Showing posts with label PATENT. Show all posts
Showing posts with label PATENT. Show all posts

Saturday, May 26, 2018

Intellectual Property Markets

Patents, trademarks, and copyrights are hardly new. Trademarks came first, in the 1200s in England. Patents were next, in the 1400s in Italy. Copyrights emerged in the early 1700s in England. For the United States, laws passed in the 1790s protected patents and copyrights. Trademark laws arrived in the 1870s following legislative activity throughout Europe. These are the three primary types of intellectual property (IP) that can be “registered” with governments for protection. Each are made public, and available statistics for all countries make it possible to track global activity.

Registered IP Boom: What is happening is not a surprise. There are several factors, besides globalization and competitiveness, that fuel the growth. First is the ability to monetize IP. IP used to be part of the price of a product. It still is, but it can also be sold or licensed or bartered in an increasingly liquid marketplace. Transactable IP, which began in the early 2000s, increased the size of the available market. Providers of software and services could now create many more capabilities than simply IP inventory management systems for companies.

Open innovation came of age a few years later, spurred by giants such as Procter & Gamble that set a goal to in-source 50% of their innovations from other companies. As the internet increasingly enabled global connectivity, big data and algorithmic analytics came of age. All the pieces were now in place to take a company’s IP portfolio and compare it to any company or set of global statistics.

Finally, coming full circle, this easily comparative global information spurred further growth as analysts warned companies about not keeping up with the Joneses. Geometric growth has been going on for the past five to seven years.

IP Networks: Another important growth driver are IP organizations that are not the actual governmental registration bodies. Western economic zones have assembled neighboring countries into consortiums and/or empowered agencies that oversee activities and influence country policies and legislation, such as Europe, Eurasia, the Arab States, and Africa. Asian countries appear to be taking a more solo approach.

On a larger scale, the World Intellectual Property Organization has become an increasingly important player. It was established in 1967 by the United Nations as a self-funding agency. It is located in Geneva, Switzerland, and represents 191 of 195 countries. WIPO, as it is known, is the global forum for IP services, policy, information, and cooperation. It is a great source of information on all registered IP. Get on their e-mail list and you will have your finger on the pulse.

Patents & Trademarks: There will always be regional, vertical, and other types of segment competitors, but a look at several WIPO’s global services likely portends the future of IP. WIPO offers three global registration platforms: for utility patents (PCT), design patents (Hague), and trademarks (Madrid). Users file a single “international application” directly with WIPO, which then handles the various country filings. This is a great assist for emergent countries and regions, and is also increasingly used by industrialized nations which already have plenty of infrastructure for registration and enforcement.

Copyrights: Copyrights are also increasingly being monetized. After the “free thinking” period when the internet boom began, the realization that content has value started to return. Giant companies and organizations around the globe now compete to gather and charge for access to their content. The list is long. Copyrights have a couple interesting twists. First is the ability to digitally identify every single publication, a systems capability that has been evolving since 1998.

Does it sound to you like the future of registered IP is headed to be a transactable commodity?

Thursday, May 28, 2015

India’s IPR environment is maturing

Legal systems are in place, landmark judgements have been pronounced, and next-gen policies are being evolved

The establishment of the World Trade Organisation (WTO) at the conclusion of the Uruguay Round (UR) on negotiations in 1995 signalled a quantum leap in integrating developing countries with the global economies. Developing countries undertook greater commitments lured by additional market access in agriculture, textiles and the movement of people.

In a well researched report by RIS India , the gains from the UR proposals were estimated to be between $213-$510 billion a year, with developing countries benefiting to the tune of $86-$122 billion. Empirical evidence suggests that there has been a significant deviation of these income flows to the developing world in favour of the developed world.

Works in progress
The Indian intellectual property rights system represents one of the most mature IP systems amongst developing countries, although some of the studies rank it below China, which is often accused of thefts, counterfeiting, piracy and cyber attacks on IPRs. Successive Indian governments have put in efforts to improve IP legislation since 2000. Jurisprudence has consistently evolved, institutions like the Intellectual Property Appellate Board (IPAB) have been established, and landmark judgments by the judiciary have been given in the past few years. In recent times, key efforts have been made by the PMO to revisit the IP regime and a task force has been set up to evolve a next generation IP policy for our nation.

There have been acrimonious noises made by US industry against Indian IP legislation and its interpretation by the government and judiciary. Criticism of certain provisions in the Patent Act that renders evergreening of patents ineligible for grant has generated considerable heat. Similarly, lack of IP enforcement, a non-responsive legal system, lack of awareness and compulsory licensing have all come under fire.

On the ground, it appears to be a lot of work in progress. Significant policy changes in recent years by successive governments have been responsible for the evolution of IP legislation in our country. Indian pharmaceutical companies have become globally competitive in the generics market.

Not only are Indian companies competitive, the drugs produced by these companies have pharmacologically better characteristics and quality. Some of these domestic companies are also entering into licensing agreements with global players such as Sanofi, Forest Laboratories, Bristol Myers Squibb, Merck, and Eli Lilly and AstraZeneca in the R&D space. Over 50 NCEs/NMEs from Indian companies are at different stages of development for new drugs. This marks the entrance of Indian pharma companies in drug discovery; an innovation cycle that may be fraught with difficulties but is equally rewarding of success.

On copyright

In the case of the entertainment and IT industry, the recent involvement of the HRD ministry with industry associations such as Ficci, BSA and MPA are providing copyright enforcement training to police officers and its governing officials. To deepen awareness on copyrights, the ministry is in the process of finalising the inclusion of IPR as a compulsory subject in K-12 education. These are likely to see much anticipated reduction in unlicensed software and piracy of music and films.

There have been pioneering judgments that decisively deal with digital TM violations, meta tagging and parallel imports, making our legal environment more responsive and intolerant towards IP abuse. The decision of grant of interim royalty payouts by the Delhi High Court in the Ericsson vs Micromax case is a turning point in the “no damage cover” regime prevalent in India.

In the engineering and manufacturing sectors, IP capability and process maturity appear to be the binding-glue that will allow OEMs (original equipment manufacturers) transfer critical IPRs to Indian companies without fear. These ingredients must find a place in training each skilled worker in this exercise of nation-building. It is recommended that each set of National Occupational Standards must aim to create workers who are knowledgeable, innovative, skilled and IP centric.

India’s openness to re-examine its IPR laws and policies, and establish a think-tank and an empowered group on IPR reflects serious intentions of her transforming attitude towards IPRs.


Sunday, March 29, 2015

Delhi High court grants interim injunction; restrains Glenmark from selling generic version of anti-diabetic drug Januvia (Sitagliptin)

On April 2013, Glenmark launched the generic version of Merck’s popular antidiabetic drug Januvia (Sitagliptin) and Janumet (combination of sitagliptin and Metformin). Subsequently Merck filed a suit against Glenmark seeking interim relief. The Delhi HC (Justice Rajiv Sahai Endlaw) denied interim relief to Merck. After denial of interim relief, Merck was also briefly engaged in mediation with Glenmark over the Januvia patent. Readers may recall that we had blogged about it here here and here. Aggrieved by the denial of interim relief Merck also filed an appeal, seeking injunction.The Delhi High court division bench granted the interim injunction. This post aims to analyze the interim injunction order. IN209816 (product patent claiming Sitagliptin) is the subject of the present suit.(Long post warning*)

Merck’s arguments:
Merck contended that Sitagliptin Phosphate Monohydrate cannot be prepared without manufacturing the active ingredient, the Sitagliptin molecule. Merck also alleged that Glenmark willfully infringed the suit patent.
Glenmark’s arguments
Glenmark alleges that the patent is invalid under Section 64(1) of the Indian patents act:
The patent is lacks inventive step over prior art, patent. Glenmark further alleged that the suit patent is a “cut and paste job” from these two patents, specifically European Patent 1406622 and WO2001034594 A1.
The complete specification of the patent does not sufficiently and fairly describe the invention and the method by which it is to be performed, since the patent does not describe the preparation of the Sitagliptin free base or Sitagliptin phosphate monohydrate, but only its hydrochloride salt
Strangely enough, Glenmark also contended that the suit patent is not useful and lacksindustrial applicability because Sitagliptin free base is itself unstable. Glenmark also stated that the Sitagliptin phosphate monohydrate was the molecule used in the clinical trial, and not Sitagliptin Free Base.
The claim goes much beyond the limited disclosures in the specification, and thus the claim is over-broad or an impermissible Markush claim that creates a false monopoly.
Glenmark alleges that Merck did not comply with its obligation under Section 8 of the act to disclose patent applications made for the “same or substantially the same invention”. It was alleged that Merck did not disclose 5948/DELNP/2005 (for Sitagliptin Phosphate Monohydrate), 1130/DELNP/2006 (Sitagliptin Phosphate Anhydrate), 2710/DELNP/2008 (Sitagliptin plus Metformin) or subsequent international applications for these compounds either.
I wonder; where does one draw the line for Section 8 disclosure? What amounts to “disclosure of same or substantially same inventions” is a grey area! In my opinion 5948/DELNP/2005, 2710/DELNP/2008,1130/DELNP/2006 and their foreign equivalents are subject matters of separate patents and are not divisionals and do not claim priority from the original product patent IN209816.If section 8 requires one to disclose all related applications in the relevant arena – this is a separate patent landscape project in itself.
Curiously, Glenmark also argues that Sitagliptin phosphate monohydrate is qualitatively different from the Sitagliptin free base – it has enhanced pharmaceutical qualities (the reverse Section 3(d) argument so to speak!).This, according to Glenmark, means that the manufacture of Sitagliptin phosphate monohydrate does not violate a patent for the Sitagliptin free base simpliciter.
Courts observations:
In an exceedingly well reasoned judgement the Division bench (Justice Ravindra Bhat and Justice Najwi Wazir) of the Delhi High court made the following observations:
Regarding prior art the court notes that irrespective of whether the two patents are similar or not, EP 1406622 was published on after the priority date for the suit patent, and therefore does not qualify as prior art.
Regarding sufficiency of disclosure in the complete specification, the court observed that the patent sufficiently discloses the Sitagliptin free base, which in itself is clear, precise. The question whether the suit patent sufficiently discloses Sitagliptin phosphate monohydrate was left open.
Regarding industrial applicability, the court rightly observed that while the patent claims disclose the Sitagliptin free base, the description relating to the issue of industrial applicability recognizes that the Sitagliptin free base will be attached to some carrier (salt form). That carrier, however, is NOT the crux of the invention but only an inert component that does not add value to the therapeutic or medical value, which is the true core of the invention. It would be a far cry to hold that Sitagliptin is useless for any known purpose. The Court also noted that Sitagliptin was not known before, and its introduction allows for the inhibition of the DPP IV enzyme in such a manner as previously unknown, whether through one inert carrier or another.
Regarding Markush claims, , for the limited issue in these interim hearings the Court notes that the Markush formula and all combinations “share a common use or property” and “ share common structure factors relevant to determine the validity of a Markush patent, as per the Draft Guidelines of Indian patent office. The court opined that whilst it may be appealing at first blush to limit a pharmaceutical patent only to the exact and precise compounds and chemical structures disclosed, that may render genuine medical inventions to naught.
Regarding Section 8 (foreign filing disclosures) the court observed that Merck in the modified Form 3, disclosed foreign filings for patent related to combinations of Sitagliptin and metformin. The Court further stated that Section 8 only mandates the disclosure of patent applications outside India and not within. This is clear from the wording of Section 8 itself.
The court also frowned upon Glenmark’s at risk launch and observed that the fact that Glenmark did not utilize the opposition mechanisms weighed in favour of grant of interim injunction.
The court carefully and meticulously evaluated the three factors involved in grant of interim injunctions.
Prima facie case: The court succinctly captured the crux of the case and noted that Merck had established a strong prima facie case on the merits of the suit claim. It is established that Glenmark uses Sitagliptin free base as the active component in its chemical formulation. The court was totally unimpressed with the unsubstantiated argument advanced by Glenmark that their generic version uses Sitagliptin Phosphate monohydrate, which is manufactured directly without using the Sitagliptin free base. The court further stated that the fact that Merck unsuccessfully pursued a separate patent for Sitagliptin Phosphate is irrelevant .Thus; prima facie infringement of Merck’s patent is established, in the opinion of this Court.
Irreparable injury: Whether the claimant would suffer irreparable injury in the absence of interim injunction?- It may be argued that no injunction should be granted since all damages from loss of sales can be compensated monetarily ultimately. For this argument – the court countered that, prices may not recover after the patentee ultimately prevails, even if it is able to survive the financial setback (or “hit”) during the interim, which may take some time. The victory for the patentee therefore should not be pyrrhic but real.
Balance of convenience: The court must look at the public interest in granting an injunction, as access to drugs, is an important factor especially in case of a condition as prevalent as diabetes. Here, the price difference between the commercial products sold by Glenmark and MSD is not so startling as to compel the court to infer that allowing Glenmark to sell the drug, at lower prices would result in increased access. The court observed In the Hoffman la Roche case the price differential was about 300% and therefore in that case, held that balance of convenience did not lie in favour of grant of injunction as the possibility of several thousand being denied access to the generic drug was real.

Sunday, December 28, 2014

Classified Patents, Nintendo, Amazon: Intellectual Property

Maryland inventor has asked a court to clarify whether his patent applications are classified.
Frank Joseph Trunk III of Gaithersburg, Maryland, sued in federal court in Washington, saying he filed patent applications in the area of physics and material physics beginning in 1994. The applications were related to engineering design, “both civil and military,” he said in court papers.
Beginning in January 2000, he said, his applications were made subject to a secrecy order on aircraft and ship stealth technology, submarine stealth technology and nuclear-weapon design. Trunk said he had never been issued a security clearance nor had he ever been granted contractor status that would enable him to get a security clearance.
As a result, he claimed, he was placed under the threat of possible criminal violations for possession of classified information without a security clearance. In his complaint, Trunk said his various attempts over the years to get clarification of his patent applications’ status have brought him contradictory responses. As a result, Trunk said, he has had to forgo possible consulting arrangements with NASA and its contractors because he believes he cannot discuss or disclose the information in his applications.
He asked the court to rule on whether his applications are still classified or if they have been declassified, whether property declassification procedures have been followed and if he is authorized to have access to that information.
Trunk also is seeking a list of agencies that consider the information still classified and a statement of the conditions under which the information may be disclosed.
When he filed his complaint Dec. 8, he asked that the entire case be sealed. The court rejected that request, saying Trunk failed to provide support for his motion to seal “as it is unclear whether the government ever classified the patent applications to begin with.” The court ordered the Trunk’s complaint and the entire case be unsealed.
According to the database of the U.S. Patent and Trademark Office, there is one published patent application -- 20050032029 -- with a Frank J. Trunk listed as the inventor. The application covers a method of solving engineering design problems related to stress, strain and deformation of viscolastic materials, those having viscous and elastic properties. It was submitted in July 2001 and not published until February 2005. It lists an address in Houston for the inventor.
Gary Hnath of Chicago’s Mayer Brown LLP, counsel for Trunk, said in an e-mail this application was originally classified and his client is seeking clarification on whether it has been properly unclassified.
The case is Trunk v. Mabus, 1:14-cv-02139, U.S. District Court, District of Columbia(Washington).

Sunday, September 14, 2014

Software patents are crumbling, thanks to the Supreme Court

The Supreme Court's June ruling on the patentability of software — its first in 33 years — raised as many questions as it answered. One specific software patent went down in flames in the case of Alice v. CLS Bank, but the abstract reasoning of the decision didn't provide much clarity on which other patents might be in danger.
Now a series of decisions from lower courts is starting to bring the ruling's practical consequences into focus. And the results have been ugly for fans of software patents. By my count there have been 11 court rulings on the patentability of software since the Supreme Court's decision — including six that were decided this month.  Every single one of them has led to the patent being invalidated.
This doesn't necessarily mean that all software patents are in danger — these are mostly patents that are particularly vulnerable to challenge under the new Alice precedent. But it does mean that the pendulum of patent law is now clearly swinging in an anti-patent direction. Every time a patent gets invalidated, it strengthens the bargaining position of every defendant facing a lawsuit from a patent troll.
The end of "do it on a computer" patents
In the late 1990s and early 2000s, the Patent Office handed out a growing number of what might be called "do it on a computer" patents. These patents take some activity that people have been doing for centuries — say, holding funds in escrow until a transaction is complete — and claim the concept of performing that task with a computer or over the internet. The patents are typically vague about how to perform the task in question.
The Supreme Court invalidated a patent like that in its decision this year. The patent claimed the concept of using a computer to hold funds in escrow to reduce the risk that one party would fail to deliver on an agreement. The Supreme Court ruled that the use of a computer did not turn this centuries-old concept into a new invention.
That has emboldened defendants in cases involving similar patents. And in recent weeks, the courts have been following the Supreme Court's lead and ruling that these patents are illegal:
·         On July 6, a Delaware trial court rejected a Comcast patent that claimed the concept of a computerized telecommunications system checking with a user before deciding whether to establish a new connection. The court noted that the steps described in the patent could easily be performed by human beings making telephone calls.
·         On July 8, a New York court invalidated a patent on the concept of using a computer to help users plan meals while achieving dieting goals. The court was unimpressed with the patent holder's argument that some of the details in the patent — such as the use of "picture menus" to choose meals — was sufficient to render it a patentable idea.
·         On July 17, the Federal Circuit Appeals Court (which is in charge of all patent cases) rejected a patent on the concept of keeping colors synchronized across devices by building a profile that describes the characteristics of each device. The court held that the creation and use of these profiles were merely mental steps that could be done by a human being and were therefore not eligible for patent protection.
·         On August 26, the Federal Circuit rejected a patent that claimed the concept of running a bingo game on a computer. "Managing the game of bingo consists solely of mental steps which can be carried out by a human using pen and paper," the court ruled. Converting that process into a computer program doesn't lead to a patentable invention.
·         On August 29, a California court struck down a patent on a method of linking a mortgage line of credit to a checking account. The court said that the generic computer functions mentioned in the patent were not enough to merit protection.
·         On September 3, a Texas trial court invalidated a patent on the concept of using a computer to convert reward points from one store to another. The court held that the "invention" claimed by the patent "not fundamentally different from the kinds of commonplace financial transactions that were the subjects of the Supreme Court’s recent decisions."
·         In a second September 3 decision, a Delaware trial court rejected a patent on the concept of an intermediary selectively revealing information about two parties to each other — using a computer. The court noted that it has long been common for corporate headhunters to withhold certain information about an employer from potential employees (and vice versa) until both parties are ready to proceed.
·         On the same day, the same Delaware court invalidated a patent on the concept of using a computerized system to "upsell" customers who buy one product on other products that might interest them. The court pointed out that upselling is as old as commerce itself.
·         In a final decision the same day, the Federal Circuit appeals court struck down a patent that claimed the concept of using surety bonds to guarantee a transaction — using a computer. The court pointed out that surety bonds have been around since ancient times, and performing this well-known transaction with the help of a computer doesn't turn it into a patentable invention.
·         On September 4, a California trial court rejected a patent on the concept of using a computer network to ask people to do tasks and then wait for them to do them. The court pointed out that people have done this with telephones for decades, and that doing the same thing over the internet doesn't count as an invention.
·         On September 11, a Florida court invalidated a patent on the concept of subtracting a small amount of money from each of many payments in order to accumulate a larger sum of money — using a computer. The court noted that this kind of schemes has been widely known for centuries. For example, the plot of Superman III involved a villain using this kind of scheme to steal from co-workers' paychecks.
These rulings might seem like common sense, but it's important to remember that every single one of these patents was examined and approved by the patent office. That's because until recently, this kind of "invention" was considered eligible for patent protection. The patent office has issued hundreds of thousands of software patents over the last two decades, and many of them look like this.
But now the courts are sending a pretty clear message: you can't take a commonplace human activity, do it with a computer, and call that a patentable invention.
For example, recent court rulings could make it easier to challenge Amazon's infamous patent on 1-click shopping, which claims the concept of ordering things over the Internet with a single click. The steps described in the patent — receiving an order from a regular customer, retrieving pre-stored shipping information for the customer, shipping the item to the customer — have been performed by delivery businesses for decades. If Amazon's patent were challenged, courts might be skeptical that performing these steps on a computer constituted a patentable invention.
Software patents in danger
The recent string of decisions invalidating software patents on subject-matter grounds is unprecedented. This chart, based on data from Lex Machina,  shows the number of subject-matter decisions the courts made between 2007 and 2013:

The 14 patents the courts invalidated on subject matter grounds in 2013 was a record for recent years (such decisions were rare in the 1990s and early 2000s). And this chart reflects decisions on all types of patents, not just software patents. With 11 software patents invalidated in just the last three months, the courts are on track to blow away last year's record with software patent cases alone. So this is the most hostile the courts have been to software patents in at least two decades.
The real question is how far the courts will take this logic. Because strictly speaking, all computer programs perform sequences of mathematical operations that could — in principle — be performed by a human being. As the legal scholar Robert Merges has noted, the logic of the Supreme Court's Alice ruling could call almost all software patents into question.
"My immediate reaction was that this would be extremely bad for software patents," patent attorney Gene Quinn wrote last week of the Alice ruling. He interviewed patent scholar Mark Lemley. While Lemley doesn't think all software patents are invalid, he predicts that "a majority of the software patents being litigated right now" will be found invalid based on the Supreme Court's precedents.
There are hundreds of thousands of software patents on the books, so the courts won't be able to invalidate all of them. But if patent holders continue their losing streak of recent months, it will dramatically shift the balance of power between plaintiffs and defendants. Software patent holders will know that if they take a case to trial, there's a high probability that their patent will be destroyed — meaning they not only lose that case but also lose the ability to use the patent against other defendants. That will make plaintiffs — and especially trolls wielding patents of dubious quality — more gun-shy, giving defendants a lot more bargaining power.
Research shows that patents on software are particularly prone to litigation. There are several reasons for that:
Software patents can be extremely broad. For example, a famous patent covers the concept of purchasing products online with one click. Another patent owned by a troll called MPHJ has a patent that covers the concept of scanning documents to an email address. This kind of broad patent makes it easy for businesses to infringe by accident.
Most companies aren’t just users of software, they also have IT departments and web developers that produce it. So firms that wouldn’t otherwise have to worry about patent law are at risk of infringing software patents.
Software is extremely complex. Computer programs contain thousands, and sometimes millions, of lines of code. Since patents can be infringed in just a few lines of code, there’s no practical way for companies to figure out which patents their software products might be infringing.

Human DNA belongs to no one, it shouldn't be patented

The Australian federal court ruled that isolated human genetic material can be patented. The US supreme court disagrees – and the Americans got it exactly right.
In June 2013, the US supreme court held that mutant BRCA 1 human DNA, isolated from the human body, is not a patentable subject matter under US patent law. Last Friday, an Australian full federal court held that it is patentable subject matter under Australian patent law.
It would have been simple to distinguish the US supreme court’s decision on the basis that patent laws between the two countries differ: different legislatures, different statutes, different jurisdictions. Instead, the Australian full federal court took an unprecedented swipe at the US Supreme Court by suggesting that all nine justices of US supreme court had misunderstood the facts, the science and the law.
How did this happen?
To understand it, we have to go back to June 1988 when representatives of the European, Japanese and US patent offices came to an understanding about what to do with patents over DNA. It was less than two years after Genentech Inc had floated on the American stock market. Recombinant technology, invented by Professors Boyer and Cohen, enabled the production of pure human proteins using human sourced DNA. Patents granted over isolated human genetic material extracted from the human body, much like mining claims over alluvial gold, spurred a DNA gold rush.
Patent offices and patent attorneys and their customers, patent monopolists, wanted to cash in. Patent monopolies provided the perfect means to maximise revenues.
It did not take long before the first patent cases over disputed territory came before the courts. In 1989 in Britain, the court of appeal held that DNA was a discovery of nature and invalidated Genentech’s patent claims to the isolated DNA of human tissue plasminogen activator, a naturally produced human protein.
The European Patent Office, which had already granted patents over isolated DNA, was shocked by the British rebuke. It took immediate action. By 1998 the European parliament passed the European biotechnology directive, ensuring that the European Patent Office’s approach was mandated as law throughout the EU.
In the US, the Patent Office which had implemented the tripartite patent policy was granting thousands of patents over isolated human DNA. The policy had become entrenched around the world. It was wrongly assumed to be consistent with US patent law. In 1980 the US supreme court held that “anything under the sun made by man” was patentable, upholding a patent application to genetically modified bacteria that degraded crude oil.
By 2005 over 20% of the human genome was the subject of US patents.
Then in March 2010, the first shockwave hit the global biotechnology industry. A US district court judge held the patent claims over isolated BRCA genetic mutations invalid. They were not inventions. An appeal to the US federal circuit soothed fragile nerves. Then, a second US federal circuit appeal seemed to settle the issue. However, the US supreme court overruled it.
The US Supreme Court held that the isolation of DNA from a human being does not result in something that displays “markedly different characteristics from any found in nature”. It is not the same as a genetically modified bacteria that degrades crude oil. While that bacteria is the product of human ingenuity, the isolated BRCA gene mutations are not.
Since then, the US Supreme Court has been savaged by the patent monopolists. The US Patent Office, which has issued new patent examiner guidelines consistent with the decision, has been vilified.
Patents over human DNA, a material that nobody invented, will, as the US justices’, warn: “impede the flow of information that might permit, indeed, spur, invention.”
The Australian judges, in contrast, argue that: “This case is not about the wisdom of the patent system ... It is not about whether, for policy or moral or social reasons, patents for gene sequences should be excluded from patentability.”
Americans are now free to use DNA to develop new products. Australians are not. Neither are Europeans.
Which is the more desirable policy outcome?
I believe the US supreme court got it exactly right.
The British Statute of Monopolies of 1623, the first statutory expression of English patent law, was a product of economic policy. It sought to provide the ingenious with free and unfettered access to the store of common knowledge and property so as to reward the act of true invention. Human DNA regardless of its form, belongs to no one. No one invented it. And no one should be able to patent it.

Sunday, September 7, 2014

Patent Office opens up data of expired patents

The know-how and technological details of the patents, which has already been expired or lapsed validity in the country, is being opened up for the small and medium enterprises to utilise them for their business growth, said a higher official in the Indian Patent Office. India is also expected to sign a bilateral agreement with the European Patent Office (EPO) by September to have cooperation in various levels.

Participating in the inaugural function of 5th edition of IPEX 2014- conference on emerging trends in IP management and commercialisation, Chaitanya Prasad, controller general of patents, designs and trademarks, said that the patent office is offering the details of the expired through its website, free of cost.

He said that the knowledge of the expired patent, which becomes a public property, could be used by the small and medium level enterprises to develop new products. However, they cannot re-patent it.

Speaking about the proposed tie up with the EPO, expected to be signed in Geneva in the last week of September, he said that the agreement would be to develop biannual work plan to work on cooperation in various aspects including the training and data exchange of human resources and practices, along with other things,” he said.

In terms of standard practices, he said that the Patent Office wants to be at par with the best of the world practices by 2020 and at present, the patent examiners in India are almost twice faster than the examiners in US and European Patent Offices.

Around 43,000 applications are filed with the Patent Office every year. While majority of patent applications are filed by foreign firms, majority of trademark applications are from Indian applicants. Of the total patent applications, around 20 per cent are from Indian firms while in trademarks, the Office gets around 2.02 lakh applications a year, of which almost 90 per cent are from Indian applicants.

In order to improve the efficiency of patent filing mechanism, the Patent Office is planning to have all banks under its comprehensive payment gateway from early next week, which would be helpful for its applicants to pay online.


Thursday, January 30, 2014

Why India needs to take intellectual property seriously

Without reform of IP law, Indian companies - and broader economic growth - will remain stunted

DR. Reddy's Laboratories' chairman, called for the Indian pharmaceutical industry to move up the value chain from generics through investing in research and innovation, reported the Business Standard last week. Mr Prasad's aspirational call to action is, however, a sad reminder of how the government's policies create a hostile environment for investment and hobble Indian creativity. A salient example of these counterproductive policies are the attacks on some 15 medicine patents over the past 18 months. While hailed often as victories, these manoeuvres jeopardise the investment India needs to build intellectual capital, foster growth and employment, and develop medicines relevant to Indian needs.

The idea underpinning intellectual property (IP) protections is to encourage innovation. With an assurance of temporary exclusivity, people will invest resources to create new products and technologies, knowing that if they achieve a breakthrough their efforts will be rewarded. (It typically takes a decade and over $1 billion to develop a successful new drug.)

Creating incentives for innovation is an idea reaching back hundreds of years. In the 18th century the framers of the US Constitution included a provision that calls on the Congress to grant authors and inventors "the exclusive Right to their respective Writings and Discoveries" in order to promote progress in science and the arts.

In the intervening years, robust IP rights have helped spark innovation and growth in countries - both developed and developing - throughout the world. As much as 40 per cent of US growth in the 20th century was a result of innovations, according to Nobel laureate Robert Solow. And one of India's most successful companies - Tata - has prospered on the strength of its IP. As of 2012, Tata Motors held 833 patents and Tata Steel had 1,230 patents.

Just as countries with strong IP rights have a foundation for prosperity, countries lacking such protections find innovation and growth more daunting. It is sadly unsurprising that India receives low marks on innovation scorecards. As President Pranab Mukherjee pointed out in his National Technology Day speech in May, "India's innovation bottom line is not very encouraging." He observed that the US and China receive 12 times as many patent applications as India.

Regrettably, he did not elaborate on how IP rights foster innovation - nor did he dwell on how these protections encourage foreign direct investment (FDI). It is well established that such investment brings with it new technologies, higher productivity and wages, and spillovers to other firms that spur modernisation. International businesses also bring R&D to countries that provide supportive environments. That increased R&D is often aimed at unmet local needs, such as drug company investment in tropical disease research. Weak IP protection directly discourages such R&D.

While India did revise its IP laws in 2005, enforcement has been inconsistent, at best, and carve-outs for generic drugs have compromised its integrity to the short-term benefit of the owners of generic companies. These shortcomings help explain why India attracts a mere three per cent of global R&D spending. (China, with its stronger IP law, attracts about 14 per cent and Japan about 11 per cent, reports the Battelle Institute.) These data reinforce the World Bank's findings that multinational firms locate R&D in developing countries with effective IP rights.

As noted, corporations consider IP protections when making decisions about where to direct their FDI. The Organisation for Economic Cooperation and Development has found that a one per cent change in the strength of a country's IP rights environment is associated with a 2.8 per cent increase in FDI inflows. That's bad news for India. From 2010 to 2012, the United Nations reports, India's stock of FDI totalled just 11.8 per cent of its GDP. The average for all developing economies was 30 per cent.

While these data underscore India's failure to attract foreign investment, some argue that IP conflicts with Indian interests. The reality is quite different, as explained by Kiran Mazumdar-Shaw, chairman of Bangalore-based Biocon. "We must understand that intellectual property is important for India to embrace and respect and protect," she told the Press Trust of India. "If you cannot demonstrate that IP is safe in the country, I think you are not sending the right message, you are not going to find people investing in India."

Moreover, IP is not the obstacle to access to healthcare that some officials and activists allege. The Supreme Court's recent decision denying Novartis's rights to Glivec, a patent recognised in over 40 countries, has been acclaimed as an advance in patient access. However, Novartis was already ensuring that 95 per cent of the Indians who were prescribed Glivec received the cancer medicine for free.

The very real obstacles to medical access in India stem principally from the government's failings. It devotes a mere 1.2 per cent of GDP to health care, a level lower than in Haiti, and India lacks the insurance, doctors, clinics and hospitals necessary to make use of the full potential of modern medicine. These monumental challenges won't be addressed by headline-catching patent revocations, but will require sustained investment and reform.

If India is serious about attracting FDI and becoming an innovation hub, it should reform its IP law to ensure the protections that are a mainstay of the world's advanced economies. Absent such protections, R&D will regrettably go elsewhere, India's "innovation bottom line" will continue to disappoint, and, most troubling, the Indian people will be denied new opportunities, new knowledge, and new medicines.

Protecting patents: India worst in world

Despite the current decade being called Indias “decade of innovation”, the country has been ranked at the bottom of the list of 25 countries in terms of its intellectual property (IP) environment. According to the 2014 International Intellectual Property (IP) Index by the US Chamber of Commerce’s Global Intellectual Property Center (GIPC), India’s percentage score has fallen from 25 per cent in 2012 to 23 per cent.

“The continued use of compulsory licences, patent revocations, and weak legislative and enforcement mechanisms raise serious concerns about India’s commitment to promote innovation and protect creators,” the report said.

The index, titled Charting the Course, gives a snapshot of the IP environment of 25 countries.

David Hirschmann, president and Chief Executive Officer of GIPC, said: “Nations – big and small – are wrestling with domestic legislation, judicial proceedings, criminal proceedings, and other processes regarding IP. These are all opportunities to chart a course toward a strong IP environment.”

He said along with these opportunities, some countries are taking backward steps on IP. “India, which again finished last in the second edition of the Index, continues to allow for the deterioration in its IP climate.”

The US is the highest-ranking country, followed by the UK and France. The five BRICS economies — Brazil, Russia, India, China, and South Africa — continue to face serious challenges.

According to the report, several factors led to the deterioration of the IP environment in India. For instance, in the biopharmaceutical sector, “Indian policy continued to breach international standards of the protection of innovation and patent rights, revoking patents generally accepted around the world and announcing that other patented medicines are being considered for compulsory licences.”

The report also mentions the Supreme Court’s April 2013 ruling on the patentability of the anti-cancer drug, Glivec, that the drug does not meet patentability standards imposed by the Indian Patent Act.

India scored poorly in the areas of patents, copyrights, enforcement, membership and ratification of international treaties (in which it scores zero), among others.

“The continued use of compulsory licences, revocation of patents, and weak legislative and enforcement mechanisms across all IP rights raise serious concerns about India’s commitment to promoting innovation,” the report said.

Most high-income economies — with notable exceptions such as Canada, New Zealand, Chile, and the United Arab Emirates (UAE) — have robust national IP environments in place. The weakest national IP environments are in the lower-middle-income countries such as Vietnam, Indonesia, Thailand, and India.

Some of the developments, which are expected to improve the IP climate globally include the fact that currently 12 countries — the US, Japan, Australia, Peru, Malaysia, Vietnam, New Zealand, Chile, Singapore, Canada, Mexico, and Brunei Darussalam — are negotiating the Trans-Pacific Partnership Agreement, which is expected to set a higher standard in the Pacific region, and help in protecting and enforcing IP.

Moreover, the US is currently negotiating with the European Union on a trade and investment partnership agreement, which is supposed to promote competitiveness, growth, and jobs.

China continues to show strength in the patents arena, earning the highest score of all middle-income countries and even outperform high-income countries such as Chile and the UAE. While progress is being made, China’s overall IP environment continues to see challenges, particularly with regard to trademark and trade secrets as shown by its overall score.

According to a 2013 study by the European Patent Office and the Office of Harmonization for the Internal Market on the impact of IP rights and IP-based industries on the EU economy, IP-intensive industries generated almost 26 per cent of all direct and 35 per cent of indirect jobs.

The report also found that IP-intensive industries produced almost 39 per cent of EU-wide gross domestic product (GDP), worth almost euro 5 trillion.


IPAB refers opposition to anti-cancer drug to patent office

The Intellectual Property Appellate Board (IPAB) has asked the patent office to consider afresh a matter related to the patent application of US-based Abraxis BioScience for its anti-cancer drug Abraxane, following pre-grant opposition by Hyderabad-based Natco Pharma.

Natco has developed a generic version of the drug under the brand name Albupax. Emails sent to Celgene, which acquired Abraxis BioScience in 2010, and Natco Pharma for comment on the order didn’t elicit a response till the time of going to press.

IPAB set aside an order of the Assistant Controller of Patents & Designs, saying it was passed in “flagrant violation of principles of natural justice”. An order issued by IPAB Chairman K N Basha and technical member (patents) DPS Parmar said it remanded the matter to the Assistant Controller of Patents & Designs for fresh consideration. It also directed the procedure be completed within three months from the date of the IPAB order.

On July 24, 2009, the assistant controller of patents & designs had refused to grant a patent to US-based Abraxis BioScience’s albumin-bound paclitaxel for an injectable suspension that had the brand name Abraxane and was used in the treatment of breast, lung and pancreatic cancers.

It has a net sales of $649 million and is expected to reach $1.5-2 billion by 2017, said the company's counsel. Abraxis Bioscience was acquired by New Jersey-based Celgene Corporation during 2010 and the upfront payment value of Abraxis BioSciences was at around $2.9 billion.

Natco Pharma complained that they were not offered a copy of an affidavit from Anindy Sircar who was a representative from Biocon, which was filed by Abraxis to establish enhanced efficacy. The bench ordered that the Assistant Controller should provide a copy of a particular affidavit to the generic manufacturer and they shall be given opportunity to give reply.

Justice Basha said that the bench is not going into the merits of the claim and contention of both the sides on merit and the order is only on the contention that there is a violation regarding principles of natural justice.

The first priority application for patent on the drug was filed by Abraxis on December 9, 2002 and the application was published under section 11 (A) on April 1, 2007, after which Natco Pharma has filed a pre-grant opposition against giving approval of patent to the drug. Natco has developed the generic version of the drug, under the brand name Albupax.

The originator firm argued in IPAB that the decision of Assistant Controller of Patents was wrong, and the order in dispute is liable to be set aside for gross violation of principles of natural justice. It contested that the Assistant Controller has heard and put in order on the grounds of insufficiency (which means the claims are not supported by the examples and description), which was not pleaded by Natco.

It also argued that the controller did not provide opportunity to the company to argue the dispute as per provision under Section 14 of the Patent Act, 1970, which is appealable. Instead, the petition was argued under section 25(1), which was not appealable during 2009. The counsel appeared for Abraxis informed that it was only after a Delhi High Court order observing that the pre-grant opposition is appealable, that the company could file an appeal with the IPAB.

The company also argued that during the procedure in the patent office, on March 10, 2009 Natco Pharma filed additional document and Abraxis objected taking this into consideration through an interlocutory petition. Without even looking into the said petition the controller proceeded to hear the matter, it alleged.

The counsel appeared for Natco argued that the impugned order does not cause any violation of principles of natural justice and said that the patent official was right in refusing patent for the drug.

The IPAB bench said that the finding and consideration on the ground of insufficiency, especially when it was not pleaded, “is illegal”.


Sunday, December 22, 2013

Intellectual Property – Copyright, Patent, Trademark, Industrial Design, Geographical Indications

Intellectual property refers to creations of the mind, such as inventions; literary and artistic works; designs; and symbols, names and images used in commerce. Intellectual property is protected in law by, for example, patents, copyright and trademarks, which enable people to earn recognition or financial benefit from what they invent or create. By striking the right balance between the interests of innovators and the wider public interest, the Intellectual property system aims to foster an environment in which creativity and innovation can flourish.

Intellectual property

Copyright is a legal term used to describe the rights that creators have over their literary and artistic works. Works covered by copyright range from books, music, paintings, sculpture and films, to computer programs, databases, advertisements, maps and technical drawings.

A patent is an exclusive right granted for an invention. Generally speaking, a patent provides the patent owner with the right to decide how - or whether - the invention can be used by others. In exchange for this right, the patent owner makes technical information about the invention publicly available in the published patent document.

A trademark is a sign capable of distinguishing the goods or services of one enterprise from those of other enterprises. Trademarks date back to ancient times when craftsmen used to put their signature or "mark" on their products.

Industrial designs
An industrial design constitutes the ornamental or aesthetic aspect of an article. A design may consist of three-dimensional features, such as the shape or surface of an article, or of two-dimensional features, such as patterns, lines or color.

Geographical indications
Geographical indications and appellations of origin are signs used on goods that have a specific geographical origin and possess qualities, a reputation or characteristics that are essentially attributable to that place of origin. Most commonly, a geographical indication includes the name of the place of origin of the goods.

Monday, December 16, 2013

Delhi High court - pleadings in patent copyright infringement cases

In two interesting judgments, in two different cases, Justice Murlidhar of the Delhi High Court has ruled on the scope of pleadings in patent infringement lawsuits and the liability of Indian subsidiaries of global app-stores in copyright infringement lawsuits filed by a book publisher.
1. Telefonaktiebolaget LM Ericsson v. Mercury Electronics & Anr.
This is the famous Micromax case that we have blogged about previously on the blog overhere and here. Ericsson has sued Micromax for a sum of Rs. 100 crores for infringing 6 of its standard essential patents and even got an ex-parte interim injunction on the very first day.
This specific order of Justice Murlidhar, dated December 6, 2013 (available over here) was necessitated by an interlocutory application filed by Ericsson under S. 151 of the CPC requesting the Court to take on record certain affidavits by Ericsson’s executives and a claim-chart in a sealed envelope. The order is not very clear on why these affidavits were filed under S. 151 (which deals with the ‘inherent powers of the court and is supposed to be a provision of the last resort).
Micromax however did object to the attempt to bring on record the affidavits, with its counsel Akhil Sibal arguing as follows:
“Ericsson has failed to construe each of the suit patent claims in the body of the plaint itself. He submits that in a suit for infringement of patents, it was mandatory for the Plaintiff to set out, in detail, the claims under the patents as well as explain whether the patent covered a particular component/element/device/method etc. corresponding to a technical specification for a technology that forms a part of a standard. In other words, it was necessary for the Plaintiff to show that the suit patent was an essential patent for such standard. According to him, merely describing the function of each patent, as has been done in para 20 of the plaint, is insufficient. He stated that the plaint only described the net result that could be achieved by deploying the suit patents and not how that result was achieved.”
Sibal continued with the argument that “that the attempt to bring on record the affidavit of Mr. Olofsson ought not to be permitted. It would amount to indirectly permitting the plaint to be amended to make good an obvious defect. He submitted that Court should consider Ericsson’s prayer for interim injunction only on the basis of the existing pleadings without taking into account the affidavit of Mr. Olofsson.”
 Given the fact that Singh & Singh the law firm representing Ericsson, engaged three top-notch Senior Advocates to argue the matter, it was obviously a high-stakes issue for Ericsson.
Examining the precedents on the point, the High Court summarised the position of law as follows “In sum, the law explained in the above decisions is that the plaint itself must set out with sufficient clarity the specifications and the claims under the suit patent, the results they seek to achieve and in what manner the defendants have infringed the suit patents.”
After examining the affidavits, the Court concluded that the information disclosed in the affidavits was within the purview of the plaint & the documents filed along with the plaint and hence Ericsson was allowed by the High Court to bring on record the affidavits. Ericsson can therefore use these affidavits to argue even the interim injunction.
The decision could have been more nuanced. For example a plaint is supposed to contain only facts and the issue of claim construction, infringement etc. are mixed issues of law and fact. Indian courts should therefore give plaintiffs more leeway in drafting of their pleadings. Expecting plaintiffs to pack their plaints with the most intricate details of their patents is going to make matter very complicated.
2. Blueberry Books & Othrs v. Google India Pvt. Ltd. & Othrs
In this first of its kind lawsuit, Blueberry Books a publisher of children’s books had sued a web and mobile application developer for making available books on an app titled “Story Time for Kids”, whose copyright was owned by the Plaintiff, through various app-stores, without taking prior permission of the Plaintiff. The remaining defendants were Google Inc., Research in Motion, Apple and Amazon, along with their Indian subsidiaries (with the exception of Amazon), because the app in question was made available through these online stores.
The present judgment of Justice Murlidhar, issued on November 28, 2012 (available overhere) was with specific regard to Order 1 Rule 10 applications filed by the Indian subsidiaries of Google, RIM & Apple on the grounds that they had no control over the app-stores in question.
Blueberry, argued that the subsidiaries were necessary parties since they had assets within India unlike their parent companies. The Court declined to buy this argument concluding that “The mere fact that Defendant No.2 happens to be the subsidiary of Defendant No.1 and Defendant No.3 a subsidiary of Defendant No.4 would not be sufficient for making them parties to the suit, if they are not, in any way, involved in the infringing activities complained of.” As a result, the Court deleted the subsidiaries of Google Inc. and RIM.
Apple,  was not so lucky. The Court ruled that prima facie it appeared that the iTunes stores could be accessed through the website of Apple India Pvt. Ltd. thereby giving enough cause to retain Apple India as a party to the suit. The Court ruled that the issue of whether Apple India Pvt. Ltd. had control over iTunes, could be decided only after evidence was led during trial.
Amazon Inc.,  argued that it should be exempted on the grounds of lack of jurisdiction since the app in question could be downloaded only within the U.S. Hence Amazon argued that only the American Courts would have jurisdiction over the claims for copyright infringement. Justice Murlidhar agreed and deleted Amazon from the array of parties.