LTD, I need some more insight: Big Pharma isn\'t true Capitalism, right?

Blazing Saddles

Pursuit Driver
Here's a link that is very disturbing to me, at least on the surface. It seems like a big collaboration between Pharmaceutical companies and our Gov't. I know the new health care law won't take away from them but I just need more information on how this can be beneficial to anyone but the CEO. Are all these guys in the gov't pockets and we're holding the bag?

There are a couple of bad words in the text. I don't like them either but nothing I could about it.

http://www.dangerousminds.net/comments/get_your_pitchforks_ready_a_tale_of_a_1_greed_head_that_will_fry_your_mind
 
There are a few CEO's with what most would call usury compensation packages. However, this is the exclusive purview of the Board of Directors. If I was a large shareholder, I would certainly demand that the package be reviewed.

There has always been an "unnatural" union of government and big pharma, because in spite of the huge R&D costs, a government patent and FDA approval on a new drug to treat common ailments is a license to print money. To me the worst offenders in the patent lottery are the "me too" companies that make small inconsequential changes to a proprietary drug, get their own patent and FDA approval, and then start their own money printing press. These companies are quite willing to "invest" in lawmakers who might favor their products.

I really think that the drug patent process and protections need to be reviewed, because the government is granting a huge monopoly for many years.
 
lotstodo said:
There are a few CEO's with what most would call usury compensation packages. However, this is the exclusive purview of the Board of Directors. If I was a large shareholder, I would certainly demand that the package be reviewed.

There has always been an "unnatural" union of government and big pharma, because in spite of the huge R&D costs, a government patent and FDA approval on a new drug to treat common ailments is a license to print money. To me the worst offenders in the patent lottery are the "me too" companies that make small inconsequential changes to a proprietary drug, get their own patent and FDA approval, and then start their own money printing press. These companies are quite willing to "invest" in lawmakers who might favor their products.

I really think that the drug patent process and protections need to be reviewed, because the government is granting a huge monopoly for many years.
With this kind of activity, the door is wide open for politicians to swoop in on the masses and create a windstorm of protest. Without proper research, some may fall for the notion that we need gov't healthcare and a single payer system. Hmmmmmmm, could that be a subtle plot behind this whole industry? Who knows.......I know we are benefiting from either side.
 
lotstodo said:
There are a few CEO's with what most would call usury compensation packages. However, this is the exclusive purview of the Board of Directors. If I was a large shareholder, I would certainly demand that the package be reviewed.

There has always been an "unnatural" union of government and big pharma, because in spite of the huge R&D costs, a government patent and FDA approval on a new drug to treat common ailments is a license to print money. To me the worst offenders in the patent lottery are the "me too" companies that make small inconsequential changes to a proprietary drug, get their own patent and FDA approval, and then start their own money printing press. These companies are quite willing to "invest" in lawmakers who might favor their products.

I really think that the drug patent process and protections need to be reviewed, because the government is granting a huge monopoly for many years.
This is a part of what the Chief's Law Firm does, drug patents. I don't know this company. I'll have to ask her.
 
lotstodo said:
There are a few CEO's with what most would call usury compensation packages. However, this is the exclusive purview of the Board of Directors. If I was a large shareholder, I would certainly demand that the package be reviewed.

There has always been an "unnatural" union of government and big pharma, because in spite of the huge R&D costs, a government patent and FDA approval on a new drug to treat common ailments is a license to print money. To me the worst offenders in the patent lottery are the "me too" companies that make small inconsequential changes to a proprietary drug, get their own patent and FDA approval, and then start their own money printing press. These companies are quite willing to "invest" in lawmakers who might favor their products.

I really think that the drug patent process and protections need to be reviewed, because the government is granting a huge monopoly for many years.
The Chief's response:
The small inconsequntial changes to a proprietary drug would not be patentable subject matter because it would be obvious and not novel. To get a new patent on a known drug would require unexpected results which would not be inconsequntial. Any "me too" company that comes up with a nonobvious new use or new component of a known drug deserves a patent.
 
Callahan said:
lotstodo said:
There are a few CEO's with what most would call usury compensation packages. However, this is the exclusive purview of the Board of Directors. If I was a large shareholder, I would certainly demand that the package be reviewed.

There has always been an "unnatural" union of government and big pharma, because in spite of the huge R&D costs, a government patent and FDA approval on a new drug to treat common ailments is a license to print money. To me the worst offenders in the patent lottery are the "me too" companies that make small inconsequential changes to a proprietary drug, get their own patent and FDA approval, and then start their own money printing press. These companies are quite willing to "invest" in lawmakers who might favor their products.

I really think that the drug patent process and protections need to be reviewed, because the government is granting a huge monopoly for many years.
The Chief's response:
The small inconsequntial changes to a proprietary drug would not be patentable subject matter because it would be obvious and not novel. To get a new patent on a known drug would require unexpected results which would not be inconsequntial. Any "me too" company that comes up with a nonobvious new use or new component of a known drug deserves a patent.

I am speaking of the copycat companies that followed market leaders like Lipator. While there are certainly slight chemical differences between Lipitor and the other Statins, there is no clear evidence of any health difference between them. They may be chemically different, but study after study says that they are functionally exactly the same not only in class but in function. Yet they all have a patent, FDA approval, and they all print money. To me, at least morally, the Johnny Come Lately does not deserve the same protection as the originator of the Statin Drug does, because the originator invested far more in R&D and have a far larger investment to recover before the drug becomes public domain.

Case in point. A while back myself and our company invested 2 years and over $3 million in the development of a gravity flow beverage display rack (I know right, who would have thought). We had a patent and produced them exclusively for 2 years, selling to all the big beverage companies. Our competitor, reverse engineered our mechanism, made very minor changes to the material, and got their own patent. Both units worked exactly alike. We invested millions, they invested maybe a couple of a hundred thousand. They would never have come up with the idea on their own, an idea I might add that is still in every grocery store in America after nearly 40 years. But they soon had almost half the market.

I'm not a lawyer, but they told us that the other company deserved their own patent. I think that "deserved" is a highly subjective word when seen from my perspective.
 
I, too, am not an attorney, but I am a Patent Agent, registered to practice before the U.S. Patent Office. What you have described as your situation appears to be an infringement under the doctrine of equivalents, and I am truly surprised that your competitor was able to obtain a patent. For your enlightenment, the following citations relate to the doctrine of equivalents under U.S. patent law.

A product that does not literally infringe a patent claim may still infringe under the doctrine of equivalents. Warner-Jenkinson Co. v. Hilton Davis Chem. Co., 520 U.S. 17, 41 U.S.P.Q. 2d 1865 (1997). The touchstone under the doctrine of equivalents is whether the differences between the accused product and the claimed invention are insubstantial. When the differences are other than insubstantial, infringement should not be found. Digital Biometrics, Inc. v. Identix, Inc., et al., 149 F.3d 1335, 1349, 47 U.S.P.Q. 2d 1418, 1428 (Fed. Cir. 1998). In making a determination under the doctrine of equivalents, the court may consider whether the accused product performs substantially the same function, in substantially the same way, to obtain substantially the same result as the claimed invention. Dawn Equip. Co. v. Kentucky Farms Inc., 140 F.3d 1009, 1016, 46 U.S.P.Q. 2d 1109, 1113 (Fed. Cir. 1998).

The Inspector speaks highly of you and I thought you would find the case law of interest. -- The Chief
 
Callahan said:
I, too, am not an attorney, but I am a Patent Agent, registered to practice before the U.S. Patent Office. What you have described as your situation appears to be an infringement under the doctrine of equivalents, and I am truly surprised that your competitor was able to obtain a patent. For your enlightenment, the following citations relate to the doctrine of equivalents under U.S. patent law.

A product that does not literally infringe a patent claim may still infringe under the doctrine of equivalents. Warner-Jenkinson Co. v. Hilton Davis Chem. Co., 520 U.S. 17, 41 U.S.P.Q. 2d 1865 (1997). The touchstone under the doctrine of equivalents is whether the differences between the accused product and the claimed invention are insubstantial. When the differences are other than insubstantial, infringement should not be found. Digital Biometrics, Inc. v. Identix, Inc., et al., 149 F.3d 1335, 1349, 47 U.S.P.Q. 2d 1418, 1428 (Fed. Cir. 1998). In making a determination under the doctrine of equivalents, the court may consider whether the accused product performs substantially the same function, in substantially the same way, to obtain substantially the same result as the claimed invention. Dawn Equip. Co. v. Kentucky Farms Inc., 140 F.3d 1009, 1016, 46 U.S.P.Q. 2d 1109, 1113 (Fed. Cir. 1998).

The Inspector speaks highly of you and I thought you would find the case law of interest. -- The Chief

Thanks. I appreciate the info. I didn't know anything about the case law involved, and this was back in the seventies, but I don't know that would make any difference. I think that the problem, at least to me in lay terms, is the legal definition of "insubstantial", or how it is sometimes decided by the courts, versus what the everyday person would recognize as such. Sometimes I'm completely stymied by the apparent similarities between patented products. There is no doubt that Lipitor and Crestor (just using as an example) are synthetic statins of slightly different chemical makeup. But there is also no doubt that Crestor built upon the work done by Parke Davis. There is also no doubt that they perform substantially the same function in substantially the same way to achieve exactly the same result, but yet they both have patents. Is it fair that the government should grant the exact same monopoly to AstraZeneca as they did to Parke Davis? That's what I mean by "me too" patents.

The same applied to our product. Their defense, as I understand it, was that the change from PE to a nylon compound increased impact resistance and lifespan. We said t hat was a specious claim, because the lifespan of our product exceeded the lifespan of the entire display, and the part was never exposed to impact sufficient enough to cause failure. In the over two years of use, we had to replace only a handful of those parts, and those were most likely due to assembly defects. Therefore, the change in material was of no value to the customer from either a durability or lifespan standpoint. In fact, it increased the overall cost of the part, making it actually inferior to our part. We noted that changing the part to Teflon coated titanium would also do the same, but like their change, was of no functional value and would raise the cost of the part.

They provided testing that proved that their part was indeed more impact resistant and longer lasting than ours, a claim we never disputed, and on the basis of that they got a patent.

What gripes me the most, is that they would have never even come up with the idea of a gravity fed beverage rack that allowed complete stocking of even the overhead with product always at the front of the shelf. That was the real uniqueness of the product, not the plastic slide.

I am named on five patents, and only two of them were not copied by a competitor before the patent expired. I guess that means that two of the five were pretty much useless. :D

Again thanks for the info Chief. I don't envy what you guys have to go through. I'd much rather think up the goofy stuff and let others deal with the headaches .
 
I can see your argument; however, if you view the chemical structure of both drugs, they are substantially different. (Please Google "Crestor compound structure" and "Lipitor compound structure" to view the PubChem Chemical Database). While Crestor and Lipitor are both statin drugs, Lipitor is an atorvastatin calcium hydrate and Crestor is a rosuvastatin calcium. The two drugs have totally different chemical compounds. As such, each compound is novel and nonobvious due to their chemical structure.

You mentioned "... there is also no doubt that Crestor built upon the work done by Parke Davis." It appears that the makers of Crestor recognized that targeting the hydroxymethylglutaryl coenzyme A (HMG-CoA) reductase inhibitor reduces cholesterol levels, and they were able to make a new compound having a substantially different chemical structure that also targets the hydroxymethylglutaryl coenzyme A (HMG-CoA) reductase inhibitor.

Believe it or not, these chemical differences in compounds are very substantial in the pharmaceutical arena. And it takes many years and millions of dollars to select a specific compound and bring it through FDA approval and to the market. Clinicians need to have choices of drugs, because some patients can tolerate one drug, but not another having the same functionality. -- The Chief
 
It's like I always say, It's a sorry man that won't find his wife a job. I already feel a nap coming on for tomorrow afternoon.
 
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