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IP Trends in the Emerging Field of Mobile Medical Apps (mHealth)

In recent years, most leading pharmaceutical companies have been moving to reinvent their business models to face the challenges of providing low-price medicines, of the patent cliff, and of demographic changes. This has led to the entry of large information technology (IT) based companies, and of mobile-based healthcare firms who have been recently very active in the healthcare mobile sector. Information technology, telecommunications and internet-based digital and social innovations are leading to an increase in accessibility in the healthcare sector and the healthcare market enabled by a mobile health (mHealth) applications revolution. The areas into which mHealth has made the most inroads are: improved efficiency of primary care delivery, portability, convenience and improved patient monitoring. Current mHealth apps help to control and monitor common conditions like high blood pressure and diseases like diabetes and, indirectly, to encourage users to change their lifestyle due to the continuous monitoring of the mHealth apps. mHealth applications' functionality is already well developed by the mobile application companies, who continue to play a vital role in providing affordable healthcare solutions to patients and serious revenue stream to investors, as illustrated in PwC diagram.

Ethical issues

Since mHealth applications involve personal data related to healthcare, the US Food and Drug Administration (FDA) is starting to regulate the mobile app sector. "The FDA has already cleared a few mobile medical apps used by health care professionals, such as a smartphone-based ultrasound and mHealth application that allows doctors to view medical images and X-rays. The FDA issued its Draft Guidance on Mobile Medical Applications in July 2011 stating that it would apply its regulatory requirements to a subset of mobile health apps that both: (1) meet the definition of a "device" under Section 201(h) of the Federal Food, Drug and Cosmetic Act; and (2) were "used as an accessory to a regulated medical device" or "transform a mobile platform into a regulated medical device". On August 1, 2014, the FDA released draft guidance that exempted from premarket 510(k) review many low-risk medical devices including certain mobile applications that can convert a cell phone into a medical device, such as a thermometer or a stethoscope. The FDA also announced its intention not to enforce compliance with premarket review requirements for these devices and noted that it did not expect manufacturers to submit 510(k)s for these devices prior to adoption of a final rule or order. The FDA’s recognition that these devices are sufficiently well understood and do not present risks that require premarket review to ensure their safety and effectiveness and its corollary decision to exercise enforcement discretion as to these devices, eases the regulatory burden on medical application developers and expands opportunities for continued development and dissemination of important mobile tools for improving patient care and physician practice."

(According to Mobile Medical Applications: Guidance for Food and Drug Administration Staff issued on September 25, 2013)

The patent scenario

There has been a "mobile revolution", with consumers using smartphones with different software platforms to access global information at any time from any location and with individuals able to share information at the click of a button, whatever their locations may be. As illustrated in the patent filing graph to the right , this has resulted in a wide range of patents being filed, covering various aspects of such applications.

For mHealth applications, apps and devices provide accurate diagnosis and targeted therapy. Examples of patents for mHealth apps include: management of blood pressure by utilizing wearable intelligent sensors and personal healthcare information systems; and a smart phone that can perform an electrocardiogram (ECG) monitoring the electrical activity of a person’s heart.

To summarize, the above data shows that mHealth is an emerging field.  mHealth can combine a variety of platforms and protocols such as staff scheduling; tracking and travel management; and visit record and care plan administration. Other mHealth applications which may be patentable include, for field service personnel such as visiting staff in the home healthcare field, providing improved monitoring, reporting, data communication, and tracking of information.

Therefore, there are excellent opportunities for both start-ups and Big-Pharma companies to direct, combine and leverage current technology to the mHealth future.

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A not-so-odd trio: medical marijuana, fraud and patents?

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A not-so-odd trio: medical marijuana, fraud and patents?

One of the most dynamic new areas of patent activity has been medical uses for cannabis, as start-ups seem to be cropping up at a pace commensurate with the legal production of the plant itself. An interesting angle on the possible financial risks in entering the space was suggested by Jeffrey H. Kramer of Kroll Global Fraud Report 2015-2016, who focuses on what he claims are the particular risks of fraud in the field. Kramer writes as follows... read more >

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Sentiment Analytics

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Sentiment Analytics

Sentiment Analytic or opinion mining is predicted by many commentators to be entering a growth phase, fueled by advances in machine learning, multilingual analysis, image and video analysis and insights into consumer emotion analytics, big data handling and networks.

Through sentiment analytics companies discover what their public thinks about them. Providers of such analytical tools may combine open source or tailored algorithms with proprietary platforms, dashboards.

A large number of patents and patent applications have recently been filed that are directed towards protecting the IP around sentiment analytics and opinion mining. Novel and advantageous arrangements of open source products,  have every chance of being patent protectable, and companies inthis field are becoming very mindful thattrade secret protection is inadequate for fear of reverse engineering.

In fact, even in the new and narrow field of sentiment analysis, there are (see below) over 250individual patent and patent applications and the filings are increasing massively  as companies attempt to protect their assets and also create freedom to operate  issues for their competitors. Outside investors and strategic partners factor in patent due diligence and patent valuations along with other assets of the company.

 PATENT FILINGS FOR SENTIMENT ANALYTICS: THE SURGE

The main concentration of patenting efforts are in the US and China, with Europe coming in a poor third.

The main subjects claimed for patent protection within sentiment analysis are shown above.

The entry ticket for getting into this field is relatively low. Strategies  for start ups tend to fall into either cross media analysis  combining Natural Language Processing, images and video, or highly specific features within these segments. The patent filings made by IBM, Google, Amazon, Facebook , NASDAQ , Thomson and others (shown below) should provide tempting incentives forstart ups with patent licensing or monetising aspirations.

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IP in China: Part I

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IP in China: Part I

Utility Model Patent system in China and relevant IP strategy

  • Invention patents protect inventions, which provide any new technical solution relating to a product, a process or improvement with practical applicability. They provide 20-year protection from date of filing and are subject to substantive examination.
  • Utility model patents protect any new technical solution relating to the shape, the structure, or any combination, of a product which is fit for practical use. They provide 10-year protection from date of filing and are not subject to substantive examination.
  • Design patents protect any new external features of a product fit for industrial application including the shape, pattern, color or any combination thereof, which creates an aesthetic feeling and is fit for Intellectual Asset management. They provide 10-year protection from date of filing.

The utility model patent system is less common than invention patents, although still widespread in over 70 patent issuing authorities. China’s Patent Law is modelled to certain extent on that of Germany. For product inventions, it provides for utility model patents as well as invention patents. Utility model patents are inexpensive to apply for, are not substantively examined, have lower thresholds for inventiveness, are registered quickly (often nine and 12 months from filing, as opposed to the typical three to four years it takes for invention patents) and enjoy a presumption of validity that makes them hard to ignore. Utility model patents have real significance in China. One well-known case is Chint V. Schneider Electric, which French electrical company Schneider Electric was ordered to pay its Chinese rival Chint Group 333 million yuan (about $45 million U.S.) in damages for infringement of a Chinese utility model patent.

There is however tremendous disparity between the filing rates for foreign and domestic companies for utility model patents in China. According to statistics from State Intellectual Property Office (SIPO), in 2010, Chinese applicants filed 407,238 (99.4%) utility model applications while foreign applicants only filed 2,598 (0.6%). The accumulative numbers from April 1985 to December 2010 are respectively 2,397,523 (99.3%) and 16,801 (0.7%). A possible explanation is that foreign applicants from countries where no utility model system exists, e.g. the U.S., may not be familiar with it. In addition, the uncertainty of the validity of utility models makes it a second tier patent devalued by some practitioners. There may be many reasons for the disparity, but when considering the benefits of utility model patents (many) against the burdens (few), it is clear that foreign businesses are a long way behind the curve in this crucial area. The simple fact is that foreign companies should seriously consider filing utility model patent applications in China for all their significant product developments.

Furthermore, patent law in China allows applicants to file applications for both an invention patent and a utility model patent in respect of the same invention at the same time, a recommended strategy is to file both a utility model patent and an invention patent simultaneously to benefit from the speedy granting of the utility model patent, which can then be abandoned in favor of the longer protection of the invention patent when that eventually grants.

In past 20 years, Israeli entities filed 5,999 invention patent applications in China and only 211 utility model patents. Before 2010, the application of Chinese Utility model from Israel is less than 5 per year. There have been significant increase since 2010 (Fig. 1). The applications are mainly related to the controlling or regulating systems, radiators or aerials for microwave heating et al (Fig. 2).

Fig. 1 Application of China Utility model patents by Israeli entities

Fig. 2 Analysis of technology fields of China Utility model patents filed by Israeli entities

In summary, utility model patents can be effective, low-cost tool for protecting innovation in China. For foreign companies just starting their business in China, utility model patents are useful for build a patent portfolio quickly and inexpensively. Israeli companies may want to reassess their filing strategies in China and change their thinking of utility model patents. 

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Cancer Immunotherapy: Patent Trends

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Cancer Immunotherapy: Patent Trends

Cancer Research Catalyst, the official blog of the American Association for Cancer Research (AACR) states: Top Trend in Health Care in 2015: Cancer Immunotherapy (December 21, 2015).  It is reported that this year alone, the U.S. Food and Drug Administration (FDA) approved five cancer immunotherapies, including the first immunotherapies for lung cancer and children with cancer.
These advances in cancer immunotherapy are the result of long-term investments in basic research on the immune system—research that continues today.
Immunotherapy is a treatment that uses certain parts of a person’s immune system to fight diseases such as cancer. This can be done in a couple of ways:

  • Stimulating your own immune system to work harder or smarter to attack cancer cells;
  • Giving your immune system components, such as man-made immune system proteins, to augment or stimulate the immune system.

Some types of immunotherapy are also called biological therapy or biotherapy.

The graph below shows that the total global spending on biologic drugs during the recent years is increasing, and it is expected to further increase in 2017.

In the last few decades immunotherapy has become an important part of treating some types of cancer. Newer types of immune treatments are now being studied, and they will impact how cancer is treated in the future.
The main types of immunotherapy now being used to treat cancer include:

  • Therapeutic antibodies: These are man-made versions of immune system proteins. Antibodies can be very useful in treating cancer because they can be designed to attack a very specific part of a cancer cell.
  • Immune checkpoint inhibitors: These types of drugs basically take the ‘brakes’ off the immune system, which helps it recognize and attack cancer cells.
  • Cancer treatment vaccines: Vaccines are substances put into the body to start an immune response against certain diseases. We usually think of them as being given to healthy people to help prevent infections. But some vaccines can help prevent or treat cancer.
  • Other, non-specific immunotherapies: These treatments boost the immune system in a general way, still helping the immune system attack cancer cells.

Many newer types of immunotherapy are now being studied for use against cancer. This additional research is currently under way to:

  • understand why immunotherapy is effective in some patients but not in others who have the same cancer
  • expand the use of immunotherapy to additional types of cancer
  • increase the effectiveness of immunotherapy by combining it with other types of cancer treatment, such as targeted therapy, chemotherapy, and radiation therapy.

We have established the patent trends in the field of cancer immunotherapy by scrutinizing the patent databases. It has been revealed that there is an ongoing increase in patent filings of cancer immunotherapy patent documents.

As shown below, the main assignees of these patent families are divided between companies such as Celgene corp and Universities and research institutes such as Texas University and Dana-Farber Cancer Institute.
 

Some of the subjects of the filed patent documents are overlapping with the research subjects reported above as currently underway, namely cancer antibodies, cancer vaccines, cancer antigen and immune system, as demonstrated by the following figure: 

Based on our patent trend analysis, it can be expected that aspects such as antibody fragments, adoptive immunotherapy, infectious diseases and autoimmune diseases may be further researched and subjected to R&D activities. In addition cancer diseases including lung cancer, breast cancer, prostate cancer and bladder cancer are predicted to be of market interest and subjected to licensing agreements in the context of cancer immunotherapy.

To summarize, the above data shows that the cancer immunotherapy industry is at an early stage, characterized by movement of knowledge from universities, hospitals and research institutes into industry, often via TTO’s. Another characteristic of early stage yet high promise of the industry is that many patent owners are substantial companies (Janssen pharmaceutica etc) but not gigantic, and there are no dominating entities. Sales are increasing, patent filings are increasing and the area is in a very dynamic state. This provides excellent opportunities for small biologically based start-ups, and also should provide a stimulus to the academic and research community to direct their research accordingly.

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A case from our practice

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A case from our practice

An application for a European patent was rejected as lacking an inventive step. The cited patent documents were quite old. We then considered the proposition that since no similar product is in the market, why would it be obvious to combine the cited technologies? Our curiosity was directed to European case law (appeal practice) to estimate the likelihood of overcoming an inventive step rejection on the basis that known technologies had not been combined for a considerably long time.

In T 1014/92 the board did not accept the appellant's argument that the long period of time (about 35 years) during which the cited documents had been available to the public without having been combined, was in itself cogent evidence that there was no obvious connection between them. The board held that this conclusion might only be drawn if evidence relating to time were corroborated by other evidence, such as long-felt want.

According to section 10.3 Long-felt need; commercial success of Guidelines for Examination (EPO), if the invention solves a technical problem which workers in the art have been attempting to solve for a long time, or otherwise fulfills a long-felt need, this may be regarded as an indication of inventive step. Commercial success alone is not to be regarded as indicative of inventive step, but evidence of immediate commercial success when coupled with evidence of a long-felt want is of relevance provided the examiner is satisfied that the success derives from the technical features of the invention and not from other influences.

Translating from legalese into common language, if we can prove that the product is successfully sold due to product properties per se, rather than mere aggressive advertising, there is long-felt want. If this is not the case, the commercial success cannot be an argument of possessing an inventive step.

To provide a broader picture, it should be pointed out that, in the US, according to Graham v. John Deere, “secondary considerations” may include evidence of commercial success, long-felt but unsolved needs, failure of others, and unexpected results. In other words, commercial success per se can be an argument to overcome obviousness rejection. There is no need to provide any proofs of “test integrity” to identify whether the commercial success was due to product properties or marketing.

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Strategies in responding to examiners

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Strategies in responding to examiners

The final substantive stage in the process of getting a patent is the examination stage, where a person from the patent office, the Examiner, will read your application and your claims, and will check the application and claims against the prior art, in other words, what has been done before.  Prior art can be patents, patent applications, published papers, or visual material, even including such things as YouTube videos.  The Examiner will search both for individual items that appear to be substantially the same as your invention and for multiple items that, in combination, appear to be substantially the same as your invention. 

Some terminology: In the United States, if there is a single piece of prior art that appears to be substantially the same as your invention, your invention lacks "novelty".  Two or more pieces of prior art which, when combined, appear to be the same as your invention deprive your invention of "inventive step". 

What strategies can be used to establish Novelty or Inventive Step?

Some of the more common ones are given below.

1.     Show that the invention contains a feature that the prior art lacks, or that all of the prior art lacks, either alone or in combination. 

For example, the invention is a sprinkler valve with a manual-off state, where water does not flow no matter what an automatic control does, a manual-on state, where water flows no matter what the automatic control does, and an automatic-control state, where water flows if the automatic control is "on" and does not flow if the automatic control is "off".

The Examiner finds a prior art valve that has all three states (manual on, manual off and automatic). 

However, the prior art valve requires two controls to enable all three states (for example, a first control that, when closed, provides a manual off state and, when open, provides an automatic control state; and a second control which, when closed, has no effect on flow and, when open, provides an always-on state.)  The invention, on the other hand, can switch between all three states using only one control. 

Since there is no way to combine the two controls of the prior art into a single control, the invention, with its single control is patentably different from the prior art.

A similar argument would hold if the Examiner found two prior-art valves, one with manual off and automatic control and one with manual-on and automatic control.   Combining the two into a single valve would, once again, lead to a device with two controls, patentably different from the invention.

2.      Narrow the patent by adding a feature to the independent claim that the prior art lacks – this is called adding a "limitation" to the patent.

For example, the Examiner has found two prior–art valves.  He says that, if one were to take a specified part out of the valve control in one patent and put it into the valve control of another patent, one would get a single-control valve with all three states. 

However, the specified part is a plate with passages in it.  If one set of passages connects the input to the output of the control, the valve is in its automatic control state.  If another set of passages connects the input to the output, the valve is in its always-on state.  If neither is connected, there is no flow – a manual-off state.  

However, in the invention, the exit flow from the valve control is down the center of the control, while the input flow is from the side of the control.  In the prior-art valve, input is from one end of the plate and output is at the other end of the plate.  Therefore, if there were flow down axis of rotation of the plate, it would be impossible to switch from one state to another. 

Therefore, add a limitation to the independent claim that the exit flow is down the axis of rotation of the valve control, since that is a patentable difference between the invention and any combination of the prior-art valves.

3.      Argue that the prior art works in a fundamentally different way than the invention.

For example, the invention is a foldable stretcher with about 5 sections which folds up into a neat rectangular package which will fit tidily into a backpack.  The stretcher is wider at one end than the other so the sections nest within each other, making the folded stretcher relatively thin.  The stretcher has carrying handles at each end, which rotate into a position alongside the folded sections. The joints between the sections comprise legs which are connected together longitudinally by wires, with each wire extending from the base of one leg to the top of the next leg so that the stretcher is stable in the unfolded state, both while resting on the ground and while being carried.  In the folded position, the legs, like the handles, lie alongside the sections. Unfolding the carrying handles tightens the wires and stabilizes the structure.

The Examiner claimed that an earlier patent, if modified by adding bits of two other patents, anticipated the invention.   The earlier patent disclosed a bed with a set of legs, diagonally connected together by hinges.  Pushing the legs to the center of the bed collapsed the bed into a set of legs and a crumpled piece of canvas. 

In this case, one could argue that the set of legs of the bed were connected by hinges diagonally across the bottom of the bed, with the hinges approximately in the middle of the legs.  This was fundamentally different from the legs-and-wires of the invention, where the legs were connected by wires, not hinges, the legs were connected together longitudinally, not diagonally, and each wire joined the base of one leg to the top of the next leg, rather than having the joining of the legs approximately in the middle of the legs for all of the legs.       

4.      Argue that it is not possible for the combination given by the Examiner to work.  For example, it can be argued that (a) it is not possible to fit the parts together, (b) although the parts can be fitted together, they will not work together once fitted, or, (c) although they fit together and work together, the result is fundamentally different from the invention.  The last can be argued, but it is the most difficult.

For example, for the stretcher above, the Examiner claimed that a combination of two earlier patents would create the invention.   One was the bed with a set of legs, as described above.  A second was a stretcher where the side poles could be separated into pieces and the whole thing, when taken apart, comprised a bunch of shortish sticks connected together by short pieces of rope (so that you had to connect together the proper pieces when reassembling the thing) surrounded by the folded canvas of the bed part. 

Against the combination, it can be argued that there is no way to attach the stretcher to the first bed in such a way as to make a structure with legs connected to the bed sides by hinges (the stricter side poles came apart for folding).  The legs of the combination would, like the legs of the bed, collapse into a bundle with all the tops at one end and all the bottoms at the other end, instead of being arranged in the head-to-tail fashion of the invention when folded.  Furthermore, the combination, when collapsed, is a bundle, not a set of bed sections nested one within the other.

5.      Another strategy involves the number of changes that would be necessary to get from the cited prior art to the claimed invention.  I once successfully argued that it would take 17 steps to get from the 3 patents cited as prior to the claimed invention so that, although combining those three patents to form the claimed invention might have been obvious in hindsight, it certainly would not have been so in foresight.

It is usually not a good strategy to argue that the invention lacks something that is in the prior art.  As long as it is possible for the prior art to work (even if badly) without the part, the lack is not a patentable difference.

For example, a device for creating a solution of fertilizer in water where a user gets reproducible results by occasionally dumping a bag of fertilizer into a water-filled tank.  This is a very simple invention – no screw feeds for the dry fertilizer, no weighing of the fertilizer, no careful control of the feed rate of the liquid going into the tank, no need to ensure that the dry bulk fertilizer remains dehydrated before use.  Just make sure that there is always solid fertilizer in the tank and make sure that the water level in the tank doesn't get too low or too high.  Also, don't dispense the solution too fast. 

Since it is possible to argue that the prior art device will work – even if badly or unreliably – without the screw feed, without weighing the dry fertilizer before introducing it into the tank, and without dehydrating the fertilizer, as long as the fertilizer sits in the tank long enough, the Examiner can say that simplifying a piece of kit is an obvious thing to do, so that it would be obvious to remove the screw feed, etc, from the prior art and get the invention, so that the invention is not patentable.     

The strategy of arguing that lack of a feature is a patentable difference can be used if (a) there is no prior-art device which lacks the feature so that everybody knows that devices of this type require the feature, or if (b) the prior art cited by the Examiner states explicitly that the prior-art device can not work without that feature and, preferably, the prior art cited by the Examiner explicitly states that that prior-art devices without the feature are intrinsically unsatisfactory.

Of course, combinations of these strategies can also be effective.  A good patent agent will always consider very carefully which strategy or strategies is most likely to be successful and to convince the Examiner to allow granting of a patent for the claimed invention.

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Arthur Hoyt Scott – homage to an inventor

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Arthur Hoyt Scott – homage to an inventor

Have you ever had the talk with your friends about: if you could choose to invent something, what it would be? I know I have.

This is the beginning of a real interesting conversation about technologies and society, and where it is headed, technologically speaking. From the invention of the wheel to the invention of spaceships and beyond. Besides the obvious side of things, which is the contribution to society (at least in my conversations), there is always the monetary incentive, which drives almost every inventor these days.

At this point of the conversation, I always come to same answer: I would choose to invent the toilet paper!!!

There isn’t a modern society today that do not consume large, almost infinite, quantities of toilet paper per year. So, I guess I won’t be doing my millions in toilet paper. But who has?

Meet Arthur Hoyt Scott, born in Pennsylvania, USA, on March 16th 1875. Discover my surprise when I found out that he was born on the same date I was born, just about 100 years before. He is formally the inventor of the throw-away paper towel. 

Not only he invented the toilet paper as we use it today, more than 100 year later, but he is the beginning of a very fruitful industry that is still developing today.

Searching for patents in this field brought to my attention very interesting facts. The number of patent applications in the technologies related, directly or indirectly, to the toilet paper have been increasing greatly in the last two decades (see graph below).

The main players in this field are Procter and Gamble™ and Kimberly Clark™. Which is not surprising since both are main players in the field of personal care products.

The surprising thing is that the mayor jurisdiction for this patents applications is China. That might be due to the fact that the production of said personal products is actually done in China.

Another interesting aspect of this data is that in a world that supposedly is going for more “green” technology, respecting the environment, reducing the usage of trees in order to avoid the increase of carbon-dioxide in the air - the technologies surrounding the toilet paper industry seem to be only increasing and developing. Just to provide a small example of what I am talking about, here are numbers regarding the sales of toilet paper, in millions of dollars (!!!):

In a world where one day there might be no more fuel-based cars, have superb nanocomputers and space travelling won’t be a dream anymore, toilet paper seems will be a constant – until somebody invents a suitable replacement for it. Therefore, we should remember those who contributed to the shape of society as we know it today – people like Albert Einstein, Marie Curie, Alexander Fleming and, of course Arthur Hoyt Scott.

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Understanding the Legal and IP Issues in 3D Printing: Part I – Trade Marks

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Understanding the Legal and IP Issues in 3D Printing: Part I – Trade Marks

3D printing, or additive manufacturing, as it is also known, has become the centerpiece for what our manufacturing future may look like. Influential commentators have dubbed 3D printing no less than the “Third Industrial Revolution”, and various national leaders have identified it as a matter of strategic importance.

Not surprisingly, given that 3D printing is a manufacturing phenomenon with the capacity to bring about profound industrial, economic and even social change, 3D printing will also raise a variety of legal challenges, including in intellectual property. There will be patent issues involving improvements in 3D printers and scanners; both trade secret and patent issues will arise in connection with the development of appropriate manufacturing materials. However, perhaps the most interesting IP questions will be in the areas of trademarks, copyright and design. This article will consider the trade mark implications of 3D printing, while copyright and design aspects will be discussed in a forthcoming article.

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