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.

Conclusion:

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.

Delhi High Court Order:

http://lobis.nic.in/dhc/SRB/judgement/20-03-2015/SRB20032015FAOOS1902013.pdf  

http://spicyip.com/2015/03/delhi-high-court-grants-interim-injunction-restrains-glenmark-from-selling-generic-version-of-anti-diabetic-drug-januvia-sitagliptin.html

Classified Patents, Nintendo, Amazon: Intellectual Property

A 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).

http://www.bloomberg.com/news/2014-12-26/classified-patents-nintendo-new-balance-intellectual-property.html

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.

THIS IS THE MOST HOSTILE THE COURTS HAVE BEEN TO SOFTWARE PATENTS IN AT LEAST TWO DECADES

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.

YOU CAN'T TAKE A COMMONPLACE HUMAN ACTIVITY, DO IT WITH A COMPUTER, AND CALL THAT A PATENTABLE INVENTION

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.

Why do so many patent lawsuits involve software?

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 Amazon.com 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.

Source: http://www.vox.com/2014/9/12/6138483/software-patents-are-crumbling-thanks-to-the-supreme-court#

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.

http://www.theguardian.com/commentisfree/2014/sep/08/human-dna-belongs-to-no-one-it-shouldnt-be-patented

Nvidia files a patent lawsuit against Samsung and Qualcomm

Nvidia filed patent infringement lawsuits in Delaware against Samsung and Qualcomm concerning graphics processor technologies which Nvidia claims those companies have used in their products without license.

The graphics chip maker also asked the U.S. International Trade Commission (ITC) "to block shipments of Samsung Galaxy mobile phones and tablets containing Qualcomm's Adreno, ARM's Mali, or Imagination's PowerVR graphics architectures."

Nvidia's Tegra mobile processors with GPU functionality compete with Qualcomm's Snapdragon and Samsung's Exynos chips.

Among the products Nvidia wants blocked are Samsung's Galaxy Note Edge,Galaxy Note 4, Galaxy S5, Galaxy Note 3, and Galaxy S4 smartphones, as well as the Galaxy Tab S, Galaxy NotePRO, and Galaxy Tab 2 tablets.

Nvidia said the seven patents it is claiming Qualcomm and Samsung have infringed concern GPU technologies like programmable shading, unified shaders, and multithreaded parallel processing.

The lawsuits are the first patent infringement complaints Nvidia has made in its 21-year history, the company.

"As the world leader in visual computing, Nvidia has invented technologies that are vital to mobile computing. We have the richest portfolio of computer graphics IP in the world, with 7,000 patents granted and pending, produced by the industry's best graphics engineers and backed by more than $9 billion in R&D," Nvidia CEO Jen-Hsun Huang said in a statement.

"Our patented GPU inventions provide significant value to mobile devices. Samsung and Qualcomm have chosen to use these in their products without a license from us. We are asking the courts to determine infringement of Nvidia's GPU patents by all graphics architectures used in Samsung's mobile products and to establish their licensing value."

Samsung told PCMag it had no comment on the matter. A Qualcomm spokesperson said the company was "aware of the complaints and [we] are evaluating them."

At issue for Nvidia are Qualcomm's proprietary Adreno GPU cores used in the Snapdragon processors, which power many of Samsung's mobile devices, as well as ARM's Mali GPUs and Imagination Technologies' PowerVR GPUs, which are used in Samsung's own Exynos mobile chips.

Nvidia claimed that it reached a dead end in negotiations with Samsung on negotiations to license its IP for use in Samsung's devices.

"With Samsung, Nvidia's licensing team negotiated directly with Samsung on a patent portfolio license," Nvidia's David Shannon said. "We had several meetings where we demonstrated how our patents apply to all of their mobile devices and to all the graphics architectures they use. We made no progress. Samsung repeatedly said that this was mostly their suppliers' problem."

http://www.pcmag.com/article2/0,2817,2467372,00.asp