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One Quarter in

US08395894-20130312-D00000.pngI’ve been working for an intellectual property firm now for three months and I thought it might be time to update my impressions of the field.

When I entered this position (as a technical patent analyst)at the start of the year, I had little background in the area. I have a few patents on work that I’ve done in my various biotech positions which I did work on assembling the data for the attorneys working in our company / the university. However, that didn’t really provide much insight into what a patent is, or what really went into making it work. In fact, one of the only things I learned is that lawyers (or at least some of them) won’t shy away from exploiting your ignorance of their system in order to get what they want. In my case, this was signing over my rights to the company I had worked for after they had laid me off.-That’s a whole other discussion though!

Screen Shot 2016-03-25 at 10.23.32 PM.pngIn the past, my writing had always been of the sort that presented data and built a story around that data in a way that was essentially persuasive in nature. Patent Applications do present data, and they can tell something of a story, but they are not meant to be persuasive documents. No one reads them for the purpose of evaluating the data to see if you’ve missed something, forgotten some important principle, or are making an invalid argument. You simply show what you have, make claims based on both the data and your ideas about it and determine if it’s:

  1. Patentable subject matter
  2. Novel work
  3. Not Obvious

Have you presented enough information such that a representative person skilled in the art can now replicate the invention(i.e. are they enabled)?

Is there an industrial application for this? Not because everything in the world needs to be commercialized, but because it is not worth the time and expense of protecting something that can’t be stolen from you in a way that you have suffered financial harm.

The last question is important because a patent is a deal between the inventor and the society. In general, the US government, at least, does not look kindly on monopolies (e.g. ma Bell). However, what a patent does is give the inventor a period of time when they can legally monopolize their invention. In exchange for this, the inventor supplies all the information one would need to recreate the invention. The public gets something and the inventor gets something. Ideas are shared, but there is still incentive to invent without sinking all your money into research and then having someone copy your work and sell it

Screen Shot 2016-03-25 at 10.25.52 PM.png

huh?

cheap.

What a patent doesn’t do is try to get you to believe that what someone is claiming as part of their invention is actually a real thing. Of course, it’s easier to get a patent on something that you have in hand, but this is not necessarily required.

Getting back to the point of having patents, this is why your brand name prescription drugs cost so much. For every life-saving medicine, there are hundreds, thousands, millions of other ineffective drugs that had to be tested along the way.That testing costs a lot of money. Moreover, it takes years of research to develop a drug to the point where it is reliably safe and effective to use. Why invest in that, if you can’t pay for the failures with your successes? The monopoly on the invention makes this worth it; it gives you time to recoup your investments and even make a profit.burger-labeled-2.jpg

One thing that has been interesting is learning more about what is, and what is not parentable in the US (point 1 from above). This remains an active question. Can a gene be patented? Can something like a gene be patented?

What if that gene is a naturally occurring thing? What if it is synthetic? What does it mean to be a synthetic gene? You can’t patent something that you didn’t invent. So, the general principle is that a simple DNA sequence, as it occurs in nature, is as unpatentable as is an abstract idea like algebra.

Some insight into trials that have been getting to this question…

Screen Shot 2016-03-25 at 10.33.34 PM.png

“Nor do we consider the patentability of DNA in which
the order of the naturally occurring nucleotides has been
altered. Scientific alteration of the genetic code presents a
different inquiry, and we express no opinion about the
application of §101 to such endeavors. We merely hold
that genes and the information they encode are not patent
eligible under §101 simply because they have been isolated
from the surrounding genetic material.
* * *
For the foregoing reasons, the judgment of the Federal
Circuit is affirmed in part and reversed in part.
It is so ordered.”
And, of course there will be dissents…
Screen Shot 2016-03-25 at 10.34.31 PM.png
Nor are patents the only kind of intellectual property. Trademarks and Copyrights are also protected by the same office. I don’t have to work with those, but there are those around me who do. I just have to admit that I’ve learned nothing about them yet- and may never.
And, as always, I keep asking myself… “is this system really serving the public good?” I definitely think that patent protection is important for there ever to be innovation that requires significant effort and expense. But I am still struggling with the fact that much of what we do is cut the world’s ideas into smaller and smaller pieces assigning each piece’s ownership to one group or another. As such, it is a lawyer’s game, where the rules have been made so byzantine that following them is nearly impossible without great expense.
 
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Posted by on March 25, 2016 in Uncategorized

 

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I’ve been away, but now I’m back.

2905f5c4f4fb0354cfc774fa213cd9bf-1Life is funny. If you were to ask me, anytime during my entire life, whether I would ever work in a law firm dealing with details, I would say that you were crazy to even ask that. Details just aren’t my thing.

Not only that, I’ve always been more that a little jaded in my view of the law and those who practice it. On the other hand, I have always thought that the Supreme Court was the most interesting part of our political system and where the more intelligent, thoughtful members of the government find themselves (even if I don’t agree with them — I’m looking at you, Anton!).

But here I am, working at a Patent Firm as a technical analyst. I wish I got to be more of a technical analyst day to day, actually. Unfortunately, that’s only part of the job. The rest is just legal office work, which amounts to a very expensive service industry where you don’t want to make anything shy of the best impression on your clients.

I couldn’t do this job if I didn’t see it as a kind of experiment though. So, if it’s an experiment, what’s the question?

The purpose of Patent Law  comes directly from the Constitution:

Article I, Section 8, Clause 8, of the United States Constitution grants Congress the power “To promote the progress of science and useful arts, by securing for limited times to authors and inventors the exclusive right to their respective writings and discoveries.”

The idea behind the law is that inventors exchange a detailed description of their inventions in a clearly defined way that would enable one of ordinary skill in their art to repeat the invention for monopoly over the use of the invention for a period of time in order to capture the financial benefit (20 years).

So, my question is, is this what patent law achieves? Is the progress of science promoted? Do inventors receive the benefit the law claims to provide? Does the public benefit from this exchange?

It’s easy to have a feeling for this, but how can one measure it? I’ve got to mull this over and come up with a list of possibilities and then start collecting some data. Ideas?

 
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Posted by on February 10, 2016 in Uncategorized

 

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Science on Trial – Science in the Media

Amongst the many interesting topics that Paul Offit’s Autism’s False Prophets brings up are how science is perceived in the media, received by the public, and judged in the courtroom.

For reference, Offit brings up the fiasco of the 1990s lawsuits against the makers of silicone implants.

Kristin E. Schleiter writes an excellent paper about the history of silicone implants and the litigation that followed them in Silicone Breast Implant Litigation in the AMA Journal of Ethics.

Breast implants, she says, were first introduced in the 1960s. In 1976, the FDA was granted the power to regulate them as medical devices, but did not specifically do so until 1988. Prior to that, in 1984, Maria Stern won [the first case against an implant manufacturer totaling] “$211,000 in compensatory damages and $1.5 million in punitive damages from silicone breast implant manufacturer Dow Corning after claiming that her breast implants caused autoimmune disease.” This was the first, but not last case to bring implants to court. In the 1990s public opinion was against the makers of breast implants and thousands of suits were filed against their makers.

A natural progression

A natural progression

-Schleiter’s paper goes through a list of important individual and class action cases that I don’t feel the need to repeat here, however it is a fascinating read.

In the midst of these lawsuits, the attorney, “John O’Connor, relied on PR and sympathy to win [his case representing client, Pamela Johnson]. O’Connor hired a public relations firm that gave interviews to Phil Donahue and 60 Minutes, and the trial was broadcast in its entirety on Court TV. At trial, O’Connor set up a rebuttable presumption, asking the jury to hold MEC liable unless the company could prove that they knew their implants were safe at the time they marketed them. “

That is, it doesn’t matter whether the implants caused damage, but instead, whether the company, MEC, could prove them to be safe.

In the wake of litigation, studies began appearing showing the lack of any connection between breast implants and negative health outcomes.

Schleiter provides a list of papers reviewing the safety or danger linked to implants consolidated here:

  •  Plastic and Reconstructive Surgery published a study that found no increase in the incidence of breast cancer in women who had received breast implants
  • The New England Journal of Medicine soon followed with a study that concluded that breast implants did not substantially increase a woman’s risk for breast cancer
  • In 1994- New England Journal of Medicine published a study by Mayo Clinic epidemiologists that found no increased risk of connective tissue disease in women with silicone gel breast implants
  • In 1995, the Journal followed with yet another study—this one larger and more refined—that found no association between implants and connective tissue disorders.
  • In 1997, the American Academy of Neurology reviewed existing silicone gel breast implant studies and concluded that there was no link between the implants and neurological disorders
  • Also in 1997 Journal of the National Cancer Institute published a review of studies and concluded that breast implants did not cause breast cancer

However, billions of dollars had already been awarded or settled upon and Dow Corning was forced into Bankruptcy.

With respect to Offit’s book, the question arises, “How should science be settled in court?” It’s tempting to say that the cases should prompt investigations that statistically determine the culpability of, in this case, breast implant manufacturers. But that leads directly to one of the core problems that raised the specter of a MMR / Autism connection. Andrew Wakefield’s paper was intended to do just that – provide scientific evidence to help determine a case. In that case, the British government provided $30M to a law firm in order to fund their investigation. But that’s not proper either. To begin with an outcome in mind, i.e. “MMR shots cause autism” and then try to uncover evidence to support that idea is putting the cart in front of the horse. It’s OK to ask, “Does MMR vaccination cause autism?” and then look for the answer, but starting with the answer in mind – No.

For those in my Pathophysiology class, consider, as you read these next chapters, how these questions should be answered. If you were in the position to outline how cases involving questions of science / healthcare should be handled in court, how would you do it? Are these questions any different from the other questions that courts have to address?

 
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Posted by on February 15, 2015 in Uncategorized

 

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A Pointer to My Post After Watching GATTACA

ImageToday’s post about the film, GATTACA, is just as much a movie review as it is a discussion of eugenics, so I thought I’d post that on my other blog instead. Go on over and check that out. That and my thoughts on an ungodly number of bad movies that I watch all the time. 

 
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Posted by on April 24, 2014 in Uncategorized

 

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The ABCs of gas law

ImageI just flipped another lesson over at TedEd. This time it’s not one that I would likely use in my biology class, but it teaches the same principles found in my iBook, The Thirteenth Labor of Heracles, so I couldn’t resist. As always, I welcome your comments – especially with respect to the clarity of the questions bundled with this video.

Find the video at:

http://ed.ted.com/on/I1Ipr9n6

Find The thirteenth Labor of Heracles at:

https://itunes.apple.com/us/book/thirteenth-labor-heracles/id567932090?mt=11

 

 
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Posted by on July 9, 2013 in Uncategorized

 

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