In the collaboration which was initiated only about two years ago in 2003, Pharmacopeia scientists identified lead compounds - from Pharmacopeia's proprietary collection of 7.5 million drug-like small-molecules - acting at Celgene's inflammation-related kinase target. The optimization of the potent and selective lead compounds to a pre-clinical development compound took little more than a year, so that the total time taken from target selection through to development was well under two years.

Pharmacopeia is entitled to on-going payments to the extent Celgene advances the program into and through clinical development, including annual payments and milestone payments at classical value inflection points. Pharmacopeia is further entitled to royalties on commercial sales of any products resulting from this collaboration.

It will be interesting to see whether or not their success will continue into 2005, but it appears as though they have the right formula for success, especially in view of the large library of compunds and lead drugs identified by Pharmacopeia. Certainly a testament to the capabilities of combinatorial chemistry, now at least twenty years old.

Continue reading "A Successful Match: Pharmacopeia - Celgene Collaboration Results in Nomination of a Ninth Novel Drug Candidate for Development"

Ten members of the Food and Drug Administration advisory panel who voted that a group of COX-2 inhibitors should continue to be sold had ties to the drug makers, a new analysis shows.

A study by the Center for Science in the Public Interest indicates that 10 of the 32 panel members had ties to either Pfizer Inc., or Merck & Co., ranging from consulting fees and speaking honoraria to receiving research support from the companies.

Continue reading "FDA Panel approving COX-2 Inhibitors had ties to the Drug Makers"

The Electronic Frontier Foundation (EFF), along with consumer advocacy groups Public Knowledge, and the Consumer Project, filed an amicus brief in the Merck v. Integra case asking the Supreme Court to protect scientific researchers from patent infringement.

Merck v. Integra, as we posted earlier here, deals specifically with information researchers submitted to the Food and Drug Administration regarding a potential cure for cancer. The EFF believes it raises broader questions about whether patent owners can stop academic researchers and inventors from studying patented inventions in order to research or improve upon them.

Continue reading "EFF Argues for "Research Purposes" Exception"

I received an updated reminder from our associates in Taiwan, Tai E International Patent & Law Office, regarding filing patent applications in Taiwan. Many people know that

Taiwan is a member of the World Trade Organization (WTO) and that it recognizes claims for priority rights from citizens of all WTO member states. Therefore, nationals of WTO member states and applicants having their place of business or residence in such states, who have filed their first patent application legally for an invention in a member state of the WTO or in a foreign country that allows Taiwan nationals to claim priority based on reciprocity, and then have filed their patent application for the same invention in Taiwan within twelve months from the filing date of their first patent application in that foreign country, may claim priority in their Taiwan application. In this regard, the application in Taiwan will be treated as if it had been filed on the same date as the first application filed in the WTO member country or the country with a specific reciprocal agreement.

Continue reading "Be Early In Filing A Patent Application In Taiwan"

As if the waters at the FDA needed further muddying, a special panel of the US Food and Drug Administration voted last Thursday to allow Pfizer's pain killer Celebrex to remain on the market, despite a finding that it can cause heart problems in some patients. The panelists voted 31-1 to keep Pfizer’s Celebrex on sale and, after a revote, favored Pfizer’s Bextra 17-13 with two abstaining. The vote for Merck’s Vioxx was 17-16, in favor of keeping the drug on the market. The panel noted that Celebrex, Bextra and Vioxx all pose a risk of heart trouble, but should be available to those who need them.

Apparently, not all cox-2 inhibitors are created equally. Structurally, they are very similar but based upon data from the clinical studies, these 3 drugs provide different side-effect profiles. Pfizer must be happy about that.

Continue reading "Cox-2 Inhibitors: It’s a Do Over!"

Even while their battle over Lipitor continues, Pfizer has sued Ranbaxy Laboratories in District Court for patent infringement of its patent on Accupril (the generic name is quinapril), an anti-hypertensive with annual sales of $550 million. Pfizer is suing on U.S. Patent No. 4,743,450, which covers the use of lactose and microcrystalline cellulose for the stabilization of quinapril.

Continue reading "Pfizer Bites Back: Sues Ranbaxy Over Accupril Patent"

If you can’t beat them, buy them……………

Novartis AG announced today (Feb. 21, 2005) that it will buy generic drugmakers Eon Labs of the United States and Hexal AG of Germany for $8.3 billion, creating the world's largest generic drug company.

Novartis Chief Executive Daniel Vasella has made no secret of his desire to build up the Swiss group's Sandoz generics business, the world's second biggest behind Israel's Teva through acquisitions. But he did not want to overpay, especially since many analysts believe the fundamentals of the German generic drugs market may be deteriorating, putting margins under pressure.

Novartis said it will buy all of Hexal and the two-thirds of Eon Labs that the German company owns for 5.65 billion euros (about $7.3 billion). In addition, Novartis expects to spend close to $1 billion to buy the remaining Eon Labs shares, which trade on the Nasdaq Stock Market.

Continue reading "If you can’t beat them, buy them……………"

Medtronic, Inc. announced that a Delaware jury rendered verdicts in patent litigation between Medtronic and the ACS subsidiary of Guidant Corporation. The jury found the Guidant Lau patents valid and infringed by some of Medtronic stents, including the S7 and Driver stents. However, there will be another hearing regarding Medtronic’s claim that Guidant’s patent is unenforceable due to "inequitable conduct," which of course, is every patent litigators way of saying hello to the other side. Medtronic claims Guidant showed "willful disregard of patent filing procedures."

Continue reading "Medtronic Found to Infringe Guidant Stent Patents"

The World Intellectual Property Organization (WIPO) has published a manual entitled "Exchanging Value – Negotiating Technology Licensing Agreements," which provides a review of some of the basic issues that arise in licensing negotiations of intellectual property, particularly patents. The publication offers a practical introduction to negotiating licensing agreements and is designed to address the needs and concerns of non-specialists. The Guide focuses on the identification, acquisition and transfer, through licensing agreements, of intellectual property, in particular patent-protected technologies.

This begs the question: "Why is WIPO, a specialized branch of the UN, publishing a booklet on negotiating licensing agreements?"

Whatever the reason and for what it's worth, "Exchanging Value - Negotiating Technology Licensing Agreements" is currently available online from WIPO’s website at www.wipo.int/ebookshop/ or from the ITC’s website at www.intracen.org/eshop.

The Baristas have updated their look and gotten a new attitude.  Thanks to Barbara, at CaricatureConnection, we now have new images on our Get to Know Your Baristas page. 

We'll be brewing up news and comments on a regular basis and appreciate your comments and suggestions. Let us know if you like our new look.  Hope you enjoy our site.

Stephen and I attended a breakfast meeting on Wednesday morning. It started at 8:00 A.M. He was there on time. He is very good at that. I, of course, was late as usual. BT (before toddlers), I was either early or on time. AT (you can figure out what it stands for), I feel like I am in slow motion or reverse motion. Who knows, maybe Brownian motion will be next, but I digress….

The meeting was hosted by Omeris. Omeris, founded in 1986 as Edison BioTechnology Center, is a non-profit organization designed to build and accelerate bioscience industry, research, and education in Ohio. As Ohio's bioscience membership and development organization, they are focused on networking the bioscience assets of Ohio.

The purpose of the breakfast meeting was for Omeris , in partnership with Cincinnati USA and BIO/START, to present Phase I data on their Targeted Asset Based Company Attraction Strategy. This Phase I data strongly support Phase II, in which Omeris will develop 2-3 Target Asset Clusters. The presentation was given by 3 of the principals at Omeris, Anthony J. Dennis, Ph.D., president, John F. Lewis Jr., vice-president and Catharina Maulbecker-Armstrong, senior consultant .

Continue reading "Why Ohio? A Strategy to Expand Bioscience Jobs in Ohio"

As tipped off by Dennis Crouch's Patently Obvious blog, the U.S. Government Department of Health & Human Services (HHS) has requested an inter-partes reexamination of U.S. Pat. No. 6,653,104 for an anti-cancer antibody assigned to Immunomedics, Inc.

See the OG Notice here.

Continue reading "HHS Requests Inter-Partes Reexamination of Immunomedics Patent"

Well, somehow I managed to miss the next round of American Idol this past Wednesday night and found myself watching 60 Minutes Wednesday night edition, with their interview of Dr. David Graham. Dr. Graham is a senior scientist within the FDA’s Office of Drug Safety and now a whistleblower at the FDA. Graham blames the FDA for allowing dangerous drugs to stay on the market. Specifically, he blames the FDA for not pulling a drug that he claims contributed to the deaths of thousands of Americans. He also points the finger at FDA management for running a dysfunctional organization.

Continue reading "FDA to Create Advisory Board on Drug Safety: Can the FDA monitor itself?"

Blogger and Patent Attorney Axel H Horns posted a nice review of the recent EU-CREST Committee on "IPR and Research" report. The Committee for Scientific and Technical Research (Crest) is the advisory committee to the Council and the Commission on subjects relating to scientific and technical research and in particular, on the co-ordination of national R&D policies.

Continue reading "EU-CREST Committee on "IPR and Research" Report"

The Washington Post reported that the USPTO rejected a patent on a human hybrid. Stuart Newman of New York Medical College tried to patent a hybrid designed for use in medical research but not yet created. The USPTO stated that the hybrid would be too closely related to a human to be patentable. The inventor wanted to set a legal precedent barring patents on human-like clones. The rejected patent application, filed in 1997, described a technique for combining human embryo cells with cells from the embryo of a monkey, ape or other animal to create a chimera.

Continue reading "USPTO Denies Patent for a Hybrid as Being Too-Human"

It hasn't a great month for the Big Pharmas when it comes to battling the on-slaught of generics. Despite being the time for Valentines and amore, Pfizer is feeling blue since the Technical Board of Appeal revoked Pfizer's "Viagra-Patent" EP-0 702 555 by dismissing the appeal against an earlier lost.

Continue reading "Big Pharmas Suffer Setbacks in February"

A U.S. District Court ordered Nobel Prize winner and former Yale University professor John Fenn, 87, to pay Yale $545,000 in royalties and penalties, and pay their legal bills of almost $500,000. While at Yale in the late 1980s, Fenn developed a method for mass spectrometric analysis of chemical compounds in solution concerned with determining the mass or molecular weight of large fragile solute species with greater speed, convenience and accuracy as well as new compositions of matter comprising populations of ions having a multiplicity of charges.

The court called Fenn's actions "fraud" and "civil theft" when he licensed the rights to U.S. Patent No. 5,130,538 to a company he partly owned, which has generated more than $5 million in royalties and could make several times that by the time the patent expires. While Fenn claimed he believed that he had a right to the patent, the court felt that he had no good-faith basis to believe so and acted to conceal the facts from Yale.

More on the Fenn case here.

Continue reading "Nobel Prize Winner Accused of Stealing Invention from Yale"

Well, I have decided to give up my Bio-IP.com site on TypePad and switch to PatentBaristas.com on a new hosting service running on MovableType. I like the idea of having the flexibility of MT and my new hosting service on iPowerWeb provides plenty of bandwidth.

Many thanks to Christina at Moxie Design Studios for helping to set up such a fun site. If you like the new design, drop me a note and let me know what you think. Take a look around, relax over a cup of joe and enjoy.

I've been trying out the free service from IPNewsFlash.com that allows you to search for patent families.  You can run a search and get a complete list of its legal status based on INPADOC data.  You just need to enter a valid publication number such as WO03054153, AU775606, US6335169 or DE10196055T and press the "Search"-button.  Of the half-dozen times I've used it, it has popped up with all the info I needed on the family tree.

Try it out at: http://www.ipnewsflash.com/family.php

The new biotechnology open-source group, called the Biological Innovation for Open Society ("BIOS"), announced that researchers from Australia published a paper in Nature describing a method of creating genetically modified crops that does not infringe on patents held by big biotechnology companies.

Like open-source software, they said the technique, and a related one already used in crop biotechnology, would be made available free to others to use and improve, as long as any improvements are also available free.

The researchers claim to have modified three types of bacteria so they could be used for transferring desirable genes into plants and these were tested on rice, tobacco and Arabidopsis.

BIOS is a spin-off of Cambia, a not-for-profit, Australian-based organization that licenses a variety of technologies under an open source principle. They believe that patents covering tools for genetically engineering plants have impeded the use of biotechnology in developing countries.

Current technologies, patented by Monsanto, Syngenta, Bayer CropScience and others, rely on Agrobacterium tumefaciens. Biotechnologist remove some of the disease-causing genes from the bacterium and insert the genes they want added to the plant, such as those providing resistance to insects or herbicides. With the new technique, called TransBacter, researchers at Cambia have modified other types of bacteria by transferring DNA from the Agrobacterium into the other bacteria.

Whether this technique will really be a true design around and circumvent current patent claim coverage is not clear.  It will be interesting to see if taking the necessary genes out of the Agrobacterium bacteria and placing them in non-Agrobacterium bacteria is enough.  Given the CAFC's continued limitation of the doctrine of equivalents, the patent holders will need to rely on close coverage.

I'm not sure the whole idea of an open-source biotechnology initiative will gain traction given the tremendous cost of biotech research and the fact that patent protection tends to be critical to biotech commercialization - unlike open-source software.

I also would take issue with the statement on the BIOS web site that "Patents were intended to inspire, advance and promote the social benefits deriving from 'science and the useful arts'. However, the complexity and volume of patents has obscured this focus."   This all sounds well and good until you realize that you can't afford to develop technologies only to have all your competitors gain a free-ride on your research expenditures. 

As Lincoln said, in a speech in 1859 "The Patent system added the fuel of interest to the fire of genius" - financial rewards act as an incentive to genius like no other.

You can read the Nature paper at:  http://www.bios.net/daisy/bios/393/version/live/part/4/data

More info at the NY Times here.

A BIOS paper describing the Agrobacterium-mediated transformation of plants is here:  http://www.bios.net/daisy/bios/50/78

As noted on Law.com, people came out in droves to the U.S. Court of Appeals for the Federal Circuit on Tuesday to listen to arguments for a case on claim interpretation.  In Phillips v. AWH Corp., 363 F.3d 1207 (Fed. Cir. 2004), the claimed term "baffle" was limited to baffles that were at an angle greater than 90 degrees.  Although the dictionary definition for "baffle" was broad, the Federal Circuit concluded that the specification only disclosed an embodiment having baffles with an angle other than 90 degrees. Judge Dyk dissented, based on the concepts that the narrow interpretation was contrary to the plain meaning in the dictionary.

The en banc rehearing order asked for briefing on the following questions:

1.  Is the public notice function of patent claims better served by referencing primarily to technical and general purpose dictionaries and similar sources to interpret a claim term or by looking primarily to the patentee?s use of the term in the specification?   If both sources are to be consulted, in what order?

2.  If dictionaries should serve as the primary source for claim interpretation, should the specification limit the full scope of claim language (as defined by the dictionaries) only when the patentee has acted as his own lexicographer or when the specification reflects a clear disclaimer of claim scope?  If so, what language in the specification will satisfy those conditions?  What use should be made of general as opposed to technical dictionaries?  How does the concept of ordinary meaning apply if there are multiple dictionary definitions of the same term?  If the dictionary provides multiple potentially applicable definitions for a term, is it appropriate to look to the specification to determine what definition or definitions should apply?

3.  If the primary source for claim construction should be the specification, what use should be made of dictionaries? Should the range of the ordinary meaning of claim language be limited to the scope of the invention disclosed in the specification, for example, when only a single embodiment is disclosed and no other indications of breadth are disclosed?

4.  Instead of viewing the claim construction methodologies in the majority and dissent of the now-vacated panel decision as alternative, conflicting approaches, should the two approaches be treated as complementary methodologies such that there is a dual restriction on claim scope, and a patentee must satisfy both limiting methodologies in order to establish the claim coverage it seeks?

5.  When, if ever, should claim language be narrowly construed for the sole    purpose of avoiding invalidity under, e.g., 35 U.S.C. 102, 103 and 112.

6.  What role should prosecution history and expert testimony by one of ordinary skill in the art play in determining the meaning of the disputed claim terms?

7.  Consistent with the Supreme Court's decision in Markman v. Westview Instruments, Inc., 517 U.S. 370 (1996), and our en banc decision in Cybor Corp. v. FAS Technologies, Inc., 138 F.3d 1448 (Fed. Cir. 1998), is it appropriate for this court to accord any deference to any aspect of trial court claim construction rulings?  If so, on what aspects, in what circumstances, and to what extent?

8.  [In a separate concurring opinion by Judge Rader]: Is claim construction amenable to resolution by resort to strictly algorithmic rules, e.g., specification first, dictionaries first, etc? Or is claim construction better achieved by using the order or tools relevant in each case to discern the meaning of terms according to the understanding of one of ordinary skill in the art at the time of the invention, thus entrusting trial courts to interpret claims as a contract or statute?

9.  Chief Judge Mayer dissented, arguing that "any attempt to refine the process is future" as long as the court refuses to reconsider the fiction that claim construction is a matter of law.

See the rehearing order here.

Dennis Crouch's Patently Obvious blog lists over 25 amicus briefs and other documents related to Phillips. 

Some have expressed concern that the United States Patent and Trademark Office (USPTO) hosted a two-day meeting last week to discuss substantive patent law harmonization. The participants, from 22 countries along with the EPO and EC, issued a Statement of Intent noting that they will convene future meetings to consider "issues with regard to intellectual property and development, including proposals for a WIPO Development Agenda and proposals relating to genetic resources.  Also, they indicated that for future meetings, they will invite "all Members of WIPO Group B, member States of the European Union, the European Commission, Member States of the European Patent Organization, and the European Patent Office."

Some developing countries and consumer groups expressed concern that the meeting was being held in part to circumvent the World Intellectual Property Organization (WIPO) and certain large developing countries that have pushed for a development agenda within WIPO.

While there is a proposal with WIPO for a substantive patent law treaty (SPLT) aimed at harmonizing substantive aspects of national patent laws, many feel that developing nations are using intellectual property issues as a way to push broader development goals.  Harmonization talks have been going on for years with no resolution.  Even with an agreement, I'm not sure how far that will take the developing nations if it doesn't include China, India, and Brazil.

More here.

As part of a proposed $2.57 trillion fiscal year 2006 budget request for the USPTO is $1.7 billion, equaling anticipated FY 2006 fee collections from patent and trademark filings. The request represents a $149 million increase over FY 2005, and reflects an anticipated rise in patent and trademark fee collections. As part of the 21st Century Strategic Plan, the USPTO plans to hire 900 patent examiners and 75 trademark examining attorneys in FY 2006.   

This sounds good but I'm waiting to see if this holds up in light of the record deficits - a projected a $390 billion deficit for next year, down from $427 billion this year.

Monsanto Co. has resolved a patent dispute with Bayer CropScience and a German non-profit research organization in a worldwide cross-license deal. This ends a long-standing rift over Agrobacterium technology, a transformation technology used to transfer a gene into a host plant's DNA with more precision and efficiency than other available methods. Scientists at Monsanto and at the Max Planck Society claim to have invented it.

You can read details about Agrobacterium-mediated transformation in plants here.

Bayer CropScience is the exclusive licensee for the Max Planck Society for the Advancement of Science. Both are based in Germany. Under the agreement, Bayer CropScience and Monsanto will cross-license the agrobacterium-mediated transformation in selected areas of the globe.

In October 2003, Monsanto and Bayer CropScience reached a truce on a 20-year patent dispute (the longest-running patent battle in the history of plant biotechnology), with both sides dismissing at least five lawsuits against each other. In that deal, the two agreed to license each other for various patented technologies, including products that are insect-resistant and herbicide-tolerant. The companies are still in a patent dispute over insect-resistant corn.

Press release here.

The United States Patent and Trademark Office revised the policy on when a second or subsequent request for reexamination is filed while an ?earlier filed reexamination? is pending, and the second or subsequent request cites only prior art, which raised a substantial new question of patentability (SNQ) in the pending reexamination proceeding.  See MPEP ? 2240 (8th ed. 2001)(Rev. 2, May 2004).  Under the new policy, the second or subsequent request for reexamination will be ordered only if that old prior art raises a substantial new question of patentability which is different than that raised in the pending reexamination proceeding.  If the old prior art cited (in the second or subsequent request) raises only the same issues that were raised to initiate the pending reexamination proceeding, the second or subsequent request will be denied.

See Notice here.

Barr Pharmaceuticals Inc. sued the U.S. Food and Drug Administration in the U.S. District Court for the District of Columbia, seeking exclusive rights to sell a generic version of Sanofi-Aventis' Allegra-D allergy drug. In the suit, Barr is challenging the FDA's policy of awarding generic exclusivity on a patent-by-patent basis rather than solely to the first company to file an application to sell a generic version of a branded drug. Allegra-D had U.S. sales of about $444 million last year.

Barr in July won tentative approval to sell generic Allegra-D, known by the chemical names fexofenadine hydrochloride and pseudoephedrine hydrochloride, pending resolution of its challenge to Aventis's patent but fears the FDA will try to force it to share the 180-day marketing exclusivity period.

Sanofi-Aventis holds patents that do not expire until between 2012 and 2019 and in 2002, Aventis obtained and listed an additional Allegra-D patent, extending its patent protection, which Barr believes that another generic company filed the first application based on the subsequently listed patent.

Under a new National Institutes of Health (NIH) public access policy, which is designed to provide easier access to tax supported research, researchers who receive grant money from the National Institutes of Health will be "asked" to submit their results to a public Web site within a year after they are published in a scientific journal.

In this split-the-baby compromise, the NIH backed off its original proposal to require such disclosure. Publishers of scientific journals, fearing that free access would undermine their subscription base, lobbied hard to against it. Advocates argued that taxpayers should not have to pay subscription or per-article fees to see the results of federally supported medical research and that it applies only to about 10% of published articles. Both sides were left dissapointed.

Proponents of free access felt that the policy should have required disclosure instead of leaving it up to scientists to decide. Now, researchers will risk the wrath of publishers if they allow free access. While no one wants to see their market share threatened, I don't think publishers should be put ahead of taxpayers.

Upon acceptance for publication, authors will be asked to submit their articles to PubMed Central (PMC), an NIH digital repository of full-text, peer-reviewed biomedical, behavioral, and clinical research journals. It is a publicly-accessible, permanent, and searchable electronic archive available on the Internet at http://www.pubmedcentral.nih.gov/.

Details of the new policy can be seen here.

Law.com reported that the California Supreme Court agreed to review an appellate decision in which a $500 million judgment for City of Hope National Medical Center against Genentech, including $200 million in punitive damages.

Genentech negotiated a license agreement to develop and market human insulin and human growth hormone based on research at City of Hope. Genentech paid a royalty on the sale of products but didn't pay for licensing revenue. The research center sued Genentech for breach of contract. The first trial ended in a deadlock favoring Genentech, but the second ended with the $500 million award. Genentech has argued that a 2003 ruling by another division of the 2nd District that said the failure to account for and pay royalties is not a tortious breach of fiduciary duty but only a breach of contract. City of Hope has emphasized Genentech's alleged fraud.

This is being closely watch as Disney, Intel Corp. and Microsoft Corp., among others, have submitted amicus briefs in an attempt to quash any tort liability stemming from licensing.

The case is City of Hope National Medical Center v. Genentech Inc., S129463.

The Cincinnati Enquirer ran an article about a new a state-created venture fund charged with raising $100 million and steering at least half of it into Ohio startup companies. The new company, Buckeye Venture Partners, will be headed by a unit of Western & Southern Financial Group of Cincinnati.  Buckeye Venture Partners will serve as administrator of the newly created Ohio Capital Fund based in Cincinnati.  Of the money entrusted to venture capital firms, no less than 75 percent must go to Ohio-based funds. And of the money invested in companies, no less than 50 percent must go to those based in Ohio. Ohio-based funds that receive OVCA money must match it with an equal amount of their own funds.

Running adjacent to this was an article detailing the decline in venture funding in the Midwest.  The article showed reports indicated that the venture capital market nationally grew by 10.5% in 2004 but Ohio received 20% less in 2004, making Ohio's share of U.S. venture capital 0.3 percent, down from 1.1 percent in 2002.  While some think this has more to do with the Midwest lagging in the recovery or that the Midwest is not a favorable business climate, it seems to indicate a continued bias towards investments on the coasts.  More often than not, we're seeing venture deals that require a move out of the Midwest to a location on the coast, generally close to the VC's home.  I guess no one wants to travel anymore.

Finally, Business 2.0 ran an article stating that they expect it to be raining cash in the coming months as much of the money raised in 2000 is in funds that will be closed to new investments after 2005, so VCs have to use that money now or return it to investors. VC's do not like losing control over funds - they'd lose the 2 percent management fees and they'd have to go raise more money again. This could mean a good window of opportunity for all sectors and regions to obtain some venture capital. It will be interesting to see what portion, if any, makes its way to the Midwest.

See the entire article here.

Under the Consolidated Appropriations Act, 2005 (Consolidated Appropriations Act), the USPTO splits the national fee for Patent Cooperation Treaty (PCT) applications entering the national stage into a separate national fee, search fee and examination fee, during fiscal years 2005 and 2006.  The USPTO announced that it is reducing the search fee and examination fee for certain PCT applications entering the national stage, effective February 1, 2005. The changes in this interim rule apply to all international applications entering the national stage under 35 U.S.C. 371 for which the basic national fee specified in 35 U.S.C. 41 is paid on or after December 8, 2004.

(1) The Office will refund the entire search fee less $100.00 ($50.00 for small entities) if the search fee as set forth in ?? 1.445(a)(2) and (a)(3) has been paid on the international application to the United States Patent and Trademark Office as an International Searching Authority for all of the claims presented in the application entering the national stage; and

(2) the Office will refund $100.00 ($50.00 for small entities) if an international search report on the international application has been prepared and is provided to the Office no later than the time at which the search fee is paid. In addition, under the authority provided in 35 U.S.C. 376, the Office will refund the entire examination fee less $100.00 ($50.00 for small entities) if an international preliminary examination report on the international application prepared by the United States International Preliminary Examining Authority states that the criteria of novelty, inventive step (non-obviousness), and industrial applicability, as defined in PCT Article 33(1) to (4) have been satisfied for all of the claims presented in the application entering the national stage.

See the Federal Register here.

As reported in the New York Times, the National Institutes of Health (NIH) announced a new supplemental ethics regulation that addresses the concerns raised by the activities of some of its employees, particularly regarding outside consulting with the pharmaceutical and biotechnology industries. The regulation was developed by the Department of Health and Human Services (HHS), with the concurrence of the Office of Government Ethics (OGE), the federal agency that prescribes executive branch-wide ethics standards.

I am against an outright ban on consulting.  While I don't think every activity should be allowed, I don't think you can ever completely eliminate conflicts of interest.  It would make more sense to try to effectively manage the conflicts than to ban them completely.  With proper disclosure and oversight, commercial activities can co-exist with academic research.

I suspect, though, that the ban has more to due with trying to put a pristine shine back on research after a few high-profile cases gave consulting a black eye.  Such Dr. Bryan Brewer Jr., chief of the National Heart, Lung and Blood Institute's molecular disease branch, who published an article on the benefits of Crestor in a medical journal "supplement" that was paid for by AstraZeneca.  In another case, Dr. P. Trey Sunderland, a senior researcher at the National Institute of Mental Health, received more than $500,000 in consulting fees from Pfizer at the same time that he was collaborating with it in his government capacity of studying patients with Alzheimer's disease.

Noteworthy is that in Sunderland's case, he did not disclose his consulting fees despite NIH rules require their disclosure.  This makes you wonder how effective this new ban will have on preventing conflicts.  There will always be some people who won't follow the rules.

The new regulation focuses on outside activities, financial holdings, and awards for all NIH employees.  Under the new rules, all NIH employees are prohibited from engaging in certain outside employment with:

1) substantially affected organizations, including pharmaceutical and biotechnology companies;
2) supported research institutions, including NIH grantees;
3) health care providers and insurers; and
4) related trade, professional or similar associations.

Investments in organizations substantially affected by the NIH, such as the biotechnology and pharmaceutical industries, are also not allowed for those employees who are required to file public and confidential financial disclosure reports, and are restricted for other staff.

See:  NIH Conflict of Interest Information and Resources and the Federal Register

mMicrosoft put out its own search engine on its MSN Web site, today.  This, after  admitting that it totally missed the boat sailed by Google Inc. and others.  While one can argue the merits of putting a lot of resources into searching the web, I thought I'd at least take a look.

I did a quick search for "Merck Teva Fosomax" on MSN and on Google in a head-to-head search comparison (yes, I know, not a scientifically valid test but that's all I had time for today).  Interestingly, MSN pulled up 11,301 web results and Google pulled up 10,600.  Given that it's newer, I expected MSN to pull up fewer spots.  More importantly, when I looked through the sites pulled up in the listed top 10 references, the quality of the references were quite different. 

While highly subjective, I felt that the Google search provided more relavent and authoritative(?) references in siting articles by CBS Marketwatch, Reuters, Boomberg, and ABCNews.  The MSN search brought up a blog site, and various marketing feeds that merely provided a short snippet and a link to another reference.  I think MSN still needs to iron out some difficulties in their page ranking methods.

To be more thorough, I looked at AskJeeves and Yahoo.com.  AskJeeves brought up 854 references, mostly from sites wanting to sell me Fosamax!  Yahoo pulled up a mere 811 references but, interestingly, many in the top 10 overlapped with those in the top 10 of the Google search.

Use this at your own risk, your milage may vary and past performance is no indication of future returns.  For now, though, I think I'll stick to Google.