Best Practice Ways to Develop IP Strategies for Crystalline Forms

Mandar Kodgule, Head of Intellectual Property and Strategy Planning at Wockhardt, joins Pharma IQ to discuss best practice ways to develop IP strategies for crystalline forms. To listen to the podcast now go to How Can Polymorph Patents Increase Cost Efficiency?

Pharma IQ: Mandar, welcome to the show. How are you today?

M Kodgule: Thanks, Helen. Thanks for the welcome, I’m alright.

Pharma IQ: I’m pleased you could join us. So, first of all, could you give us some background on your role over at Wockhardt?

M Kodgule: Basically, I’m responsible for strategic planning and global Intellectual property. That includes all the patent filings, prosecutions, litigation in the US, Europe and all across the globe. Also it gives me an opportunity to work with the business teams and with the senior management of Wockhardt in order to strategise the portfolio products and services that Wockhardt may offer in the next five years to consolidate the strategy of the company.

Pharma IQ: Can you explain how exactly polymorph patents can increase cost efficiency?

M Kodgule: Well, last year I gave a presentation for IQPC which suggested that if you plan your strategies properly, as companies like Pfizer and Novartis and Roche and Sovay have already done, it is a great opportunity if you want deal in a good amount of money by blocking others in the polymorph area. So there is a huge amount of opportunity.

If I calculate, people have made close to about $10bn just using the polymorph as a tool for preventing competition in the marketplace, and that’s huge money that we are talking about. Year on year, that’s a huge amount that we are talking about. So, I think this is a very important perspective when you’re thinking of polymorph as a tool which can prevent competition and give you that extra advantage at the marketplace.

Pharma IQ: What are the top five strategic considerations in having a healthy polymorph patent portfolio?

M Kodgule: The most important thing is: what is the policy, company policy, the strategy, or the product policy? what exactly is the product meant for? Then you must have backed up a sound strategy wherein you’re going to talk about why you want polymorph patents. Is it something which makes sense? And, lastly and most importantly, how are you going to prevent if somebody is going to be infringing, so the assertions or assertiveness of your patients, and who in the infringement? More than anything else, even if somebody is infringing, how are you going to prove that infringement at the court? So, all in all, it is the cost, is the product strategy, it is the cost most importantly, and the significant stress on enforceability and proving infringement.

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Pharma IQ: Now, how is the regulatory landscape changing and what impact is it having on the enforceability of polymorph patents?

M Kodgule: The regulatory impact, more or less, is becoming quite deeply focused on the polymorph patents, but more than anything else, the legal impact of changing the polymorph patents suits. Lately, you see the patent officers are really reluctant in granting the patent applications, especially in the European context.

If you want to look at some of the very successful patents which prevented the competition at the marketplace were applied much before 2000 or so, and these are the patents which are, in a way, controlling the markets. But coming off lately, post-2000, patent officers are becoming very smart day by day, so they are, in a way, preventing a grant of the patent applications, come what may. So the strategy, moving forward, has to be how to make your polymorph patent applications much more oriented towards the grant when a European or a US examiner is going to see it.

What is going to be your strategy, whether you want a US-centric approach or a Europecentric approach? The regulatory scenario is not common, the legal scenario is not common for all the countries and that is what is causing more of an uncertainty in terms of the polymorph applications. One country may require separate data; another country may require altogether separate data. Now bridging all those gaps is something a polymorph expert or a lawyer who’s prosecuting those patent applications should keep in mind, moving forward.

Pharma IQ: Now, I also understand that excessive innovation in the polymorph arena is leading to misuse in certain cases. Can you explain why this is so?

M Kodgule: Without naming anybody, you have at the conference... and last year’s also expressed serious concerns over this area, but many of the companies, without having a particular strategy, they just are filing patent applications after applications on the polymorphic forms. Now that’s not good from an innovation perspective because the examiners are now seeing all this as just another guise by a generic company or as somebody to just get something which is not a true invention granted. So because of these excessive filings, examiners have starting seeing this as abuse. They’re granting less and less patent applications, moving forward, so that is what is causing this.

Secondly, there is no control over the enforceability. So what you’re doing is you’re putting a lot of pseudo-polymorphs, a lot of unstable polymorphs, into the market which are not going to be beneficial in terms of preventing competition also or in terms of creating new avenues to do research on polymorphic patents. So basically this is destroying the value which was existing some time back on the polymorphic forms.

Pharma IQ: Can you sum up the strategic challenges which must be addressed in order to help create polymorphic wealth?

M Kodgule: As I said, the most important challenge, moving forward, is how you are going to convince the patent examiners. Do you have thoroughly backed-up data when you’re prosecuting the patent applications? Do you have enough material which can be used as a tool for making some differentiation at the marketplace? What is going to be your cost strategy, I would say? What is your cost strategy; how are you going to manage cost in the long run? After the grant of the polymorph patent, what is your exact strategy going to be? Assertive? Defensive? What exactly? That is the most important thing, but believe me the patent office challenge is the most important challenge, moving forward.

Pharma IQ: Thank you. Some good tips there. Finally, just to give a taster, if you could narrow it down, what key take-home point will you be offering in your presentation?

M Kodgule: The take-home points that I’ll mention is the balance of the polymorph... I want to set up a balance sheet for polymorphic forms. This balance sheet will include who has done what in terms of getting the polymorph patents first granted and how effectively they have been using those polymorphic patents. So a strategy behind effective drafting, effective prosecution, strategising, can be laid out. Secondly, I also want a wider perspective wherein some miserable examples of polymorph patents... those unsuccessful cases, how people became unsuccessful in filing polymorph applications and then that has really not resulted in a significant advantage to their company.

Moving forward, the challenges; how to avoid excessive innovation in the polymorph area; how to strategise this whole thing in such a way that these become tools for curtailing competition rather than becoming a nuisance for the scientific community.

Pharma IQ: We hope that it provides a useful forum. Mandar, thank you so much for your time today. It’s been great to get your insight into this area. Thank you.

M Kodgule: Thanks, Helen. It’s always good to speak with you. Thanks.

IQPC

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