Patent Docs

Maybe It Isn't Going to Get Much Better

    By Kevin E. Noonan --

One of the hopes of the members of the patent community who have been paying attention is that the passing of the current administration may result in better times for the U.S. patent system.  Political appointees like Secretary of Commerce Guttierrez, USPTO Director Jon Dudas, and Undersecretary of Commerce Margaret Peterlin will certainly be packing up their desks next January.  However, we can expect that the Congress will be similarly constituted as it is now, and that could result in efforts for even more dubious patent reform schemes.

This message is delivered by Professor Harold Wegner (at right) in a cover story article published in ipFrontline (see "Keys to 111th Congress Patent Reform").  The source of his concern is the patent economics tome Patent Failure: How Judges, Bureaucrats, and Lawyers Put Innovators at Risk by James Bessen and Michael J. Meuer.  The work has been lauded by patent academia:  Professor Dennis Crouch excerpted it extensively on his Patently-O blog prior to publication, and the published work carries glowing accolades from the darling of patent academia, Professor Mark Lemley of Stanford University.  While the approval of the academic patent intelligentsia is one thing, more worrisome is that Patent Failure thesis, the familiar "the patent system is broken," is gaining traction among policymakers.

The basis for this influence can be summarized in this graph (from Professor Wegner's article):

The graph purports to show not just that the patent system is broken, but calls into question the system's value to innovation and the U.S. economy.  The graph is based on two statistics:  the positive value of patent protection versus the negative effects of patent litigation.  The message of the graph - that patents cost more than they are worth - seems simple and empirical.  While acknowledging that patents seem to benefit certain industries, like biotechnology and pharmaceutical companies, the message of this analysis is that the majority of American "mainstream" industries suffer more harm than benefit from the patent system.

But as Professor Wegner notes, there are some indications that the data don't completely support the message.  For example, the profits ascribed to the pharmaceutical industry are only $15 billion, citing his analysis of the data from his review of Patent Failure in The Financial Times:

The fraction of patents in the biotech/pharma and chemistry sectors may be small in terms of numbers of patents but that is where patent exclusivity is most vigorously enforced and where the bulk of all patent rent value lies.  The authors estimate the global patent value for US companies in the chemicals (including pharmaceuticals) sector in 1999 was $[15 billion] compared with only $3.2 [billion] for all other sectors.  In fact, the $[15 billion] figure is ridiculously low:  sales of the top 10 drugs account for roughly $40 [billion] in domestic sales alone – with no patent protection, that $40[billion] would vanish.

("The right medicine for a flawed system," May 8, 2008).

Further, Professor Wegner notes that when Eli Lilly and Company lost its patent on Prozac® in 2001, "its market cap dropped $36 billion in one day, roughly triple what the authors say is the annual profit for the entire pharmaceutical and chemistry industries in one year."  He also identifies the reason for this discrepancy:  "the auhors have explained the seemingly low figure of $15 billion in annual patent profits in pharmaceuticals and chemicals by stating that their figures are calculated based upon "patent 'rents' not sales and not patent value.  . . .  In economic theory it is the rents from patents, not the associated sales, that provide the reward to inventors."  One way of looking at this analysis is to say that patent rents are the measure of the difference between the profits that are made with patent protection and the profits that would be made in the absence of patents.  Another way is to recognize that it assumes that there would be profits for pharmaceuticals in the absence of patents, an analysis that ignores the reality that pharmaceutical companies (and their investors) need patents to ensure sufficient return on investment (ROI) necessary to justify the risk created by the supranormal costs of bringing a drug to market.

As noted in an earlier Patent Docs post, the Bessen-Meurer analysis is at odds with the results of a study by the European Commission reported in 2005 and directed to the very question of the economic value of patents in Europe (the study was entitled "Study on Evaluation the Knowledge Economy - What are Patents Actually Worth?").  The study was comprehensive, surveying 9,000 patent owners who had used the European Patent Office to obtain patents between 1993 and 1997.  The study showed that the median value (half the respondents reporting more and half less) of the patents produced was €300,000, and 10% of the respondent patent owners reported values of €10 million or more.

As an antidote - or perhaps a prophylactic - to "reforms" driven by the Bessen-Meuer analysis, Professor Wegner proposes the following changes in U.S. patent law that might be sufficient to appease the patent "reformers" while not wreaking extensive havoc on innovation:

• Establish a patent maintenance fee system along the lines of the ones in most European countries, where patents are subject to an increasing annuity for each year of patent life; this would impose a much higher cost on patent "trolls" and discourage acquisition of patents merely to assert them against mainstream industries.

• Permit delayed examination (up to seven years) to let commercial activities weed out those applications that are not necessary to protect a product or provide a competitive advantage.  Professor Wegner opines that the failure to enforce most patents indicates substantive examination is an "extreme waste of money" for most patents.  He even proposes a "spoonful of sugar" for the USPTO, where the examination fees would still be collected and subject to only an 80% refund if an applicant decides not to pursue examination.

• In an effort to balance the interests of patent-dependent industries like biotech/pharma with those industries that may suffer more of a burden than a benefit, Professor Wegner proposes giving intervening rights to anyone who commercializes an invention more than 30 months after an application filing date (i.e., one year after the application publishes), while permitting applicants to obtain an "unlimited" extension of prosecution of a pending application.  The latter would purportedly be beneficial to biotech and pharma companies, by giving them time to collect clinical trial results.  An additional benefit, according to Professor Wegner, would be that "the majority" of patent applications would be abandoned prior to prosecution.

• In the event these reforms are implemented, Professor Wegner proposes that all continuation applications (excluding divisional applications) be prohibited at any time after 18 months from filing.

• He would also bolster inter partes reexamination, which has not been particularly successful.  The Professor blames the PTO for the "bottleneck"; the estoppel provisions in the 1999 law provide an equally likely explanation not mentioned by Professor Wegner.  His proposal would put all inter partes reexaminations under a single administrative patent judge and have all proceedings take place before the Board, with the examining corps providing "designated examiners" to assist in the initial reexamination.  As part of this reform (but justified in its own right) there would be a substantial increase in the number of APJ's.

The viability of these ideas, as well as the veracity of Bessen-Meuer's analysis, will be the subject of future posts (and Patent Docs has, in fact, already discussed several of these ideas).  For now, Professor Wegner's article merely reinforces the message that we all need to remain vigilant in protecting the integrity of U.S. patent system.  Or maybe to put it more bluntly:  it's not over.

Save the Date -- Initial Scheduling of the Tafas/GSK v. Dudas Appeal

Earlier this month, we reported that the U.S. Patent and Trademark Office had filed a Notice of Appeal with the Court of Appeals for the Federal Circuit, challenging the decision of Judge William Cacheris of the U.S. District Court for the Eastern District of Virginia to permanently enjoin the Patent Office's continuation and claims rules package in the consolidated cases of Tafas/Smithkline Beecham Corp. v. Dudas.  Judge Cacheris' ruling was based on his determination that the continuation and claims rules "are substantive in nature and exceed the scope of the USPTO's rulemaking authority under 35 U.S.C. § 2(b)(2)."

The Federal Circuit has now issued a Notice of Docketing, which sets some of the deadlines for the appeal.  Among the deadlines that have been set are the following:

• June 2:  The Appellants (Dudas and the USPTO) must serve on the Appellees (Tafas and GSK) a designation of materials from which the appendix will be prepared;

• June 18:  The parties must file a Docketing Statement, indicating inter alia the relief being sought and providing a brief statement of the issues to be raised on appeal;

• July 3:  The parties must file a Certificate of Compliance with Federal Circuit Rule 11(d), which requires the parties to review the record to determine whether any portions subject to a protective order must remain protected on appeal; and

• July 18:  Under Federal Circuit Rule 31, the Appellants have sixty days from the docketing date to serve and file their opening brief.

The Appellees' briefing (and subsequent briefing) will be cued off the date by which the Appellants file their opening brief, so those dates are yet to be determined.  However, assuming that the parties each take the maximum time to file their briefs, and seek no extensions, the Appellees' brief would be due on August 27th (the Appellees have forty days after the Appellants' brief is served to file their own brief), and the Appellants' reply brief would be due on September 10th (the Appellants have up to fourteen days to serve and file a reply brief, though the time to file a reply can be shortened to ensure that the reply is served in advance of oral argument).  The principal briefs are limited to 30 pages, or up to 14,000 words, and the reply brief is limited to 15 pages, or 7,000 words.

Sherri Oslick, Benjamin Huber, and Donald Zuhn contributed to this report.

For information regarding this topic, please see:

• "USPTO to Appeal Tafas/GSK v. Dudas," May 7, 2008
• "BIO Responds to Events of the Day," April 1, 2008
• "No April Fool's Joke -- Tafas and GSK Win on Summary Judgment," April 1, 2008
• "PLI's John White Discusses Tafas/GSK v. Dudas," February 11, 2008
• "Judge Cacheris Takes GSK Case under Advisement," February 8, 2008
• "GSK Summary Judgment Hearing Set for Friday Morning," February 7, 2008
• "New Briefing Deadline Set In PTO Rules Case," December 18, 2007
• "Court Sets Summary Judgment Schedule in New Rules Case," December 3, 2007
• "No Discovery in New Rules Case," November 27, 2007
• "Tafas v. Dudas; SmithKline Beecham Corp. v. Dudas (E.D. Va. 2007)," October 31, 2007
• "USPTO Late to Its Own Party," October 31, 2007
• "GSK Secures Injunction," October 31, 2007 (includes links to Court's Order and Opinion)
• "Senator Schumer Sends a Signal," October 30, 2007
• "GSK TRO/Preliminary Injunction Hearing," October 29, 2007
• "AIPLA Supports GSK's Lawsuit Against the Patent Office's New Rules," October 25, 2007
• "GSK Brings Out the Big Guns Opposing the New Continuation and Claims Rules," October 24, 2007
• "Hooray! - (Finally) the Big Dogs Have Joined the Hunt," October 11, 2007
• "Rules Challenger Amends Complaint and Withdraws PI Motion," September 11, 2007
• "Inventor Sues PTO to Prevent New Continuation and Claims Rules from Taking Effect," August 30, 2007

Rough Times Ahead for Biotech Industry?

    By Donald Zuhn --

With the BIO International Convention less than a month away, a report in the San Francisco Chronicle is predicting that the U.S. biotech industry may be looking at some rough times ahead.  The Chronicle's prediction is interesting given its citation of a recent Ernst & Young study that noted that U.S. biotech companies had secured $21.3 billion in financing in 2007.  The portion of this total coming from venture capital firms ($5.5 billion) topped the record set in 2000 at the height of the Human Genome Project.

Showing a hint of partisanship, the Chronicle observed that the Bay Area ("where the industry was born") had topped all other regions in funding in 2007, with Boston coming in second.  In particular, the Bay Area biotech cluster consists of the 77 biotech companies having 40% of the market value of U.S. biotech companies, and the New England biotech cluster consists of 62 companies having 17.6% of the market value.

The Chronicle's less than sunny forecast was based on comments from Ernst & Young's U.S. life sciences director, Scott Morrison, who noted that many factors could lead to a downturn in financing in 2008.  Among these factors is the subprime mortgage meltdown, which Morrison said was partly to blame for a 60% decrease in biotech funding this year.  Morrison noted, however, that the industry was well-prepared for a financing squeeze, as almost half of the 386 U.S. traded biotech companies have more than two years of cash reserves on hand, and more than a quarter have five years of cash reserves.

And it may not even be necessary to tap into these cash reserves, since, according to Morrison, venture capital funding continues to be strong.  The primary reason for the steady VC funding appears to be the desire by big drug makers to replace drugs that will soon be going off patent with new therapeutics, a quest that often finds the big drug makers acquiring or partnering with VC-funded smaller companies.  (The Ernst & Young report noted that the value of biotech mergers, acquisitions and drug development alliances was nearly $60 billion in 2007, which was a new high.)

The San Jose Mercury News also reported on the Ernst & Young report, focusing on the fact that biotech companies once again spent more money than they took in, losing almost $2.7 billion last year.  On the bright side, this was down from the $7.4 billion in losses the industry suffered in 2006.

Lobbying Spending Spree Continues

    By Donald Zuhn --

The Senate patent reform bill may or may not be dead (see "Bush Administration Continues Attempt to Destroy U.S. Patent System").  However, if the bill's time has indeed come and gone (at least as far as the 110th Congress is concerned), its passing will be due in no small part to the efforts of biotech and pharma companies to aggressively lobby against the bill.

For the past few months, we have been reporting on the recent lobbying expenditures of a number of biotech and pharma companies.  For example, we noted that Millennium Pharmaceuticals, Genentech, AstraZeneca, and Abbott Laboratories spent between $1.28 million and $4.4 million on lobbying in 2007.  Most of these funds presumably went to lobby on the patent reform and follow-on biologics bills that were being considered by Congress last year.  More recently, we reported that Abbott spent $880,000 on lobbying in the first quarter of 2008.

Two more reports regarding first quarter spending can now be added to the list.  First, the Houston Chronicle reported last Friday that Cephalon, Inc. spent $512,000 on lobbying in the first quarter.  While the Frazer, PA-based biotech company lobbied in favor of more funding for the FDA and for new standards for alcoholism treatments (Cephalon markets the injectable drug Vivitrol® for treating alcoholism), it also lobbied against the Senate patent reform bill.

Topping both Abbott and Cephalon, however, was Amgen Inc.  Forbes.com reported that the Thousand Oaks, CA-based biotech company spent $2.5 million on lobbying in the first quarter.  Amgen's lobbying efforts were aimed in part at the patent reform and follow-on biologics bills.  With respect to the follow-on biologics legislation, Forbes.com indicated that Amgen was pushing for a compromise before the fall elections, when Democrats are expected to pick up additional seats in Congress.

However, as we noted earlier this month, with the patent reform bill seemingly stalled in the Senate, the follow-on biologics legislation on the backburner (notwithstanding the biotech industry's desire to negotiate a compromise), and the economy struggling, it will be interesting to see if biotech and pharma companies begin to cut back on lobbying in the second quarter.

For additional information regarding this topic, please see:

• "Abbott's First Quarter Lobbying Tab Hits $880,000," May 2, 2008
• "Abbott Spent $4.4 Million on 2007 Lobbying Effort," March 17, 2008
• "Biotech and Pharma Companies Spent Millions on Lobbying in 2007," March 5, 2008
• "Millennium Pharmaceuticals Spent $1.28 Million on Lobbying in 2007," February 8, 2008

ETC Group Opposes "Climate Ready" Gene Patent "Grab"

    By Donald Zuhn --

Last week, both The Washington Post and Nature News reported on the efforts of biotech companies to secure patents directed to gene-altered crops that are designed to withstand the effects of global warming.  The impetus behind both articles was a 30-page report entitled "Patenting the 'Climate Genes' . . . and Capturing the Climate Agenda," which was released by the Erosion, Technology and Concentration (ETC) Group, an activist organization based in Ottawa, Ontario, on May 13th.  (Patent Docs readers are no doubt familiar with the ETC Group, as we have reported on a few of the Group's other initiatives; see links below.)

According to the ETC Group, biotech and agrochemical companies such as BASF, Monsanto, Bayer, Syngenta, and Dupon have been "stockpiling hundreds of monopoly patents on genes in plants," and that the companies intend to market genetically engineered crops containing such genes (i.e., "climate ready" plants) as being able to withstand environmental stresses such as drought, heat, cold, floods, and saline soils.  The ETC Group contends that the above companies have thus far filed 532 patent applications worldwide (in 55 patent families) on such genes, and warns that "[i]n the face of climate chaos and a deepening world food crisis, the Gene Giants are gearing up for a PR offensive to re-brand themselves as climate saviours."  The Group argues, however, that "patented techno-fix seeds will not provide the adaptation strategies that small farmers need to cope with climate change," and that the so-called "Gene Giants" are merely engaging in "climate change profiteering."

To prevent such "profiteering," the ETC Group is pushing for a worldwide suspension of patent grants for climate-related genes and traits.  The Group hopes that such action might be taken at either the U.N. Convention on Biological Diversity on May 19-30 or the United Nations-FAO High-Level Conference on World Food Security and the Challenges of Climate Change and Bioenergy on June 3-5, and that following the implementation of such a suspension, world governments would initiate an investigation into the social and environmental impact of patents directed to climate ready genes and plants.  The ETC Group is also urging "inter-governmental bodies to identify and eliminate policies such as restrictive seed laws, intellectual property regimes, contracts and trade agreements that are barriers to farmer plant breeding, seed-saving and exchange."

Not surprisingly, the companies accused by the ETC Group of engaging in "climate change profiteering" see their role in a much different light.  According to The Washington Post article, the biotech companies seeking gene patents contend that climate ready plants will be critical to solving the problem of world hunger and that absent patent protection, such plants will not be developed.  In addition, a spokesperson for Monsanto noted in the Post report that Monsanto and BASF were participating in a project, funded by the Bill and Melinda Gates Foundation, to develop drought-resistant corn that would be made available to African farmers royalty-free.

One of the ETC Group's criticisms regarding the 532 filed applications is that these applications contain claims that are far too broad, encompassing numerous plants and a litany of environmental stresses.  However, because the vast majority of these applications have yet to issue as patents, the actual claim scope that the applicants will be able to secure remains unclear.  ETC Group executive director Pat Mooney concedes this point in the Nature News article, admitting that "the companies are casting the net as wide as they possibly can, and then they will sort it out afterwards."

Dr. Alan Bennett (at left), a plant geneticist at the University of California, Davis and the head of the the Public Intellectual Property Resource for Agriculture (PIPRA), a non-profit initiative supporting agricultural innovation for both humanitarian and small-scale commercial purposes, put the debate between the ETC Group and the agricultural-biotech industry  into some perspective in the Nature News report.  Calling the introduction of the global warming angle nothing more than a public relations stunt, Dr. Bennett observed that the agricultural-biotech industry was merely engaging in business as usual; namely, focusing on the search for hardy crops that survive in harsher environments (i.e., poor soils, less water, fewer fertilizers), and the genes responsible for conferring such traits.

For additional information regarding other related topics, please see:

• "Playing the Bioterror Card in the Synthetic Biology Debate," December 19, 2007
• "The Synthetic Biology Sky is Not Falling," December 16, 2007
• "Patent Life (Really)," June 11, 2007

Bush Administration Continues Attempt to Destroy U.S. Patent System

    By Kevin E. Noonan --

Just when you thought it was safe to stop worrying about the stalled "patent reform" bill in the Senate (S. 1145), along comes Secretary of Commerce Carlos Gutierrez (at right), trying to reenergize the IT community in Silicon Valley to push for passage of this misguided bill.

Last week, Mr. Gutierrez announced his intention to meet with leaders of the IT community in an op-ed piece published in the San Jose Mercury News (see "Get moving on patent reform measure stalled in Senate").  Mr. Gutierrez bemoaned that negotiations over the bill had stalled and that the legislation was unlikely to pass this year (see "Senate Patent Reform Bill: R.I.P.?").  The Secretary emphasized the importance of intellectual property protection to the U.S. economy, citing a value of $5.5 trillion corresponding to 40% of the U.S. economy and employing 18 million Americans.  All important and vital statistics, sadly misapplied in defense of a bill guaranteed to put those jobs and technology at risk.

Tellingly, the Secretary cites "products such as cell phones and blenders, to high-technology microchips and heart valves" as deserving protection.  Not surprisingly, he neglected the contributions of the biotechnology and pharmaceutical industries and the importance of patent protection to those industries; these industries do not comprise the intended Silicon Valley audience.  He then set forth "a way forward" to pass legislation "streamlined" to contain only some of the many provisions contained in S. 1145.  (Some provisions, such as Senator Sessions' "patent infringement 'get out of jail free'" portion of the bill, has already been deleted.)  The Secretary's "way forward" includes these provisions of the bill (as presented in the Secretary's op-ed article):

• Damages:  The debate has largely focused on how different business models win or lose under the current system.  This is the wrong way to approach the issue.  Our patent system must work to encourage innovation in all sectors of the economy, and it shouldn't tilt toward one industry or another.  Most agree on reforms that would give judges additional authority to direct juries as to which factors they may consider in determining the compensation for infringement.  Judicial guidance will help ensure more rational decisions while protecting judicial discretion.

• Post-grant review:  Most agree that establishing cost-effective alternatives to litigation after a patent is granted would be a significant improvement.  One way to accomplish this is to provide a venue for patent holders and patent challengers to resolve their differences in front of experts at the Patent and Trademark Office.  This should include protections to ensure that it does not become a vehicle to harass the patents of competitors.

• Patent quality:  The Senate bill currently includes language that emphasizes the importance of patent quality at the front end of the process.  This reform is essential.  Our patent system faces increasingly complex applications, which is why - despite significant productivity initiatives - the patent office currently has a backlog of 760,000 patents and the average patent exam takes 31 months.  Requiring quality on the front end will allow us to speed the flow of new ideas through our innovation pipeline.

Secretary Gutierrez calls these the provisions "where there is broad agreement on the need for reform."  Many would differ with this assessment (see "Commerce Secretary 'Entirely Wrong' on Inequitable Conduct Reform").  The Secretary's bill would include Applicant Quality Submissions, placing the examination burden on applicants rather than the Office.  Anyone with any real experience knows that the philosophical underpinning for these provisions, that applicants are in the best position to know the relevant prior art, is deeply flawed and any factual basis is due to the overwhelmingly high percentage of recently hired new examiners.  And this situation is the result of mismanagement and years of insufficient funding for the Office.  These transient circumstances are not an acceptable or adequate basis for twisting the fundamental balance between applicants and the Office, a conclusion seemingly beyond the ken of those in the Administration fomenting for this dubious reform.

The other patent-unfriendly provisions provide post-grant review for an Office without any apparent confidence in the integrity of the examination process, and a damages provision demonstrating a similar lack of confidence in the ability of the judiciary to determine the fair and proper amount of damages for patent infringement.

Once again, in this election year it is important for those in the patent community with actual experience, who are not career bureaucrats looking to improve performance statistics or political employees padding their resumes for the next government job or K Street consultancy, to contact their Senator and tell them the "compromise" offered by the Secretary is merely the "worst of" S. 1145.  Passage would not represent compromise but rather capitulation, to those whose intention is to gut rather than bolster the U.S. patent system.  It is still time for us to remain vigilant.

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.

Salix Pharmaceuticals, Inc. et al. v. Novel Laboratories, Inc.
3:08-cv-02311; filed May 14, 2008 in the District Court of New Jersey

Infringement of U.S. Patent No. 7,169,381 ("Colon Cleansing Compositions and Methods," issued January 30, 2007) following a paragraph IV certification as part of Novel's filing of an ANDA to manufacture a generic version of Salix's MoviPrep® (PEG 3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate and ascorbic acid oral solution, used for cleansing of the colon as a preparation for colonoscopy).  View the complaint here.

Bayer Schering Pharma AG et al. v. Sandoz, Inc.
1:08-cv-00980; filed May 12, 2008 in the District Court of Colorado

Infringement of U.S. Patent No. 5,569,652 ("Dihydrospirorenone as an Antiandrogen," issued October 29, 1996) following a paragraph IV certification as part of Sandoz's filing of an ANDA to manufacture a generic version of Bayer's Yasmin® (drospirenone and ethinyl estradiol, used as oral contraception).  View the complaint here.

Novartis Pharmaceuticals Corporation et al. v. Roxane Laboratories, Inc.
2:08-cv-02272; filed May 9, 2008 in the District Court of New Jersey

Infringement of U.S. Patent Nos. 5,840,763 ("Treatment of a Latent Infection of Herpes Viruses, issued November 24, 1998), 5,916,893 (same title, issued June 29, 1999), and 5,866,581 ("Penciclovir for the Treatment of Post Therapeutic Neuralgia," issued February 2, 1999) following a paragraph IV certification as part of Roxane's filing of an ANDA to manufacture a generic version of Novartis' Famvir® (famciclovir, used for the treatment of acute herpes zoster (shingles), the treatment or suppression of recurrent genital herpes in immunocompentent patients, the treatment of recurrent herpes labialis (cold sores) in immunocompetent patients, and the treatment of recurrent mucotaneous herpes simplex infections in HIV-infected patients).  View the complaint here.

Pamlab, L.L.C. et al. v. Hi-Tech Pharmacal Co., Inc. et al.
1:08-cv-00967; filed May 8, 2008 in the District Court of Colorado

Infringement of U.S. Patent No. 6,528,496 ("Compositions Treating, Preventing, or Reducing Elevated Metabolic Levels," issued March 4, 2003) based on defendants' manufacture and sale of its Folamin, allegedly the same as Pamlab's Foltx® (vitamin B12, vitamin B6, and folic acid, used to treat hyperhomocysteinemia).  View the complaint here.

Possible Limitations to EGFR-targeted Cancer Therapies

    By Kevin E. Noonan --

An important consequence of the biotechnology revolution has been an increased understanding of the molecular biology of cancer.  Tyrosine kinases, including the eponymous src oncogene, provide important targets, comprising a family of plasma membrane proteins that in certain incarnations act as growth factor receptors.  Until now, therapeutic agents were primarily inhibitors of the tyrosine kinase activity, acting either directly or by preventing dimerization frequently associated with activating the kinase function.  However, a report published in Cancer Cell on May 6th illustrated a heretofore unknown activity of these receptors that calls into question the ultimate efficacy of the known inhibitors (see "Survival of Cancer Cells Is Maintained by EGFR Independent of Its Kinase Activity").

The study was performed on the epidermal growth factor receptor, one of a family of such receptors that includes the HER2/neu target of Genentech's breast cancer therapeutic Herceptin®.  EGFR (at left) is the target of several anticancer drugs, including several monoclonal antibodies.  These include panitumumab, sold by Amgen as Vectibix® for EGFR-expressing metastatic colorectal cancer, and cetuximab, sold by Bristol-Myers Squibb as Erbitux® for EGFR-expressing metastatic colorectal cancer and head and neck cancers.  Another class of anti-EGFR drugs inhibit the tyrosine kinase activity; these include gefitinib, sold by AstraZeneca as Iressa® for treating locally advanced or metastatic non-small cell lung cancer (NSCLC), and erlotinib, sold by Genentech as Tarceva® for the treatment of NSCLC and pancreatic cancer.  However, the success of these drugs has been more limited than expected, even in light of the otherwise poor prognosis of the typical patients for these therapies.

The authors of the Cancer Cell report propose a reason for the less than expected results:  in addition to the known function of EGFR for promoting cellular proliferation associated with the tyrosine kinase activity, EGFR has the newly-found property of promoting active glucose uptake in cancer cells, preventing cell death.  The experiments were performed on human cancer cells in vitro, showing that treatment with EGFR inhibitors did not kill the cells (although it did prevent receptor autophosphorylation via the tyrosine kinase activity and reduce cell proliferation).  In contrast, transfecting the cells with EGFR-specific siRNA (that reduced EGFR expression) promoted autophagic cell death, i.e. cannibalization of cellular structures and components for energy.  Analysis of the cells for intracellular glucose revealed no change in the presence of EGFR inhibitors, but marked reductions after transfection of EGFR siRNA resulting in lowered or abolished EGFR expression.  Autophagy could be prevented by increasing the extracellular glucose concentration.

The cancer cells assayed in these experiments expressed two cell surface glucose transporters:  GLUT1, which responds to increased extracellular glucose levels and is a passive transporter, and SGLT1, a sodium-dependent ATPase capable of active transport against a glucose concentration gradient.  Reduction of EGFR expression had no effect on GLUT1, but reduced SGLT1 detected by Western blot analysis.  The autophagic effect was mimicked by treating the cells with SGLT1-specific siRNA.  The combination of these results indicated that reduced intracellular glucose concentrations in response to reduced EGFR expression was mediated by SGLT1, and could be compensated by increased GLUT1-mediated glucose transport in response to increased extracellular glucose concentrations.  RT-PCR experiments on SGLT1 mRNA showed that SGLT1 gene expression was unaffected by EGFR downregulation, and treatment of proteosome inhibitors prevented reduction of cellular glucose levels mediated by SGLT1, establishing that SGLT1 degradation was the mechanism responsible for the observed effects.  Physical interaction between EGFR and SGLT1 was shown by co-immunoprecipitation using anti-EGFR antibodies, and this interaction was shown in MCF-7 cells (which express only very low levels of EGFR) transfected with wildtype as well as tyrosine kinase mutant EGFR.  The specificity of these effects was demonstrated by inhibiting endogenous EGFR expression using a 5' untranslated region (UTR)-specific siRNA, and rescuing the phenotype by transfecting the cells with wildtype or tyrosine kinase mutant EGFR species lacking the 5' UTR.  Finally, the specificity of SGLT1 involvement in autophagy caused by reduced intracellular glucose concentrations was established using MCF-7 cells (which do not express SGLT1) showing marked sensitivity to reductions in extracellular glucose in the culture media.

These results provide an explanation for the persistence of cancer cells in the face of EGFR-targeted therapies, but also suggest a molecular explanation for the relative failure of these agents to be more effective as anticancer agents.  Importantly, these results also suggest that combination therapies, perhaps with anti-metabolic or antiglycolytic agents, may provide improvements in treatment for EGFR-expressing tumors.

Conference & CLE Calendar

May 28, 2008 - Advanced Patent Licensing 2008: What You Need to Know Before Licensing Your Patent (Practising Law Institute) - New York, NY

May 28-30, 2008 - PharmaBiotech IP Summit (Worldwide Business Research) - Philadelphia, PA

June 11, 2008 - Advanced Patent Licensing 2008: What You Need to Know Before Licensing Your Patent (Practising Law Institute) - San Francisco, CA

June 16, 2008 - Prior Art & Obviousness 2008: The PTO and CAFC Perspective on Patent Law Sections 102 & 103 (Practising Law Institute) - San Francisco, CA

June 17-20, 2008 - BIO International Convention (Biotechnology Industry Organization) - San Diego, CA

June 18-20, 2008 - Fundamentals of Patent Prosecution 2008: A Boot Camp for Claim Drafting & Amendment Writing (Practising Law Institute) - New York, NY

June 23, 2008 - Multilateral Patents (Law Seminars International) - San Francisco, CA

July 1, 2008 - Prior Art & Obviousness 2008: The PTO and CAFC Perspective on Patent Law Sections 102 & 103 (Practising Law Institute) - New York, NY

July 9-11, 2008 - Fundamentals of Patent Prosecution 2008: A Boot Camp for Claim Drafting & Amendment Writing (Practising Law Institute) - San Francisco, CA

July 16, 2008 - Patent Claim Construction Workshop (Law Seminars International) - Seattle, WA

July 24-25, 2008 - Advanced Patent Prosecution Workshop 2008: Claim Drafting & Amendment Writing (Practising Law Institute) - New York, NY

August 11-12, 2008 - Advanced Patent Prosecution Workshop 2008: Claim Drafting & Amendment Writing (Practising Law Institute) - San Francisco, CA

September 11-12, 2008 - Current Issues in Complex IP Licensing (Law Seminars International) - Philadelphia, PA

September 15-16, 2008 - Biotech Patents (American Conference Institute)***

September 22-23, 2008 - FDA Boot Camp (American Conference Institute)***

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

ACI Biotech Patents Conference

American Conference Institute (ACI) will be holding its 10th Annual Forum on Biotech Patents on September 15-16 in Boston, MA.  The conference will allow attendees to:

• Establish essential strategies to prepare their companies or clients in light of frenzied upheaval in the patent world;
• Analyze the profound and potentially earth shattering ramifications of recent court decisions impacting patents, particularly Tafas/GSK v. Dudas;
• Implement an effective working relationship with the USPTO to successfully manage their patent applications;
• Identify problem behaviors that could result in a claim of inequitable conduct;
• Maximize their patent strategy when considering Board of Appeals and Interference action;
• Optimize their knowledge of the impact and ramification of potential follow-on biologics and antibody technologies in the patent arena;
• Uncover the key to an effective global patent strategy in light of world-wide patent practices; and
• Expand their skills in drafting, executing, and prosecuting biotech applications.

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

• Key biotech cases to watch and how they may impact your practice;
• The industry speaks:  Maximizing your relationship with the PTO;
• Navigating the Board of Patent Appeals and Interferences in light of the KSR decision;
• Life on the patent tightrope:  Updates on the proposed rules and patent reform;
• They are coming:  Preparing your practice for the inevitable insurgence of follow-on biologics and predicting the future of the biotech industry;
• The international perspective:  Changing patent practices in the EU and India;
• Practicing biotechnology arts:  Claim drafting strategies;
• Ex Parte Kubin:  A case study -- to be presented in part by Patent Docs author Kevin Noonan;
• Strategies and applications to implement during all stages of the biotech patent prosecution process to prevent allegations of inequitable conduct; and
• Different but the same:  The unique nature of prosecuting antibody therapeutics applications under the standard patent prosecution process.

An additional master class entitled: "Drafting Successful Patent Applications for Biotechnology Related Inventions" will be offered on September 17, 2008.  The master class will walk conference attendees through the process of drafting the claims and specifications for biotechnology applications related to inventions such as research tools, pharmaceuticals, genomics, proteomics and diagnostics, and provide attendees with tools to draft strong applications that will be well positioned to withstand future challenges.  In addition, the master class will cover issues that should be considered when drafting claims in the context of litigating or licensing patent claims related to biotechnology inventions to help attendees prepare patents and structure deals that provide real value.

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

The registration fee ranges from $2,195 (conference alone) to $2,795 (conference and master class).  Those registering on or before July 21, 2008 will receive a $300 discount off the registration fee and those registering on or before August 18, 2008 will receive a $200 discount off the registration fee.  Those interested in registering for the conference can do so here, by calling 1-888-224-2480, or by faxing a registration form to 1-877-927-1563.

Patent Docs is a media sponsor of ACI's Biotech Patents conference.

ACI FDA Boot Camp Conference

American Conference Institute (ACI) will be holding the next session of its FDA Boot Camp conference on September 22-23 in Boston, MA.  The conference will allow attendees to:

• Master the basics of the application and approval processes for drugs, biologics, and devices;
• Comprehend the structure of the FDA and the roles of the CDER, CBER, & CDRH;
• Develop a practical working knowledge of clinical trials for drugs and biologics and the clearance process for devices;
• Appreciate the regulatory balance between brand name and generic products;
• Understand the complexities of the patent and IP landscape, including the Hatch-Waxman Act, Orange Book, 180-day exclusivity, 30-month stay, Paragraph IV, NDA, ANDA, and 505(b)(2);
• Recognize the role of labeling in the drug/biological product approval process;
• See the importance of cGMPs to the post-approval regulatory process;
• Navigate the protocols of adverse events monitoring, pharmacovigilance, and Risk Evaluation and Minimization Strategies (REMS);
• Learn how devices are classified, monitored, and regulated; and
• Explore the FDA's expectations and guidance for recalls.

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

• The basics:  Understanding and working with the FDA -- jurisdiction, functions, organization, and operations;
• The nature of the approval process;
• Understanding the clinical trial process for drugs and biologics;
• Patent and IP overview:  Hatch-Waxman, trade dress, and more;
• Drugs and biological products:  Labeling;
• cGMPs:  Drugs and biologics (current good manufacturing practices);
• Non-patent exclusivity (part of the conference's patent track) -- to be presented by MBHB colleague and Orange Book Blog author Aaron Barkoff
• Bioequivalence:  What patent lawyers need to know (patent track)
• Follow-on (comparable or biosimilar) biologics (patent track)
• Adverse events monitoring, pharmacovigilance, and risk management;
• Medical devices:  Classification and the essentials of the device premarket review process;
• Post-market requirements and concerns for medical devices;
• Medical device labeling and advertising; and
• Recall guidance for drugs, biologics, and medical devices:  What you need to know.

The agenda for the FDA Boot Camp conference can be found here.  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.  Those registering on or before July 18, 2008 will receive a $300 discount, and those registering on or before August 29, 2008 will receive a $200 discount.  Those interested in registering for the conference can do so here, by calling 1-888-224-2480, or by faxing a registration form to 1-877-927-1563.

Patent Docs is a media sponsor of ACI's FDA Boot Camp conference.

Another Modest Proposal on Reducing the Backlog of Pending Patent Applications

    By Kevin E. Noonan --

On Tuesday, U.S. Patent Commissioner John Doll (at right) touted several initiatives being pursued in the U.S. Patent and Trademark Office to reduce the backlog of pending cases (see "Lunch with Commissioner Doll").  He also said he (and the rest of PTO management) welcomed whatever creative ideas that the patent community has to solve the Office's backlog problem.  Since we at Patent Docs believe Commissioner Doll is sincere (although occasionally misguided) in his passion for improving the U.S. patent system, we thought about his invitation seriously and have the following recommendations, based in part on what the Commissioner said "was working" among the current Patent Office initiatives.

This proposal is based on many of the current initiatives in the office, including accelerated examination and efforts to promote examiner interviews as well as disclosure of "the best" prior art known to the Office and applicants.  In this proposal, the Office would offer applicants an incentive that for every application that an applicant abandons, another, related application would receive accelerated examination.  The related application receiving this benefit would be of applicant's choosing, but would be limited to applications in which the remaining issues were scope issues (i.e., generally related to issues arising under 35 U.S.C. § 112) rather than prior art issues (i.e., relating to rejections under § 102 or § 103).  Applicants could make an application eligible for acceptance into the accelerated program by filing an amendment that would overcome any pending § 102 or § 103-related grounds of rejection.  In addition, for any application undergoing accelerated examination, any claims subject to restriction and eligible for rejoinder would be rejoined for examination.  Upon notice of accelerated examination, applicants would have to certify that they had performed a search, under PTO guidelines, and had submitted all art uncovered in the search or cited in any corresponding foreign patent office.  However, there would be no obligation for the applicant to characterize the references, and a presumption would arise that a search conducted under PTO guidelines satisfied the provisions of Rule 56.  There would be no time limitation on this form of accelerated examination, unlike the program currently in place that has a 12-month "filing to decision" goal; the applications in this program would be treated like reexaminations or under the former "petition to make special" practice (they would be treated with special dispatch and advance to the head of the examiner's "to do" list).  Extensions of time to respond would be limited to good cause shown or unavoidable delay.  Applicants opting for this program would be entitled to an examiner interview after submitting the art, either with the primary examiner or a SPE having signatory authority, and with the goal of arriving at patentable subject matter as a result of the interview.

The benefits of the program are that at least one application would be abandoned for each application in the program; even if an applicant were to obtain a patent and file a continuation, the Office would have the benefit of reducing the backlog by two cases for every additional new one (the abandoned application plus the granted patent counting as two dispositions).  Moreover, presuming a fair percentage of the cases in the program would have divisional applications (the PTO's rationale for the now-enjoined claims and continuation rules showed that about 40% of the "rework" applications were divisionals), there may be more than two dispositions for each additional continuation.  Assuming even 10% of the applications in the backlog would participate in the program, the overall reduction in the number of backlog cases could be on the order of 25%.  This trend could be accelerated by targeting applicants with large pending portfolios.  For example, IBM has a total of 23,731 published applications in the PAIR system, and Microsoft has another 12,507 applications.  The Office is certainly aware of other entities "responsible" for a large proportion of the backlog, and such entities could be reminded of the offer in all Office Actions or other Office correspondence they receive.  (The Office would have to make a determination whether it was worthwhile to include the offer to all applicants in all papers sent by the Office.)

The program could also work for small entities, although it might be prudent to waive the requirement for abandoning related applications for these applicants.  This is because these applicants typically have far fewer applications contributing to the backlog, and accelerated examination might provide them with sufficient protection that related applications would no longer be necessary.  It is expected that the program would have little effect on "new technology" application filings.

Unlike the now-enjoined new rules, the benefits of this proposal is that they are voluntary and so do not constitute a taking or other encroachment on an applicant's rights or expectations and as such should be less exposed to judicial challenge.  For applicants, the proposal offers the benefits of reduced prosecution costs, reduced pendency times, and more focused PTO examination.  The Office benefits by reducing the backlog as well as having a larger percentage of applicants being involved in examiner interviews; Commissioner Doll reported that both examiners and applicants thought the interview process was the greatest benefit of the current accelerated examination program.  And the public benefits because the examiner will have had the "best" art available for examination and the best understanding of the invention through the interview process, thereby ensuring maintenance of high patent quality.  Transparency concerns could be met as they are now, by the requirement that the applicant provide an interview summary as part of any response filed after the interview.

Commissioner Doll expressed a fairly negative view about blogs and bloggers, with perhaps some justification in view of the penchant for some to use their blogs as tools to criticize or "vent" their frustrations with the Office.  (It is likely denizens of the Office have the same needs, which are occasionally revealed in the commentary sections of some patent law blogs.)  However, blogs and bloggers are also people invested in the patent process, and who take the time to make proposals like this one as part of the patent community's effort to contribute to solving the problems that actually exist in the U.S. patent system.  We hope that Commissioner Doll (or a minion) takes the time to think about what we propose here, at least as a starting place for addressing the very real problems that Mr. Doll has taken so much time and effort to emphasize in his formal dealings with the public.  There are ideas out here, Commissioner Doll; is anyone in the Office listening?

For additional information on this and other related topics, please see Patent Docs' "Post GSK: Where Do We Go from Here?" series:

• "Readers Propose Changes," January 8, 2008
• "Accelerated Examination," November 13, 2007
• "Deferred Examination," November 12, 2007
• "Co-owned, Co-pending Applications," November 11, 2007
• "Increased Fees for Continuations," November 8, 2007
• "Regional Patent Offices," November 7, 2007
• "Tailoring Protection and Examination," November 6, 2007
• "Annuities," November 1, 2007

MM&M Names Pharma Top 20

    By Donald Zuhn --

Earlier this month, the monthly healthcare marketing publication Medical Marketing & Media (MM&M) announced the release of The Pharma Report 2008, MM&M's list of the top twenty pharmaceutical companies (as determined by U.S drug sales in 2007).  According to MM&M's report, the top twenty pharma companies for 2007 were:

1.  Pfizer - $23.52 billion
2.  GlaxoSmithKline - $20.14 billion
3.  Merck & Co. - $17.64 billion
4.  Johnson & Johnson - $16.28 billion
5.  AstraZeneca - $15.47 billion
6.  Amgen - $14.34 billion
7.  Novartis - $13.92 billion
8.  Sanofi-Aventis - $10.87 billion
9.  Eli Lilly and Co. - $10.28 billion
10.  Abbott Labortories - $9.06 billion
11.  Genentech - $8.76 billion
12.  Wyeth - $8.61 billion
13.  Teva Pharmaceuticals USA - $7.93 billion
14.  Bristol-Myers Squibb - $6.87 billion
15.  Boehringer Ingelheim - $5.76 billion
16.  Schering-Plough - $4.69 billion
17.  TAP Pharmaceuticals - $4.54 billion
18.  Forest Laboratories - $3.87 billion
19.  Hoffman-LaRoche - $3.58 billion
20.  Takeda Pharmaceutical - $3.51 billion

MM&M also took the opportunity to discuss the state of the pharma industry, noting that the U.S. drug market grew by only 3.8% in 2007 as a result of the loss of product exclusivity, low levels of product growth, and safety concerns.  Diana Conmy, of IMS Health (a pharmaceutical and healthcare consulting company), noted that "if you look at the top five companies, they are the folks that (also) have big blockbusters going off patent," and that "some of the safety issues are also prevalent within the top 10."  MM&M predicted that as larger drug makers are impacted by a number of 2008 patent expirations (see Figure 10 from the report; shown below), "smaller or mid-size drug companies may be better positioned to take advantage of the current marketplace due to their involvement in specialist-driven areas."

The Pharma Report 2008, Medical Marketing & Media.

The report also included a list of the top twenty prescription drugs by U.S. sales (see Figure 2 from the report) and a list of the top twenty therapeutic categories by U.S. sales (see Figure 3 from the report; shown below).

The Pharma Report 2008, Medical Marketing & Media.

Congressman Berman Is on the Case

    By Kevin E. Noonan --

One of the frustrations of those opposed to actions taken by the Administration over the past eight years has been the lack of Congressional oversight, in view of the congruency of the party in power of the legislative and executive branches.  Although in theory this left the judicial branch to supply a check (or a balance) on public policy, the courts are a blunt and slow tool (and are not above their own type of partisan bias; see Bush v. Gore ).  However, this trend began to turn with the election of the members of the 110th Congress, where the opposition party came to power and, although lacking a sufficient majority to impose its will, maintains the power to police.

One part of the Administration that has suffered mightily as a result of this lack of oversight is the Patent Office, where the current Director and his minions have presided over one of the great adventures in mismanagement in U.S. history.  But it appears that at least some of the Members of Congress are beginning to notice:  at the end of April, Howard Berman (D-CA), Chairman of the Subcommittee on Courts, the Internet, and Intellectual Property of the House Judiciary Committee sent Jon Dudas, Director of the U.S. Patent and Trademark Office, a letter requesting information to supplement Director Dudas' February 27, 2008 testimony before the subcommittee at an oversight hearing (see "House Subcommittee Holds USPTO Oversight Hearing").  Although on its face the letter was a cordial request for additional information, even the most casual perusal of the contents of the letter indicates that Congressman Berman (at right) has something on his mind.

The letter contains eighteen numbered paragraphs covering a wide range of topics.  And the questions are specific, asking Director Dudas (at left) to reconcile or justify his testimony with either Patent Office behavior, statements, or actions.  These topics include:

• Projections as to the number of applications expected to be filed over the next five years.  The Congressman wants to know what methods (including computer programs) the Office uses to make these projections and what considerations are included in its calculations.  The letter specifically references the enjoined continuation and claims rules, and asks to what extent the projections were based on anticipation that the new rules would be implemented.  It also points out that the FY2008 budget projected an 8% per year increase, while the FY2009 budget projects a 5% per year increase.

• In view of the status of the enjoined new rules, the Congressman asks what actions the Office and/or Congress could take to address the pendency backlog, either at a 5% per year or 8% per year patent application increase level.  The letter also cites the GAO Report that claimed the Office could hire 2,000 new examiners per year for the next five years and still not decrease the backlog (the GAO report estimates the backlog would continue to grow, under this scenario, from 260,000 in FY2007 to 953,643 at the end of FY2011).  The letter notes that the source of the GAO's estimates was the PTO, and thus requests Director Dudas to provide all information supporting these estimates.

• Turning to the corps of patent examiners, the letter cites statements in the GAO report alluding to internal Office review of production goals for examiners.  The letter then cites Director Dudas' testimony before the subcommittee that the Office was beginning to review production goals.  Congressman Berman asks Director Dudas to provide a description of the methods being used to perform this review, the personnel involved in the review, and a timetable for its completion.  In this regard, the letter also asks for an accounting of the discrepancy between the GAO report's statements, that most examiners who leave the Office do so in response to management (including the production goals), and Patent Office statements that most examiners leave the Office for "personal reasons."  The letter specifically asks questions regarding putative exit interviews given to departing examiners that Director Dudas used to support his testimony, including the percentage of departing examiners who had participated in said interviews.

• Patent allowance statistics, specifically the decline in allowance rate from 70% in 2000 to 44% in 2007. The letter asks whether the Office included Requests for Continued Examination in its statistics, and if so how.

• The letter requests further information on the progress of plans for regional patent offices, and asks what resources have been used, particularly in view of the failure of the program to be included in the FY2009 budget.

The letter turns more frank with regard to two issues:  the statutory requirements for making changes in the Office's internal management structure, and the behavior of "senior PTO officials" in the RIM v. NTP reexamination.

• The letter also asks for information regarding whether the Office violated Acts of Congress as well as Commerce Department rules when implementing the creation of the Office of Enforcement.  Specifically, the letter reminds Director Dudas that the 2006 Science, Justice, Commerce Appropriations Act requires that, before the Office can "reprogram" funds it must notify Congress fifteen days prior to reprogramming, and that Departmental Administrative Order (DAO) 203-13 defines reorganization ("establishment, consolidation, abolition or 'other significant change'") as "generally considered a reprogramming that triggers the disclosure requirement."  Director Dudas had testified to the subcommittee that elimination of the Office of Enrollment was a "realignment," and the letter requests the Director to inform the subcommittee of the criteria used to distinguish between the two.  In this regard, Congressman Berman asks the Director for an accounting of all other actions taken by the Office that were deemed a "realignment" (and putatively outside the rule requiring Congressional notification) and a "detailed description" of the basis for so doing in each instance.

• The letter cites an article in Time magazine from 2006 and an e-mail from James Toupin that "senior Administration officials" met with RIM's CEO Jim Balsillie during the pendency of the NTP reexamination.  Calling it "ex parte activity," the letter asks Director Dudas to identify all senior Patent Office personnel involved in such meetings, and for the Office's policy regarding these contacts.

The answers to these questions should be interesting indeed.  Also included in the letter are even more pointed questions posed by Congressman Darrell Issa (R-CA), a subcommitee member:

• Congressman Issa (at right) wants to know the policy basis for the Office to eschew implementing a "request for examination" requirement, as a way to reduce the backlog based on the experience in other countries that "10% to 40%" of all applications are allowed to lapse for failure to request examination.

The letter gives Director Dudas until May 19, 2008 to provide answers to these questions, pointedly including the subcommitee's address (B-352 Rayburn House Office Building, Washington, D.C. 20515).

While these actions are to be applauded, they carry with them the feeling of being too little, too late.  The same "senior Patent Office officials" responsible for the ineffectiveness of the Office to address its problems will be leaving in less than twelve months, and those who willingly and enthusiastically fell into step behind their misguided proposals may be expected to leave as well.  The legacy of these officials, like so much of the rest of the current administration, will be of opportunities lost, squandered by an appeal to authoritarian rulemaking rather than consensus building with Patent Office stakeholders.  In view of the current parlous state of the USPTO, Inauguration Day 2009 (fittingly, a PTO holiday) can't get here soon enough.

ADDENDUM:  For a chilling set of allegations of misconduct in the NTP patent reexaminations (the subject of one of Congressman Berman's inquiries to Director Dudas), we direct our readers to the last twenty pages or so of NTP's response, filed April 24, 2006 in Re-examination Control No. 90/007,731, 90/006,675, and 90/006,533 (consolidated) (see Patently-O link).  NTP alleges multiple acts of misconduct against senior administration officials (including Director Dudas and Commissioner Doll), based on e-mail correspondence and other documents obtained under a Freedom of Information Act request.  (Thanks for Peter Zura's 271 Patent Blog for alerting us to these allegations.)