that our firm often does more legal work for people that don’t ask for advice ahead of time than do. That is, we do more work after a client has already forged ahead and gotten into trouble than if they had asked for guidance beforehand. I offer this tidbit without fear of losing lots of business — very few people will take the recommendation of seeking advice early and often.
The most shocking part of the LegalZoom site is the note that “Patent attorneys typically charge $600/hour.” [Special note to readers, if you are paying $600/hour for patent drafting, please contact me immediately. I know no one who charges that much.]
LegalZoom claims to have helped over 400,000 satisfied customers take care of common legal matters and that their documents contain “advanced provisions not found in simple “do-it-yourself” kits or manuals.” At least they offer a 100% Satisfaction Guarantee so that if you are not satisfied with the services for any reason, they will correct the situation or provide a refund, your choice.
It’s a minefield of legal dangers out there so tread carefully.
Brand-name and generic medicines: Both play an important role in health care today
by Larry Lucas
My job representing America’s pharmaceutical research companies requires me to be on the road a lot. As a “road warrior,” I spend a great deal of time in communities across the country talking to patients about the health care issues that matter most to them. Without a doubt, the most common question asked of me is, “Larry, what’s the difference between the generic and brand-name medicines my doctor prescribes?”
First, let’s consider brand-name medicines. New, brand-name medicines are on the cutting-edge of science with each medicine representing an average of $1 billion and 12 to 15 years of research and development. Creating and discovering these breakthrough medicines is complex; the chances of a drug making it from the lab to your medicine cabinet are remarkably small. On average, only five of every 10,000 compounds investigated make it to clinical trials. Of those five, only one is ever approved for patient use.
With the time, money and risk involved with creating and discovering new medicines, some may wonder why we bother. The answer is simple: New medicines help people live longer, healthier lives. A study by the National Bureau of Economic Research noted that new medicines account for 40 percent of the increase in longer life spans. And while new medicines might cost more than older ones, they can help save on overall health care costs. A study by Columbia University economist Frank Lichtenberg found that each additional dollar spent on using a newer prescription medicine (instead of an older one) saves more than $5 in other health expenses.
Each patient is unique in how their bodies respond to particular medications, and there might be instances where your doctor determines an older medicine with a generic equivalent to be your best treatment option. But what is a generic medicine, exactly? The Food and Drug Administration (FDA) defines a generic drug as a copy of a brand-name drug in dosage, safety, strength, how it is taken, quality, performance and intended use. Generic medicines play an important role in health care today; they currently account for 67 percent of medicines prescribed, according to data from IMS Health. But only your physician can decide if a generic medicine is best for you.
Everyone wants to save money, of course, and taking the generic equivalent of brand-name medicines can be a good way to do that. But generic medicines might not always be the best option for you. First, not every medicine has a generic equivalent. Second, generics may have different dosage requirements. For example, the brand-name version of a medicine may require you to take the medication once daily, whereas the generic version requires you to take it three times per day. This kind of change might not work for you. As with any prescription medicine – generic or brand-name – it’s important to consult your physician about all of your health care options.
The Partnership for Prescription Assistance (1-888-4PPA-NOW or www.pparx.org), a national program sponsored by America’s pharmaceutical research companies, can also help you save on your prescription medicines. This program provides a single point of access to information on more than 475 patient assistance programs. More than 2,500 brand-name and generic prescription medicines are available through the participating programs. So far, the program has already helped nearly 5 million people in need nationwide.
America’s pharmaceutical research companies are committed to helping patients, and that means developing newer, better medicines. One of every five dollars in revenue is poured back into research and development. This investment is making a significant impact on many health conditions that disproportionally affect African Americans; today there are 114 medicines in development to treat cardiovascular disease, 95 medicines in development for diabetes and 67 medicines that target HIV infection. These medicines will go a long way to helping close the health disparity for our community.
Larry Lucas is a vice president for Pharmaceutical Research and Manufacturers of America (PhRMA).
While it seems that just about everyone is jumping on the green bandwagon, there is money to be had in global disaster, too. Climate change can be profitable.
Human-induced climate change could trigger climate shocks in all ecosystems that will profoundly affect crops, livestock, fisheries and forests and the billions of people whose livelihoods depend on them. Extreme climate events (especially hotter, drier conditions in semi-arid regions) are likely to slash yields for maize, wheat, rice and other primary foodcrops.
Seed companies are now positioning themselves to take advantage of such changes with genetically engineered seed crops that can withstand such changes. While good for the seed companies, this has some groups concerned. ETC Group, a nonprofit dedicated to the conservation and sustainable advancement of cultural and ecological diversity and human rights, has issued a report showing the policy implications of such a gene patent grab.
The group sites examples such as:
A temperature increase of 3–4 degrees Celsius could cause crop yields to fall by 15–35 percent in Africa and west Asia and by 25–35 per cent in the Middle East according to an FAO report released in March 2008.
65 countries in the South, most in Africa, risk losing 280 million tonnes of potential cereal production, valued at $56 billion, as a result of climate change.
Projected increases in temperature and changes in rainfall patterns will decrease growing periods by more than 20 percent in many parts of sub-Saharan Africa.
Farmers in dryland areas of sub-Saharan Africa will experience revenue losses of 25% per acre by 2060. The overall revenue losses of $26 billion per annum would exceed current levels of bilateral aid to the region.
The report shows that many of the world’s largest seed and agrochemical corporations are obtaining patents on genes in plants genetically engineered to withstand environmental stresses such as drought, heat, cold, floods, saline soils, and more. BASF, Monsanto, Bayer, Syngenta, Dupont and biotech partners have filed 532 patent documents (a total of 55 patent families) on so-called “climate ready” genes at patent offices around the world.
This can be seen two ways: One, it is a way for companies to prepare to meet a foreseeable demand in the face of climate change and a potential world food crisis. Or, it is an opportunity for corporations to push genetically engineered crops using climate change as a scapegoat. The truth is probably somewhere in between but the concern is that proprietary technologies will ultimately concentrate corporate power, drive up costs, inhibit independent research, and further lessen the ability of farmers to save and exchange seeds.
Beyond the U.S. and Europe, patent offices in major food producing countries such as Argentina, Australia, Brazil, Canada, China, Mexico and South Africa are also seeing huge increases in patent application filings. Monsanto and BASF have put togehter a $1.5 billion partnership to engineer stress tolerance in plants. Together, the two companies account for 27 of the 55 patent families (49%) of those identified by ETC Group.
The question now according to the ETC Group: “Will farming communities now be stampeded by climate change profiteering?” While I disagree with their assertion that “the patent grab on so-called climate-ready traits is sucking up money and resources that could be spent on affordable, farmer-based strategies for climate change survival and adaptation,” there can be an issue when the top 10 seed companies control 57% of the global seed market.
ETC Group is now urging governments meeting at the U.N. Convention on Biological Diversity in Bonn (May 19-30) and at the joint United Nations-FAO High-Level Conference on World Food Security and the Challenges of Climate Change and Bioenergy (3-5 June 2008) must recommend that governments suspend the granting of all patents on climate change-related genes and traits.
The indefatigable Blawg Review Editor has asked Patent Baristas to host the next Blawg Review after Aussie law professor Mirko Bagaric of Moral Dilemma was unable to fulfill his duties due to an unexpected scheduling conflict with a case.
In the interest of God, Country and mercy, please send me your suggested additions to Blawg Review #161, which will be held next Monday. Keep in mind that it will be on Memorial Day so it would be helpful to have additional suggestions to honor the occasion. I’d especially like to hear from/about sites that are not perennials on Blawg Review.
We’ll try to do justice for the event although the bar has been set quite high after last week’s Law Blog Review for the Week of May the 19th in the Year of Our Lord Two Thousand and Eight hosted by Mistress Ruthie at Ruthie’s Law. I think we shall now go and enjoy some tea whilst we ponder our task ahead.
The book “Patent Appeals: The Elements of Effective Advocacy in the Federal Circuit” by Mark Simon Davies (Oxford University Press, USA) provides detailed guidance for IP lawyers on the requirements for an appellate brief set out in the Federal Rules of Appellate Procedure 28(a). The book inherently focuses on the U.S. Court of Appeals for the Federal Circuit but other appellate courts are also covered (e.g., the Ninth Circuit and Second Circuit).
Not being an appellate lawyer, I was hesitant to review a book on such a specialized topic. Patent prosecution and transactional lawyers tend to steer clear of arcane rules regarding what size font to use in a brief and debating whether it would be better to use serif or sans serif. But I gave it a read after deciding that all patent work is about obtaining patent protection that is ultimately found to be both infringed and valid. In the end, that means getting past any final review at the Fed Circuit.
Like it sounds, the book covers the nitty-gritty regarding the organizational requirements for an appellate brief. However, along the way the author provides some insight on the informal expectations and special challenges presented by a patent appeal. Each chapter contains general advice on how to prepare a certain section of the brief — from Statement of the Facts to Summary of the Argument — along with samples and some inside tips. The book also covers post-briefing issues, petitions for panel rehearing and rehearing en banc as well as advice on hiring appellate co-counsel.
What’s important is that the author sets out the new dynamic of patent law where the Federal Circuit is under intense scrutiny by the Supreme Court. Between 1998 and 2005, the Supreme Court took up ten cases (10 of 502 or double the historic average) and reversed in 9 of 10 of these cases. The take-home message is that everything has to be geared as though addressed to the Supreme Court and the author urges avoiding reliance on any kind of Federal Circuit test. From eBay v. Mercexchange to KSR Int’l Co. v. Teleflex Inc., the Supreme Court has shown time and again that it just doesn’t think much of the Fed Circuits cute little tests. In KSR, the justices show their disdain in a protracted exchange:
Chief Justice Roberts: “It adds a layer of Federal Circuit jargon that lawyers can then bandy back and forth, but if it’s — particularly if it’s nonexclusive, you can say you can meet our teaching, suggestion, or motivation test or you can show that it’s nonobvious, it seems to me that it’s worse than meaningless because it complicates the inquiry rather than focusing on the statute.”
Goldstein: “Mr. Chief Justice, the reason that the Federal Circuit disagrees and over 30 years this special court has elaborated this problem – is that we need a guidance, we need guidance for the lower courts. We need to focus them on the right question, and for patent examiners and patent practitioners, and the right question is not is — was someone merely capable of putting the two together. The right question is is there any reason to believe that it would have been apparent at the time of the invention to create this invention whether it’s through a teaching, a suggestion, a motivation.”
Justice Scalia: “I agree with the Chief Justice. It is misleading to say that the whole world is embraced within these three nouns, teaching, suggestion, or motivation, and then you define teaching, suggestion, or motivation to mean anything that renders it nonobvious. This is gobbledygook. It really is, it’s irrational.”
Practice tip: avoid reference to any test.
Mark Simon Davies is a counsel in O’Melveny & Myers LLP’s Washington, D.C. office. He has argued more than twenty-five cases, including Festo Corp. v. SMC, Corp., Fed. Cir. No. 95-1066 (en banc), and Southco Inc. v. Kanebridge Corp., 3d Cir. 02-1243 (en banc).
Editor-in-Chief Barista Stephen Jenei is a patent attorney and Owner of Jenei LLC. When not serving up patent chat over a steaming cup of java, he's handling a diverse intellectual property practice in the biotechnology, pharmaceutical and chemical fields. More info @ Jenei LLC