Thursday, May 7, 2015

Which " reforms " are we talking about in Indian patent Law

There appears to be some confusion.

Mr. Hatch ( probably the hatch-Waxman-Act fame ) is putting pressure on US govt by saying that India has done some IP violations during international trade. This happened on 30th April . See here

Beats me which violations ? Does anybody know ?

Where is the confusion ?

PM said that a newly formed "IPR think tank" had been set set up and its 'suggestions' will be adopted. Interestingly the three member committee initially set up in July 2014 (which released a draft report See here .) was arbitrarily scrapped 3 days after its report ( now scrapped) was filed and a new 6 member team was formed which submitted a 30 page report in December 2014 read here . PM has been referring to this draft but the 'suggestion' are not known in public domain.

It is speculated that the suggestions shall comprise Data Exclusivity and Patent Linkage which in fact are TRIPS plus provisions.


Commerce and Industry minister Ms. Sitharaman says that Indian IP law is strong enough and in compliance with TRIPS . see here

On one side PM wants to revise the IPR policy whereas the commerce minister stands by the present policy. This is the confusion.

We await how the future unfolds.

What is not confusing for sure though ..is that ...the pharmaceutical business is behind this  & the Section 3d... which nails the 20 year patent monopolies applied for through claiming incrementally derived synthetic modifications to the existing drugs which fail to document enhancement (at least 30%, do not recollect where did I find this number ..but it does exist somewhere in relevant literature, I will have to dig..) in desired net therapeutic effect.

If the slumdogs of the third world could innovate with the Joneses residing in economies where Iyn Rand still rules the minds ...that is the question.

Is India really ready to face the challenges of brave new market forces ? Can India hinder the wrongful diversion of material made under compulsory licence ? How long can India hide behind the excuses of accessibility / affordability and yet wish to benefit from the outcome of innovative efforts carried out in large MNCs ?


Sunday, December 14, 2008

Sweat News for Generic Sugarbusters


I am always entertained by Pioglitazone news items appearing every now & then. It is an ancient molecule. I made it in 1990 while at BootsPharmaceuticals. Dr. Lokhande & Mr. Joshi were the fine chemists in my group who synthesised it. We needed it along side Ciglitazone and asankyo compound CS 045 for comparing the activities of compounds inour Antidiabetic screening programme.
Pioglitazone still lives on in the Actos. Year 2010 expiry whichappeared distant is now nearing rapidly. Thanks to Hatch & Waxman.------------------------------------------------------------------------------------ Quoting from Pharmabiz.com
US court upholds Takeda's award of attorney's fees on Actos patent caseSaturday, December 13, 2008 15:00 ISTOsaka, Japan


Takeda Pharmaceutical Company Limited (Takeda) announced that the USCourt of Appeals for the Federal Circuit affirmed Takeda's award ofattorneys' fees against generic drug manufacturers, Mylan Inc andAlphapharm Pty, Ltd, arising out of Takeda's successful enforcement ofits patent covering the active ingredient in ACTOS (pioglitazonehydrochloride). Mylan Inc must pay Takeda and its wholly-ownedsubsidiary, Takeda Pharmaceuticals North America, Inc (TPNA) $11.4million plus interest, and Alphapharm Pty, Ltd. must pay $5.4 millionplus interest.
Takeda and TPNA sued Mylan and Alphapharm for patent infringement as aresult of their filing of Abbreviated New Drug Applications (ANDAs)seeking FDA approval to market a generic version of Takeda's ACTOS.Mylan and Alphapharm challenged the validity and enforceability of USPatent No. 4,687,777 which covers pioglitazone, the active ingredientin ACTOS. The US District Court for the Southern District of New Yorkheld that the Mylan and Alphapharm challenges to the '777 patent werenot certified in good faith, as required by the Hatch-Waxman Act. TheCourt also found that both Mylan and Alphapharm had engaged inlitigation misconduct. The court awarded Takeda its full amount ofattorneys' fees claimed against both Mylan and Alphapharm. Thatdecision was affirmed by the US Court of Appeals for the FederalCircuit on December 8, 2008

Sunday, October 19, 2008

Absent Innovation culture, Disowning and Other Dangerous things

If you remember Prof. George Lakoff, by reading this title, you are right. This renowned linguist wrote a book entitled “Women, Fire and other dangerous things” where he addressed interesting aspects of categorisation. I wouldn’t elaborate on it here. The book must be read in original though. This I mentioned since I borrowed Prof. Lakoff’s style.

Present text is about the attendant hue & cry about so called corruption in Indian patent office. This tempest was set in by a small butterfly article fluttering its wings in the Mint.

What is on record is that about 130 patent examiners in Indian Patent office helped grant about 15000 patents in one year (2007-08). This has been compared to EPO statistics where 4000 examiners helped grant 54000 patents in a year. An inference is drawn without any evidence on record that the system is greased with money which makes so many applications go through smoothly.

One wonders if this is fair to so many serious examiners who might be doing their jobs right without ‘extra cash’ as a carrot. I am not saying that all is well in Indian patent offices. In fact a couple of months back, I almost fainted after receiving an answer from a guy in Patent office’s library whom I asked if Dr. Mashelkar visited there in recent past. He coolly told me to leaf through the visitor’s register there kept in a corner in which all library visitors wrote their names. He just didn’t know who Dr. Mashelkar was. But by quoting this example I wouldn’t generalise that whole office staff is absolutely ignorant.

Likewise for a few examiners who might be part of dangerous liaisons during some part of grant process, I would not condemn the whole system. It ain’t cricket!


India might be having patent protection mechanism since 1911 but patent awareness is of recent times. If Britons are to be credited for installing this system, they may not shrug off the dire failure in teaching technocrats patentese and for failure in sowing the seeds of innovation culture.

The innovation culture is just absent here. Indians traditionally are just not into observing, documenting and using the surroundings for their material well being. If I write that science culture itself is absent, I might invite an avalanche of criticism. But I will tell you something. Although I have used the word ‘canary yellow precipitate’ several times while describing an outcome of certain chemical test, I have not seen Canary till now. I even didn’t know for quite long that this was name of a bird found in western countries and not sighted at all in India. Indians get science educated in a setting where the teachings are not internalised. Above example can be contrasted with my own experience when I was TA'ing in north america. There I came across a stunning visual description of a chemical reaction product which ‘looked like a rotten beer” to an undergrad in my lab. The product really looked like a rotten beer. The pragmatic thinking of west didn’t grow overnight. West has had a long tradition since renaissance period. Indian renaissance may be dated to 1947 the year of freedom.

Now the inventors and patent examiners are also product of this culture where ‘innovation is not intrinsically respected’. Property is hated, owning something is just a matter of following grand design. ‘Disowning’ is great. “Obedience” has to be inculcated. These are the memes we in India have grown-up with.

Corruption if any (and it could be there) would be just a symptom of several dangerous & deep seated issues.
Now Indians can’t claim monopoly on corruption. It will be very naïve to eliminate incidences of corrupt practices in patent offices of other countries.

If I were a Patent Examiner with a target of finishing at least 10 applications per month alongside attending several training sessions, I am better off going by what Assistant Controller allows. I won’t venture being a maverick. I wouldn’t see many mavericks upstairs too, so why set an example which will not benefit me? Moreover, why should I risk my career for the so called inventors who are busy in exploiting consumers? I am good in handling language, good in referring to the patent manual & have several applicants or their representatives eager to give me free ego trips. I wouldn’t do knit-picking what others afford to do sitting in easy-chairs ; I would just do my job because that’s my choice, last year when I visited Vaishnvi devi or Nasik an year before ; I thanked god for the bread & butter provided to me. I would rather carry on with this job, enjoy whatever ego gratification it provides without worrying about fancier pastures. I have done fairly well for my background. I am doing OK. Nothing earth shaking is happening around me. These big inventions and that entire publicised innovation news item are good as a read with a glass of fruit juice I have begun to afford these days. Nothing can be innovated, it is already with you; it is only resurrected. I cannot maintain few properties I have. Many times I think they are not mine, it is my luck that I am blessed with the material wealth I have. Things are fine the way they are. It is all pre decided.


I do not think quixotic expectations from Patent Examiners will lead to quality enhancements overnight. A person in the system is a part of the society he/she comes from. If managing more than one house, civil properties is difficult, one just can’t be expected to know the prowess of intellectual property & to know how wealth could be generated through it across the borders.
It is not far stretched.

Where Innovation culture is absent & distributing something to everybody like ‘Prasad’ is commonplace, claiming ownership on the technological advances is difficult to digest.
This again is not far stretched.

The persons who are not serious about respecting innovative activities, who do not respect ownership on intellectual property and who will not assert at right place on right time, will not be able to function properly as the facilitators of innovative culture.

One just can’t say - “I want these examiners to follow the Manual verbatim, if you can’t get the job done, clear the place”. The examiners are not robots.

One has to address this issue in holistic manner to attain desired goal of honest & transparent system. Smartly worded and ill founded criticism without deep analysis will only harm the system. There are better ways of catching attention than putting examiners/agents in a corner and squandering accusations.

Good structured training, adequate patience and empathy will help the examiners at various stages on the learning curve. It is surely understandable that we expect exquisitely drafted FER, a prudent application of law and overall a well home- worked boldness in performing on this extremely important position. But it is going to take time.

Patent examiner being part of the absent-innovation-culture will not feel the sanctity of patent law.

Thank you for reading.

Saturday, October 11, 2008

Check the numbers before you are tempted to believe in them

I have always wondered about authenticity of statistics quoted in popular journalism. Say CRO earnings in pharmaceuticals in India or CRO/BPO projects lost/gained by Indian Industry. Many times numbers are too large to comprehend for a middle class mind. But the numbers are attractive enough to remember & tempting enough to pass on to each other after 4 beers.

One would ask , what is the harm ?

Actually right question would be , where is the beaf ?!!

I have always intuitively felt that , major workforce stems from the middleclass which contributes to churning out the value in any organisation. That workforce is too busy to verify the statistics. Their decisions about continuing in the present job are propelled by how green they think is the grass on other side of the fence. Incorrect money statistics leads to wrong perception. Persons are lured into quitting the jobs , based upon what they think is their market value elsewhere.

Wrong statistics leads to wrong moves. I need not elaborate the cascade effects it may illicit thru out the industry segment.

I am quoting here one article which describes the 'Phantom Figures' in circulation on IP lost in USA due to piracy.
http://arstechnica.com/articles/culture/dodgy-digits-behind-the-war-on-piracy.ars/1" target="_blank">http://arstechnica.com/articles/culture/dodgy-digits-behind-the-war-on-piracy.ars/1

If you pay any attention to the endless debates over intellectual property policy in the United States, you'll hear two numbers invoked over and over again, like the stuttering chorus of some Philip Glassopera: 750,000 and $200 to $250 billion. The first is the number of U.S. jobs supposedly lost to intellectual property theft; the second is the annual dollar cost of IP infringement to the U.S. economy.These statistics are brandished like a talisman each time Congress isasked to step up enforcement to protect the ever-beleaguered U.S.content industry. And both, as far as an extended investigation byArs Technica has been able to determine, are utterly bogus. "I have said it thrice," wrote Lewis Carroll in his poem The Huntingof the Snark, "what I tell you three times is true." And by thatstandard, the Pythagorean Theorem is but schoolyard gossip comparedwith our hoary figures. As our colleagues at Wired noted earlier thisweek, the 750,000 jobs figure can be found cited by the U.S.Department of Commerce, Customs and Border Patrol, and the U.S.Chamber of Commerce, among others. Both feature prominently onTheTrueCosts.org, an industry site devoted to trumpeting the harms ofpiracy. They're invoked by the deputy director of the U.S. Patent andTrademark Office. And, of course, they're a staple of indignant pressreleases from the congressional sponsors of tough-on-piracy legislation. By more conventional standards of empirical verification, however,the numbers fare less well. Try to follow the thread of citations totheir source, and you encounter a fractal tangle of recursivereference that resembles nothing so much as the children's gameknown, in less-PC times, as "Chinese whispers," and these days moreoften called "Telephone." Usually, the most respectable-sounding authority to cite for the numbers (the FBI for the dollar amount,Customs for the jobs figure) is also the most prevalent, but in each case, that authoritative "source" proves to be a mere waystation on along and tortuous journey. So what is the secret origin of these ubiquitous statistics? What doomed planet's desperate alien statisticians rocketed them to Kansas? Ars did its best to find the fountainhead. Here's what we discovered.

Looking for lost jobs First, the estimate of 750,000 jobs lost. (Is that supposed to be per year? A cumulative total over some undefined span? Those who cite thefigure seldom say.) Customs is most often given as the source forthis, and indeed, you can find press releases from as recently as2002 giving that figure as a U.S. Customs and Border Patrol estimate.Eureka! But when we contacted CBP to determine how they had arrivedat that imposing figure, we were informed that it was, in essence, agoof. The figure, Customs assured us, came from somewhere else, andwas mistakenly described as the agency's own. This should come as no great surprise: CBP is an enforcement agency, whereas calculating thetotal loss of jobs from IP infringement would require someterrifyingly complex counterfactual modeling by trained economists. Similar claims have appeared in Customs releases dating back at least to 1993, but a CBP spokesperson assured us that the agency has neverbeen in the business of developing such estimates in-house. With Customs a dead end, we dove into press archives, hoping to findthe earliest public mention of the elusive 750,000 jobs number. And we found it in (this is not a typo ) 1986. Yes, back in the days when"Papa Don't Preach" and "You Give Love a Bad Name" topped the charts,The Christian Science Monitor quoted then-Commerce Secretary MalcomBaldridge, trumpeting Ronald Reagan's own precursor to the recentlypassed PRO-IP bill. Baldridge estimated the number of jobs lost tothe counterfeiting of U.S. goods at "anywhere from 130,000 to 750,000." Where did that preposterously broad range come from? As with thenumber of licks needed to denude a Tootsie Pop, the world may neverknow. Ars submitted a Freedom of Information Act request to the Department of Commerce this summer, hoping to uncover the basis ofBaldridge's claim (or any other Commerce Department estimates of joblosses to piracy) but came up empty. So whatever marvelous proof the late secretary discovered was not to be found in the margins of any document in the government's vaults. But no matter: By 1987, that Brobdignagian statistical span had been reduced, as far as the presswere concerned, to "as many as 750,000" jobs. Subsequent reportage dropped the qualifier. The 750,000 figure was still being bandied about this summer in support of the aforementioned PRO-IP bill. $250 billion? What's that in real money? What, then, of that $200 to $250 billion range? Often, it's attributed to the Federal Bureau of Investigation, and indeed, theBureau routinely cites those numbers. According to FBI spokespersonCatherine Milhoan, the figure "was derived through our coordinationwith industry, trade associations, rights holders, and other lawenforcement agencies" at a 2002 anti-piracy confab. But neither theBureau nor the National Intellectual Property Rights CoordinationCenter, which assembled the inter-agency powwow, could find anyrecord of how that number was computed. At this point, it's necessary to get a little speculative. As withCustoms, the FBI is not in the habit of doing sophisticated economicanalysis in-house. And the last time the government conducted anysort of verifiably rigorous study of the costs of IP theft=97aboutwhich more presently=97it was a protracted undertaking that involvedsending detailed questionnaires to hundreds of businesses, whichgovernment economists concluded was still insufficient to produce areliable figure for the economy as a whole. However, $250 billion is about the number you come up with if you start with $200 billion in1993 dollars and adjust for inflation to 2002. And that lower end ofthe range, $200 billion, happens to date back to 1993. Another group that routinely uses the $200 to $250 billion figure isthe International Anti-Counterfeiting Coalition, which (along withthe FBI) is often given as the source of the number. Thatorganization's white papers, as recently as 2005, footnote the figureto 1995 congressional testimony urging passage of what became theAnticounterfeiting Consumer Protection Act of 1996. So Ars dug intothe archives at the Library of Congress to discover where thewitnesses before the House and Senate Judiciary Committees got theirdata. Several of the witnesses were conspicuously vague about theirsources. An IACC factsheet submitted for the hearings said the groupitself "estimates the economic cost due to product counterfeiting toexceed $200 billion each year," a number repeated by the group's then-president, John Bliss. Congressman Bob Goodlatte (R-VA) gave the samefigure without sourcing. But several witnesses pointed to Forbesmagazine as the source of the number. Rep. John Conyers (D-MI) notedthat the International Trade Commission had placed the size of thecounterfeit market at $60 billion in 1988 and that "a more recentestimate by Forbes Magazine says that American businesses are losingover $200 billion each year as a result of illegal counterfeiting."Finally, Charlotte Simmons-Gill of the International TrademarkAssociation was kind enough to give a precise citation: the October25, 1993 issue of Forbes. Ars eagerly hunted down that issue and found a short article oncounterfeiting, in which the reader is informed that "counterfeitmerchandise" is "a $200 billion enterprise worldwide and growingfaster than many of the industries it's preying on." No furthersource is given. Quite possibly, the authors of the article called up an industrygroup like the IACC and got a ballpark guess. At any rate, there isnothing to indicate that Forbes itself had produced the estimate, Mr.Conyers' assertion notwithstanding. What is very clear, however, isthat even assuming the figure is accurate, it is not an estimate ofthe cost to the U.S. economy of IP piracy. It's an estimate of thesize of the entire global market in counterfeit goods. Despite theefforts of several witnesses to equate them, it is plainly not on parwith the earlier calculation by the ITC that many had also cited. But here, at last, we have a solid number to sink our claws into,right? Sure, it's 20 years old, but the U.S. International TradeCommission at least produced a reputable study yielding a definitefigure for the cost of piracy to the U.S. economy: $60 billion annually. Well, not quite. "Biased & self-serving" The number the ITC actually came up with, based on a survey ofseveral hundred business selected for their likely reliance on IP forrevenue, was $23.8 billion=97the estimated losses to their respondents.That number was based on industry estimates that the authors of the study noted "could admittedly be biased and self-serving," since the firms had every incentive to paint the situation in the most dire terms as a means of spurring government action. But the figures atleast appeared to be consistent and reasonable, both internally andacross sectors. The $60 billion number comes from a two-page appendix, in which theauthors note that it's impossible to extrapolate from a self-selecting group of IP-heavy respondents to the economy as a whole.But taking a wild stab and assuming that firms outside their sampleexperienced losses totaling a quarter to half those of theirrespondents, the ITC guessed that the aggregate losses to the economymight be on the order of "$43 billion to $61 billion." The survey also, incidentally, asked respondents to estimate thenumber of job losses they could attribute to inadequate intellectualproperty protection. The number they came up with was 5,374. If weassume, very crudely, that job losses are proportionate to dollarlosses, then the ITC's high-end estimate of $61 billion in totaleconomic costs would correspond to a loss of not 750,000 jobs, but 13,774. If we want to be very precise, however, we should note that the ITCwas not calculating losses from IP "theft," but rather "inadequateprotection" of intellectual property. And "inadequate protection" wasinterpreted to mean protection falling short of the level provided byU.S. law. The protection provided by a foreign country might bedeemed "inadequate," the study explained, if "exceptions to exclusiverights are overly broad" for example, if a country's law contained"broad exceptions for public performances in hotels or film clips" or"too broad exceptions for educational photocopying." A legal regime could be "inadequate" because "terms of protection are too short" or because of "inadequate" civil or criminal remedies, meaning monetarydamages or criminal penalties for infringers were not high enough. Calculating the net cost of piracy to the economy One final, slightly theoretical point deserves emphasis here. All theprojections we've discussed, the rigorous and the suspect alike,calculate losses in sales or royalties to U.S. firms. This is oftenconflated with the net "cost to the U.S. economy." But those numbers (whatever they might be ) are almost certainly not the same. When someone torrents a $12 album that they would have otherwise purchased, the record industry loses $12, to be sure. But that doesn't mean that $12 has magically vanished from the economy. On the contrary: someone has gotten the value of the album and still has $12 to spend somewhere else. In economic jargon, charging anything for pure IP "which has a marginal cost approaching zero once it has been produced" creates a deadweight economic loss, at least in static terms. The actual net loss of IP infringement is an allocative loss that only appears in a dynamic analysis. Simply put, when people pirate IP, the market is not accurately signaling how highly people value the effort that was put into creating it, which leads to under production of new IP. To calculate the net loss to the economy over the long run, you'd need to figure out the value of the lost innovation in which IP owners would have invested the marginal dollar lost to piracy, and subtract from that the value of the second-best allocation which is to say,whatever the consumer of the pirated good spent his money on instead and the value of the deadweight loss (free music or software is a neteconomic benefit to someone) incurred by pricing IP at all. If that sounds incredibly complicated, it is. And in fact, it's more complicated than that, because as Yochai Benkler has argued persuasively, IP is an input to innovation as well as the product of innovation. So under certain very specfic conditions, "piracy" can produce net gains. While it seems extremely unlikely that this is the case in the aggregate theft almost certainly does impose neteconomic costs simply calculating lost sales and licencing fees, assuming someone could produce a credible figure, would not provide a complete picture of the economic impact of IP infringement. It would give us, at most, one side of the ledger. Conclusions But enough theory and speculation; here is what we can say forcertain: the two numbers that are invariably invoked wheneverCongress considers the need for more stringent IP enforcement are, atbest, highly dubious. They are phantoms. We have no good reason tothink that either is remotely reliable. Perhaps more importantly, both numbers are seemingly decades old,gaining a patina of currency and credibility by virtue of having beenlaundered through a relay race of respectable sources, even as theirorigin recedes into the mists. That's especially significant,because these numbers are always invoked as proof that the piracy problem is still dire that everything we've done to step upinternational enforcement of intellectual property laws has been invain. But of course, if you simply recycle the same numbers from 15 and 20 years ago remember that IACC's 2005 publications still citethat 1995 congressional testimony, from which it seems safe to inferthat they have no more recent source then it will necessarily seem as though no ground has been gained. Neither figure is terribly plausible on its face. As Wired noted earlier this week, 750,000 jobs is fully 8 percent of the currentnumber of unemployed in the United States. And $250 billion is morethan the combined 2005 gross domestic revenues of the movie, music,software, and video game industries. Still, anything is possible: The figures could happen to be more or less accurate. But given the shady provenance of the data, the onething we know for certain is that we don't know for certain. Andwe're making policy on the basis of our ignorance.