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« Software Sector Leads First Quarter Venture Funding to Thirteen Year High; Biotech Sector Finishes Second (Again) | Main | Rep. Anna Eshoo to Address Congressional Battle for Biotech on BioCentury This Week »

May 01, 2014

Comments

I remember when Erwin Chermerinsky taught the con law part of the BARBRI course, he did not attempt to synthesize various (contradictory) doctrines. He just said, "This is what the court said in this case", and limited himself to the facts of each case (knowing that the bar exam itself would be so limited). It's not just too bad the USPTO hasn't taken a similar approach in applying the Myriad decision; it's amazing that the PTO is as out of touch with reality as is SCOTUS.

Kevin,

Sherry's analysis is spot on. Our Judicial Mount Olympus simply ignores the language of the patent statutes when it doesn't suit their anti-patent purposes, Breyer being a prime example of that problem. Now the USPTO has picked up on this dysfunctional approach by Our Judicial Mount Olympus to be a license to promulgate these inane Guidelines. And people wonder why the patent bar is so unhappy with Our Judicial Mount Olympus?

What about a judicial challenge of the Guidelines based on a procedural due process violation? The PTO did not follow proper rulemaking procedures under the Administrative Procedures Act for these Guidelines, which have resulted in a loss of property.

@Nate:
My understanding is that because the Guidelines are just that - guidelines for the examining corps and not regulations of the kind that appear in Chapter 37 CFR - no rulemaking procedure is required. They're like the MPEP, and do not have the force of law. The problem for patent applicants is that the examining corps will follow the guidelines unless and until case law makes it clear that they are wrong, and that is a lengthy and expensive process through which many applicants will have to suffer. Best hope in the short run is that the uproar from interested groups will cause the PTO to revise the guidelines.

I agree with Ms. Knowles' broad thesis (Congress should step in to reverse some of the Supreme Court's recent 101 jurisprudence), but her essay was a terrible piece of writing.

The essay is supposed to be about 101, but nearly a third was given over to a digression about how badly the courts used to mess up "inventive step" jurisprudence before Congress added 103 to title 35. What is this supposed to prove? That the courts can get things wrong? Such a thesis hardly deserves this sort of extensive treatment, especially when the subject matter is so orthogonal to the broader point.

I am also not clear as to what I should make of the claim that "[t]he US is losing its position as the global leader in biotechnology." What does that have to do with 35 USC 101? Does Ms. Knowles imagine that US researchers are motivated by US patent law, while foreigners are motivated by their respective laws? Surely not. Korean biotech firms are hoping to sell their inventions in the US at least as much as they are hoping to sell them in Korea.

If the US courts restrict the scope of patent protection biotech companies can get in the US, this will not discourage biotech researcher from working in the US. Rather, it will discourage investors from investing in biotech, both in the US and abroad. This is bad, but it will not affect the US any more particularly than anywhere else.

GrzeszDeL,

Your thinking that the essay was poorly written based on your comment of "What is this supposed to prove?" only proves that you lack the appreciation of what 101 covers.

The 1952 Act has direct and meaningful implications to what 101 covers PRECISELY because Congress acted to add 103.

That you lack this understanding does not at all mean the two are "orthogonal." It merely means that you do not understand the importance of the point.

Does Ms. Knowles believe that facts about biological correlations can be protected with patents, as Prometheus attempted to do?

Apparently so.

There's no reason to take her fearmongering about the end of biotech any more seriously than the NRA's fearmongering that the "government is going to come take away all your guns." She's an industry shill.

Skeptical: "The 1952 Act has direct and meaningful implications to what 101 covers PRECISELY because Congress acted to add 103."

Did Congress intend to make products of nature eligible for patenting?

Skeptical,

I fear that TBP (aka "Malcolm Mooney," "MM," etc.) is on the loose again. Guilty until proven otherwise.

Get well soon PatentDocs from your apparent latest infestation of Malcolm Mooney and his merry band of sockpuppets.

When I see a new name trot out the notion that someone is trying to patent information itself, well, that alone makes me skeptical.

But when that person comes out and starts calling others the names that would easily fit that person, I become more than...

I think what Dr. Knowles was doing was pretty clear. First, she was pointing out that the concept of "inventiveness," as a requirement for patentability, was and has been accepted to be what we consider obviousness today. Dr. Knowles didn't reinsert this concept into the Section 101 context, Justice Breyer did in his Mayo decision. In pointing this out, the piece also points out another example of the Court ignoring what Congress has mandated in view of its own plenary review of patent law - something it does nowhere else (remember, the Chief Justice voted in favor of the healthcare act last term on the grounds that while the Court may not think much of an Act of Congress, it could only override that decision if Congress had overstepped its Constitutional grounds). More on that later.

As for the science, the argument is persuasive that the PTO Guidelines make patent ineligible "products of nature" far in excess of what is required by the Court's Myriad decision. This became even more evident at a BIO meeting last week, where a PTO representative would not concede the patent eligibility of a novel anticancer drug isolated from a natural source, formulated with a naturally occurring substance like starch, as a pharmaceutical formulation. Far from being alarmist, Dr. Knowles is accurately illustrating the consequences that will certainly arise from the PTO's current position.

One more thing. As noted above, even the Court recognizes the limits of its own authority, and even in the patent area Congress had overruled Court decisions - Roche v. Bolar and Deepsouth Packing come to mind. The issue here is what is the consequence when the Court, not Congress, acts in ways that do not "promote the progress" of the useful arts by, as here, ruling in ways that justify the type of categorical exclusion of patent eligibility reflected in the PTO Guidelines?

As for MM etc., he is welcome on this site, provided he (nor anyone else) descends to the level of "Jane, you ignorant slut!"

A reader having trouble connecting writes:

"I heartily endorse Sherry Knowles’ comments, but I have a question for her and the PatentDocs readers: do you think it is possible that the USPTO has created these radical and onerous Examination Guidelines with the ultimate BENEFIT of patentees in mind, because they utterly disagree with both Mayo and Myriad? Keep in mind the way the PTO administration was dissed by the DoJ on the SCOTUS amicus briefings (a forced “joint” brief in Mayo; DoJ only in Myriad, with the execrable “magic microscope” theory and other policy nonsense), and how apologetic the administration and examining corps seem to be in promulgating the Guidelines.

Is it possible that by extending in these Guidelines the radical change in the law regarding patent-eligibility created by Mayo and Myriad to the broadest (un)reasonable interpretation, the USPTO is providing the framework and extreme motivation for the patent bar, BIO, AIPLA, PhRMA and other stakeholders to go to Congress to get this unwarranted judicially-created disaster fixed, for once and for all? Is this the motivation to amend 100(a), 100(b) and/or 101 to make it clear what subject matter IS patentable, including isolated natural products, natural laws plus ANY application, any method that includes a machine or transformation, etc.? Because it is clear we cannot rely on the courts to fix this – history shows that SCOTUS will only make it worse the next time they get their hands on a case with patent-eligibility issues.

In other words, rather than pursuing a policy of Chamberlain-eseque appeasement, trying to get the USPTO to back off here and there on particularly egregious results of the Guidelines, but losing on the primary issue of expanding the scope of exclusion from patent-eligibility, perhaps the patent bar, BIO, AIPLA, PhRMA and other stakeholders should USE these Guidelines to march on Congress and DEMAND amendments to the statutes to prevent this. Whether or not that was the USPTO’s actual intent, this may be the ONLY way to stem the tide of anti-patent judicial legislation, and to avoid being nibbled to death by ducks – increasingly anti-patent SCOTUS decisions that undermine settled expectations of the industry and especially the investors in biotechnology and pharmaceutical companies."

I wish I shared our reader's optimism on the PTO's political sophistication or the prospect of Congress getting this right (much more likely in my view that Section 101 would become a forest of special interest "thou shalt nots") but these views deserve to be heard and so we repost them here.

Calling someone an industry shill (without backing that call up with any analysis of the legal points put forth) seems an awful lot like:

"Jane, you are a female who has many casual sexual partners, lacking knowledge or awareness in general."

But with far less panache.

As to "optimism on the PTO's political sophistication or the prospect of Congress getting this right,"

I too remain...

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