As the Year 2007 draws nearer, Indian pharma industry will possibly be gearing up to face lot more patent issues and challenges in launching new drug products and in particularly strategizing domestic operations for achieving new milestones in post product patent era. Mail-box patent applications are being slowly taken up for examination, with some facing uphill task of pre-grant oppositions while remaining others escaping unnoticed. However, in the middle of all speculations regarding public health issues and resistance from local NGOs, Swiss multinational Roche finally managed to bag first pharmaceutical product patent for its hepatitis biotech drug 'Pegasus', eventually putting Indian pharma industry on the track of risky patent battles.

Inevitable change
Over the past couple of years, the growing Indian pharma landscape has got increasingly competitive and challenging, which further got on edge by unfamiliar patent issues and possibly would be witnessing lot more vibrancy in patenting phenomenon, particularly alienated patent battles. Undoubtedly, these battles are going to be tough challenge for Indian pharma companies, probably requiring drastic changes in their present operations which will possibly be changing the facet of Indian pharma industry be it from regulatory or pricing or alliances or competitiveness standpoint.

As it is well-known, India got away with 10 years transitional period under WTO before becoming a TRIPS amenable member, to include minimum requirements for uniformity of patent law which not only required uniform patent term but also patent protection to pharmaceutical, chemical and biotech products. This was the critical time span, when Indian pharma industry started realizing the need for inevitable change to face alienated patent challenges in post 2005 but to what extent Indian pharma industry has succeeded in that still needs to be seen. In the meantime, India brought three amendments to the Patents Act, 1970 to meet its obligations under TRIPS agreement which not only changed the parameters of Indian patent law but also forced Indian pharma industry to restructure its strategies to face patent challenges. The first (1999) of the three amendments introduced the provisions for Exclusive Marketing Rights (EMR) for pharmaceutical and agro-chemical products.

The second amendment made some critical amendments including term of patent, narrowing the scope of patentable inventions, provisions regarding PCT and importantly inserting section 5 (2), famously known as 'Mail-box' provision. Finally, the third amendment (2005) deleted EMR provisions and reintroduced the product patent in the field of pharmaceutical, chemical, agro-chemical and food by omitting section 5(2). However, the third amendment further narrowed down the scope of pharmaceutical patentable inventions. But what is important is that, the third amendment is not a mere amendment but an alarming bell for Indian pharma industry indicating the countdown is over now and it's time to look out for patent minefields.

Interestingly till date, nothing exceptional has happened on patent frontier, not a single infringement suit filed by any patentee is being reported and Indian pharma industry is still going smooth and steady but certainly has become cautious in launching new drugs, particularly post-1995 molecules. Importantly, none of the foreign MNCs has clearly revealed their standpoint or future strategies regarding patented drugs. At least what is evident that the number of Indian patent applications filed by Indian and foreign pharma companies have drastically gone up, for reserving their strategic patent spaces.

Patent battles: Already fired-up
The forum of patent battles in India, unlike in US and Europe, are not only limited to the Court of Law but also being fought on various frontiers in the form of pre-grant oppositions, resistances from local NGOs and strategic management alliances. In fact, local NGOs has categorically played a critical and decisive role in challenging patent applications, even forced GlaxoSmithKline to withdraw its Indian patent application for antiretroviral drug Combivir. Till date local NGOs has filed pre-grant oppositions against number of patent applications filed under section 5(2) of the Patents Act, 1970 which includes Novartis patent application for anti-cancer drug Imatinib Mesylate and antiretroviral drug Revataz, Gilead patent application for antiretroviral drug Viread and avian flu drug Tamiflu, Roche patent application for antiviral drug Valcyte and GlaxoSmithKline patent applications for antiretroviral drugs Combivir and Abacavir Sulfate.

Formally, Indian patent battlefields can be categorized into judicial and quasi-judicial forums.
The patent office is vested with the power to decide the third party rights to oppose the patent application/patent under the forum called Pre-grant opposition and Post-grant opposition respectively (Section 25 of the Patents Act 1970).

The pre-grant opposition (also called representation by way of opposition) as well as post-grant opposition could be filed at the appropriate office under mutually exclusive eleven grounds that includes obviousness, anticipation, prior publication, prior public knowledge or use, wrongfully obtained invention, not patentable under the statute, insufficient disclosure, non disclosure or wrongful disclosure of source of invention or related geographical indication, non disclosure under section 8 or misrepresentation of facts, application not made within twelve months from the date of first application in case of convention application and claimed invention already claimed in a complete specification published on or after the priority date of the applicant's claim. Till date, Indian patent office has received total 148 pre-grant oppositions against 'mail-box' patent applications.

However, there are certain critical issues that need to be addressed like whether the forum of pre grant and post grant opposition is available simultaneously or it will follow the principle of res judicata (Court of Civil Procedure) and whether the procedure of pre-grant opposition also needs a well-defined procedure like post grant opposition.

At judiciary, the district court has first instance jurisdiction to decide the case for declaration as to non-infringement, relief in cases of groundless threat of infringement proceeding and for any infringement action (Section 104 of the Patents Act 1970). If the defendant makes a counter claim for revocation of the patent, suit along with the counter claim shall be transferred to the High Court for decision. All the grounds of revocation are also available for defenses in suit for infringement. The reliefs, which a court of law may grant in any suit for infringement, include an injunction (under Order 39, rule 1 and 2 of code of Civil procedure) and damages or an account of profits at the option of the plaintiff.
However, the judicial activism in case of patent litigation is yet to be seen.

Tip of the Iceberg
To avoid resistance from Indian pharma companies, innovators, in particular foreign pharmaceutical MNCs has also started building strategic business alliances by offering licenses to Indian pharma companies in return of reasonable royalties. Recently, Gilead has granted non-exclusive licenses for manufacturing and distribution of tenofovir disproxil fumarate to eleven Indian pharma companies including Ranbaxy and Matrix Laboratories. Earlier, Roche struck licensing deal with Hetero for oseltamivir phosphate whereas Emcure entered into licensing deal with Bristol-Myers Squibb for atazanavir. This strategy may favor Innovators in avoiding complex issues related to compulsory licenses under section 84 of the Patents Act 1970.

With this, the patent battles is not going to be that easy for Indian pharma industry as innovators trying different strategies to make themselves eco-friendly with Indian generic market and at same time trying to procure patents against their pending patent applications. On the other hand, local NGOs determination to ensure availability of cheap generic drugs may hurt patent applicants and would create potential barrier in procuring drug patents in India. But where it will lead Indian pharma companies which has now started realizing the importance of patents from business perspective and slowly found dividing on patent frontier: Opposition or License? This is just the tip of the Iceberg!
(The author is working with a Mumbai-based pharmaceutical company)