Gene Quinn over at IP Watchdog is doing a survey to see what sites people think are the top patent blogs. We’re not sure if there can ever be a list of top blogs given the differences in focus but it is a way to discover some new patent blogs, so take a look.
The survey only allows you to pick one top blog but it does give you the option to list all of the blogs you read regularly.
Take the two question Patent Blog Survey here.
BIO Conference attendee Cynthia Shippam-Brett picked up an Apple (PRODUCT) RED Special Edition iPod shuffle after being the first person to find me on the Exhibitor Hall floor at Bio2009 and ask for the Patent Baristas’ iBarista iPod.
Cynthia is a member of the Intellectual Property Group in the Vancouver office of Gowlings. While her practice is focused on patent prosecution and drafting for the life sciences, she said she’d enjoy listening to the iPod.
After spending time talking about US and Canadian patent prosecution over Tim Horton’s coffee — and getting a good laugh about the merits of trying to traverse a restriction in the US — Cynthia gave me a stuffed red blood cell toy to give my daughter. I wonder what nightmares that could cause?
Sir Elton John gave the keynote address today at the 2009 BIO International Convention today in Atlanta. He emphasized that we need to get past our “standing stereotypes and prejudices that inhibit our efforts to combat AIDS.”
Citing such stigmas, he noted that HIV/AIDS has fallen off the radar yet there is a critical need for advances in the treatment of HIV/AIDS. “All of us must confront the reality of the AIDS epidemic,” he implored.
Elton John spoke about having lost 60 friends to AIDS and said that he launched the Elton John Aids Foundation (EJAF) out of guilt for not doing enough. Since 1992, the Foundation has raised $150 million toward fighting and preventing the HIV/AIDS epidemic.
EJAF focuses on supporting community-based prevention programs, harm reduction programs, public education to reduce the stigma of HIV/AIDS, advocacy to improve AIDS-related public policy, and direct services to persons living with HIV/AIDS, especially populations with special needs.
To support Sir Elton’s efforts, the Biotechnology Industry Organization has pledged a generous donation of $150,000 to EJAF. Now, you can make a donation to help match it!
Make your contribution at I am Biotech.
The stats:
University of Missouri v. Professor: Round 2
Earlier, the university filed a lawsuit in federal district court against chemical engineering professor Galen Suppes to regain rights to his research relating to renewable energy. Now, a federal judge has dismissed the lawsuit ruling that federal patent law does not apply in the case. The university says that chemical engineering professor Galen Suppes sought patents without assigning to the university and failed to assign his inventions according to university rules. Suppes has said he sought ownership of his inventions only after the university failed to commercialize his research. The university then filed a similar lawsuit in Boone County Circuit Court on the same day the federal suit was dismissed.
Chief Circuit Judge Michel Never Saw A (Completely) Bad Patent
Judge Michel gave the keynote at the FTC hearings on “The Evolving IP Marketplace”, addressing the state of patent law and patent reform. Highlight:
I’ve been on the court for twenty years and eight months, and I cannot ever remember seeing a single patent, I’m sure they’re out there, but I can’t remember seeing one where every single claim was invalid. I’ve seen innumerable patents where some of the broader claims either were indefinitely broader or were damn close, but in all of those cases, the narrower claims seemed to me equally clearly to be plainly valid. So what we really have is a problem of some over-broad claims getting through the system, slipping through the sieve that in the ideal world would catch them. (via 271 Patent Blog)
FDA Says Cheerios Cereal is a Drug
The FDA has issued a warning letter to General Mills alleging “serious violations” of the FDC Act in the label and labeling of Cheerios cereal. Specifically, the FDA contends that the following label claims make Cheerios an unapproved new drug under FDC Act § 505(a) because they indicate that the cereal is intended to prevent, mitigate, and treat hypercholesterolemia:
(via FDALaw Blog)
Talking with Acting Commissioner for Patents Peggy Focarino
Gene Quinn of IPWatchdog spoke with Acting Commissioner for Patents Peggy Focarino about what the Patent Office is trying to do to enhance quality and make a better, smoother process. In discussing a new Ombudsman, Focarino had this to say:
We are still in the process of working out the implementation details, but each TC will have an ombudsmen who will serve as a resource to applicants on TC-specific issues. I envision this resource to be a facilitator of sorts who can resolve administrative issues quickly and get an application back on track when problems arise. This resource is independent of an examiner’s chain of command so can be viewed as a neutral facilitator by the applicant.
In the Irony Can Be Pretty Ironic Category
Two enforcement lawyers at the Securities and Exchange Commission are being investigated by federal prosecutors and the FBI for possible insider-trading violations, according to a report from the SEC’s inspector general. No wonder the SEC was too busy to get around to firguring out Bernard Madoff’s $65 billion Ponzi scheme. (via WSJ Law Blog)
ed.
Where will all the bloggers be during BIO? Apparently, they’ll all be at a lot of social functions:
BIO International Convention Bloggers Meetup
Monday, May 18, 5:00 pm – 6:30 pm
A special happy-hour for bloggers at the 2009 BIO International Convention. They’ll have lots of fun giveaways, courtesy of IAmBiotech.org.
Georgia World Congress Center (GWCC)
BIO Think & Drink Area
East Plaza Entrance, Building A, Level 4
Details here.
Tuesday Think & Drink: Industry Is from Mars, Academia Is from Venus
Tuesday, May 19, 5:00 pm – 6:30 pm
Sponsored by: SUTHERLAND
Hosted by: Editors of Nature Biotechnology
East Plaza Entrance, Building A, Level 4
Details here.
BIO 2009 Tweetup (#BIOtweetup)
Tuesday, May 19, 5:00 pm – 6:30 pm
Free beer & food
Georgia World Congress Center (GWCC)
Pavilion #2817- Tu May 19 5-6.30
Details here.
Also, don’t miss the more than 40 BIO Exhibitor Hospitality Receptions Tues 5 – 6:30 pm. See the BIO Party List here. I’ll look for you there. I hope to give some iPods away.
The American Civil Liberties Union (ACLU), the Public Patent Foundation (PUBPAT), and a whole host of others have filed a lawsuit challenging patents on two human genes associated with breast and ovarian cancer claiming such patents stifle research that could lead to cures and limit women’s options regarding their medical care.
The lawsuit, Association for Molecular Pathology, et al. v. United States Patent and Trademark Office, et al., was filed in the United States District Court for the Southern District of New York against the PTO, Myriad Genetics and the University of Utah Research Foundation, which hold the patents on the BRCA genes. The plaintiffs in the lawsuit include several patients and more than a dozen universities, genetic specialists and medical associations, such as the Association for Molecular Pathology and the American College of Medical Genetics.
The challenged patents cover diagnostic tests for mutations along the genes, known as BRCA1 and BRCA2, which are responsible for most cases of hereditary breast and ovarian cancers. The suit claims that patents on two human genes associated with breast and ovarian cancer are unconstitutional and invalid because “human genes are products of nature, laws of nature and/or natural phenomena, and abstract ideas or basic human knowledge or thought.”
Since the U.S. Patent and Trademark Office (PTO) granted patents on the BRCA genes to Myriad Genetics, Myriad’s lab is the only place in the country where diagnostic testing can be performed. Because only Myriad can test for the BRCA gene mutations, others are prevented from testing these genes or developing alternative tests. Myriad’s monopoly on the BRCA genes makes it impossible for women to use other tests or get a second opinion about their results, and allows Myriad to charge a high rate for their tests – over $3,000, which is too expensive for some women to afford.
The ACLU says that patenting the genes limits research and the free flow of information, and as a result violates the First Amendment. The ACLU’s lawsuit is, in effect, challenging the entire practice of gene patenting so the case could have wide-reaching effects for the research and genetic diagnostics fields. A draft report by the NIH shows that around 20 percent of human genes currently are patented, including genes associated with Alzheimer’s disease, muscular dystrophy, colon cancer, and asthma, and corresponding to 4,382 of the 23,688 genes as of 2007. The genes found in the claims of over 4,270 patents.
As these things usually go, the issue is not that Myriad has a patent and is keeping withheld from patients. The issue is that Myriad is charging high prices, which could possibly keep some women from seeking preventative genetic testing. There is a natural cycle where medical breakthroughs receive patent protection, which allows the patent-holder to charge higher prices. High prices yield high profits, which creates an incentive to develop the next generation of therapeutics and diagnostics.
The question might be better framed as “Who should pay for health care costs as expensive diagnostics become available?” It would seem to be more productive to focus on what we can do to address health care costs that are spiraling out of control. There is nothing particularly extraordinary about gene patents that should require that they be held to a higher standard than, say, pharmaceutical patents or non-gene based diagnostics, both of which can be subject to high cost and limited availability based on the patent holder’s rights.
As the courts have opined:
A gene is a chemical compound, albeit a complex one, and it is well established in our law that conception of a chemical compound requires that the inventor be able to define it so as to distinguish it from other materials, and to describe how to obtain it. Amgen Inc. v. Chugai Pharmaceutical Co. and Genetics Institute, Inc., 927 F.2d 1200.
For various reasons — rational or irrational — groups that oppose gene patents have made the BRCA1 and BRCA2 patents the poster children of an anti-gene patent movement. For one thing, the Myriad patents cover tests related to breast cancer, a disease with unusually high media attention lately. For another, Myriad has been particularly aggressive in its tight control over licensing. Among the thousands of patents on human and animal genes, the Myriad patents have attracted by far the most notoriety.
The ACLU now wants to go beyond claiming a defect in the particular patents and instead claim that all gene patents should be disallowed. Claiming that such patents are unconstitutional, however, is unlikely to go very far. The U.S. Constitution itself is quite broad in its grant, stating:
The Congress shall have Power … To promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries; Art. 1, Sect. 8.
The U.S. Supreme Court has given this grant broad interpretation, citing the Committee Reports accompanying the 1952 Act showing that Congress intended statutory subject matter to “include anything under the sun that is made by man.” Diamond v. Chakrabarty, 447 U.S. 303 (1980). Under this interpretation, live, human-made micro-organisms (as well as isolated nucleotide sequences) were deemed patentable subject matter under § 101. An appeal that gene are unpatentable as somehow different seems to be an attempt to use fear of vitalism in genes to get such patents disallowed.
While human genes are products of nature, the Myriad patents claim isolated forms of the genes not the genes in there natural state. That is, imagine pulling out a gene in its unrecognizable natural state hidden among a million other base pairs in the genetic code. One patent for example, U.S. Pat. No. 5,747,282, claims “[a]n isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO:2.”
In the end, a fight over the patentability of isolated genes is misplaced and is not likely to change the overall landscape of diagnostic and therapeutic costs. Very often, patents are obtained not just on the isolated gene but also on methods of use and as part of more complex assays or kits. Preventing just one kind of claim might provide some additional competition in the marketplace but any impact would likely be muted.
Earlier, the Board of Appeal of the European Patent Office (EPO) upheld a rejection of some of the BRCA1 claims in Europe based on failure to meet the disclosure requirements in a 1994 US patent, changing the priority date to a 1995 patent deemed too late to claim the gene itself. After seven years of legal tussling, the patents were allowed in amended form where the original scope was reduced to cover only frameshift mutations and not the gene itself. Even then, it is the frameshift mutations that account for most of the relevant mutations in BRCA1 so the practical effect may be quite limited.
Gene patents have been around now for decades and are unlikely to go away now just because a lawsuit was filed. An argument that gene patents should not be allowed so that patients could have access to cheaper versions could just as easily be applied to every patentable item that finds a use in health care from pharmaceuticals to medial devices to hospital instrumentation. Really, almost anything right down to the paper used for writing prescriptions.
In the end, patents work more or less as expected. They reward innovation for a limited time. When the patents expire, the discoveries are available to everyone. Forever.
Plaintiff and supporter statements and a copy of the complaint can be found here. More information, including a video of why they’re fighting to knock out the breast cancer test patents, plaintiff and supporter statements and a copy of the complaint, is here.
A copy of the complaint is also available here: myriad-brca1-complaint (pdf)
In a follow-up to an earlier discussion about the shift in position by the DOJ’s Antitrust Division, which has withdrawn a September report that “raised too many hurdles to government antitrust enforcement and favored extreme caution” toward antitrust enforcement action, Hal Walker of Foley & Lardner has sent details on the confirmation hearing questions of Christine Varney, Assistant Attorney General of the Antitrust Division.
Earlier, Sen. Arlen Specter (R-Pa.), criticized Varney for what he called “incomplete answers” to his written questions; in many of her answers, she declined to give specifics and instead promised to work with other administration officials, learn more about an issue, or “vigorously enforce” the antitrust laws.
Answers to Questions for the Record Confirmation Hearing of Christine A. Varney Before the Senate Judiciary Committee.
March 10, 2009
Questions from Senator Specter
11. Despite numerous decisions to the contrary in the courts, the FTC continues to vigorously prosecute generic and brand drug makers for entering into agreements settling patent infringement litigation in which the generic firm agrees to delay entry. During your testimony before the Committee, you suggested that you might be opposed to any drug patent settlement that included a so-called reverse payment. To clarify, does that mean that you believe any settlement in which a generic firm receives something of value, or receives a reverse payment—no matter the amount— violates the antitrust laws?
Answer: Every case must be examined on its own merits, and certainly there are some disputes where settlements can be procompetitive.
a. If a patent is valid and applicable, then a settlement allowing a generic to enter the market before the expiration of the patent-no matter what the generic manufacturer receives¬would actually increase competition. Why should such settlements be unlawful? Why should patent holders not enjoy the presumption that their patent is valid until there is some evidence that it is not?
Answer: Lawful patents should be enforced and upheld until their expiration. A patent holder who enters into a commercial arrangement to allow a competitor to enter the market prior to the patent’s expiration would most likely be procompetitive.
b. If not all settlements in which a generic firm receives something of value violate the antitrust laws, might the court in the underlying infringement case be in the best position to assess the potential anticompetitive affect of a settlement?
Answer: The merits of any infringement claim can be difficult to determine. I believe available evidence must be reviewed by a court to assess the merits of the infringement claim. In cases where a court finds no infringement, there is unlikely to be an anticompetitive effect in determining a patent holder’s rights. However, antitrust authorities may have an interest in participating in instances where there is a settlement in cases when the underlying infringement claim is not resolved through a full adjudication.
c. Do you believe it is appropriate for a government agency to continue litigating an issue
when every circuit court to address the issue has rejected the agency’s argument?
Answer: While the Federal Trade Commission has primary jurisdiction over the pharmaceutical industry, I continued to be concerned that certain reverse payment settlements, which slow the entry of generics drugs into the market, can negatively impact consumer choices and costs. Regardless of the position taken on these particular patent settlement cases, I think it is important for the antitrust agencies views are aligned on these issues, if possible. To that end, if confirmed, I pledge to work with the FTC to align the agencies’ views on this matter and develop a unified approach to dealing with reverse payment settlements. I believe that consumers are benefited by generic entry — the result is typically more choices and lower prices. If confirmed as Assistant Attorney General for Antitrust, I will work to ensure consumers’ choices are maintained. I hope these additions will further clarify my views.
Original answer to entire question 11:
Answer: While the Federal Trade Commission has primary jurisdiction over the pharmaceutical industry, I am very concerned that certain reverse payment settlements, which slow the entry of generics drugs into the market, can negatively impact consumer choices and costs. Regardless of which position you take on these particular patent settlement cases, I think it is important for the antitrust agencies to speak with one voice on this issue. To that end, if confirmed, I pledge to work with the FTC to more closely align the agencies on this matter and develop a unified approach to dealing with reverse payment settlements.
The Patent Baristas are rocking BIO again and you can, too! Editor-in-Chief Barista, Stephen Jenei, will be giving away some iPod Shuffles at the 2009 BIO International Convention, May 18-21 at the Georgia World Congress Center in Atlanta, Ga.
Basically, all you have to do to win is be the first person to find me on the Exhibitor Hall floor at Bio2009 and ask for the iBarista iPod. That’s it.
Each day I attend of the convention, I will carry one Apple (PRODUCT) RED Special Edition iPod shuffle (1 GB) — in honor of attendance by Sir Elton John. I’ll keep the iPod on my person when about the Hall floor. The first person to find me in the Exhibitor Hall and specifically ask me for the iBarista iPod shuffle prize, gets it on the spot (see all the iPod Giveaway Terms and Conditions here).
Of course, the trick is that there are over 20,000 attendees expected and that’s a lot of folks walking around over 220,000 square feet of exhibition space. But, I ran in to lots of people I know last year so I know it’s possible. I’ll be visiting quite a number of booths so look for me around the hall — I can’t wait to give these away!
If you’d like to meet up during the Bio09 conference, drop me a note and we’ll schedule some time to have coffee together.
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
