The Dolcera Blog

Test of enablement - “Any analysis of whether a particular claim is supported by the disclosure in an application requires a determination of whether that disclosure, when filed, contained sufficient information regarding the subject matter of the claims as to enable one skilled in the pertinent art to make and use the claimed invention.”  Source
I have always considered the CAFC judgments as one of the best repository to learn intellectual property. I happened to come across a very interesting case.
Janssen Enablement Alzheimers (pdf) - This case (relating to US Patent No. 4,663,318) goes to prove the necessity of writing very detailed specifications backed with strong experimental data for claims to be upheld in the court of law. In this case, Janssen claimed use of a certain drug ‘galanthamine’ for treating Alzheimers. At the time of submitting the patent for review, the inventor who later on licensed the granted patent to Jansen, did not have sufficient experimental data proving direct probable linkage to use of galanthamine for Alzheimers treatment. USPTO examiner also cited this point, yet issued the patent (this part is weird). Eventually, the claims of this patent were held invalid due to an ‘enablement’ clause - in simple terms, enablement here means the specification did not directly support the claims of the inventor.
The discussions were also adverting to the utility requirement which prevents mere ideas from being patented. As noted in Genentech, Inc. v. Novo Nordisk A/S, 108 F.3d 1361, 1366 (Fed. Cir. 1997), “[p]atent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable.
Being an inventor myself, this case intrigues me that if we find a novel use for a patented compound, we can get a patent for it. From a business perspective, I feel that it would be prudent that pharmaceutical firms keep track of formulation patents/method of use patents filed by competitors over its own molecule portfolio. This is on the assumption that the competitors are trying to find novel uses of a compound patented by the inventing pharmaceutical firm. If successful, the competition would need to pay royalties to the patent holder of the novel compound (assuming the patent holder is willing to license it on fair terms).
For the patent searching fraternity, the hypothesis of determining patent quality based on disclosed experimental data is quite sound. However, it becomes difficult to retrieve if the experimental data paragraphs are added during the later stages of patent prosecution. The US PAIR information workaround to access the office actions will be of little help especially if the number of patents to be examined is large.

Tweet This Post  Delicious This Post  Digg This Post 

Case background    Avandia is the popular drug name marketed by GSK had strong sales of 2.3 billion USD in 2007 till reports of its cardiovascular risks came out in the market place (forcing lots of physicians to change prescriptions to their patients, though the data was proclaimed as inconclusive by FDA).
    Avandia finds strong applications for glycemic control or in others words for diabetes type II treatment. Its active ingredient is a compound called Rosiglitazone, and a variant of this chemical compound was patented by GSK with expiry in 2005  (US5741803).

GSK Indian strategy

—————————–

Per change in the Indian patent act in 2005, GSK filed a patent for the same active ingredient as disclosed in US 5002953 as an Indian patent 00295/DELNP/2003 trying to claim the ethanesulfonate salt of the active ingredient. This patent was subsequently rejected by the India Patent office citing no evidence of the complex showing substantially different clinical efficacy than the available pharmaceutical version of Rosiglitazone.

However, it is interesting to note that GSK has not given up. It has at least three more pending application before the IPO for the same compound Rosiglitazone and we will have to see how the IPO deals with that. These applications are:- 
    a) IN3546/DELNP/2004 in which GSK has tried to patent a cyclodextrin complex of rosiglitazone and

    b) IN4030/DELNP/2005 in which GSK has tried to patent the process for manufacture of a rosiglitazone polymorph (the maleic ester form as patented in US7358366)
    c) IN6569/DELNP/2007 in which GSK has tried to patent a novel method of delivering rosiglitazone (enmeshed in nanofibres)

To counter this threat, Cadila and Dr. Reddys have also filed process patents for manufacture of amorphous Rosiglitazone maleate.

Only time will tell, who will win the Rosiglitazone turf war in India.

Source:

FDA Orange book - http://www.accessdata.fda.gov/scripts/cder/ob/docs/patexclnew.cfm?Appl_No=021071&Product_No=002&table1=OB_Rx

Indian Patent office

US Patent Office

Economic times

—

Lakshmikant Goenka

Tweet This Post  Delicious This Post  Digg This Post 

http://www.cafc.uscourts.gov/opinions/09-1001.pdf

It is our contention that in the globalized world of manufacturing, where most of the manufacturing activity happens outside the developed world, having legally valid patents in the manufacturing hubs of China, Mexico or India can pay off handsomely. A legal right in those countries can ease gathering of evidence as can be seen in the case below where video shots of manufacturing process used in Mexico is used as admissible evidence.

This case pertains to an infringement claim won by Gemtron Corp. against Saint Gobain for refrigerator shelf manufacturing method and design.

Background:
Saint Gobain manufactures refrigerator components in Mexico and sells them in the United Sates. Gemtron Corp. has a patent for manufacture of refrigerator shelves where by a glass portion of the shelf is held to a polymeric base using ‘fingers’ and not ‘adhesive’ ( a traditional method) filed in both USA and Mexico.

Gemtron Corp. alleged that Saint Gobain was infringing on its patents since it was using a similar method for manufacturing its shelves - in which a glass portion is held to its polymeric base using ‘fingers’. Saint Gobain was countering Gemtron Corp. allegation saying that the claim 23 of the ‘673 Gemtron patent was only a ‘process’ patent and hence the end result from the process (the end design or the structural component) was not claimed. The CAFC rejected Saint Gobain’s plea on the grounds that the result of a claimed process which lead to a unique structural change were also by default patentable subject matter.

In order to refute Saint Gobain’s claims that its manufacturing process was significantly different than claimed in the patent, Gemtron Corp. showed videos of the manufacturing process used at Saint Gobain’s manufacturing site in Mexico. The video clearly proved similarity in the process used at Saint Gobain manufacturing site.

In the overall case argument, while the moot point was the ’structural component’ or the design of the shelf, it can be argued that the video showing Saint Gobain’s manufacturing process was also helpful in winning a non-technical jury’s verdict to prove wilful infringement at the district court level.

- Lakshmikant Goenka

Tweet This Post  Delicious This Post  Digg This Post 

http://www.cafc.uscourts.gov/opinions/07-1583.pdf

In this classic case of Friskit v/s Real networks, Friskit alleged Real networks media players had infringed its patents that claimed as its inventive the following (a) a media player with integrated search and playback features and (b) wher the entire control of the media player rest with the server side with no software (OS) from the client side assisting in the operation of the media player.

Real cited the following product and website evidence to counter Friskit. It cited the features available at www.iuma.com and Winamp to counter Friskit’s claims. In both cases of iuma.com and Winamp offered a media player interface with a search box. When a search was conducted, a new mini-browser window would pop up that would get populated with the search results. These search results could be dragged and dropped into the media player interface for immediate play-back with minimal intervention from the client side. Friskit’s only difference was the same interface (with no special mini-browser) window poping up providing this functionality.

The court cited KSR v/s Teleflex and found Friskit’s claims as obvious stating that as per the KSR case ‘predictable use of known elements according to their cited function’ results in obviousness.

Tweet This Post  Delicious This Post  Digg This Post 

Mr. Mekete had filed the 5602905 patent in 1995 that allowed for a user to utilize commercial online services from a CPU, that had a modem and credit card reader coupled to the CPU, and where the CPU had a software installed to fulfil this transaction.

Later in August of 1998, Mr. Mekete filed for a reissue of his ‘905 patent since he believed he had severely limited his invention by not claiming the use of ‘online services perse’ from this CPU terminal.

Mr. Mekete’s patent is interesting since this ‘905 patent has 93 citations and hence is a seminal patent in that respect.
When Mr. Mekete filed for re-issuance of his patent, the BPAI rejected his assertion on grounds of obviousness. BPAI cited combination of 3 different references as a source to reject Mr. Meketes claim. Mr. Mekete appealed the BPAI decision with the CAFC that re-affirmed the BPAI decision.

Mr. Mekete’s arguments were that his invention was a commercial success since more than 50% of the internet kiosks were using the method he wished to Claim. However, the Board and the CAFC argued that when there is no-established co-relation between commercial success and the invention (in other words, the inventors commercialization efforts are not the reason for the success of the invention per-se) then the grounds to grant a patent based on utility is ‘weak’ - and also, that makes the BPAI argument to combine elements from ‘three’ different sources to reject the patent on ‘obviousness’ grounds as ’strong’.

- Lakshmikant

Tweet This Post  Delicious This Post  Digg This Post 

http://www.cafc.uscourts.gov/opinions/08-1259.pdf

In an interesting case, bankrupt GM won a patent suit for its popular OnStar navigation system.
The OnStar navigation system acts like a warning system for manouever points that are going to come up within a certain pre-specified distance from the car. The calculations regarding the relative position of the car from the manouever point is done remotely, and the only information displayed in the device in the car is the ‘distance value’ to the manouever point.

VIP had filed a patent in which the co-ordinate of the manouever point is downloaded and compared with the car co-ordinates (obtained using GPS systems) on the mobile system. They do not represent the distance between the manouever point and the car co-ordinates as scalar values, but simply represent them on a scale ‘relative to each other’.

On this semantic difference VIP lost its case against GM in both the district court and the Federal Appeals court. The CAFC and district courts did not find any reference of possibility to display scalar values on the mobile device either in the Patent specification or at anytime during the patent prosecution history.

Tweet This Post  Delicious This Post  Digg This Post 

It seems ironical that the leading business schools of India like FMS invite startups like ours to present our entrepreneurial journey to them. I indeed found it ironical when I was invited to speak by the E-cell of FMS to speak on the journey of Dolcera when I knew that less than 1% of FMS joins start ups in lieu of offers from the ‘big firms’.

Initially I was not tempted to go to FMS to speak since it would involve travel from Hyderabad to Delhi and when your travel costs are not paid for, you wonder if for a start up it is worth the investment. Something in me said it may be worth while as an investment to get the word out about Dolcera among the B’school students, kindle a spark in them that makes them joining a start up exciting.

I wanted to impress the B’school students no end, since I wanted them to find Dolcera exciting. However, the more I thought about what could excite them, the more I was pushed towards writing the naked truth. I decided that the truth, as is for all startups, is a mixture of failures, albeit stupid and obvious, and a mixture of successes. It is about the personal pain and anguish one faces when faced with challenges - social, monetary and filial.

I prepared extensively and landed up at their campus. I was quite impressed by the attendance to the sessions - it seemed quite an audience had the latent desire to write history. I opted to take the first slot (quite an easy get for me since it seems most speakers did not want to take it) of the day since I did not want to speak after lunch to avoid speaking to sleepy eyes and somnolent brains. I spoke at length and with all my heart. I told them about the journey of Dolcera, that took close to 2 years to shape up. I told them how during those 2 years none of the 3 founders took any salary and one of them ran up debt on his credit card. I shared with them how we ‘invested’ those years into something we would never do for the rest of the company’s time. In summary, I gave them some business mantras for being a successful entrepreneur:
(a) Invest in ‘differentiators’ - there is someone mightier and richer than you out there who can kill you if you don’t
(b) Test market your ‘differentiators’ - what looks good on paper may not actually sell
(c) Hedge sales bets - don’t focus too many efforts on one segment just because that segment looks most likely to buy on paper
(d) Build organization capacity - put some of your money where your idea is/mouth is
(e) Invest in specialized skills to scale - do not be penny wise pound foolish. Scale can only come if you hire specialists. While one may start off as a hands on manager, to grow the organization beyond a point, specialists are needed.
(f) Talent hunt - The ‘big cool firms’ don’t eat away all the talent in the market. If you know what you want, you will get such people at relatively low costs.
(g) Fail and fail quickly - This is most important so that expensive resources are not lost just betting on one thing.

Next I shared with them how to prepare to be an ‘entrepreneur’. I told them entrepreneurship training is all about mindsets. Things one can do to nurture these mindsets are follows:
(a) Find some idols you can relate to - Idols can be a big source of inspiration
(b) Talk to people - try to network with people even with those who are not in your web of contacts. Believe me there are people out there who are willing to talk and help. (like us who went to FMS even when we knew less than 1% actually join start ups)
(c) Read extensively - Reading about market trends will give perspectives on evolving market dynamics and opportunities.

I summarized the talk with some mantras that are as universal as entrepreneurship perhaps is.
(a) Entrepreneurs fail but they fail quickly - Reduce the cost of failure
(b) Entrepreneurs know that failure is a guarantee - one or many strategies you follow is bound to fail. So be prepared for it.
(c) Entrepreneurs know how to delay gratification
(d) Entrepreneurs don’t judge their self worth by looking at their peers or calculating opportunity costs

Lastly I told them that careers for failed business entrepreneurs is extremely bright in the corporate world. Since most corporates value people who have had an experience of failing. To ensure a successful corporate career, after an entrepreneurial venture failure, I told them to ensure they fail with a bang than with a whimper. Failure with a bang will teach them many things, and help them tell a wonderful story of time well spent on learning valuable lessons.

Coming back to the irony, while I was applauded for my talk and many people accosted me for advice, not one applied to join Dolcera. Measured in that sense, my talk was not that effective. But then, it is hard for today’s MBA graduates to junk opportunity costs when their cost of opportunity has risen so significantly.

I just hope rising salaries don’t dampen the spirits of to be entrepreneurs from B’schools as our country needs many of them. I also hope MBA’s realize soon that their 2 years training during MBA program is all tailored to managing others business than their own. I do hope that the thoughts I shared, and what many other bloggers do so well, can help them take the plunge into entrepreneurship, where every journey is as sweet as its successful destination.