Patent Baristas

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.