Well, I am now back from a rather somewhat self-imposed hiatus from the Barista blawg site. The events of the past 2 weeks in my life, ranging from my toddler having surgery to selling my house, finding a new place to live for the entire herd, and having to move in 2 weeks time, all have taken a toll on any extra time I might have had to devote to any extraneous mental meanderings which I could have posted to this site.

That being said, anyone who knows me, also knows I am a die-hard animal-lover. So should it come as any surprise that since scientists have engineered a variety of barnyard animals to produce human proteins, they can now do the same trick in plants? (I love it - leave those furry creatures alone!)

Biolex, Inc., a privately held protein therapeutics company, today announced the issuance of a patent that broadly claims methods for immunizing a human or non-human animal against an antigen by administering an antibody produced by transgenic plants. This is the first patent ever awarded for the use of "plantibodies" (plant-made antibodies) to treat humans. Biolex now has exclusive rights to five U.S. patents in its Plantibodies portfolio, giving the company coverage for the production of antibodies in transgenic plants and their use to treat humans.

The specific patent issued from the U.S. Patent and Trademark Office is USP 6,852,319, entitled, "Method of Use of Transgenic Plant Expressed Antibodies." It was issued to The Scripps Research Institute, where the technology was developed, and exclusively licensed to Epicyte Pharmaceutical which was acquired by Biolex in 2004.

Biolex would now appear to have a pretty big patent “stick” they can wield and it will be interesting to see how they choose to and can actually use it.

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Continue reading "I just want to say one word to you...just one word. Are you listening? "Plantibodies"*"

There's a nice update on the new Japanese Intellectual Property High Court on Bill Heinze's I/P Updates blog. The new court was organized because the Supreme Court, which is supposed to unify legal precedents, takes too long to complete hearings and it now only rules on constitutional issues.

The new court will reportedly have 18 judges and will serve as the court of first instance over whether the Patent Office's decisions are appropriate. It also will serve as a court of appeal, after Tokyo and Osaka district courts, on compensation suits concerning the infringement of patent rights and injunctions.

It appears that the Intellectual Property High Court will introduce a collegiate court system using five judges, as opposed to the normal collegiate court system of three judges. The new system will only deal with cases in which similar lawsuits have received different rulings or rulings that may influence business activities.

In addition to patent violation lawsuits, the expanded court system could target cases over how much a company should pay an employee who was responsible for a breakthrough invention. As we reported earlier, the inventor of an LED technology settled a lawsuit for 840 million yen ($8.1 million) with his former employer, the Nichia Corporation, for inventing blue-light-emitting diodes.

If the calculation of the cost to be paid to an in-house inventor were harmonized, it could be a model for companies to develop an incentive system.

More here.

This week in Science Magazine, a team led by Dr Mary Higby Schweitzer of North Carolina State University and the North Carolina Museum of Natural Sciences reports finding a 68-million year old Tyrannosaurus rex fossil that appears to contain elastic soft tissues, blood vessels and cells and it's still transparent and pliable. This goes against the conventional wisdom that soft tissue should not last beyond 100,000 years.

This presents the possibility of extracting its DNA and, through the miracle of science, growing your own T. Rex. I've been dreaming of this my whole life and now it's a step closer due to U.S. Pat. No. 6,872,552, "A Method of Reconstituting Nucleic Acid Molecules" issued today to Burt D. Ensley, Ph.D, Chairman of MatrixDesign, and CEO of DermaPlus, Inc. This patent covers methods for recovering and reconstituting genes from "degraded" DNA samples, and could allow scientists to reassemble everything from prehistoric, extinct animals to unsolved crime scenes. See Press Release here.

While there's a bit of rhetoric to the press release, Dr. Ensley stated that "by stringing together the pieces of aged DNA, we should be able to reconstruct genes from animals such as the wooly mammoth, giant sloth, saber-toothed cat or even from tissues of the Tyrannosaurus rex that was described last Friday in the journal Science."

What could be cooler than this?

Those who know me know I have an attention span that's measured in microseconds. Therefore, when people started talking about podcasts and podcasting as "the next big thing", I let out a groan thinking this would be yet another thing I wouldn't be able to pay attention to long enough to benefit. But after giving it some thought, I'm starting to reconsider. After all, I do listen to some streaming audio as a way of time-shifting my listening and for some programs (like Car Talk on NPR with Click and Clack) reading the transcript on-line just wouldn't provide the same enjoyment as listening - or at least it wouldn't have nearly the same impact.

And so I tuned in to the new intellectual property law podcast put together by Douglas Sorroco, Stephen Nipper, and Matthew Buchanan as a joint venture called RETHINK(IP) ALOUD (in MP3 format) - a sort of three-way, long-distance intellectual property law podcast (now being called a blawgcast).

I was a little taken aback by the size of the first casting (21MB!) but I decided to give it a try. I found it engaging and enjoyed that it was very professional - including some cool guitar intro music ['Hastings Street' by Blind Blake and Charlie Spand]. It was also nice to hear some of the real "voices" behind Phosita, Promote the Progress, and the Invent Blog.

They're asking for any comments and/or suggestions and/or praise to: rethinkip@gmail.com. I recommend you give it a whirl as an alternative format for getting some IP updates and then send them your thoughts.

Also of note, if you are interested in blawgcasts, there is now one easy RSS feed to get updates from the new site called blawgcast.com, put together by Kevin Heller (Tech Law Advisor) and Evan Schaeffer (Notes from the (Legal) Underground) - a sort of one stop source for all your legal podcasts.

Both of these efforts are first rate and deserve high praise. We look forward to the evolution of the species.

Damon Darlin at B2Day posted a note about Postal Watch being up in arms about the Postal Service using Special Cancellations of stamps with little characters from the animated movie, Robots.

I have to admit, this is one of those items that seems like an abuse of governmental powers. Actually, I don't think it is as bad as when the commercial character is actually on the stamp, but pretty bad.

"Special Cancellations" are generally used to commemorate a ubiquitous non-commercial event but here, the Post Office is printing an Ad for the Twentieth Century Fox/Blue Sky movie "Robots" on billions of cards and letters.

PostalWatch points out that the mail is NOT the property of the Postal Service to deface and alter at will. The Postal Service is not free to sell, trade or otherwise barter with private for-profit business interests to piggyback commercial advertising messages onto the face of people's cards and letters.

According to the Domestic Mail Manual (DMM):

2.0 Special Cancellations - Special cancellations are authorized only if the scheduled observance either is for a national purpose for which Congress has made an appropriation or is of general public interest and importance for a definite period and not conducted for private gain or profit.

A robot movie is an important national purpose? Postal officials claim the deal is a cross-promotional licensing arrangement and that "no money changed hands." Great. Like the Post Office needs to advertise. I'm not going to be pacified unless I get my own cross-promotional licensing arrangement to have the Baristas put on a stamp in exchange for a Post Office Ad on patentbaristas.com!

Boston Scientific Corp. announced that a jury in Delaware found that one of the company's cardiovascular stents infringed on a patent held by Johnson & Johnson. Monetary damages will be determined in a later hearing and there are likely to be post-verdict motions and hearings, as well as an appeal.

During an earlier trial of the case in late 2000, J&J asserted that Boston Scientific's NIR stent infringed six claims from four different patents. The jury found that one of those claims infringed and awarded damages of $324.4 million. The other five claims were found to be either invalid or not infringed. In March 2002, the judge set aside the damage award, and held that two of the four J&J patents had been obtained through inequitable conduct in the U.S. Patent and Trademark Office. It's likely that J&J will ask the court to reinstate the $324 million damages award.

More here.

For an interesting PowerPoint of the effects of litigation on the stent market by Hannah Yun, see here.

It illustrates how litigation costs of $400K to $48 million are quite small in comparison to the $300 million to over a $1 billion in revenues a company can receive from stent sales (2003).

The National Academies' National Research Council has come out encouraging the National Institutes of Health to foster independence among postdoctoral scholars, entry-level faculty, staff scientists, and other new investigators in biomedical research by improving their training and giving them more resources to pursue their own projects.

In case you think this is not a problem, consider that the median age at receiving their first R01 grant is 42 for those holding Ph.D.’s. In 2003 investigators under the age of 40 received less than 17 percent of the agency's competitive research awards -- down from more than 50 percent in 1980.

Among the recommendations are:

1. Enforce a 5-year limit on the use of any funding mechanism—including research grants—to support postdoctoral researchers.

2. Postdoctoral researchers should be more independent and less dependent of the research grants of PIs. NIH should reallocate support away from the R01 and toward individual awards and training grants.

3. Provide equal opportunities for non-U.S. citizens on postdoctoral training awards. Modify citizenship requirements or make available “alternative and equivalent mechanisms of support”

4. Postdoctoral scientists should receive improved career advising, mentoring, and skills training.

5. Postdoctoral Independent Research Award. A new research award for an independent research project

6. NIH should commission an independent evaluation of the different models of postdoctoral support.

The report noted that in most cases, biomedical postdocs are paid through "R01" research grants that are made to principal investigators (PIs). Consequently, postdocs are often required to spend their time focused on the research of these senior investigators, a pattern that may stifle their creativity.

The report went so far as stating that applicants for R01 grants seeking postdoc assistance should be required to provide lists of current postdocs as well as the names, laboratory tenure, and present job status of all postdocs supported in the past decade.

Like ever lengthening doctoral programs, it is obvious that the system encourages keeping new faculty/scientists in a low paying, hard labor position as long as possible (which sounds an awful lot like the associate track for lawyers). Perhaps I would have finished my doctoral dissertation work if it had not seemed so much like the ever elusive "piece of cheese" that kept getting moved further and further away.

More available here.

See the slide show here.

There seems to be quite a few protests of India's passage this week of a new patent law that prevents domestic drug companies from making low-cost generics of expensive Western medicines, saying millions of poor people across the world will be affected.

The changes in patent rights come from India's membership in the World Trade Organization (WTO), which requires India to enforce stricter patent rules for its pharmaceutical industry. Groups like Oxfam seem to think that the problem lies with the TRIPS agreement (trade-related aspects of intellectual property rights) and that it should be reformed. Under TRIPS, India had to introduce amendments to its existing patent act by January 1, 2005. Unfortunately, the Indian government waited until the very last minute and then had to rush it through the parliament.

International aid groups believe the new law will limit the supply of cheap generic drugs to impoverished nations, threatening the survival of AIDS and cancer patients - when almost 50 percent of 700,000 HIV patients taking antiretroviral medicines in Africa, Asia and Latin America rely on low-cost drugs from India. A month's dose of a generic AIDS drug cocktail costs US$30, or 5 percent of similar drugs sold by Western producers.

There were some last minute amendments were to tighten the definition of "new inventions" to prevent drug companies from winning new patents by making minor changes to existing drugs. The law also allows patents to be challenged even before they are granted. On the other hand, the bill says the government's ability to override patents requires a wait of at least three years before this is allowed, except in a national emergency.

Amazingly, even though India has some 5.1 million HIV-infected people (the second largest number after South Africa) it is NOT seen as a national emergency(!).

The issue does not seem to be one of patents or drug company profits (whether the drug company in question is located in the West or in a developing nation). The issue is really one of how can affordable health care be provided to those who need it and who should pay for that care if they cannot? The answer can't be to place the entire burden on drug companies who then shift the cost to countries paying full freight. Instead, all wealthier developed nations need to step up and provide financial assistance to bring the costs down for those in need.

Then someday, just maybe, a drug company will have the resources to finally discover a cure.

Resources: the World Health Organization.

More here.

A Canadian court ruled in favor of Sanofi-Aventis, maker of the top-selling blood thinner Plavix, preventing Apotex from selling a generic version of Plavix in Canada. Plavix is one of the three top-selling drugs in the world with sales of $5.4 billion. Sanofi has a similar suit against Aptoex and Dr. Reddy in the U.S. Apotex and Dr. Reddy argue that the United States patent for active ingredient in Plavix, which expires in 2011, is not sufficiently different from another Sanofi patent that expired two years ago. This could effect Bristol-Myers Squibb's sales since they divide the profits from Plavix with Sanofi.

Plavix was approved by the FDA in 1997 as the (+)-enantiomer, and its five-year exclusivity period, granted for all New Chemical Entities, expired last year. The first patent covering Sanofi’s oral antiplatelet chiral drug clopidogrel bisulfate (US 4,529,596), was filed in 1983 and expired in July 2003, and claims both enantiomers and their mixture, whereas a later patent (US 4,847,265), due to expire in 2011, claims only the (+)-enantiomer.

The earlier patent claimed, but did not describe, the (+)- and (–)-enantiomers, although it states that “the invention relates both to each enantiomer and their mixture”. In the description of the activities of each enantiomer in the ‘265 patent, data show that the (+)-enantiomer is pharmacologically superior in activity and less toxic than both the (–)-form and the racemate.

Was the development of Plavix as a single enantiomer in the 1980s nonobvious? A problem for Sanofi is that in the 1980s, single enantiomers were already a significant and important component of approved drugs.

See the story here.

As brought to light by blogger B2fxxx there was a story in the Economist about a recent study published in Science magazine concerning the viability of gene patents in general. See here.

Jordan Paradise and her colleagues at the Illinois Institute of Technology, published a study stating that more than a third of the patents they examined had claims that did not meet the requirements for patentability, that is, useful, novel and non-obvious, as well as meeting the requirements for description and enablement under section 112.

The group looked at gene patents including include not just human gene sequences, but patents that cover any human genetic material, such as mutations in a gene, or diagnostic methods that utilize human genetic material that would effectively preclude the use of that material by others. They chose genetic diseases that were subject to "public attention" and for which problems in gene patents could potentially have an impact on research and health care. Collectively, they examined 1,167 claims in 74 patents on genes related to nine diseases. If a claim failed to meet one of the legal requirements for a patent, it was deemed "problematic."

In the judgment of the authors, 38% of the specific claims were problematic and 73% of the patents contained at least one such problematic claim. As for the causes of the problems, slightly more than 40% were due to concerns about utility - that is, whether the invention could yield correct results. Slightly less than 40% raised concerns because their descriptions were inadequate. The remainder failed the novelty and non-obvious requirements, or lacked "definiteness."

Without seeing the actual specifications and claims in question, it is difficult to assess their results and conclusions. They cite some problems that seem straight forward, such as patents claiming more than what the inventor actually discovered, for example, claiming the sequence of a protein within a patent and then also asserting rights over all of the DNA sequences that encode for that protein without describing those DNA sequences. That would seem to be a clear cut problematic claim. However, they noted written description problems by stating that "One patent covers not only the particular polymorphism the inventor discovered but all other polymorphisms discovered in the future by anyone else in a region encompassing over 12 mega-base pairs (Mbp)." If true, then this would seem to be also problematic.

There are some inherent problems with any study where patent claims are deemed problematic by the authors, rather than the courts, so it's difficult to say if what the authors deem problematic would ultimately be determined invalid by a court. While problematic claims can act as a drag on commercialization, there isn't any indication it is a worse problem in biotech versus other, high-tech specialties.

I don't think it's really new to point out that biotechnology patents are difficult to prosecute and often have less than optimal claim language. It feels a little like complaining about the weather. I agree with the authors that one potential remedy may be more training or special selection of patent examiners. Not to mention better pay so that better Examiners are attracted from the beginning and have more incentive to stay on board longer. I feel the little hairs on the back of my neck bristling, though, at some of their ideas such as having biotech applications reviewed by the USPTO with different levels of scrutiny. I think this will meet considerable resistance, if you agree that Anything Under the Sun is patentable. Besides, what specialized patents couldn't be improved with higher levels of scrutiny? I always have trouble with making any particular area more "special" than another.

I do like the author's suggestion that the USPTO could also change its financial incentives to promote quality over quantity. Currently, patent examiners are encouraged with monetary bonuses to grant patent applications since patent examiners receive a salary bonus based on the number of final allowances or rejections of a patent authorized. Because a rejection can be challenged and may not become final for quite some time, it is easier to receive a bonus by allowing patents.

Let's hope the changes announced by Commissioner Duddas will improve everyone’s circumstances.

See more on the Town Hall meeting here.

Legal Times published an article detailing the prevalence in the business of corporate espionage using the Freedom of Information Act (FOIA) to gain competitive information. Companies are increasingly turning to teams of hired lawyers and analysts who request all data involving a competitor. Targets have included Boeing, MCI WorldCom Inc., McDonnell Douglas, and the General Electric Co. At stake are potential trade secrets including detailed line item pricing schemes and labor rate data - sometimes more than 10,000 pages of detailed cost breakdowns.

The Freedom of Information Act is traditionally thought of as an instrument used by reporters and the public to obtain information on how the federal government operates and how tax money is spent. But during the past 20 years, a whole industry has sprouted that uses the FOIA to gain intelligence on companies doing business with the government and then sells the info to competing contractors. Typically, the FOIA request is not made by an intermediary so that the real party of interest remains private.

Meanwhile, targets try to do all they can to prevent such disclosures and, if they cannot persuade the government to keep the information confidential, they'll go to the courts and file what is known as a reverse FOIA action. However, government agencies will agree to release detailed pricing data since that increases competition among contractors in order to secure better deals for the government.

The Court of Appeals for the District of Columbia Circuit has defined a "reverse" FOIA action as one in which the "submitter of information -- usually a corporation or other business entity" that has supplied an agency with "data on its policies, operations or products -- seeks to prevent the agency that collected the information from revealing it to a third party in response to the latter's FOIA request." CNA Fin. Corp. v. Donovan, 830 F.2d 1132, 1133 n.1 (D.C. Cir. 1987). Typically, the submitter contends that the requested information falls within an Exemption of the FOIA, [5 U.S.C. § 552]

Update. See the Ten Excemptions: Download file

In a "reverse" FOIA suit "the party seeking to prevent a disclosure the government itself is otherwise willing to make" assumes the "burden of justifying nondisclosure." A challenge to an agency's disclosure decision is reviewed in light of the "basic policy" of the FOIA to "'open agency action to the light of public scrutiny'" and in accordance with the "narrow construction" afforded to the FOIA's exemptions.

The seminal case in the reverse FOIA area is Chrysler Corp. v. Brown, in which the Supreme Court held that jurisdiction for a reverse FOIA action cannot be based on the FOIA itself "because Congress did not design the FOIA exemptions to be mandatory bars to disclosure" and, as a result, the FOIA "does not afford" a submitter "any right to enjoin agency disclosure."

Federal trial and appellate courts across the country are split on whether certain pricing information should be released. In one recent case, a federal appellate judge in the District pointed out that the Justice Department has never litigated the fundamental question of whether prices charged to the government for specific goods could be confidential commercial information or trade secrets under FOIA or the Trade Secrets Act. Most cases turn on whether the company whose data is at stake can show that releasing the information would cause substantial harm.

More alarming is one court's holding that, "[t]he harm from disclosure is a matter of speculation, and when a reviewing court finds that an agency has supplied an equally reasonable and thorough prognosis, it is for the agency to choose between the contesting party's prognosis and its own." McDonnell Douglas, 215 F. Supp. 2d at 205; accord CNA, 830 F.2d at 1155).

However, the U.S. Court of Appeals for the D.C. Circuit has twice ruled that detailed price information should stay confidential. In one opinion from 1999, Judge Laurence Silberman wrote that the government failed to claim any legal authority for releasing line item pricing information involved in McDonnell Douglas' contract with NASA: "If commercial or financial information is likely to cause substantial harm to the person who supplied it, that is the end of the matter, for the disclosure would violate the Trade Secrets Act."

Inventors should be aware of the implications of FOIA since an invention is not patentable in the US if it has been described in a printed publication more than 1 year prior to filing a U.S. patent application and foreign filing rights are lost immediately. A grant is considered published when it is considered accessible, that is, after the grant was allowed and it had been indexed and a copy of the proposal could be obtained through a request under FOIA

It would therefore be possible for a research scientist, with a long-term federal (or state) grant, to propose a course of research and speculate on findings. Then, when the studies are concluded, this same scientist could find that the technology developed during the course of the research is barred from patent protection by the researcher's own proposal. To prevent a bar, and to fall within the exceptions of the FOIA, each individual page should be marked "Confidential" and a legend affixed to the front page that states:

"Confidential. This document, or portions of it, contains confidential information that is, or may become, the subject of a United States patent application and is important to future commercial efforts based on such confidential information. Accordingly, this document and the confidential information contained herein are exempt from disclosure under the Freedom of Information Act, Sections 552(b)(3) and (b)(4) of Title 5 of the United States Code and corresponding regulations of United States government agencies."

In addition, a cover letter should accompany each grant proposal submitted to an agency of the state and federal government providing a rationale for keeping the proposal confidential and request that the applicant is notified of all requests the agency receives for copies of the proposal under the FOIA.

Specific details concerning individual granting agencies are available from each agency. In addition, some changes in the language used in the proposal could help future patentability. If possible, avoid direct and definite predictions concerning the results of the research. Statements in a proposal that "the research should lead to outcomes such as ..." or "I believe that the research will result in ..." may constitute a public disclosure of a potential invention.

Maybe it’s the cold weather and the gloom of February, but cupid did not bestow any Valentine’s day gifts on the biotech industry for the month of February.

"Although the biotech industry managed to hold its own during much of the month with the Burrill Select Index up slightly into the final weekend of February, the news that Biogen Idec (BIIB) and partner, Elan PLC (ELN) were pulling from the market their new drug for multiple sclerosis, Tysabri, not only gutted the value of both companies immediately, but also dampened the performance of other publicly traded biopharmaceutical firms," noted G. Steven Burrill, CEO of Burrill & Company, a San Francisco based life sciences merchant bank. The Burrill Biotech Select Index ended February down 2%, compared to the NASDAQ, down less than 1% and the DJIA, up nearly 3% for the month.

"The news about Tysabri couldn't have come at a worse time, following as it did in the footsteps of tremendous controversy surrounding the use of COX-2 inhibitors," said Burrill. "Less than two weeks after the FDA expert advisory panel voted in favor of allowing the arthritis painkiller Vioxx and other COX- 2 inhibitors to remain available on the market under strict conditions, Biogen Idec and Elan make the announcement that physicians should suspend dosing of Tysabri until further notice ... investors were taken completely off guard," he explained.

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Continue reading "Biotech Does Not Do Well for February"

As you may have seen in the news (see, for example, here), Microsoft is now calling for reforms to the U.S. patent system in four areas: improving patent quality, reducing excessive litigation, improving the coordination of international patent law, and increasing the accessibility of patent laws for small companies and individuals. What's not to like?

While some of Microsoft's gripes are certainly legitimate, they're not all together novel or ingenious. Microsoft General Counsel Brad Smith is advocating:

a. An end to patent fee diversion to other government uses. The U.S. Patent and Trademark Office has seen annual applications triple to more than 350,000 since the 1980s while funds to support the agency have not kept pace. Smith stated that this would best address patent quality and limit a system of "patent litigation lottery." You'd be hard pressed to find someone who's against this -- other than the recipients of fee diversions, of course.

b. A special court to hear all patent cases at the federal district level, a la the Court of Appeals for the Federal Circuit, in an effort to bring consistency and predictability to patent litigation. Smith asked for a system that could alert the USPTO about questionable patents during the review process itself and not just after issuance through litigation, i.e., allow administrative challenges.

c. A need for patent plaintiffs to demonstrate that they or their company would face irreparable harm that could not be compensated by monetary damages before a court issues a patent injunction on a defendant. As pointed out by patent litigator Dave Schmit, the current standard for getting a temporary injunction is not different in that one must show: (1) likelihood of success on the merits; (2) irreparable harm to plaintiff, i.e., a non-economic harm that cannot be compensated for by monetary damages; (3) lack of irreparable harm to defendant in granting the injunction; and (4) that public interest is met. Therefore, it is not clear exactly what higher standard is being requested by Microsoft.

d. The coordination of international patent offices and their legal standards including mutual recognition of patents in Europe, Japan and the United States. Raise your hand if you've never heard this one. What, no one? Microsoft also lambastes the 'first to invent' standard for awarding patents pointing out the obvious that very other country applies a 'first to file' standard. Certainly not an original idea but maybe Microsoft has the clout to see some movement on this.

e. Finally, Smith called for the elimination of patent filing fees for individuals and small businesses. I don't know what to think about this idea other than it seems like the way some financial aid works where income alone doesn't really tell you the financial status of someone. Is this really the fairest system given that some individuals and small businesses have more economic power than many large businesses? What about eliminating taxes on individuals and small businesses?

At the same time, as reported in the Washington Times, the U.S. Patent and Trademark Office has begun a hiring spree to reduce an expected backlog of 580,000 applications by the end of the year. The USPTO plans to hire close to 1,800 patent examiners over the next two years, increasing its current staff of 3,800 examiners by 47 percent. This will be paid for by higher fees, which began in January and are expected to bring an extra $400 million for the patent office. I haven't seen anyone mention the quality of Examiners to be hired, only the quantity of Examiners. Let's hope the USPTO will put some of that scratch towards higher Examiner pay.

Last year, the patent office received 376,810 applications, up 6 percent from the 355,418 applications in 2003. About 50 percent of the requests are for technology such as semiconductors, computer hardware and software, and telecommunications. And, as many of you are acutely aware of, the average wait is about 2-1/2 years from the time of filing except that patents for computer technology and biotechnology products are taking up to five years or more. Unfortunately, everyone seems to agree that the situation probably will get worse before it gets better.

A patent was awarded to the U.S. Department of Agriculture and the multinational company WR Grace & Co. in 1995 for the fungicidal properties of seeds extracted from the neem tree, native to India. But, the European Parliament's Green Party, India's Research Foundation for Science, Technology and Ecology, and the International Federation of Organic Agriculture Movements fought to have it revoked on the grounds of biopiracy.

'Biopiracy' describes a process in which living resources or traditional knowledge and practises are patented, thus applying intellectual property restrictions to their use. The resources in question are predominantly from developing countries, and are the subject of patent applications by companies in developed countries. The neem tree has been used for thousands of years in India in agriculture, public health, medicine, toiletries, cosmetics and livestock protection. According to advocates of the biopiracy rule, a patent application should always be rejected if there is prior existing knowledge about a product.

The patent was revoked five years after it was awarded, but the decision was appealed by the Department of Agriculture and WR Grace. The decision on March 8 brings the ten-year dispute to a close.

The basis of the challenge to the patent was that the fungicide qualities of the neem tree and its use had been known in India for over 2,000 years. The neem derivatives have also been used traditionally to make insect repellents, soaps, cosmetics, tooth cleaners and contraceptives. In 1995, WR Grace patented neem-based bio pesticides, including Neemix, for use on food crops. Neemix suppresses insect feeding behaviour and growth in more than 200 species of insects. But the EPO agreed that the process for which the patent had been granted had actually been in use in India for many years.

Biopiracy advocates are trumpeting the decision as a victory in the fight to stop big business exploiting plants and genes at the expense of poor people in the developing world. They believe the livelihoods of poor farmers in developing countries will be undermined.

Granted, patents should not be granted on known materials but many developing countries want to deny patents for new uses of a known product or process, including second use of a medicine. I believe in the old saying that only God works from scratch, the rest of us have to start with known materials. Why would any country want to stifle innovation of new uses for known materials? It sounds a little like cutting of your nose to spite your face.

See more here.

In a March 8 opinion, a three-judge panel of the U.S. Court of Appeals for the 11th Circuit in Atlanta rejected a 2003 Federal Trade Commission (FTC) ruling that Schering-Plough Corporation's patent settlements with two other companies amounted to pay-offs not to compete. The FTC claimed that the company illegally kept cheaper versions of blood pressure drug, a controlled-release potassium chloride supplement K-DUR(R) 20 (potassium chloride), USP off the market.

The judges noted that: "Simply because a brand-name pharmaceutical company holding a patent paid its generic competitor money cannot be the sole basis for a violation of antitrust law."

The company has consistently maintained that the patent litigation settlements complied with the law and benefited consumers by allowing generic product to enter the market two to five years before the expiration of the relevant patent.

Schering-Plough holds a formulation patent for K-DUR, which gives the company the right to exclude infringing products into 2006. In 1995, Upsher- Smith and ESI Lederle filed separate Abbreviated New Drug Applications (ANDA) with the U.S. Food and Drug Administration (FDA) seeking to market generic versions of K-DUR. Schering-Plough brought separate actions against both companies alleging that their products infringed Schering-Plough's patent. In each case, Schering-Plough and the parties settled before trial. Under the settlements, licenses were agreed to allowing Upsher-Smith to bring its product to market in September 2001 and ESI Lederle to bring its product to market in January 2004.

The FTC Bureau of Competition in March 2001 filed a complaint in Washington, D.C. before an FTC administrative law judge charging that the patent litigation settlements involving K-DUR were anti-competitive and violated the Federal Trade Commission Act.

Get the full decision here: Download file

In Seattle this week, baristas will compete in the Specialty Coffee Association of America’s 2005 U.S. Barista Championship (USBC). Alas, the Patent Baristas will not being attending, given that they just enjoy drinking coffee -- not making it. The Barista Championship will feature fifty-five of the most skilled baristas from around the country creating some of the world’s finest coffee concoctions.

Competitors will prepare and serve 12 coffee drinks – four espressos, four cappuccinos and four original signature drinks of their own creation – all within a 15-minute timeframe. Judges will focus on station cleanliness, taste, beverage presentation, technical skills and total impression.

While we don't know beans about running an espresso machine, we'd like to show support of some of our favorite people on earth. Send us a photo of yourself at the competition and we'll post it here!

The Finals and Award Ceremony will be Sunday, March 13. More info here.

As a follow-up to my Friday, March 4 post regarding Biogen’s MS drug Tysabri, in an “unrelated” event, Biogen announced the resignation of the executive, Thomas J. Bucknum, effective immediately, and gave no reason for the resignation.

Bucknum's sudden departure, comes amid a regulatory inquiry into his sale of Biogen stock the same day the company says it learned of patient illnesses that led to Tysabri's withdrawal from the market. Besides Mr. Bucknum, at least three other Biogen executives or directors sold shares before Feb. 18.

Bucknum exercised stock options and sold 89,700 shares on Feb. 18 at $67.12 a share, earning a profit of nearly $2 million, according to a filing with the Securities and Exchange Commission. Not bad for a days’ work, if you can get it. That same day, Biogen said that it learned two patients in a clinical trial of Tysabri were suspected of having a rare but deadly brain infection. Ten days later, Biogen and its partner, the Elan Corporation, suspended the sale of Tysabri, setting off a 43 percent drop in Biogen's share price and a 70 percent decline in Elan's.

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Continue reading "Biogen Exec Resigns Amid SEC Controversy (or...Get that Man a Poncho!)"

In the same year that the international patent system marked the filing of the one millionth international patent application, a record number of applications, just over 120,000, were filed in 2004 using the Patent Cooperation Treaty (PCT) of the World Intellectual Property Organization (WIPO). Despite reports of the early demise of its research capabilities, the United States continued to top the list of largest users with 41,870 applications, representing 34.9% of all applications in 2004.

See the report here.

Applicants from Japan (16.6%), who unseated their German counterparts in 2003 for the number two spot, maintained their second place position, followed by Germany (12.4%), France (4.4%) and the United Kingdom (4.2%). Use of the PCT in Japan grew by 15% in 2004. The Republic of Korea (19.3% growth), and China (37.8% growth) also showed a significant increase in filings. The report indicated that further growth is expected from the Asian continent in the coming years, noting that if current rates of growth continue, China will overtake Australia in 2005 to become the twelfth largest user of the system.

The top ten users of the PCT from developing countries include: Samsung Electronics, (Republic of Korea), LG Electronics (Republic of Korea), Huawei Technologies (China), Ranbaxy Laboratories (India), Agency for Science, Technology and Research (Singapore), ZTE Corporation (China), LG Chem (Republic of Korea), Electronics and Telecommunications Research Institute (Republic of Korea), Council of Scientific and Industrial Research (India), and UTStarcom (Republic of Korea).

The rise in applications reminds me of the oft-misquoted line "Everything that can be invented has been invented" erroneously credited to Charles H. Duell, U.S. Commissioner of Patents, in 1899. It's now believed to stem from Patent Office Commissioner Henry Ellsworth’s 1843 report to Congress in which he states, "The advancement of the arts, from year to year, taxes our credulity and seems to presage the arrival of that period when human improvement must end." Ellsworth was merely using some rhetorical irony to emphasize the growing number of patents but the hyperbole was lost on someone. Don't look for the end of invention any time soon.

See more here.

Under Secretary Jon Dudas identified three new United States Patent and Trademark Office (USPTO) initiatives that will speed patent prosecution, and which will save applicants about $30 million annually at a "town-hall meeting" held last Friday in Chicago. Of course, it was a town hall meeting that charged admission but I digress. According to a press release by the USPTO, the initiatives include changing the rules for appeal conferences, eliminating the backlog of ex parte re-examinations and creating a more transparent office.

Dudas said that USPTO customers will save at least $30 million annually due to a new program this year that allows applicants to request an appeal conference and learn the results before having to file an appeal brief. Currently, when applicants appeal rejections to the Board of Patent Appeals and Interferences (BPAI), they must file a notice of appeal and an appeal brief. The next step is an appeal conference. Statistics demonstrate that appeal conferences result in approximately 60% of cases being returned to the patent corps. I would like to see customers could save even more money by having more and better trained Examiners in order to avoid the necessity of many of the appeals in the first place.

In regard to ex parte re-examinations, the USPTO will change the way it handles requests to ensure that re-examination remains a viable, cost-effective alternative to litigation. According to Under Secretary Dudas, the new system will allow the agency to the complete processing of 420 cases that have been pending for more than two years. Also, three-examiner panels will be assigned to each re-examination, compared to the past practice of assigning a single examiner to each case - all to ensure that current and future ex parte re-examinations take no longer than two years to process.

Dudas also discussed his concept of a more transparent office, pledging to provide USPTO customers not only with more information, but information and numbers that have greater meaning. He spoke at a "town meeting" sponsored by the American Intellectual Property Law Association (AIPLA), the Federal Trade Commission, and the National Academy of Sciences.

Just when you thought it was safe to say “FDA”, and things seemed to be calming down ever so slightly with the uproar over COX-2 inhibitors and scrutiny over the FDA approval processes, the issue of suspect drugs plaguing the pharmaceutical industry has now spread to the biotech sector, with one of its best performing companies and a partner pulling their highly touted multiple sclerosis drug from the market.

Biogen, Inc., the makers of Tysabri, a new drug used to treat multiple sclerosis, announced Monday they are voluntarily suspending sales of the drug after one patient died and another developed a serious disease of the central nervous system.

Biogen Idec hammered out the details of the marketing suspension over the weekend in talks with FDA officials. The decision by Biogen Idec and the FDA to immediately suspend distribution and administration of Tysabri is a cautious approach that may have been influenced by the recent disclosure of newly discovered risks associated with the COX-2 inhibitors. Recall that in September, Merck pulled Vioxx off the market citing a new study linking the medication to increased risk of heart attack and stroke.

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Continue reading "Drug Recall Hits Biotech Sector: Swim at your own risk?"

Walker Morris in London sent a note regarding the October, 2004, opinion in the patents case Kirin-Amgen v. Hoechst Marion Roussel. The case was the first opportunity for the House to consider the critical question of the extent of protection conferred by a patent under the provisions of the European Patent Convention (EPC), which were incorporated into UK law by the Patents Act 1977.

The dispute between Amgen and Transkaryotic Therapies, Inc. (TKT) relates to the production of erythropoietin ("EPO"). EPO is produced in the kidneys in minute quantities. It was discovered that EPO had the useful property that it stimulated production of red blood cells and as a result it was very valuable for the therapeutic treatment of anemia.

Amgen invented a process of producing EPO by recombinant DNA technology. For this invention Amgen was granted a European Patent (EP0148605B2). Essentially, Amgen had discovered a way of inserting the genetic code for the expression of EPO (or a part of the EPO protein) into a host cell. Amgen’s patent was directed to this invention. TKT developed a different method of producing EPO. TKT discovered a way to "switch on" a cell’s natural ability to express EPO. This method was unknown at the priority date of the patent. Amgen sued for infringement of Amgen’s patent.

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Continue reading "UK Courts Set Limits on Claim Coverage of Unknown Technologies"

The Baristas will be attending the Ohio Valley Affiliates for Life Sciences Group (OVALS) regional conference  "The Promise of Innovation: OVALS Making It Happen" on March 7-8, 2005, at the Dayton Marriott Hotel in Dayton, Ohio. 

Register and see Agenda.

The OVALS Partnership developed in 2002 as a forum to discuss and stimulate economic development opportunities for Life Sciences within the "Ohio Valley" region.

I was recently reminded about how easy it is to lose patent rights due to a miscalculated publication. Since I regularly represent universities and other research institutions in patent matters, I'm very familiar with publication pressure felt by faculty and students and the inherent rush to be the first to present findings to peers. I made many of these types of presentations myself as a graduate student.

Last month, I had a researcher who did all the things necessary to protect his invention, or so he thought. While the inventor knew enough to submit the invention for filing prior to publication in a journal, it came to light that the invention was disclosed by the inventor and his student a month earlier in a poster presentation at a conference. As you may know, a case this past fall illustrated the dangers of prior publications in the In re Klopfenstein decision.

Get the complete opinion here: Download file

In In re Klopfenstein, the inventors applied for a patent on October 30, 2000. Their patent application, Patent Application Serial No. 09/699,950 (the '950 application), disclosed methods of preparing foods comprising extruded soy cotyledon fiber. The '950 application claimed that feeding mammals foods containing extruded SCF may help lower their serum cholesterol levels while raising HDL cholesterol levels.

However, in October 1998, the inventors presented a printed slide presentation at a meeting of the American Association of Cereal Chemists ("AACC"). The fourteen-slide presentation was printed and pasted onto poster boards. The printed slide presentation was displayed continuously for two and a half days at the AACC meeting. In November of 1998, the same slide presentation was put on display for less than a day at an Agriculture Experiment Station ("AES") at Kansas State University. The poster presentation presented to the AACC and at the AES in 1998 disclosed every limitation of the invention disclosed in the '950 patent application.

The court noted that neither presentation contained a disclaimer or notice to the intended audience prohibiting note-taking or copying of the presentation. No copies of the presentation were disseminated either at the AACC meeting or at the AES, and the presentation was never catalogued or indexed in any library or database.

The examiner found all of the claims anticipated by this reference or obvious in view of it and other references. The inventors argued that this reference was not a "printed publication" because no copies were distributed and because there was no evidence that the reference was photographed. The examiner rejected these arguments and issued a final office action rejecting the claims of the '950 application. The inventor's appealed the examiner's decision but the Board of Appeals affirmed on the grounds that the full invention of the '950 application was made publicly accessible to those of ordinary skill in the art by the this reference and that this introduction into the public domain of disclosed material via printed display represented a "printed publication" under 35 U.S.C. § 102(b).

In its decision, the court stated that "distribution and indexing are not the only factors to be considered in a §102(b) 'printed publication' inquiry." The court looked at the length of time the display was exhibited, the expertise of the target audience, the existence (or lack thereof) of reasonable expectations that the material displayed would not be copied, and the simplicity or ease with which the material displayed could have been copied.

Finally, the court held that:

Upon reviewing the above factors, it becomes clear that the Liu reference was sufficiently publicly accessible to count as a "printed publication" for the purposes of 35 U.S.C. § 102(b). The reference itself was shown for an extended period of time to members of the public having ordinary skill in the art of the invention behind the '950 patent application. Those members of the public were not precluded from taking notes or even photographs of the reference. And the reference itself was presented in such a way that copying of the information it contained would have been a relatively simple undertaking for those to whom it was exposed—particularly given the amount of time they had to copy the information and the lack of any restrictions on their copying of the information. For these reasons, we conclude that the Liu reference was made sufficiently publicly accessible to count as a "printed publication" under § 102(b).

After reviewing this case, I had to wonder whether or not it would have saved the application if the inventors had just included a statement on the poster presentation to the effect of "Proprietary Materials. Copying of any information contained herein is strictly prohibited." I would argue yes given that the court made a point of stating that the inventors should have taken protective measures ... "even a simple disclaimer informing members of the viewing public that no copying of the information will be allowed or countenanced."

The court made a big deal about how long the poster was accessible stating that "The duration of the display is important in determining the opportunity of the public in capturing, processing and retaining the information conveyed by the reference. The more transient the display, the less likely it is to be considered a "printed publication." ... Conversely, the longer a reference is displayed, the more likely it is to be considered a "printed publication."

This doesn't leave researchers with very clear guidance. Since it seems that the inventors in In re Klopfenstein left their poster on display too long, it begs the question as to how many minutes or hours are still transient. Had the presentation been only the "less than a day" display at the AES conference, would that have been OK? Several hours? Fifty-seven minutes? Without any clear guidelines, researchers should be on notice that anything beyond a very "transient" slide presentation should be approached with caution.

I just wanted to pass along the information as an FYI. While faculty and students will always want to present their research in abstracts, posters and papers, I think it would be valuable to advise them to err on the side of caution. It could be living dangerously but one might want to try to (a) omit critical details from any such poster presentations to keep them from being enabling in a patent sense, (b) limit presentations to as little time as possible, and (c) add a disclaimer that the materials are proprietary and copying if strictly forbidden.