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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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Unaltered genes are a product of nature and not patentable

Image

See this Jim? It’s not patentable.

The Supreme Court of the United States released its ruling on the ‘Association for Medical Pathology v. Myriad Genetics, Inc.’ case today. Briefly, they ruled that Myriad’s patent is invalid as they merely discovered a natural entity. Because they did not alter the material in any way vital to their industry or possess a methods claim associated with this material, their patent fails because  “laws of nature [or] natural phenomena …lie beyond the domain of patent protection” according to precedent set under United States Code. 

Wait – you mean the USC clearly states that they couldn’t patent this stuff?  Well, no.

USC Title 35 Part II Chapter 10 Section 101

“Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor…”

The applicable precedent case is Mayo v. Prometheus___566 U.S. In that case, Prometheus had a patented clinical diagnostic kit that Mayo Collaborative Services (a nonprofit affiliated with the Mayo Clinic) used for some time until they developed their own version of the kit. (A pretty close precedent). In this case, the court ruled that, “Because methods for making such determinations were well known in the art, this step simply tells doctors to engage in well-understood, routine, conventional activity previously engaged in by scientists in the field. Such activity is normally not sufficient to transform an unpatentable law of nature into a patent-eligible application of such a law.”

My Interpretation

From these rulings it appears that in order to become a patentable entity a gene must be novelly transformed in some manner that makes it functionally distinct from the naturally occurring entity, or that the method for interrogating the gene involves some novel method beyond what is previously known art. 

 
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Posted by on June 13, 2013 in Uncategorized

 

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