Saturday, May 31, 2014

May 31, 2014 – UN No tobacco Day

Copyright © Françoise Herrmann
 
The  campaign theme for the WHO/UN World No Tobacco day is: Raise Taxes!


There is plenty of evidence that this public health strategy works. For example, California Proposition 99 Tobacco tax increase (voted in 1988), and the overwhelming defeat in 2000 of Proposition 28 Repeal of “first five” cigarette taxes, in conjunction with other public health measures was estimated in 2004 to have reduced the burden of the California state healthcare system by 86 billion dollars in reduced incidence of lung cancer and heart disease [Glantz and Balbach, 2000]
 
And for anyone with doubts about government tobacco interventions, The World Bank has also conducted research concerning the myths surrounding tobacco control, and for example, the following myths in particular [World Bank]:
1.  Governments will lose revenues if they increase cigarette taxes, because people will buy fewer cigarettes
Wrong. The evidence is clear: calculations show that even very substantial cigarette tax increases will still reduce consumption and increase tax revenues [..]
2.  Tobacco addiction is so strong that simply raising taxes will not reduce demand; therefore, raising taxes is not justified 
Scores of studies have shown that increased taxes reduce the number of smokers and the number of smoking-related deaths. Price increases induce some smokers to quit and prevent others from becoming regular or persistent smokers. [plus lots more..]
3.  Governments will lose revenues if they increase cigarette taxes, because people will buy fewer cigarettes 
Wrong. The evidence is clear: calculations show that even very substantial cigarette tax increases will still reduce consumption and increase tax revenues [..] 
4.  Smuggling and illicit production will undermine the effects of raised tobacco taxes 
Smuggling is a serious concern. But even in the face of smuggling, the evidence from a number of countries shows that tax increases still increase revenues and reduce cigarette consumption […]
5.  Tobacco control will result in permanent job losses for an economy 
[…] Studies for this report show that most countries would see no net job losses and that a few would see net gains if consumption fell. 
6.  Governments should not discourage smoking other than making its risks widely known. Otherwise, they would interfere with consumers’ freedom of choice 
[…] the choice to smoke may differ from the choice to buy other consumer goods and governments may consider interventions justified. 

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So...after May 31 ,2014...  the future has to be ...  smoke-free planet earth!
 

References
Glantz, S. A. and E. D. Balbach (2000) Tobacco war. Oakland, CA: University of California Press.
The World Bank – Tobacco

Friday, May 30, 2014

Oh, patents! Quitlines

Copyright © Françoise Herrmann

 

Ok, this is it.  Ready or not,  tomorrow is May 31, 2014 UN World No Tobacco Day!

 

Just to complete the tour of patented smoking cessation treatments reviewed in this blog, here are a few quitlines and programs to support your decision to quit, and to help you handle all the psychological aspects of smoking cessation.

  • The NIH - National Cancer Institute's 800-QUIT-NOW (800-784-8669)
  • The American Cancer Society's Quitline at 800-ACS-2345 (800-227-2345)
  • The American Lung Association Lung Helpline offers services in 150 languages, 7/7 from 8 am to 12 pm, 1-800-LUNGUSA or 1800-586-4872
  •  CDC – Centers for disease control - TIPS from former smokers – I am ready to quit now! http://www.cdc.gov/tobacco/campaign/tips/quit-smoking/
  •  smokEnders: addresses the psychological aspects of smoking cessation with “no scare tactics, no pharmaceuticals, no gums no patches, no shock therapy, no herbal concoctions”, at small cost. http://www.smokenders.com/
  • Nicotine Anonymous – A 12-step, one day at a time program mapped onto AA – Alcohol Anonymous http://www.nicotine-anonymous.org/
  • The Five Day Plan (McFarland & Folkenbeg, 1964)  of the Seventh Day Adventists Church. This is the first, and oldest, smoking cessation program in the US. Here is a link to the Online individual 5 day plan, (yes, just 5 days): http://www.starthealthcare.com/index.php/stop-smoking-5-days-plan/

There are no patents associated with Quitlines… but all of these programs and services are purported to greatly augment your chances of success and to provide best results when associated with treatments such NRTs (Nicotine Replacement Therapy) and/or medication, which are very patented, as you may have discovered in previous posts to this blog.
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Good luck in your resolve!
Remember, if at first you don’t succeed, then try again. 
And as President Obama is fond saying: "Yes you can".

 

References
MedinePlusStop smoking support programs
McFarland, W.J. & E.J. Folkenberg (1964) The five day program to help individuals stop smoking: A preliminary report. Conn Med, 1964, Dec. 28:885-90. 
Kerkvliet, J.L and N.L. Fahrenwald (2014) Tobacco quitline outcomes by service. SD Med, 67(1)25-9. 

Thursday, May 29, 2014

Oh, patents! Oral transmucosal NRTs

Copyright © Françoise Herrmann

 

Ok, May 31, 2014  UN World No Smoking Day,  minus 36 hours! Or, what you really want, without the pain of withdrawal…!

Nicotine replacement therapies (NRTs) are recommended by the NIH (National Institutes of Health), the ACS (American Cancer Society) and the ALS (American Lung Association) as first line approaches to smoking cessation. NRTs  include patches, lozenges, sprays and gum. (See a previous post on .. for Transdermal nicotine patches). Research indicates that NRTs in association with counseling double your chances or quitting (Pierce et. al, 2012)

 If your Doctor skipped town, or has already given up on you… then you can always go to Walgreens to pick up some nicotine gum or lozenges, marketed under the brand name Nicorette®, one of the first FDA-approved NRTs.
 
Nicotine gum marketed as Nicorette®  uses a “park and chew” technology. Using the “park and chew” technology, a consumer “bites” on the gum to release nicotine, and then “parks” the gum inside their cheek, and then ”bites” again when more nicotine is needed. This prevents excess nicotine release, and the ensuing undesirable side effects such as dizziness, nausea or stomach problems.

The original (and expired) Nicorette® nicotine replacement patents from the 1970s are US3877468 titled Chewable tobacco substitute composition, disclosing Chewable smoking substitute composition comprises at least about 40 percent by weight of a gum base and a tobacco alkaloid dispersed in said gum base in an amount sufficient to provide smoking satisfaction.; US3901248 titled Chewable smoking substitute composition and US3845217 titled Buffered smoking substitute compositions. More recent Nicorette® patents include the nicotine lozenge patent  US2011110880 titled Nicotine Lozenge compositions, and  a flavoring patent,  US2006275344 titled Flavoring of drug-containing chewing gum.

Incidentally, nicotine gum is  a very patented product! The EPO returned 184 patents for a search on “nicotine gum”. There are in fact many different sorts of nicotine gums, that is, different formulations of the gum base and of the non-toxic active nicotine ingredient; different oral transmucosal delivery systems or release technologies for the nicotine in the gum; and different flavors that may be added to the gum to make it palatable or compatible with release of the active ingredient.

Here is an additional short list of the nicotine gum patents:
  • US2014099269 Chewing gum having sustained release of nicotine
  • US2013323184 Method of providing fast relief to a user of nicotine chewing gum
  • US2012039981 Coated nicotine-containing chewing gum, manufacture and use thereof
  • WO2013059592 Excipients for nicotine containing therapeutic compositions
  • WO2014091631 Method of releasing nicotine from chewing gum
  • US6344222B1 Nicotine, hydrophilic and hydrophobic polymer, buffer time-release agents (to improve release rates of nicotine)
  • US8658200 Flavoring of drug-containing chewing-gums
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Finally, here is a cessation quote to ponder:
“Nicotine is an addictive poisonous alkaloid C5H4NC4H7NCH3, derived from the tobacco plant. Nicotine is also used as an insecticide. Approximately 40 milligrams* of nicotine is able to kill an adult (Merck Index).” (Extracted from US2006275344)
 *40 mg = 1 US teaspoon 
Reference
John P. Pierce, Sharon E. Cummins, Martha M. White, Aimee Humphrey, and Karen Messer (2012)
Quitlines and nicotine replacement for smoking cessation: Do we need to change policy? Annual Review of Public Health, 33:341-356.
http://www.annualreviews.org/doi/abs/10.1146/annurev-publhealth-031811-124624

Wednesday, May 28, 2014

Oh, patents! Bupropion Hcl

Copyright © Françoise Herrmann 


Just three days till May 31The UN World No Smoking Day! And just enough time for your physician to perhaps decide on prescribing bupropion hydrochloride in sustained release (SR) form, commercially marketed as Zyban® by GalxoSmithKline as an effective aid to smoking cessation.

This pharmacotherapy for smoking cessation differs from nicotine and nicotine-replacement therapies in that it is an active ingredient  completely un-related to nicotine.  It is the third and most recent approach to smoking cessation. As a reminder the other combination lines of treatment are behavioral and nicotine-replacement-type therapies, such as transdermal patches, gum and lozenges.

The active ingredient bupropion hydrochloride was initially marketed in the United States as an antidepressant under the brand name Wellbutrin®, manufactured by GlaxoSmithKline. The structure of the active ingredient bupropion hcl is similar to diethylpropion, an appetite suppressant. Clinical testing of the drug demonstrated its effectiveness as a cessation drug as it doubles the success rate of the cessation, and is as effective as nicotine replacement therapies in conjunction with behavioral therapies (Roddy, 2004). It is unclear how bupropion hlc actually supports cessation although the effects of the drug on brain activity are known. It is hypothesized that inhibition of the reduction of dopamine and noradrelanine levels occurring with nicotine withdrawal is probably responsible. (Roddy, 2004).

Bupropion hlc is a highly patented compound. The search term “bupropion” returned 453 hits at the EPO!

The discovery of the compound is patented in US3819706 titled Meta chloro substituted alpha-butyl-amino propiophenone, as well as many of  its various formulations, for example US2011020446 titled Method and formulations for making pharmaceutical compositions containing bupropion.

  The various properties of the compound (including smoking cessation) are patented:
  • as an anti-depressant, for example, US2009304786 titled Stable dosage forms of an antidepressant
  • as appetite suppressant, for example, US2011144145 titled Methods of treating visceral fat conditions or US 2011098289 titled Method for treating obesity
  • as treatment for sexual dysfunction,  for example WO2012028834 titled Use of bupropion in the treatment of sexual dysfunction
  • as an aid to smoking cessation: for example US2003064092 titled Pharmaceutical composition containing two active ingredients for smoking cessation or US2004225020 titled Methods and compositions for aiding smoking cessation and for treating pain and other disorders using optically pure (-)-bupropion

 And the mode of delivery of the compound (in SR- Sustained release form) and its manufacture are patented, for example in US2010008987 titled Modified release pharmaceutical composition of bupropion hydrochloride, considering all the severe side effects that occur at peak plasma levels.

There are however warnings associated with the use of this therapy, as it is linked to neuropsychiatric reactions, suicidal thoughts and behaviors, particularly with younger populations. (GSK – Zyban)
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So, with just a couple days left before the big Q day, Carpe Diem!

 References
Roddy, E. (2004) Buproprion and other non-nicotine pharmacotherapies. BMJ Feb. 20, 2004, 328(7438):509-511.
GlaxoSmithKline – Zyban  - Highlights of prescribing information

Friday, May 16, 2014

ERRATA – fda.gov vs fda.org

 

The FDA (Federal Drug Administration) website is fda.gov.

The website fda.org which posts ads for BUY NOW Premium™ Vapes is some other third party website with more than a few bogus links…

The bottom line on ecigs is that there is no safety and efficacy data available, and these products are not regulated as smoking cessation devices.

On April 24, 2014, the FDA filed a proposal to include ecigs in its jurisdiction over tobacco products, but this is still a pending legal matter.  [FDA News release]

The FDA.gov
site does not post any BUY NOW ads for ecigs nor for any other kinds of products!

Reference
FDA News Release - FDA proposes to extend its tobacco authority to additional tobacco products, including e-cigaretteshttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm394667.htm

Oh, patents! Smokeless blucigs™

Copyright © Françoise Herrmann


In France the verb “fumer” (to smoke) is being replaced with the verb “vapoter” (to vape) in reference to the use of smokeless electronic cigarettes.  And in this case, it follows that the French e-cig smoker becomes a “vapoteur” (+masculine) or “vapoteuse” (+feminine), whereas in English, that would perhaps be a “vaper” or an “e-cig” user.


E-Cigs, and blucigs™ in particular as an example of the marketed product, are electronic cigarettes, rechargeable and purported green, the same size as tobacco cigarettes. They are called “blu” because of their LED tip that lights up blue with every puff (or “vape”). The blucig™ contains a rechargeable battery for the LED light, a cartridge of “smoke juice” (that is a proprietary liquid concoction containing nicotine, but without the 7000 chemicals created when burning tobacco cigarettes such as carbon monoxide, nitrogen oxide, hydrogen cyanide and ammonia), a heating cell for the “smoke juice”, an atomizer that vaporizes the “smoke juice”, and a silicone tip designed to supply the “deeply satisfying resistance” of a puff (or “vape”)!  So, when you inhale or “vape”, the activated battery turns on the blue LED light and heats the “smoke juice”, which is then converted to vapor that is inhaled or “vaped”, providing users or “vapers” with an experience just like smoking a tobacco cigarette, without any of the burning and harmful “smoke”.


The blucig™ cigarette pack design is patented as design patent (USD700994), and the original vaporizing cigarette patent US3200819 titled: “Smokeless non-tobacco cigarette” was filed in 1965.  Interestingly enough,  the original smokeless cigarette invention was “ to provide a safe and harmless means for and method of smoking by replacing burning tobacco and paper with heated, moist, flavored air; or by inhaling warm medication into the lungs in case of a respiratory ailment under direction of a physician”. Thus, the smokeless cigarette was originally designed both as a medicine delivery system and a substitute to tobacco smoking. 

However, it was only at the beginning of the 21st century that electronic cigarettes were manufactured and brought to the market, via China, where they were patented alternatively as “electronic aerosol cigarettes(CA2647212 A1), electronic atomization cigarettes (CA2562581 A1) and later in the US as “electronic smoking-substitute devices(US20100031968 A1).

Now, if you intend to quit smoking on May 31 – World No tobacco Day, and have in mind that you might still puff vapor (or vape) on something like electronic cigs, in replacement of the 7000 (yes, seven thousand) chemical compounds created when puffing on a tobacco cigarette, 70 of which are known carcinogens according to the American Lung Association [ALA], you might want to hold off until you hear what the NIH (National Institute of Health) has to say about e-cigs, and exercise caution.

First, according to Kushner et. al (2011) electronic cigarettes are novel nicotine delivery systems, rather than nicotine replacement systems. They are termed ENDS (Electronic Nicotine Delivery Systems) by the WHO (World Health Organization) and there is no data on the safety or efficacy of the “smoke juice” containing aromas and propylene glycol, or the vapors inhaled. Only those E-cigs marketed for therapeutic purposes can be regulated by the FDA Center for Drug Evaluation and Research (CDER). And because there is no data on such items as: potential risks when used as intended;  how much nicotine is being inhaled or other potentially hazardous chemicals; and whether there are associated benefits when using the products,  e-cigs are not approved as a smoking cessation device.

So, in the countdown to May 31, 2014 – World No Tobacco Day, you may want to be cautious about switching to e-cigs (blucigs™ , Premium™ vapes or any other e-cig brand), since the “smoke juice” that is vaporized and inhaled is a complex substance for which there is still no efficacy or safety profile. Indeed, e-cig ad messages display: Don’t quit. Switch., which at best appears to be defeating its own purpose..

On the other hand… there are BUY NOW! Premium™ vapes advertisements on the splash page of the FDA website..! [FDA(2)] So, go figure out the bottom line to the bottom line…!

References
FDA – Electronic cigarettes
http://fda.org/
Kushner, W. G., Reddy, S. and H.S. Paintal (2011) Electronic cigarettes and third hand tobacco smoke: two emerging health care challenges for the primary care practitioner. International Journal of General Medicine 4: 115-120.

Thursday, May 15, 2014

Oh, patents! Transdermal nicotine patch

Copyright © Françoise Herrmann

The NIH (National Institutes of Health) NIDA (National Institute on Drug Abuse) suggests one or a combination of three approaches to quit smoking:
  1. Behavioral (e.g.; counseling, self-help or the Department of Health 800-QUIT NOW hotline)
  2. Nicotine replacement therapies or NRTs (e.g.; nicotine patches, nicotine gum, nasal sprays, inhalers and lozenges), and
  3. Medication (e.g.; Zyban, and Chantix which blocks nicotine receptors) [NIH, Drug Facts]

Transdermal nicotine patches thus offer a nicotine replacement approach to quitting. A search for nicotine patches at the EPO yields several different patents. For example:
 
US4920989 and US5016652 both titled:  Method of aiding in reduction of the incidence of tobacco smoking are assigned to the University of California.They disclose transdermal patches for administration of nicotine to the bloodstream. at a rate sufficient to correspond to the nicotine level in the blood which is achieved by the normal smoking patterns of the individual”; and additionally, a combination nasal aerosol spray (in US4920989) designed:  “to provide desired sensations in the respiratory tract to which the user is accustomed from normal tobacco use.” 

The stated advantage of this form of nicotine replacement therapy, compared to nicotine gum for example, is that it is able to deliver adequate quantities of nicotine in the blood stream, without the displeasing taste of nicotine gum or the gastroinstestinal upset.

The abstract for US4920989 in included below with a patent figure drawing and a commercial figure drawing of the transdermal reservoir patch:

A method of aiding in the reduction of incidence of tobacco smoking. The method comprises applying a patch containing nicotine to the skin of a person with whom smoking reduction is desired and allowing the nicotine to transdermally migrate into the person's bloodstream to achieve a desired systemic nicotine level. The method also comprises the simultaneous administration of a nicotine containing aerosol spray to the oral cavity of the user in order to provide the desired sensations in the respiratory tract to which the user is accustomed from normal tobacco smoke. A combination of the spray and transdermal patch is also provided such that an occlusive patch is applied to the skin of the person with whom smoking reduction is desired and the nicotine containing aerosol spray is delivered to the oral cavity simultaneously with the application of the nicotine from the patch.


There are many other patents related to dosage and/or comfort of transdermal nicotine patch therapy. For example:

US5230896 titled Transdermal nicotine delivery system discloses “a novel transdermal delivery system to satisfy addicted smokers’ cravings” which offers an option to transdermal patches containing a reservoir of the drug.  The novel construction of the patch consists of a nicotine base within an acrylate polymer matrix, so that the patch is neither bulky nor conspicuous when worn.

US5603947 titled Method and device for providing nicotine replacement therapy transdermally/transbucally discloses a patch for heavy smokers which delivers an average flow rate of nicotine that exceeds the prior art delivery amounts.

There are also known disadvantages of the transdermal delivery mode, in general, and in particular for nicotine delivery (Prausnitz & Langer, 2008). For example, one of the known disadvantages is skin irritation that can be caused by the patches. This problem is addressed and patented, for example in US2013053357 titled: Skin irritant suppression and transdermal preparation which discloses delivery of an irritant suppression agent in conjunction with a drug such as nicotine, in a transdermal patch. 

US2009169606 titled Low flexural strength transdermal tobacco alkaloid patch also addresses the issue of patch comfort and the risks of leaking in transdermal reservoir technology by disclosing a patch with a high degree of flexibility (i.e. low flexural strength).
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So… in the countdown to May 31 World No tobacco day – transdermal nicotine replacement patches appear as one patented option available to assist with cessation. 

References
NIH – Drug Facts: Cigarettes and other tobacco products
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2700785/   
Prausnitz, M. R. & R. Langer (2008) Transdermal delivery
Nat Biotechnology, Nov.2008, 26(11), 1261-1268


Countdown to May 31, 2014 - World No Tobacco Day

Copyright © Françoise Herrmann

Puff, puff, puff … If you think that no one smokes any more… consider the following figures from WHO (the World Health Organization).  
  • Almost 80% of the world’s one billion smokers live in low and middle income countries.
  • Tobacco claims the lives of almost 6 million people every year.
  • Tobacco kills more than half of its users. [WHO (1) Tobacco Fact Sheet].
 Or consider the following US figures from the National Cancer Institute (NCI):
  • Each year tobacco use claims 440,000 deaths.
  • At least 30 % of all cancer deaths are attributed to smoking, which makes quitting smoking a top priority for reducing the risks of cancer. [NCI, Tobacco Use]

And that’s not all… take a peek at the figures related to SHSsecond hand smoke
  •  There are an estimated 600,000 deaths worldwide related to second-hand smoke (SHS), that is, more than 1% of all deaths, including 165,000 children. [WHO (2), Burden of SHS]
Considering the above figures, WHO considers smoking a global epidemic, and organizes each year, on May 31, a No Tobacco Day. The UN/WHO No Tobacco Day is designed to raise awareness about tobacco-related health risks, and offer effective policies for reducing tobacco consumption.


And on a much smaller scale… for anyone trying to quit, May 31 is a great target date, per the NCI cessation programs. In other words, it’s a great day to quit, at least for 24 hours…in the company of millions worldwide, and of course, to continue quitting the next day too, and perhaps the day after…. and the day after…


And, in any event to never give up trying to quit… until the battle is won, even if it means setting another No Tobacco Day, or any number of additional No Tobacco Days.  According to the NIH (National Institutes of Health) NIDA (National Institute of Drug Abuse): 

“Tobacco addiction is a chronic disease that often requires multiple attempts to quit.” [NIH, Dug Facts]
In preparation of the big Q(uit) Day, the next posts are designed to offer a few patented solutions to quitting.


References
NCI – Tobacco Use
NIH – Drug Facts: Cigarettes and other tobacco products
WHO (1) Tobacco Fact Sheet No. 339 – Updated July 2013
http://www.who.int/mediacentre/factsheets/fs339/en/   
WHO (2) Worldwide burden of disease from exposure to second-hand smoke 
http://www.who.int/quantifying_ehimpacts/publications/shsarticle2010/en/

Sunday, May 11, 2014

EPO Oscars 2014 - Time to vote!

Copyright © Françoise Herrmann

It’s that time of the year again! The European Patent Awards ceremony will be held this year in Berlin, Germany, on June 17, 2014.

Until June 10, 2014, you (dear reader) may participate in this event by casting your vote for the Popular Prize Award. And in many ways your vote counts twice, since for every vote cast, the EPO will donate .25 Euros (twenty five cents) to the Child Vision Project, up to a maximum of 25,000 Euros.

The Child Vision Project was set up by Joshua Silver, professor of physics at Oxford University in the UK, 2011 EPO awards finalist, and inventor of the water-filled adjustable lenses, enabling the distribution of glasses to third world countries for less one Euro per pair. Considering the ratio of optometrists per capita of 1:2 million in countries like Mali for example, it is estimated that an appointment would take up 200 years… So, adjustable glasses, constructed with fluid filled lenses, enables self-adjustment of lenses using a tiny wheel, which either pushes the liquid in a chamber between two plastic lenses outwards creating plus lenses for longsighted people, or the other way, inwards, for negative lenses and shortsighted people!

You may cast your vote(s) free of charge at www.eop.org/vote



And probably due to the special gifts attached to your vote, the voting rules are as follows: “You can vote once a day for as many of the 15 finalists as you wish. However, you cannot vote for the same inventor more than once a day. Voting is free of charge.” (!)


Your vote also qualifies you for the drawing of a free “cell-fuel” charger for your mobile devices…!



Among the brilliant contending inventions for the Popular Award:
  •  EP1527050 - Drug against multi-resistant tuberculosis (Koen Andries [BE] et al.)
  •  EP0946450, EP2242806, EP2282203 - Self-cleaning cement (Luigi Cassar [IT] et al.)
  • EP2129792 B1 - Microchip for quick DNA testing (Christofer Toumazou [UK])
  •  EP1873259, EP1750771, EP1583832 - Gene-silencing technique to treat disease (Tomas Tuschl [DE])
  •  EP2375481 - Implantable biofuel cell that runs on glucose (Philippe Cinquin [FR] et al.)
  •  EP1947966 - Inflatable bike helmet (Teresa Alstin, Anna Haupt [SE])
  • EP1885477, EP1937395 - Energy-efficient water purification (Peter Holme Jensen [DK])
  •  EP1223637, EP1380069, EP1258054Fractal-based antenna for mobile phones (Carles Puente [ES] et al.)
  • EP0171069, EP0681906, EP1946910, EP0852536 - 3D printing (stereolithography) (Charles W. Hull [US])


For additional information regarding 3D printing, one of the contenting invention, please visit additional posts from this blog:



Wow patents! Bioprinting
Oh, patents! Bio ink & 3D printing
Oh, patents! 3D construction printing


And for the contending multiple-drug resistant TB invention, please visit the post celebrating World TB day:

Pharmaceutical patents - MDR-TB*