Patent Docs

Conference & CLE Calendar

January 6-10, 2010 - 27th Annual National CLE Conference (Law Education Institute, Inc.) - Vail, CO

January 20-21, 2010 - Life Sciences IP Due Diligence (American Conference Institute) - New York, NY

January 25-26, 2010 - European Pharmaceutical Regulatory Law Boot Camp (American Conference Institute) - New York, NY

January 26-27, 2010 - Advanced In-House Counsel Forum on China IP Law (C5) - Shanghai, China

January 27-28, 2010 - Pharma & Biotech Patent Litigation (C5) - Amsterdam, Netherlands

February 9, 2010 - Patent Prosecution: Best Practices for Reducing Costs While Improving Patent Quality (Technology Transfer Tactics) - 1:00 - 2:30 PM (EST)

February 24-25, 2010 - 2nd Expert Forum on ITC Litigation & Enforcement (American Conference Institute) - New York, NY

March 2-4, 2010 - 6th Annual Biosimilars Conference (Visiongain) - Boston, MA

***Patent Docs is a media partner of this conference or CLE

ITC Litigation & Enforcement Conference

American Conference Institute (ACI) will be holding its 2nd Expert Forum on ITC Litigation & Enforcement from February 24-25, 2010 in New York, NY.  The conference will offer practical advice for seizing the opportunities and meeting the challenges offered by fast-paced ITC litigation and allow attendees to:

• Evaluate and compare the potential benefits of selecting ITC or another venue;
• Navigate the ITC's complex procedural rules;
• Understand and resolve questions relating to "domestic industry" standards;
• Meet the demands of accelerated motion practice and discovery;
• Implement effective defense and intervention strategies in a Section 337 action; and
• Enforce ITC exclusion orders.

In particular, ACI's faculty will offer presentations on the following topics:

• Evaluating where to litigate international IP disputes;
• Positioning complainants, respondents and intervenors in Section 337 cases;
• Successfully working the logistics of Section 337 litigation;
• Keynote address by Chief Judge Paul R. Michel of the U.S. Court of Appeals for the Federal Circuit;
• Coordinating related parties & proceedings;
• Managing litigation through discovery, claim construction, summary determination and trial;
• Meeting the challenge of the ITC’s unique trial procedures;
• View from the Bench -- Chief Administrative Law Judge Paul J. Luckern, Administrative Law Judge Theodore R. Essex, and Administrative Law Judge Robert K. Rogers of the U.S. International Trade Commission;
• Seeking commission review and modification of ALJ decisions;
• The year in review -- Commission and Federal Circuit decisions in Section 337 cases;
• Understanding and maximizing the available remedies in Section 337 ITC cases;
• Seeking enforcement of exclusion orders;
• Successfully appealing Section 337 determinations;
• A view from the ITC General Counsel's office;
• Keynote address by Shara Aranoff, Chairman of the International Trade Commission;
• Handling ITC ancillary proceedings and parties;
• Addressing downstream remedy strategies post-Kyocera;
• Meeting the challenges faced by in-house counsel in Section 337 cases; and
• Meeting the challenges raised when assisting foreign companies in the ITC with focus on Asian companies.

Two breakout sessions will be offered from 9:00 am to 12:00 pm on February 26.  The first will address Section 337 complaints and responses, and the second will address enforcement of ITC exclusion orders.

A complete brochure for this conference, including an agenda, list of speakers, and registration form can be downloaded here.  The registration fee for the conference ranges from $2,195 (conference alone) to $2,795 (conference and breakout session).  Those registering by January 5, 2010 will receive a $300 discount off the registration fee and those registering by January 29, 2010 will receive a $200 discount off the registration fee.  Those interested in registering for the conference can do so here, by calling 888-224-2480, or by faxing a registration form to 877-927-1563.

Audioconference on Patent Prosecution Cost Reduction

Technology Transfer Tactics will be offering an audioconference entitled "Patent Prosecution: Best Practices for Reducing Costs While Improving Patent Quality" on February 9, 2010 from 1:00 - 2:30 PM (EST).  Dr. Jean Baker and Jack Cook of Quarles & Brady will provide specific prosecution strategies that Technology Transfer Offices can adopted to significantly reduce legal bills while improving overall patent quality.  The audioconference will address the following topics:

• Disclosure evaluation:  Strategies for distinguishing what TTOs can patent from what TTOs should patent to avoid unnecessary filing costs;
• Strategies for increasing the probability of successful licensing at the disclosure stage
• Ten proven tips for TTOs to reduce patent preparation costs;
• Working with researchers to enhance disclosures and claims construction;
• Reducing unnecessary paperwork and associated attorney costs; and
• Structuring patent prosecution:  Practical strategies for TTOs and licensees to increase the efficiency of prosecution, while reducing the cost and staff burden.

The registration fee for the seminar is $197.  Those interested in registering for the seminar, can do so here.

Biosimilars Conference

Visiongain will be holding its 6th Annual Biosimilars Conference on March 2-4, 2010 in Boston, MA.  At the conference, Visiongain faculty will offer presentations on the following topics on March 3-4:

• Opportunities and challenges for biosimilars in the global market;
• Commercializing biosimilars:  Will they really be able to compete?
• Demystifying the market aspects/implications of follow on biologics;
• The impact of a patient centric viewpoint on biosimilars;
• Strategies for process development/manufacturing of biosimilars (for global markets);
• Bioassays for biosimilars;
• Immunogenicity Programs -- Not just another box to check;
• Role of USP standards in the quality assessment of biological medicines;
• An overview on regulatory and scientific issues of biosimilars and follow-on biologics;
• Legislative and regulatory developments impacting the biologics and biosimilars marketplace;
• Trends and technical challenges for the development of biosimilars in China;
• Follow-on Biologics (Biosimilars) development with approval and market access;
• Biosimilars -- Succeeding in the market of the future; and
• Clinical Phase 1 PK/PD trials for biosimilar/follow-on products.

In addition, a pre-conference interactive biosimilars workshop entitled "Creating confidence in a new wave of biologics therapy -- Overcoming barriers to entry" will be offered on March 2.  The agenda for the Biosimilars Conference can be found here.  A complete brochure for this conference, including an agenda, list of speakers, and registration form can be downloaded here (free registration required).

The registration fee ranges from £1299 ($2,099.31) for the conference alone to £1699 ($2,745.75) for the conference and workshop; the fee for attending the workshop alone is £599 ($968.04). Those interested in registering for the conference can do so here.

Gene Patenting Debate Continues - Round Three

    By Donald Zuhn --

Last week, National Public Radio's Science Friday, which is broadcast nationwide as part of NPR's Talk of the Nation, examined the issue of gene patenting.  The debate over gene patenting reignited in May as a result of the Association for Molecular Pathology v. United States Patent and Trademark Office case, in which a group of patients, physicians, academic researchers, and medical societies filed suit against the U.S. Patent and Trademark Office and Myriad Genetics, among others, over several patents claiming human BRCA1 and BRC2 genes and methods for detecting mutations in these genes to diagnose a predisposition to breast and ovarian cancer (see Patent Docs reports here and here).  Since then, two public radio debates have focused on the issue.

In June, Dr. Hans Sauer, the Associate General Counsel for Intellectual Property for the Biotechnology Industry Organization (BIO); Joshua Sarnoff, Professor of the Practice of Law at American University's Washington College of Law; and Shobita Parthasarathy, Co-Director of the Science, Technology and Public Policy Program at the Ford School of Public Policy at the University of Michigan discussed the topic on WAMU, Washington, DC's leading public radio station (see "Gene Patenting Debate Continues").  And last August, Kevin Keenan, Executive Director of the ACLU for San Diego and Imperial Counties; Stacey Taylor, a partner at DLA Piper; and Dr. Leonard Deftos, Professor of Medicine in Residence at the University of California, San Diego, and Adjunct Professor of Law at California Western School of Law tackled the issue on San Diego's KPBS "These Days" program (see "Gene Patenting Debate Continues - Round Two").  This past Friday, Patent Docs author Dr. Kevin Noonan, a partner at McDonnell Boehnen Hulbert & Berghoff, and Daniel Ravicher, the Executive Director of the Public Patent Foundation (PUBPAT), which is serving as co-counsel in the Association for Molecular Pathology case, squared off in a third debate on the topic on NPR's Science Friday.

Science Friday host Ira Flatow (at right) began the program by asking Mr. Ravicher why the lawsuit was brought.  Mr. Ravicher replied that the suit was "about whether or not the government has the right to grant exclusive rights to one company over our genes" as well as the knowledge of gene mutations that might relate to a predisposition for particular types of diseases.  He added that the suit was filed because Myriad Genetics, which co-owns the seven patents-in-suit, had been asserting the patents in a way that "crack[s] down on anyone else doing any research" and "anyone else doing . . . second opinion testing."  After Mr. Flatow noted that the PUBPAT website describes gene patent holders as having "the right to prevent anyone from studying, testing, or even looking at a [patented] gene," Mr. Ravicher declared that "there's absolutely conclusive ownership of the gene by the patent holder."

Mr. Flatow then turned to Dr. Noonan (at left) for a response, asking whether he agreed with Mr. Ravicher's assessment.  Dr. Noonan conceded that Mr. Ravicher was "technically correct," but before he could opine further, Mr. Flatow asked whether it was true that "people aren't even able to look at the gene?"  Noting that "[t]he National Library of Medicine has a list of most of the major scientific journals in the U.S. and abroad," Dr. Noonan revealed that a search of the collection for BRCA references yielded "almost 3,500 papers that have been published about these genes, some as recent as last month."  (In addition, a search of the NCBI PubMed database yields 1,145 references containing "BRCA" in the title or abstract.)  In view of the NLM search results, Dr. Noonan contended that "the idea that people are not doing scientific research on these genes is just wrong," explaining that "[w]hat people are not being [allowed] to do, and what some of the named plaintiffs in this lawsuit are trying to do, is provide clinical testing."  According to Dr. Noonan, it was the commercial use of the BRCA sequences, and not the research use of the sequences, that was precluded.  Mr. Ravicher, however, replied that he represented researchers at the University of Pennsylvania, Emory University, and the University of California-Los Angeles, all of whom had received "very nasty letters" from Myriad saying that "[w]e know that you are doing things with these genes that relate to breast and ovarian cancer, and you shall stop or pay us money."  He added that "BRCA analysis at the University of Pennsylvania [had been] shut down because of Myriad's patent assertion."

Returning from a short break, Dr. Noonan noted that he was on the program to defend gene patenting (and not necessarily Myriad), stating that "it would be a mistake for the United States government -- whether through the courts, through Congress, or through the Patent Office -- to not allow genes to be patented."  When asked why this would be a mistake, he replied that "[b]esides being contrary to 200 years of natural products patenting," a prohibition on gene patenting would adversely impact the disclosure of gene sequences and investment in biotechnology.  Explaining that "in the biotechnology space, investment is critical," Dr. Noonan noted that "[m]ost of the companies that do this are small companies like Myriad, and unless there's some way for investors -- in something that's very high risk and [where] most of the products fail -- to get their investment back, you're not going to have investment."  As a result, "you don't have the drugs and the diagnostics that the biotechnology industry has developed over the past 25 years, and I think that we're in worse shape if we don't have them."

In response, Mr. Ravicher (at right) argued that "[t]here are valid reasons to have patents on many things, but you can have patents on too many things, and there's a line that's been drawn by the Supreme Court, and we fully believe that these patents land on the wrong side of that line."  When pressed by Mr. Flatow to discuss the impact of the lawsuit on investment, Mr. Ravicher noted that "patents have both an incentivizing and a chilling effect," and analogized gene patents with a patent on the law of gravity, stating that "the Supreme Court has said that you can't patent some things [that] are basic laws of nature because that would have such a dramatic, countervailing chilling effect on everyone else -- all 300 million other Americans and any research that they might do on that subject -- that granting a [patent] to that one party isn't worthwhile."

Mr. Flatow next asked Dr. Noonan whether he could patent a cure for cancer discovered in the course of doing research on a patented gene.  After Mr. Flatow outlined a lengthy hypothetical involving Bill Gates, Dr. Noonan observed that "we could spin hypotheticals all day, but it gets down very much to what exactly is it that you're doing."  Dr. Noonan added that "if you isolate [a patented] gene and use it, then you would be infringing," but "whether or not that would be something that you would be sued for . . . would depend on the circumstances."  When Mr. Flatow asked whether a patent holder could bring suit for "any arbitrary reason," Dr. Noonan responded that Rule 11 of the Federal Rules of Civil Procedure precluded such a suit, and "[y]ou have to have a good faith belief that somebody has infringed your patent."  Mr. Ravicher, however, noted that Rule 11 did not apply "to sending nasty letters."  Explaining that a lot of researchers were either universities that have "very skittish university counsel offices" or small businesses that "could never afford to defend themselves," Mr. Ravicher argued that "[m]erely the threat of a lawsuit just through a letter, which doesn't have to meet Rule 11, often chills conduct that most reasonable people would agree would never be covered by a valid claim of any patent."

Turning to the impact of the claim term "isolated," Mr. Ravicher argued that:

[M]ost reasonable people would agree that if the patents were just on the BRCA genes, that would not be valid because that exists in our body -- the genes exist in our body.  It's that these patents say an "isolated gene," and the Patent Office . . . said that . . . if you isolated the gene, then that's patentable.  And we just think that's incorrect.  That's like saying I can go out into nature, I can dig up some gold, I can isolate it from the mountain, and well now I deserve a patent on gold, and that's just not the law.

(Mr. Ravicher also contended that the decision to grant gene patents containing claims reciting "isolated" sequences was related to the "very pro-business, pro-patent Administration" under which authority the Office operated.)  With regard to the patentability of natural products, Dr. Noonan countered that antibiotics made by bacteria and the anti-cancer drug taxol, which is produced in the bark of the yew tree, were both examples of patentable natural products.  As for the BRCA genes, he contended that:

(a) they're not identical to what's in the chromosome, (b) they're not in the chromosome anymore, and (c) they are much more converted [or] changed as the Supreme Court would say by the "hand of man," than . . . taxol from the yew tree.  So if you're going to use the traditional standards of what you have to do to change something that is found in nature to make it patentable, these genes satisfy that criteria hands down.

Acknowledging that "Kevin does an excellent job of presenting our opponent's point of view," Mr. Ravicher noted that the plaintiffs in the BRCA case nevertheless disagreed.  According to Mr. Ravicher, "[a]ll those isolated natural product claims have never been upheld by the Supreme Court, and we think they would be invalid under binding precedent."

For the last portion of the program, Mr. Flatow took calls from listeners.  The first caller stated that while she couldn't "fault the company Myriad, because they are the holders of the patent that was granted legally," and therefore she didn't "see any point in any lawsuits against them," she appeared to favor Mr. Ravicher's argument regarding the claim term "isolated," and thus saw "quite a bit of validity in complaints or suits against the U.S. Patent Office."  Mr. Ravicher noted that he:

[W]ould disagree [with the caller] when she concedes that these patents are legal.  There are many things done under our previous Administration that were not legal.  Just because the Patent Office has granted a patent doesn't mean it's actually valid.  In fact, about half of the patents granted by the Patent Office and that are later litigated in court are found to be invalid.  They were wrongly granted by the Patent Office.  That's because the Patent Office has been created to be a pure patent-issuing Office under previous Administrations.  Under the new Administration, we expect that to change.  So I would not concede that these patents are valid just because they were granted.

Unfortunately, Mr. Ravicher's attack on patent validity has some holes.  As an initial matter, Mr. Ravicher provided no support for his assertion that "about half of the patents . . . litigated in court are found to be invalid."  According to the Patstats.org, however, in cases where patent validity was at issue, the patent holder prevailed 59.8% of the time in 2008.  Mr. Ravicher's comment about patent validity also glosses over the motivation of accused infringers to invalidate asserted patents, as well as the impact of recent Federal Circuit decisions (e.g., KSR International Co. v. Telflex Inc.) on patents that were examined and granted years ago.  With respect to Mr. Ravicher's comment that the USPTO had been "created to be a pure patent-issuing Office under previous Administrations," one hopes that he was not referring to the most recent Administration, as the Office's efforts to push through the claims and continuations rules (among other rules packages) and "reject, reject, reject" mantra contradict such a characterization.

Turning to the cost of Myriad's test, Mr. Flatow asked Dr. Noonan whether there wasn't "something ethically, morally wrong with not allowing someone to come up with a cheaper test that potentially cancer patients can afford."  Dr. Noonan responded that he didn't have "any evidence that Myriad is the most profitable company in the country, or that what they're charging is excessive," adding that if Myriad was "making money hand over fist and w[as] on Forbes' front cover as the most profitable biotechnology company, maybe you'd have an argument."  He argued that Myriad appeared to be charging an amount that merely "justified the investment to [develop] the test in the first place."

The second caller to the program admitted that she was "still a little unclear on this isolating of the gene," and asked:

I have the gene, right?  It's in me?  So they've isolated it, but I have the gene, right?  So, why don't I have the patent on the gene, or why can't I sue Myriad?

Agreeing with the caller, Mr. Flatow exclaimed that Myriad was "using your gene!" and asked Dr. Noonan for comment (while also accusing him of "trying to make light" of the caller's question).  Dr. Noonan argued that he was not making light of the question, and added that the caller's (and Mr. Flatow's) comment was "the emotional crux of the ACLU lawsuit."  He contended that:

[N]obody is going to knock on your door, like Michael Crichton said in a New York Times editorial a few years ago, and give you a bill for using your gene.  That's just -- it's great -- it gets people all excited and all upset, but it's just -- frankly, at the end of the day, it's a lie.

The third (and final) caller observed that "the recommendation typically for women who test positive for the BRCA gene is to have a double mastectomy and their ovaries removed, and it's troubling that you can do this and you can't really get a second opinion," and noted that "[t]here's no other company you can go to get this test done before you have this very radical life changing surgery."  Dr. Noonan replied that he had "spoken with some people at Myriad [who] say nobody ever asked them for the second diagnosis," and therefore speculated that "the second opinion option is one that may still be out there."  Mr. Ravicher, however, asserted that he had "actually written a letter to Myriad on behalf of my client who has already paid [for one test]," and that Myriad had "refused to grant our client in this lawsuit the right to get a second opinion."  Dr. Noonan asked Mr. Ravicher whether this letter had been sent to Myriad after the lawsuit was filed, and Mr. Ravicher acknowledged that it had.

After Mr. Ravicher suggested that an individual could get a second opinion outside the U.S. "because these gene patents are not allowed in most other countries in the world," Mr. Flatow compared such an option with the dilemma facing women prior to Roe v. Wade.  Mr. Ravicher noted that he had "seen another analogy, which was with respect to patents on human embryonic stem cells in this country, which were granted [in the U.S.] but not granted in other countries."  He suggested that these patents had forced "many researchers . . . to move their labs to foreign countries like Singapore because the [stem cell] patents didn't exist there."  Exposing the flaw in Mr. Ravicher's analogy, Dr. Noonan pointed out that "the reason those labs moved offshore was the Bush Administration's restriction on the cell lines," rather than the assertion of stem cell patents.

While Mr. Flatow's guests found little common ground, they did agree on one thing at the conclusion of the debate:  that the case would likely be appealed to the Federal Circuit regardless of who wins at the District Court level.

For additional information regarding this and other related topics, please see:
• "BRCA Patent Suit to Continue in Southern District of New York," November 2, 2009
• "Empirical Research Fails to Support Gene Patenting Ban," October 22, 2009

• "Gene Patenting Debate Continues - Round Two," August 4, 2009
• "The Unwanted Consequences of Banning Gene Patenting," June 16, 2009
• "Falsehoods, Distortions and Outright Lies in the Gene Patenting Debate," June 15, 2009
• "Gene Patenting Debate Continues," June 9, 2009
• "Association for Molecular Pathology v. U.S. Patent and Trademark Office," May 17, 2009
• "Court Report: Special Edition," May 13, 2009
• "Gene Patenting and the Wisdom of Judge Lourie," April 12, 2009
• "Science Article Should Help Allay Gene Patenting Fears," December 17, 2008

Patent Reform Efforts Opposed by Small Business Group

    By Kevin E. Noonan --

Until now, the major bones of contention over the Senate's patent "reform" bill (S. 515) have centered around two provisions:  putting in place statutory language governing how damages are to be assessed, and instituting a post-grant review system modeled on the European opposition, and that will be more extensive than current re-examinations.  These provisions have been the motivating force for a variety of "high-tech" companies (predominantly information technology companies like Cisco and Intel) and their lobbying arms (such as the Coalition for Patent Fairness (sic)), aimed at addressing "unconscionable" damages verdicts (typically but not always by juries) and the purportedly "low quality" of patents being granted by the U.S. Patent and Trademark Office.  A major breakthrough in passing the bill from the Senate Judiciary Committee was a "compromise" worked out by Chairman Leahy (D-VT), Senator Feinstein (D-CA), and then ranking Republican member Specter (R-PA) (see "Senate 'Patent Reform' Bill (S. 515) Voted out of Judiciary Committee").  In that compromise, the judge in a patent infringement case would assume a "gatekeeper" role, purportedly to stem the worst excesses of easily-swayed juries.

The resulting bill enjoyed bipartisan but not universal support, with notable dissenting views voiced by Senators Hatch (R-UT) and Kyl (R-AZ); indeed, Senator Hatch stormed from the hearing room oblivious to Senator Leahy's entreaties not to go.  Senator Kyl, as he has with regard to prior versions of the bill, objected that Patent Office representatives had not been consulted regarding whether the post-grant review provisions were realistic in terms of personnel and the Office's budget.

Missing from the fray has been any objection to some of the other aspects of the bill, specifically the change from a "first-to-invent" to a "first-to-file" (FTF) system, which reflects a major change in U.S. law.  Another provision (not contained in S. 515 but contained in other versions) is the grant of substantive rulemaking authority to the Patent Office.  Such provisions are a major goal of the new Commerce Secretary Gary Locke and (presumably) new USPTO Director David Kappos.

This situation changed this week, with the delivery of a letter and supporting materials to Karen G. Mills, administrator of the Small Business Administration, by the Small Business Coalition on Patent Legislation, a coalition of "early-stage start-up companies, small businesses, individuals, academic inventors, researchers and new innovative market entrants" (including the National Small Business Association, the National Association of Patent Practitioners, the Professional Inventors Alliance, the United Inventors Association, CONNECT, and IP Advocate.  In their letter (copied to Penny Pickett and Susan Walthall of the SBA, as well as Secretary Locke, Director Kappos, and Rep. Nydia M. Velazquez (D-NY), Chairwoman of the House Small Business Committee, and Senator Mary L. Landrieu (D-LA), Chair of the Senate Committee on Small Business and Entrepreneurship), the group expresses their "concerns" about the bill, focusing primarily on the first-to-file and post-grant review provisions (although they also express reservations about the PTO rulemaking portions of the bill in supporting materials appended to the letter).  The letter references Secretary Locke's earlier letter to the Judiciary Committee, where the Secretary expressed the support of the Obama Administration for these provisions, which this group's letter contends "will inflict unprecedented harm on small firms that rely on patented innovations," the "very segment of the economy that is responsible for most of America's new jobs."  The group characterizes the Secretary's position as a departure from "a decades-long, bipartisan foreign intellectual property policy position," something that is accomplished, according to the group, not by addressing the "very small number of priority contests" (interferences), but that "rewrite[s] Section 102 in its entirety, redefining the prior art . . . and weakening the grace period."  These changes have been proposed, they allege, without any study or evaluation of the expected effects of the change on U.S. patent practice, nor the effects (adverse, they claim) on patent quality of increased PTO workload.  They cite a study from McGill University (Lo and Sutthiphisal, "Does It Matter Who Has the Right to Patent: First-to-Invent or First-to-File? Lessons from Canada," NBER Working Papers, No. W14926 (April 2009)) showing "adverse" effects on small businesses in Canada and "generally negative effects on patent quality" as a consequence of Canada's adoption of a first-to-file system in 1989.

The letter also refers to comments made by Director Kappos at the Independent Inventors' Conference (on November 5, 2009) purporting to base the Office's support for the change on the burden of interference practice.  The group contests whether the "miniscule number of interference proceedings" have much to do with the harm they contend would follow from the change, from both harm to small businesses and decline in patent quality.  They catalog these adverse consequences as follows (emphasis in original):

Focusing on applications that reach the USPTO misses the point.  The harmful effects of FTF for small startups and early-stage patenting firms will be in losing patent protection on inventions for which applications will not, or could not, reach the USPTO.  Harm will arise due to the "race to the patent office" whether or not an interference occurs with a competing application.  Harm will be inflicted when inventors race to the patent office with the wrong application, for the wrong invention, and for the wrong reasons, exhausting precious resources in the process.

The letter also contests the argument that a first-to-file system would provide administrative convenience and increased certainty, contending instead that such a system would shift uncertainty onto small business to the advantage of "large patenting firms."  The letter cites the lack of in-house patent prosecution resources, less or more inconsistent funding and the need to disclose technology to investors as putting small businesses at a disadvantage to such "large patenting firms."  The letter references its supporting materials, particularly an "actual profile of a five-year R&D and invention effort of one startup member of [the] Coalition" in support of its contentions of differential harm to small businesses (slide 12):

The letter characterizes this slide as showing fifty important inventive ideas "conceived, evaluated and tested" over months or years, and that the majority of these inventions turned out to be "useless."  Accordingly, during this time, the letter says that only six patent applications were filed.  Under a first-to-file system, the letter contends that this company would have faced the "painful dilemma as to which of these inventions should be written up and filed," presumably without the benefit of the time to establish which of the fifty inventions were appropriate for filing.  These "premature guesses" would in the main have been wrong, i.e., directed to inventions later shown to be "useless," resulting in patent protection being obtained (or at least applied for) for such inventions and other, ultimately more appropriate inventions failing to obtain patent protection.

The consequence of changing to a first-to-file system would be "great risks, costs, dilemmas and increased patent prosecution uncertainties" for small businesses, the letter contends.  This will "undermine early-stage startups' ability to attract investment capital, an assertion supported by additional information in the supporting materials (see Slide 6).  The letter makes the following argument regarding whether anyone has considered the consequences of the FTF change (emphasis in original):

A related practical problem with FTF is shown in Slide 23 [of the supporting materials], which shows that prior art published less than one year before the filing date is the most frequent source for invalidating patent applications in the European Patent Office (EPO), which operates under FTF law.  This category of prior art currently cannot be used to block or invalidate patents, because the U.S. has a one-year "grace period."  Yet, no one had studied the number of U.S. patents that will be invalidated by such prior art published after the invention date if FTF were adopted, or the chilling effect that this loss of U.S. patent protection would have on innovation.  Initial detailed legal analysis of the proposed change in S. 515 reveals several of its flaws.  The analysis shows that it creates strong incentives for making early nonenabling "springing public disclosures" in order to pre-empt later filed patent applications that are enabling from being granted as patents.  Such "springing public disclosures" will also allow second inventors who file second to obtain the patent (citing B. Pedersen and J. Woo, "The 'Matrix' for First-Inventor-To-File: An Experimental Investigation into Proposed Changes in U.S. Patent Law", (December 4, 2009).

The letter characterizes as "a troubling aspect" of the Patent Office's "advocacy of the transition to FTF" the "apparent lack of data and models within its field of expertise" with regard to the "inevitable increase" of patent application filings that would result.  The letter cites statistics from the European Patent Office that almost 60% of the applications filed in the EPO are abandoned prior to examination, in contrast to a 16% abandonment rate of U.S. patent applications prior to examination.  The letter attributes this difference to the pressures accompanying the first-to-file regime, and concludes that under such a system "it takes more than two times the number of applications . . . in order to obtain one surviving application worthy of examination for patent protection" (emphasis in original).  The USPTO has "totally ignored these costly inefficiencies," the letter contends.

The letter also predicts "dire financial collateral consequences" of a change to a first-to-file system.  In contrast to the European system, where a search report is generated prior to examination on the merits (after which about one third of the applications are abandoned), in the U.S. a search is provided only after a first action on the merits.  Thus, in the U.S., the PTO would be expending "search and examination resources on applications that would otherwise" never be examined.  This would result in a "substantial increase" in the Office's upfront expenses without a concomitant increase in grant and maintenance fees, requiring "inevitable" increases in filing fees to account for these increased costs.  The letter contrasts the percentage of total patent fees garnered at the initial phases of the patenting process in the U.S. (27%) and Canada (60%), contending that this increase in initial fees would disproportionally impact small businesses and startups which would otherwise be able to defer these costs until later in the commercial development cycle.

This portion of the letter concludes by disputing the assertions in Secretary Locke's letter suggesting that changing to a first-to-file system would "'simplify the patent system, reduce legal costs [and] improve fairness,'" and that the "'complex, time-consuming and resource intensive' costs of global patent procurement are the supposed target of this 'reform.'"  There is simply no evidence for any of this, the letter asserts, and in fact there is "ample evidence" to the contrary.  The letter also notes that this change merely "give[s] away one of the few 'negotiating chips' the U.S. retains to encourage foreign patenting authorities to move in directions helpful for U.S. small business."

With regard to post-grant review, the letter voices agreement with the concerns raised in the letter sent to Secretary Locke by 56 companies on September 14, 2009 (see "Tech Companies Send Letter on Patent Reform to Secretary Locke").  The letter particularly mentions the risks to small business of "infringers who make repeated challenges to patents after they issue," particularly with provisions that permit "serial" challenges by providing an "extremely low threshold" for obtaining post-grant review, citing Scott Shane, "Problems To Be Expected From Expanded Administrative Challenges To U.S. Patents," (July 20, 2009).

Patent reform has generally taken a back-burner to health care reform and follow-on biologics legislation since the bill was voted out of committee in the spring.  In addition to these concerns, Congress has financial reform and global warming bills to contend with in its next session.  But there is a real risk that this bill will eventually come to the floor for a vote, and in view of the political constitution of the Congress, it is also likely that the bill, or something very like it, will land on the President's desk before the 111th Congress ends.  Insofar as the concerns voiced by the small business coalition resonate, it is once again incumbent that our representatives be made aware of the many flaws of S. 515.

Biotech/Pharma Docket

    By Suresh Pillai --

Teva's Discovery Request Blocked in Aricept® Suit

The U.S. District Court for the District of New Jersey has denied a discovery request by Teva Pharmaceutical Industries to examine communications between Eisai and the U.S. Patent and Trademark Office.  Eisai filed the original suit in 2005 following Teva's submission of an Abbreviated New Drug Application with the FDA seeking permission to market a generic version of Aricept®, Eisai's Alzheimer's drug.  In its complaint, Eisai alleged that Teva's proposed generic would infringe one of Eisai's patents covering Aricept®, U.S. Patent No. 4,895,841.  Teva later stipulated that, unless the claims were found unenforceable, Teva's proposed generic might infringe upon some of the claims of the '841 patent.  Subsequently, the District Court granted Eisai a preliminary injunction on grounds that Teva was unlikely to prevail in its inequitable conduct defense.

Teva's most recent discovery request was unusual in that the communications at issue are not related to the patent at issue.  Teva also sought all communications connected to abandoned Eisai applications related to benzylpiperidine.  Teva argued that these communications would help in establishing its inequitable conduct defense in Eisai's infringement suit over Aricept®.  The District Court, however, concluded that the discovery request was unnecessarily overbroad because it was outside the scope of the case at bar.

Settlement in Principle Reached in Bayer Hemophilia Drug Case

Plaintiffs Novartis Vaccines and Diagnostics and Novo Nordisk and defendants Bayer and CSL Behring have jointly asked the U.S. District Court for the Northern District of Texas to stay their patent infringement dispute over defendants' marketing of hemophilia drugs, pending the outcome of settlement negotiations.  Plaintiffs originally filed suit in February 2008 in an effort to assert their claims over the underlying patent for two of the plaintiffs' hemophiliac drugs, Kogenate® and Hexilate®, drugs whose active ingredient is recombinant antihemophilic Factor VIII.  Plaintiffs accused defendants of infringing U.S. Patent No. 7,138,505, but defendants denied that their drugs infringed, and asserted that the patent-in-suit was invalid.  A spokesperson for Bayer stated that because the parties were sufficiently close to a settlement, a stay was sought.  However, the spokesperson also stated that discussions were continuing.

Settlement Announced in Effexor XR® Infringement Suit

Mylan has announced an agreement with Pfizer that would allow Mylan to market a generic version of Effexor XR®, Pfizer subsidiary Wyeth's blockbuster antidepressant drug.  Wyeth originally filed suit in July 2007 following Mylan's filing of an Abbreviated New Drug Application with the FDA seeking regulatory approval to market a generic version of Effexor XR® (see "Court Report," July 15, 2007).  In its amended complaint, Wyeth alleged that Mylan's proposed generic would infringe three patents covering Effexor XR®, U.S. Patent Nos. 6,274,171, 6,403,120, and 6,419,958.  Mylan then sought a declaratory judgment that the patents-in-suit were not infringed or invalid.

Under the terms of the settlement, Mylan has agreed to a nonexclusive license to certain patents that permits Mylan to market generic versions of Effexor XR® on or after June 1, 2011, or earlier under certain circumstances.  The agreement allows Mylan to market 37.5 mg, 75 mg, and 150 mg versions of the drug.  Other details of the settlement agreement remain confidential.

Ariad v. Lilly: Oral Argument - Addendum

    By Kevin E. Noonan --

At the outset of the en banc oral argument in Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co. last week, Chief Judge Michel asked Lilly's counsel whether Lilly had preserved the written description issue by timely objecting to District Court Judge Zobel's jury instruction (see "Ariad v. Lilly: Oral Argument").  This question was curious:  perhaps Judge Michel (at right) wanted to be certain that the question was properly before the Court; perhaps he wanted to ascertain whether there was a simple answer to the complex question the Court had posed to the parties and amici; perhaps he wanted to avoid having the en banc Court make a definitive statement on the existence and scope of the written description requirement and invite Supreme Court review (a petition for certiorari is almost certain no matter how the Federal Circuit rules).

Charles E. Lipsey, Lilly's counsel, responded to the Court by pointing to a particular part of the record (specifically, A172-173), and promised the Court that Lilly would provide "additional information" on the question.  That information has taken the form of a letter from Lilly's counsel to the Court, outlining how the jury instructions were proposed by the parties and adopted by the District Court during the patent infringement lawsuit, and the steps Lilly took to preserve the issue for appeal.

The letter (which contains copious citation to the record) is signed by co-counsel Howard W. Levine, and relates that both parties submitted written jury instructions to the District Court, and that there was a charge conference on April 26, 2007.  However, at the charge conference, Judge Zobel informed the parties that "she had not determined how to phrase the parties' written description instructions in her 'own language' and needed additional time."  She also informed the parties that they would not have the opportunity to review the instruction before she charged the jury, but would be able to make their objections after she had charged the jury.  Mr. Levine states in his letter to the Court that Lilly timely objected to the instruction "at a sidebar conference" after the jury was charged (citing A172-173, the portion of the record cited at oral argument by Mr. Lipsey).

This objection "preserved the issue for appeal" according to Mr. Levine, citing Fed. R. Civ. P. 51(c)(2)(B) and Suprenant v. Rivas, 424 F.3d 5, 15 (1st Cir. 2005).   In addition, Mr. Levine confirmed for the Court that Lilly raised the written description jury instruction in its motion for a new trial (A2774) and in pre- and post-verdict motions for judgment on the written description issue.

Finally, the letter reminds the Court that Ariad did not argue that Lilly had not preserved the issue for appeal.

After all the effort expended by the parties, amici, and the Court in bringing this issue to the brink of an en banc decision, it is comforting to know that the entire enterprise won't be derailed on procedural grounds.

For additional information regarding this topic, please see:
• "Ariad v. Lilly: Ariad's Reply Brief," December 10, 2009
• "Ariad v. Lilly: Oral Argument," December 9, 2009
• "Amicus Briefs in Ariad v. Lilly: Regents of University of California et al.," December 6, 2009
• "Amicus Briefs in Ariad v. Lilly: Briefs by Companies," December 6, 2009
• "Amicus Briefs in Ariad v. Lilly: American Intellectual Property Law Association," December 1, 2009
• "Amicus Briefs in Ariad v. Lilly: Federal Circuit Bar Association," November 29, 2009
• "Amicus Briefs in Ariad v. Lilly: Intellectual Property Owners Association," November 25, 2009
• "Amicus Briefs in Ariad v. Lilly: GlaxoSmithKline," November 24, 2009
• "Amicus Briefs in Ariad v. Lilly: United States," November 23, 2009
• "Amicus Briefs in Ariad v. Lilly: Google, Verzion Communications Inc. and Cisco Systems, Inc.," November 22, 2009
• "Amicus Briefs in Ariad v. Lilly: Professor Christopher Holman," November 19, 2009
• "Lilly Files Principal Brief for Ariad v. Lilly Rehearing En Banc," November 16, 2009
• "Next Up: Ariad v. Lilly Rehearing En Banc," November 10, 2009
• "Federal Circuit Grants En Banc Review in Ariad v. Lilly," August 21, 2009
• "Ariad Files Petition for Rhearing in Ariad v. Lilly," June 3, 2009
• "Ariad Decision Voids Attempt to Use Broad Claiming to Avoid the Written Description Requirement," April 14, 2009
• "Ariad Pharmaceuticals, Inc. v. Eli Lilly and Co. (Fed. Cir. 2009)," April 6, 2009

USPTO Requests Comments on Enhancement of Patent Quality

    By Sarah Fendrick --

The U.S. Patent and Trademark Office and the Patent Public Advisory Committee (PPAC) have created a project to improve the overall quality of patents, reduce patent application pendency, and ensure that granted patents are valid.  The improvement initiative does not involve changes in patent law or substantive new rules, but rather the USPTO is seeking public comment on a number of categories identified in a Notice published in the Federal Register (74 Fed. Reg. 65093) on December 9, 2009.

In the past, two official metrics of examination quality were employed by the USPTO, the Allowance Compliance Rate and the In-Process Review (IPR) Compliance Rate.  The Allowance Compliance Rate was determined by randomly selecting a sample of allowed applications and reviewing the patentability of the claims, the completeness of the record, and the quality of the examiner's search.  The IPR Compliance Rate was determined by randomly selecting a sample of applications that had Office actions issued prior to allowance and reviewing indicators of quality such as whether the rejections made in the Office action were proper, whether the examiner clearly articulated the reasons for rejection, the quality of the examiner's search, and the propriety of any restriction requirement (for a full list of factors, see Notice).  The IPR Compliance Rate during 2005-2009 encompassed both final and non-final Office actions.  However, in 2010, the IPR Compliance Rate was redefined to include only non-final office actions and the Allowance Compliance Rate was changed to Final Rejection/Allowance Compliance Rate.

In an effort to improve the quality of patents and to improve upon the current metrics of examination quality, the USPTO has identified a number of categories where public comment is being sought.  The first category includes currently implemented quality measures and future measures not yet adopted.  Regarding current measures, the USPTO hopes to receive comments on how effective the current procedures are for ensuring the quality of patents.  Of particular interest are methods for finding the best prior art, obtaining a comprehensive initial application, providing first Office actions that include clear explanations of all issues raised in the action, receiving clear and comprehensive responses to Office actions, and proper use of interviews.  To address the issue of prior art, the Office is looking for comments concerning search techniques and procedures that could be used to locate the best prior art as well as technologies where it appears the best prior art is not being identified by examiners.  To ensure the receipt of comprehensive initial applications, the USPTO is soliciting comments on what current USPTO guidelines prevent effective preparation of comprehensive applications as well as methods that can be implemented to measure the quality and completeness of the submitted application.  Comments are also being sought on what aspects of an initial Office action will enhance quality and how examiners can best communicate to applicants what is needed in a response to the Office action.  Similarly, the Office is requesting comments that will ensure comprehensive responses to Office actions.  Specifically, the Office is asking for comments on what USPTO guidelines stand in the way of applicants when preparing a response that will allow for efficient examination.

The second category pertains to the stages of monitoring.  Within this category, the USTPO is looking for comments on procedures that may reduce patent pendency.  More specifically, the USPTO is considering at what stage and how frequently quality monitoring procedures should be implemented.  In addition, public input on how to effectively increase quality at initial stages of prosecution is being sought by the USPTO.

The third category concerns pendency.  Under this category, the Office seeks comments on whether the quality of prosecution and examination of an application, and quality of the granted patent, can be improved while also reducing the pendency of the process.  The USPTO also seeks input on how continuing applications influence the goal of pendency and quality.

Category four seeks comment and feedback on pilot programs and their role in ensuring quality and pendency.

Category five calls for comment on past USPTO surveys of the patent community and suggestions for improving future surveys.  The Customer Panel Quality Survey was launched in 2006 to receive input from frequent users of the USPTO concerning examination quality issues as well as a means for customers to provide feedback to the USPTO regarding quality measures.  Past participants of the survey were top filers (law firms, organizations, or individuals that have submitted six or more applications in the previous year).  Survey results are analyzed quarterly and have on average 1100 participants per quarter.

Category six regards feedback on existing tools which can aid the USPTO and its users to enhance the quality of USPTO processes.  Specifically, feedback on software tools that will facilitate monitoring, search tools, claim analysis tools, and case law identification tools is being sought.

Finally, under category seven, the USTPO seeks comments on methods that can incentivize applicants and USPTO personnel to participate in efforts to improve the quality of patents.

Individuals wishing to submit comments must do so on or before February 2, 2010.  Each comment should include:  (1) the name and affiliation of the individual responding, and (2) an indication of whether the comments offered represent the views of the respondent's organization or are the respondent's personal views.  The Office indicates that it prefers to receive comments via the internet at [email protected].  Alternatively, comments can be submitted by regular mail to:  Mail Stop Comments -- Patents, Commissioner for Patents, P.O. Box 1450, Alexandria, VA 22313–1450, marked to the attention of Kenneth M. Schor and Pinchus M. Laufer.  The Office warns that parties should not submit information that they do not wish to be publicly disclosed or made electronically accessible.

Court Report

    By Sherri Oslick --

About Court Report:  Each week we will report briefly on recently filed biotech and pharma cases, and a few interesting cases will be selected for periodic monitoring.

Cephalon Inc. et al. v. Actavis Group et al.
1:09-cv-00940; filed December 8, 2009 in the District Court of Delaware

• Plaintiffs:  Cephalon Inc.; Cephalon France
• Defendants:  Actavis Group; Actavis Pharma Manufacturing Pvt Ltd.; Actavis Inc.

Infringement of U.S. Patent Nos. RE37,516 ("Acetamide Derivative Having Defined Particle Size," issued January 15, 2002) and 7,132,570 ("Method for the Production of Crystalline Forms of Optical Enantiomers of Modafinil," issued November 7, 2006) following a Paragraph IV certification as part of Actavis' filing of an ANDA to manufacture a generic version of Cephalon's Nuvigil® (armodafinil, used to improve wakefulness in patients with excessive sleepiness associated with obstructive sleep apnea/hypopnea syndrome, narcolepsy, and shift work sleep disorder).  View the complaint here.

Pfizer Inc. et al. v. Dr. Reddy's Laboratories Ltd. et al.
1:09-cv-00943; filed December 8, 2009 in the District Court of Delaware

• Plaintiffs:  Pfizer Inc.; Pfizer Ireland Pharmaceuticals; Warner-Lambert Co.; Warner-Lambert Co. LLC
• Defendants:  Dr. Reddy's Laboratories Ltd.; Dr. Reddy's Laboratories Inc.

Infringement of U.S. Patent No. 5,969,156 ("Crystalline [R- (R*,R*)]-2-(4 Fluorophenyl)-β,δ-dihydroxy-5-(1-methylethyl)- 3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid hemi calcium salt (atorvastatin)," issued October 19, 1999) following a Paragraph IV certification as part of Dr. Reddy's filing of an ANDA to manufacture a generic version of Pfizer's Lipitor® (atorvastatin calcium, used to treat high cholesterol and heart disease).  View the complaint here.

Galderma Laboratories, L.P. et al. v. Perrigo Co. et al.
3:09-cv-02322; filed December 4, 2009 in the Northern District of Texas

• Plaintiffs:  Galderma Laboratories, L.P.; Galderma S.A.; Dermalogix Partners Inc.
• Defendants:  Perrigo Co.; Perrigo Israel Pharmaceuticals Ltd.

Infringement of U.S. Patent No. 5,972,920 ("Formulation Containing a Carrier, Active Ingredient, and Surfactant for Treating Skin Disorders," issued October 26, 1999) following a Paragraph IV certification as part of Perrigo's filing of an ANDA to manufacture a generic version of Galderma's Clobex® (clobetasol propionate, used for the treatment of moderate to severe plaque psoriasis).  View the complaint here.

Conference & CLE Calendar

January 6-10, 2010 - 27th Annual National CLE Conference (Law Education Institute, Inc.)

January 20-21, 2010 - Life Sciences IP Due Diligence (American Conference Institute) - New York, NY

January 25-26, 2010 - European Pharmaceutical Regulatory Law Boot Camp (American Conference Institute) - New York, NY

January 26-27, 2010 - Advanced In-House Counsel Forum on China IP Law (C5) - Shanghai, China

January 27-28, 2010 - Pharma & Biotech Patent Litigation (C5) - Amsterdam, Netherlands

***Patent Docs is a media partner of this conference or CLE

Pharma & Biotech Patent Litigation Conference

C5 (UK) will be holding its 2nd Annual Pharma & Biotech Patent Litigation conference on January 27-28, 2010 in Amsterdam, Netherlands.  The conference will provide strategic guidance regarding the following issues:

• Is the Enforcement Directive an effective tool for brand name pharma in enforcing patents:  Analysis of post Directive case law;
• The latest European Patent Office decisions and their implications:  Hear directly from the EPO's Legal Member to the Boards of Appeal;
• SPCs and paediatric regulation:  Recent decisions and varying application requirements across Europe;
• Pharma Sector Inquiry Final Report:  What lessons can both innovators and generics companies draw?
• European Standards on sufficiency of description post Lundbeck and Novartis v Johnson & Johnson; and
• Enforcing IP rights in China, India, Russia and Israel:  Local practitioners' guide to the facilitative provisions and stumbling blocks.

In particular, C5 faculty will offer presentations on the following topics:

• Highlights from pharma and biotech patent litigation in 2009 and trends for the future;
• The Generics (UK) v Lundbeck case and subsequent conflicting decisions in the Netherlands and Germany:  What is the European position on sufficiency today?
• Post-enforcement Directive case law across Europe:  New opportunities for effective enforcement of IP rights by innovators?
• In discussion with the European Patent Office:  Update on recent decisions;
• SPC litigation:  Recent case law and varying requirements for SPCs across Europe;
• Critical analysis of key issues and recent case law involving pediatric extensions;
• Pharma and biotech infringement litigation in China, India, Russia, and Israel;
• Special address:  How have recent landmark decisions impacted the U.S. litigation landscape? -- Judge Randall Rader, United States Court of Appeals for the Federal Circuit;
• Pharma sector final report:  What are the implications for industry?
• Settlement agreements post pharma Sector Inquiry:  What can and cannot be done?
• Beyond the injunction:  The battle for damages in pharma patent litigation;
• Using experiments in pharma and biotech patent litigation:  Key legal and practical considerations; and
• Strategies and best practice for conducting and managing complex multi-jurisdictional litigation.

An additional post-conference master class, entitled "Winning Strategies for Enforcing Your Life Sciences Patents in China and India," will be offered on January 29, 2010.  This master class will examine patent enforcement in two jurisdictions -- China and India -- that, for the European pharma and biotech industry, are crucially important given the strong presence of local generics companies.

A complete brochure for this conference, including an agenda, list of speakers, and registration form can be downloaded here.

The registration fee for the conference is £1399 ($2,044.67), for the conference plus master class £1798 ($2,627.81), and for the master class alone £499 ($729.30).  Those interested in registering for the conference can do so here, by calling +44 (0) 20 7878 6888, or by faxing a registration form to +44 (0) 20 7878 6896.

China IP Law Conference

C5 (UK) will be holding its Advanced In-House Counsel Forum on China IP Law on January 26-27, 2010 in Shanghai, China.  At the conference, C5 faculty will offer presentations on the following topics:

• Status report on recent IP regulatory and enforcement initiatives;
• Developing a filing strategy to address China's new secrecy examination;
• Incorporating utility model patents in patent strategies;
• How to collect evidence to win patent cases in Chinese Courts;
• How absolute novelty standard will challenge patent validity;
• Positioning an IP department to support legal, marketing, and R &D departments;
• Mitigating leakage of "know-how" while licensing technology in China;
• Maximizing ROI in anti-counterfeiting;
• Minimizing patent litigation risks post Schneider;
• Complying with new technology import and export measures;
• How to obtain recognition of "well-known" trademarks in China;
• Defining ownership and reasonable remuneration for inventor awards; and
• Conducting effective freedom-to-operate (FTO) analysis to ensure right to commercialize products.

In addition, two pre-conference master workshops will be offered on January 25, 2010.  The first, entitled "Fundamentals of China Anti-Monopoly Law: What Every IP Attorney Needs to Know," will be held from 9:00 am to 12:30 pm, and the second, entitled "A Deep Dive into the 3rd Patent Amendment Legislation:  What Life Science Companies Need to Know about New Patent Law," will be held from 1:30 to 5:00 pm.

A complete brochure for this conference, including an agenda, list of speakers, and registration form can be downloaded here.

The registration fee for the conference is $2,195, for the conference plus one workshop $2,795, and for the conference and both workshops $3,395.  Those registering by January 5, 2010 will receive a $200 discount off the registration fee.  Those interested in registering for the conference can do so here, by calling +44 (0) 20 7878 6888, or by faxing a registration form to +44 (0) 20 7878 6896.

Photograph of the Pudong skyline in Shanghai, China (above) by Jens Schott Knudsen, from the Wikipedia Commons under the Creative Commons license.

NPR's "Science Friday" to Focus on Gene Patenting

    By Donald Zuhn --

On December 11th, National Public Radio's Science Friday, which is broadcast nationwide from 2:00 - 4:00 pm Eastern time as part of NPR's Talk of the Nation programming, will focus on the issue of gene patenting.  In particular, the program will examine the Association for Molecular Pathology v. United States Patent and Trademark Office case, in which a group of patients, physicians, academic researchers, and medical societies filed suit against the U.S. Patent and Trademark Office and Myriad Genetics, among others, over several patents claiming human BRCA1 and BRC2 genes and methods for detecting mutations in these genes to diagnose a predisposition to breast and ovarian cancer (see Patent Docs reports here and here).

Patent Docs author Kevin Noonan, who has written a number of articles in this space on the topic of gene patenting, will be a guest on the show.  American Civil Liberties Union (ACLU) Science Advisor Tania Simoncelli will also be a guest on the show.

A list of public radio stations that broadcast Science Friday can be found here.

For additional information regarding this and other related topics, please see:
• "BRCA Patent Suit to Continue in Southern District of New York," November 2, 2009
• "Empirical Research Fails to Support Gene Patenting Ban," October 22, 2009

• "Gene Patenting Debate Continues - Round Two," August 4, 2009
• "The Unwanted Consequences of Banning Gene Patenting," June 16, 2009
• "Falsehoods, Distortions and Outright Lies in the Gene Patenting Debate," June 15, 2009
• "Gene Patenting Debate Continues," June 9, 2009
• "Association for Molecular Pathology v. U.S. Patent and Trademark Office," May 17, 2009
• "Court Report: Special Edition," May 13, 2009
• "Gene Patenting and the Wisdom of Judge Lourie," April 12, 2009
• "Science Article Should Help Allay Gene Patenting Fears," December 17, 2008