Gene Patent/Drug Pricing Concerns and Unintended Consequences Dominate Second Senate Hearing on 101

“Hans Sauer of BIO said that it is easy to argue—after the heavy lifting of discovery and development has been done and a product has made it to market—that it should not be patented in the public interest. ‘As if innovative products fell from the sky and ought to go directly into the public domain…. It is right to encourage complaints about problems, but we must do so with an appreciation of the system’s longer-term benefits for society.’”

Wednesday’s Senate hearing on patent eligibility reform, which began more than 30 minutes late due to votes on the floor, opened with Senator Thom Tillis (R-NC) reiterating that his goal in holding three hearings on this topic and receiving testimony from 45 witnesses, which is not common, is to address the concerns on all sides of the debate. Tillis noted that he and Coons had specifically invited many of the high-tech companies that do not appear on any of the rosters for the three hearings, but they chose not to participate and instead to be represented by David Jones, Executive Director of the High Tech Inventors Alliance (HTIA), who spoke today. While Tillis said, “that’s ok,” he noted that “silence is consent. What we want here is people working out of the shadows, collaboratively.” HTIA’s members include Amazon, Google, Adobe, Intel, Cisco, Oracle, Dell, and Salesforce.

Many of today’s panelists raised more substantive issues with the proposed section 100(k) and 112(f) than did yesterday’s speakers. Section 100(k)defines the term “useful” in the new section 101 and section 100(f) would eliminate functional claiming. Barbara Fiacco, representing AIPLA; Henry Hadad of Bristol-Myers Squibb and the Intellectual Property Owners Association (IPO) President; Paul Morinville of U.S. Inventor; and Phil Johnson, representing the Coalition for 21st Century Patent Reform, all raised various concerns about one or both of these sections. Notably, Hadad said that IPO has not yet taken an official position on the draft, although it meshes with its own 101 proposal, and Fiacco said that AIPLA feels 112(f) and 100(k) are areas for “further consideration.”

In addition to Senator Chris Coons (D-DE) and Tillis, Mazie Hirono (D-HI) and Richard Blumenthal (D-CT) asked several questions of the panelists today.


112(f): An Impossible Task

Paul Morinville

Morinville was the most vocal about the potential dangers of 112(f) and 100(k) for individual inventors. In his opening statement, Morinville noted that he may be the only patented inventor represented in all of the hearings—while William Jenks of the Internet Association and Jeffrey Birchak both later indicated  that they were also patented inventors, Morinville is believed to be the only sole inventor who has testified before Congress in more than a decade, as Josh Malone pointed out on LinkedIn recently.

Morinville voiced his concerns that 100(k) would “create long term confusion” regarding the meaning of the language, “field of technology” and “human intervention,” and that 112(f) would force inventors to describe every single structure in a given invention, which “will prove disastrous to tech patents.”

He explained:

“We use the language of our industry to define our inventions to someone in our industry—not to lawyers intent on word gaming; this requires using functional terms, like “fastener” “amplifier” or “memory.” There are 571 coding languages, each with multiple ways of doing the same thing. [Under the proposed 112(f)], an inventor must list every imaginable way in order to avoid legal gamesmanship. It’s an impossible task.”

Back to Basics

Hans Sauer

Hans Sauer of the Biotechnology Innovation Organization (BIO) pointed to the example of the Federal Circuit denying Roslin Institute of the University of Edinburgh a U.S. patent on a live cloned sheep on 101 grounds. “However you may feel about clones and patents, most people would agree that clones are just about the most unnaturally occurring thing under the sun,” Sauer said. He also noted that, in another case, a patented automotive drive shaft was struck down as an abstract idea “even though one can literally drop it on one’s foot.”

Both Sauer and Johnson attempted to dispel some of the more basic misconceptions currently muddying the waters in the eligibility debate. Sauer emphasized in his opening statement, and again later, that it is easy to argue—after the heavy lifting of discovery and development has been done and a product has made it to market—that it should not be patented in the public interest.  “Yet this is what many arguments against section 101 reform boil down to, as if innovative products fell from the sky and ought to go directly into the public domain,” Sauer said. “Such facile arguments ignore that the patent system encourages risk taking and long-term investment in the biggest problems facing this nation and generations to come. It is right to encourage complaints about problems, but we must do so with an appreciation of the system’s longer-term benefits for society.”

Phil Johnson

Johnson wrapped up his opening statement with a reminder to the subcommittee that the draft bill as proposed would not, “in contrast to the assertions of the ACLU and others” allow laws of nature, abstract ideas or human genes to be patented. “These would remain ineligible because they are not inventions or discoveries, did not result from human intervention and do not have a specific and practical utility in any field of technology,” Johnson said, adding that “life sciences inventions in the diagnostics area should qualify as patent eligible because they are the result of human intervention and have a specific and practical utility in the field of medicine.” Johnson also implored the subcommittee to remember that “just because something is patent eligible, doesn’t mean it is patentable”—a basic but still widely misunderstood concept.

Myriad Problems

The third panel of the day was balanced between Sauer; Natalie Derzko, Of Counsel at Covington & Burling, on behalf of the Pharmaceutical Research and Manufacturers of America (PhRMA); Rick Brandon, Associate General Counsel, The University of Michigan, on behalf of the Associations of American Universities and Council on Government Relations; and representatives of the Association for Accessible Medicines (AAM) and the American Civil Liberties Union (ACLU). The ACLU on Monday organized an urgent phone briefing for Congress and Staff to address its contention that the proposed language of the draft bill would “allow corporations to patent genes,” as one speaker asserted during the call. The ACLU was also quoted in an article published in The Washington Post on Monday in which Sandra Park, ACLU Senior Staff Attorney, said that the proposed legislation would “allow patents on basic things in nature.”

Kate Ruane

The ACLU’s main concern remains that genes would be patentable, despite much pushback from panelists and repeated assurances from Tillis and Coons that they have no such intentions. Kate Ruane, Senior Legislative Counsel for the ACLU, recounted the Myriad case and explained that “the same day the Supreme Court issued its decision in Myriad, five laboratories announced they would provide BRCA testing to patients, significantly reducing cost and providing more comprehensive testing.” Ruane maintained after being pressed by Coons that she believes the language of the current draft would allow for the patenting of genes with new utility, despite the human genome being mapped and known. Sauer dismissed this notion, saying that human genes were never patentable, although preparations of DNA molecules might be patentable, but “very unlikely human ones because those are well known, and there’s a mountain of readily searchable prior art that would be a huge obstacle to any form of patenting.”

Senator Blumenthal actively questioned this panel about his greatest concern, which is abuses of patents in the pharmaceutical industry. Blumenthal is co-sponsoring a bipartisan bill to curb the practice of “patent thicketing” and wanted to ensure that the draft bill would not encourage such abuses or raise drug prices. Jeff Francer, General Counsel of AAM, said that the bill, by expanding eligibility, “would take us backwards.” He pointed to an example of a drug with a contraindication in which the manufacturer patented the manner of diagnosing the contraindication, thereby forcing competitors to wait for the second patent to expire in order to market the drug. While the District of Delaware rejected the patent in question under the current law, Francer said he is concerned the expansion of eligibility law will make the problem worse. Derzko attempted to refocus the conversation, but Blumenthal seemed concerned when she would not agree with him outright that patent thicketing is a problem.

Richard Blumenthal

Fittingly, Blumenthal ended by saying that “this conversation has been conducted at a very high level of abstraction,” and that most average Americans would “have no idea what we’re talking about here today.”

“To the extent there is a disconnect between this conversation and the challenges faced by ordinary Americans, we need help doing our job. How to responsibly stop those abuses without stopping innovation—because we’re all in favor of innovation, but we’re also mindful of the affordability and access to those medicines, which is increasingly difficult.”

Blumenthal asked anyone with a position on patent thicketing, the effects of the 101 reforms on the practice, and real-world examples for consumers, to submit statements for the record.

Here’s the breakdown of who argued for and against the proposed reforms. Full written testimonies are now available here.


American Intellectual Property Law Association (AIPLA)
American Bar Association (ABA)
Intellectual Property Owners Association (IPO)
Paul Morinville/U.S. Inventor: (AGAINST 100(k) and 112(f))
Coalition for 21st Century Patent Reform
Innovation Alliance
Biotechnology Innovation Organization (BIO)
Pharmaceutical Research and Manufacturers of America (PhRMA)
Associations of American Universities and Council on Government Relations


High Tech Inventors Alliance
United for Patent Reform
Internet Association
Software and Information Industry Association
Association for Accessible Medicines
American Civil Liberties Union




Warning & Disclaimer: The pages, articles and comments on do not constitute legal advice, nor do they create any attorney-client relationship. The articles published express the personal opinion and views of the author as of the time of publication and should not be attributed to the author’s employer, clients or the sponsors of

Join the Discussion

29 comments so far.

  • [Avatar for Eileen McDermott]
    Eileen McDermott
    June 12, 2019 10:14 am

    Hi Mike – I was focusing only on this hearing with that list. Sherry participated in the first hearing.

  • [Avatar for Anon]
    June 10, 2019 02:37 pm

    When I said all, I truly meant all, and yes, generics would not get a pass.

    If you read the rest of my position, you would need not ask these questions.

  • [Avatar for xtian]
    June 10, 2019 01:04 pm

    Anon @21

    Are you advocating that API (active pharmaceutical ingredient) manufactures post their prices?
    Are you advocating that the fill-finishers (tableting and packing into bottles or blister packs) post their prices to Pharma?
    Are you advocating that Pharma’s post their prices to pharmacy benefit managers (the middlemen like Cardinal Healths and McKessions)?
    Are you advocating that pharmacy benefit managers post their prices to the insurance companies?
    Are you advocating that the insurance companies co/pay prices for each plan they underwrite to their consumers?

    True transparency would require “all” prices.

    Also, I assume you would also want prices for generic drugs as well. Wouldn’t you?

  • [Avatar for Anon]
    June 10, 2019 08:41 am

    Night Writer,

    Your axiom writing on that other blog is running into some severe constraints on open dialogue.

    Not only has a “Count Filter” been active, but posts on new threads (with no apparent “Count” being tripped” and “bad words” having been scrubbed STILL is having posts blocked.

    For example, your post 3 at

    is having the following reply disallowed:

    That is objectively absurd. It would mean that a patent application would have to be thousands of pages long. Now we can see the intellectual dish0nesty as they won’t admit this and spout n0nsense to confuse the ignorant.

    You are just being l @ z y (per Greg) and “proper” innovation protection policy SHOULD be in place to punish all such l @ z y people and provide EASY paths that would otherwise infringe to escape that “fate” and NOT be held to be infringing.

    Of what harm could it possibly be to force EVERY application to be hundreds or even thousands of pages long?

    Heck, let’s double down on this and make “software” claims to avoid all “easy” (since that too is nothing but l @ z I ness) use of terms sounding in function, and require total “objective physical structure” claims.

    I can see it now: an easy to understand (and certainly understood claim by that legal fiction known as a Person Having Ordinary Skill In The Art can be converted to tens or more likely hundreds of pages of “objective physical structure” of a computer readable medium described in its “programmed” state) the state of having been changed and having been configured).

    Who would complain in examining patent documents that run a few thousand pages with claims that are incomprehensible to a normal human being? Who would complain with enforcement of such?

    Certainly not those who are @nti-patent (noting that being @nti-software patent IS being @nti-patent), right?

  • [Avatar for Anon]
    June 10, 2019 08:36 am

    said that the form of the machine to perform the function in a method for processing grain did not matter

    NOT to disagree with you, Night Writer, but does not the phrasing in your last sentence remind you of anything?

    If the “objective physical structure” does not matter, then are you not merely “claiming a result?” Are you not merely “claiming an idea of itself?”

    I ask this knowing full well that the canard of “objective physical structure” runs as the baseline of those that simply despise a form of innovation that MOST EASILY is discussed in terms of action or function.

    One of the critical reasons WHY 35 USC 101 is meant as a low bar and welcoming gate is that the form of innovation cannot be known a priori, and to limit eligibility to static or “known forms” is counter to the nature of innovation itself.

  • [Avatar for Night Writer]
    Night Writer
    June 10, 2019 06:48 am

    Axiom : If the claim scope does not include every embodiments that is enabled by the spec and what is known by anyone skilled in the relevant art, then it is trivial to perform the function and not infringe. (The intellectual dishonest comes in not addressing this issue.) Merely select one of the embodiments of the invention that is enabled but not covered within the scope of the claim.

    (Note that in Deener the Scotus addressed this issue and said that the form of the machine to perform the function in a method for processing grain did not matter.)

  • [Avatar for mike]
    June 9, 2019 12:15 am

    Eileen, the FOR list above forgot to include Sherry Knowles. Also, like Paul Morinville, her testimony includes that she doesn’t agree with the current 112 proposal.

  • [Avatar for Night Writer]
    Night Writer
    June 8, 2019 05:29 pm

    The invention is the set of all the solutions that perform the function that are enabled by the specification and what is know by any one in the art.

    Scope of enablement is the proper test and there is nothing wrong with functional language and there is no such things as purely functional language when considered within the context of the specification and what is known by anyone skilled in the art.

  • [Avatar for Anon]
    June 7, 2019 01:36 pm

    1. The problem is the system as a whole, and how a lack of information (information asymmetry) promotes gaming behavior by multiple (and multiply complicit) parties.

    2. See 1. above.

    3. The remedy is as I have posted. Full transperancy, It remains odd how YOU attach the label of “coercion” many times to what is effectively merely requiring clarity. This requirement is by no means “coercion,” and clarity being required by the government exists at MANY levels and aspects of the government (a quick example is taxes).

    4. GIVEN that NO such justification is needed (as there is NO coercion), GIVEN that your use of “free country” is yet another emotive trigger word, and GIVEN that the plain fact of the matter is that the required transparency would – in and of itself – remove shadows where games are now being played, I would turn this to you and ask what possible “principle justifying” can support your opposition to this easy remedy.

  • [Avatar for Anon2]
    June 7, 2019 08:52 am


    I haven’t seen all of your posts, but from what I have read (for now specifically putting aside the white house’s edict re. advertising) you advocate enforced “transparency”, and you have alluded to much in the system which you find objectionable and requires a remedy.

    First, I am unsure exactly “what” you find objectionable consists in. The posts I read allude to something corrupt but do not identify with specificity what that corruption is. What concrete acts it consists in and why those acts constitute a violation requiring government coercion to redress. Knowing what the actions are is required to asses whether they are actions of a nature properly necessitating intervention via state coercion.

    Second, I am not entirely sure of who all the actors are and am left with the impression that the alleged corruption is not isolated to any one player in the industry.. it is not clear to me from your posts that Pharma are primarily responsible rather than any of the other cogs in the machine: doctors, medical associations, the insurance industry, government, the FDA, government regulations regarding “redistribution” (what a white wash weasel word) of wealth the medical professions, hospitals, drugs, insurance and employment. To be sure you lay most of the responsibility at their feet, but without actions, it is hard to isolate actors.

    Third, I am not entirely certain what you propose is the proper remedy to be enforced by government, or what actions the government should take to solve the problem and why it would work. Specifically what would constitute proper intervention, and only proper intervention, in a free country. “Transparency” is a vague term, it would have vastly different meanings to the Founding Fathers than it would to Stalin… many modern interpretation lie in the “vast middle ground”.

    Fourth, I cannot glean from what you have stated, upon what specific principles your remedy could be justified in a free country. You are someone who presents yourself as a classical liberal, espousing intellectual honesty, rationality, freedom, free markets, self-responsibility, and cautioning about the ends not justifying the means, and I think that if you are that person, and if you also support the white house edict, and say the things you do publicly regarding “transparency”, then you must have thought about the issues with great clarity and earnestness, and that all you say must have been justified in your mind on principle rather than from emotion, whim, or sentiment. I seek this justifying principle.

    So, I’ve seen some of what you’ve said, but I would like more specificity of the

    1 “what acts constitute the problem”,
    2 “who is responsible for commission of those acts”,
    3 “what is your remedy” and
    4 what is “the principle justifying” that remedy in a free country.

  • [Avatar for Jeffrey Birchak]
    Jeffrey Birchak
    June 7, 2019 12:33 am

    Thanks all for engaging in this discussion; this crucial policy must encourage and indeed require engaged discussion by all stakeholders, and not just aggregated mouthpieces, as noted above. It was also nice of Senator Tillis to note this as well, with his comments about HTIA again representing all these companies rather than their companies being there.

    It was also nice for the Big-tech surrogates to finally drop all pretenses this week about getting 101 eligibility correct, when during testimony on both days, it was made clear that what they want is to keep a fast-track solution for dealing with potential infringement claims through pre-trial motions. They like 101 because it results in cheap and easy decisions at the outset, with no expert testimony about the science/tech of the claimed invention. However, these decisions put expediency ahead of accuracy, and the process of Alice/Mayo has fostered a bastardized form of litigation practice where a judge decides what is and is not “abstract” or simply a “law of nature” without expert testimony and vetting of evidence. Pro-tip here, every invention ever created by necessity utilizes laws of nature and therefore is at risk of a Mayo outcome.

    @Tom Arno, Thanks for deftly identifying the two different issues at play. A policy issue that is being punted and a chemistry issue which should not be difficult, but is because the policy issue is being punted on.

    Let us remember the CAFC in Myriad gave SCOTUS every opportunity to parse this decision by repeating legitimate chemistry arguments, and instead SCOTUS did what they are best at, that is using their sense of policy ends to justify whatever holding they want. In this case, the Thomas opinion strains scientific credibility about chemical similarities of a sythesized compound with bond structures that differ from the naturally occurring form. So many times the Court uses the ends to justify the means, and the entire patent system endures waves of uncertainty resulting in horribly unfair results for some undeserving folks and undue windfalls for others. We can and should tackle the policy regarding gene sequences, but not by arguing that chemical differences simply don’t exist where they truly do.

    Finally, I would like to take this opportunity to thank Senators Tillis and Coons for running a fair and collaborative process where input has been taken from many differently situated stake-holders in developing the language proposed so far, and look forward to improving it further to provide much needed clarity to this area of the law. It is a breadth of fresh air for such policy in the area of patent laws.

  • [Avatar for Anon]
    June 6, 2019 06:40 pm


    With zero ad hominem and no emotionalism, your fixation on “coercing prices in advertising” absolutely misses the points I have been making now across several threads.

    Are you not reading what I am actually posting?

  • [Avatar for Anon2]
    June 6, 2019 05:02 pm


    Let’s step back from emotionalism and ad hominem etc. Honestly, with no snark, let’s seek to have a rational conversation.

    Government coercion of advertising is a completely different creature IMHO from ensuring well informed consent prior to executing or even at various points in a transaction.

    Principles of contract and commerce can form the basis for making parties contract with each other in good faith and absent any fraud or as you put it gamesmanship.

    First, doctors legally have a duty of care to their patients, regulation of undue influence in prescribing, suggesting options, and providing (or withholding) of information to clients/patients should be strongly policed by law surrounding those obligations.

    Second, insurance companies and Pharma should be strictly punished if they seek to interfere with the doctor-client/patient relationship and the best care for the patient through any type of influence, kickbacks, bribes, free samples.

    The doctor then stands as the one most informed and the one charged with helping a patient be informed about and in choosing the best product/drugs he or she can afford, either privately or via whatever insurance they currently have or can afford. Doctors should feel free to advise clients to change insurance policies, or brand of drugs in whatever manner is best for the client’s health and within their means.

    Doctors take it upon themselves to stay informed about the options… if information about the options is obscured… like information regarding price to the consumer or to the insurance program, then the doctor can and should in some cases suggest a different drug to the patient, thereby exerting market influence.

    The problem is that the market… i.e. patients through their doctors, in the sprawling healthcare, insurance, highly regulated pharma private-state mixed system, do not act as free market “forces” within the machinations of the system… and each participant is bought or influenced by the others in the complex chain, rather than consumer demand coming from the bottom up as it should.

    To the degree the doctor patient relationship is not upheld strictly and health care is not a free market system, the doctor-patient no longer serves the function of that demand, the doctor becomes an agent or a salesperson of the system, one which she did not create nor have any choice but to participate in… and it is in such a system where artifice is created and patients lose.

    In a free society, a doctor gets more patients and can command better rates from happy patients the better health care she can provide, and that obtains when she prescribes the most effective and cost efficient drugs which are the best for the patient’s care, within the patient’s means.

    Pharma when it engages in advertising (and I do not work for Pharma) informs consumers/patients and doctors of the products they have produced as well as advertises their brand as a producer of such products. The suggestion to “Talk to your doctor about X” is perfectly reasonable for a producer to make to a consumer who relies on a doctor’s advice for choosing which if any product should be taken for their health. Advertising in a television commercial or any other medium is an example of the exercise of commercial freedom of speech. “I HAVE X, if you are interested in buying!” Only a police state would make it illegal to disseminate such messages merely because it did not include a price.

    Transparency as to effects of a drug and what the drug costs should be part of the process by which drugs are evaluated and prescribed by doctors as part of a fair transaction but coercing prices in advertising is an over-reach. Doctors and patients should have access to this information through efficient channels.. in a freer private health care market.

  • [Avatar for B]
    June 6, 2019 04:21 pm

    The “High Tech Inventors Alliance” is a fortune 50 club. Google, Oracle, Intel, Cisco, etc. “United for Patent Reform” and the “Internet Association” represent the same companies. The directors of the “Software and Information Industry Association” are people from the same organizations. Of course they’re against strong patent rights.

    Google et al. got four voices.

    The ACLU are bafoons who think new medicines fall from the sky.

  • [Avatar for Anon]
    June 6, 2019 03:42 pm


    Full transparency is self-defining.

    I do not understand what part of that you do not understand.

    AGAIN – my call for transparency is just that: I am NOT calling for ANY forced pricing techniques. Let us ALL see what is behind the curtain as a first step.

    IF after that first step, people (all people) can come to understand exactly what mechanisms (and machinations) are afoot, THEN we can talk about any SEPARATE topics related to pricing as they may present themselves.

  • [Avatar for Mark Nowotarski]
    Mark Nowotarski
    June 6, 2019 01:48 pm

    The original patent granted after an examination was to Blaise Pascal in 1645 for his tax calculating machine. Under the proposed 101 language, this machine would not be patentable. The improvement was in a method for using gears to calculate taxes and calculating taxes is not a technology.

  • [Avatar for Eileen McDermott]
    Eileen McDermott
    June 6, 2019 01:47 pm

    haha – what’s funnier is that he didn’t say it on purpose.

  • [Avatar for xtian]
    June 6, 2019 01:43 pm


    Is your costs defined by how much it took to make 1 pill today and compare that with how much the company is selling said one pill? What about accountign for R&D costs to get that one pill approved? Would the companies be able to amortize that in their calculation? Wouldn’t true transparency call for disclosing all costs?

  • [Avatar for JTS]
    June 6, 2019 01:22 pm

    Favorite quote: Fittingly, Blumenthal ended by saying that “this conversation has been conducted at a very high level of abstraction,” and that most average Americans would “have no idea what we’re talking about here today.”

    Thanks for that, Ms. McDermott.

  • [Avatar for Tom Arno]
    Tom Arno
    June 6, 2019 01:14 pm

    The problem, especially in the biotech context, can’t be resolved by replacing vague statutory language with different vague statutory language. A few technologies need to be specifically addressed because the policy issues do not overlap. The difference between patenting a gene sequence and patenting a new drug molecule isolated from a plant for example, is that the commercial value of knowing the biological or clinical effects of the gene or mutations of the gene is entirely in that knowledge itself, it has nothing to do with the behavior of the gene sequence as a chemical. The real issue is whether or not the commercial value of this knowledge in the form of diagnostic test services or as the basis of follow-on drug discovery should be potentially monopolized with patents. There isn’t consensus on the answer to that question, but however that might be decided, it is a big problem that the conventional drug discovery process of isolating chemicals from biological tissue sources is wrapped up in the answer because you are trying to make a decision about patenting genetic knowledge based on reasoning from chemistry about when is a claimed chemical structure the same as or different from its natural state. The disagreement between the Federal Circuit and the Supreme Court about whether or not isolating DNA makes it different from a natural product or not has no relationship whatsoever with the social policy questions surrounding the patenting of gene sequences. The uncertainty, arguments, creative claim and spec drafting techniques, and the like won’t go away until a decision is made on the real policy question and that decision is codified in the statute. Unfortunately, this legislative process is going the way a lot of it does, where people don’t agree on the answer to the policy question, so each side of the debate tries to push some vague language in one direction or another, and then everyone hopes for the best in the courts. And they also sneak in unrelated but very significant things like the change to 112(f) which I’m surprised people aren’t complaining about more. All functional language in a claim is now interpreted as traditional means plus function? Wow.

  • [Avatar for Anon]
    June 6, 2019 12:21 pm


    Still fighting the simple and straightforward idea, eh?

    There is no principle upon which one could justify forcing Pharma or anyone to disclose “prices” in advertising.

    First, I am NOT talking only about advertising, and second, one can EASILY pass transparence laws. Such would be a business function – why in the world would you think that such could not be done?

    The pricing mechanism transparency is NOT an item that need accompany any advertising, and would be far more encompassing in its transparency.

    Second, ALL of the shell games and the captured entities such as insurance and third party pharmacies would be exposed merely with the transparency. NOTE that I am not saying anything whatsoever about ANY forced pricing or required changes — the transparency ALONE would provide clarity so that EVERYONE could see all the dirty little secrets in the Pharma world. And believe me, even though I am not at liberty to discuss the specifics, I am well aware of the presence of such secrets. If you are not aware of them, maybe you should not be so ardently attempting to deflect what is perhaps the best path forward.

    I do not here conflate advertising with the ultimate process of executing a transaction for consideration.

    Actually, in a different sense than you may realize, that is exactly what you are doing.

  • [Avatar for Pro Say]
    Pro Say
    June 6, 2019 12:02 pm

    Thanks Paul for your tour de force testimony.

    Sayin’ it like it is … like it isn’t … and like it should be.

  • [Avatar for Anon2]
    June 6, 2019 11:24 am


    There is no principle upon which one could justify forcing Pharma or anyone to disclose “prices” in advertising.

    If there were such a principle it would justify forcing MacDonald’s to “disclose” all the prices for everything they sell at their restaurant in every ad they make, the same for Car manufacturers, Lawyers, travel agencies, insurance, in fact, anyone who advertises for anything in any medium.

    I do not here conflate advertising with the ultimate process of executing a transaction for consideration. I take forced disclosure of the price in advertising to be just what it is.

    Can you tell me, what is that principle?

  • [Avatar for Barbara Luther]
    Barbara Luther
    June 6, 2019 10:28 am

    I wonder if BIO used the example of the 80’s when university professors would published without patenting a new drug that showed all signs of being useful in humans. Because big pharma had no exclusivity on it, they did not license of develop it – because of the costs! No patent, no drug to help patients.

  • [Avatar for Night Writer]
    Night Writer
    June 6, 2019 08:35 am

    What needs to be added to the bill is the dissolution of the CAFC. The CAFC is stacked with judges that Obama let SV select. The only path forward is to get rid of these judges.

  • [Avatar for Anon]
    June 6, 2019 08:18 am

    As to the topic of the thread, bandwidth constraints will push actual listening of the proceedings back to this weekend, but I am curious as to if anyone has provided the SIMPLE answer to Senator Blumenthal’s concerns that merely requiring transparency throughout the entire pricing mechanism (which is more than merely ‘the price,’ and includes transparency on profit margins and country to country considerations) would be a HUGE help.

    Such would NOT be “price controls,” but would merely eliminate the information asymmetry and this provide credence to whatever arguments may be advanced to justify WHATEVER prices any Pharma (including generics, and including on and off patent items) sets out.

    Currently, there simply is too much shadow work and gamesmanship and “artificial hikes and discounts” and the rackets of insurance and pharmacy groups are ALL ensnared in the machinations.

    Clarity will liberate!

  • [Avatar for Anon]
    June 6, 2019 08:10 am


    Congrats on distinguishing that patents are not engineering documents.

    (Continued) disdain though for not realizing that patents are legal documents.

    While certainly advantageous to be able to be understood by every common person, you continue to fall into the trap of thinking that legal terms and colloquial terms somehow must be interchangeable.

    That is simply not so.

  • [Avatar for Benny]
    June 6, 2019 05:18 am

    ” patents are written such that one skilled in the art may understand”.
    Err, no. Engineering specifications are written that way, because the reader is a real person with actual skill. A patent delimits what is and what isn’t part of your monopoly, and that is what must be crystal clear to me, Mr Joe Public and to Messers Tom, Dick and Harry Competitor, not how to reproduce your invention – for that there is “real world” documentation.

  • [Avatar for Jeff Hardin]
    Jeff Hardin
    June 5, 2019 11:05 pm

    I am with Paul Morinville. 100(k) has issues. What does “technology” encompass? Also, hardware and software utilities that are not “through human intervention” would be excluded, which causes a problem. For example, software that responds to other software without human intervention would not be patent eligible. I suggest, as has already been suggested in comments here on this blog, moving “through human intervention” to describe the invention or discovery, not the utility or the field of technology. This would allow a programmer or a lab technician to invent or discover (through human intervention) resulting utility (that might not need human intervention, like much software is designed to do – operate autonomously.)

    112(f) amendments crept up from nowhere. Satisfying the requirements of 112(f) would be an impossible task. Using functional language is how those skilled in the art converse, and patents are written such that one skilled in the art may understand. The proposed 112(k) functional language description requirement would require encyclopedias to be included in the description, increase costs for both applicants and the Patent Office, and would shift the focus of the invention away from being the actual invention to being all the possible permutations, which is unreasonable.