DHC awards injunction against Glenmark’s manufacture of Symed’s linezolid

On 19^th January, 2015, Hyderbad based Symed Labs won an interim injunction against Glenmark Pharmaceuticals’ manufacture of the drug ‘linezolid’, an anti-bacterial drug used for the treatment of pneumonia, among other infections, by way of the suit patented process. This order from the Delhi High Court makes Glenmark the fifth pharmaceutical company to be injuncted from selling the drug. Previous injuctions were awarded in two earlier suits against Optimus Pharma Pvt. Ltd., Alkem Laboratories Limited (Symed has now entered into a settlement with Alkem), Mankind Pharma Limited and Sharon Bio-Medicine Limited. The case is unique for several reasons the most significant being the award of multiple injunctions in a case involving the alleged infringement of two process patent (Patents No. IN213062 and IN213063).

Jurisdiction

The Defendants challenged the jurisdiction of the Delhi High Court on the basis that they are no manufacturing plants for the drug in Delhi. The Court rejected this argument and asserted jurisdiction on the basis of the presence of the Defendant’s office within the territory of Delhi, as well as, the sale of the drug in Delhi.

Burden of Proof

As per Section 104A of the Indian Patents Act, 1970, the burden of proof to show that a patented process has not be used to obtain a said product will shift onto the Defendant in the event that the Plaintiff demonstrates that

a) the patented process is for the manufacture of a new product

b) there is a substantial likelihood that the identical product is made by the process and the patentee has be unable through reasonable efforts to determine the process actually used.

However, it must first be demonstrated the product is, in fact, identical to the product obtained from the patented process.

The Plaintiff presented lab reports recording the presence of PHPFMA and Zodiac-4 in certain samples of the Defendant’s drug that were tested prior to the institution of the suit. They also presented findings as to the presence of CHFA, PHPFMA and Zodiac-4 in certain samples collected during the pendency of the suit. The Plaintiff argued that these compounds were novel intermediate compounds that were integral to the patented manufacturing process, and hence sufficient proof as per Section 104A. This in turn would shift the burden onto the Defendants to prove that the identical product was not obtained by the patented process.

The Defendant argued that the Plaintiff itself discounted PHPFMA as a novel intermediate before the European Patent Office and was hence estopped from arguing that the said compound was a unique indicator as to the patented process. They argued, rather that PHPFMA and Zodiac-4 were intermediates taught by the prior art. They further questioned the credibility of the Plaintiff’s evidence by highlighting an inconsistency in terms of the documentation of the presence of an additional compound CHFA only in the second round of testing.

The Court analysed the process patents and found against the Defendant’s averrment that the intermediate compounds were taught by the prior art. The Court, curiously, relies on a 1969 case based on the erstwhile act [Farberwek Hoechst v. Unichem Laboratories AIR 1969 Bom 255] to hold that for process patents for the manufacture of ‘new substances’, “any substance of the same chemical composition and constitution shall, in the absence of proof to the contrary, be deemed to have been produced by the patented process.”

Novel Intermediate

In response to the Defendant’s plea that the Plaintiff is estopped by the fact that [edit] they “abandoned and disclaimed PHPFMA as a novel intermediate” before the EPO, the Court found that Symed reserved the right to file a divisional application for the inclusion of claims 41 and 42 pertaining to PHPFMA as a novel intermediate, and the non exercise of that right due to a default in observing the stipulated time period, would not amount to abandoning such a claim. It further noted that the US Patent Office has affirmed the novelty of the compound (Claims 64-66 of Patent No. 7429661 B2).

Suppression of Material Facts

The Defendant accused the Plaintiff of the suppression of the fact that a) the validity of the suit patents are presently under challenge before the same court b) that there subsisted a prior business relationships between the two parties. The Court held that the disclosure as to the infringement suits in the prior case against Optimus Pharma Pvt. Ltd., Alkem Laboratories Limited and Mankind Pharma Limited [CS (OS) No. 1795 of 2012] and Sharon Bio-Medicine Limited [CS (OS) No. 1797 of 2012] constituted sufficient disclosure as the challenges to the validity of the patents were only by way of counterclaims to the infringement suits. As to the business relationship, the court found that the Defendants had only intermittently purchased around 2816 kgs of linezolid API from the Plaintiff, a fact which only strengthen’s the later’s averrment that the former procured the same to prepare finished dosages of the pharmaceutical product. The failure of the Defendant to disclose the sales figures and quantum of manufacture of the drug post 2003 added credible doubt as to their use of a non-patented process.

Drug License

The Defendants argued that in 2002, the Director General, Health Services, Government of India and later the Commissioner, Food and Drug Administration, permitted them to manufacture the drug by providing them with a drug license for the same. However, the court held that the grant of a drug license was not tantamount to a license to manufacture the drug by way of the patented process and held the same to be of “no consequence.”

Conclusion:

The speedy grant of interim injunctions for Symed is heartening from an industry point of view and flies in the face of repeated allegations that India’s IP system is unfriendly to inventors [as a aside, it will be interesting to see what the forthcoming GIPC index has to say about this]. However, there have been concerns as to unreasoned and hasty interim orders. Justice G P Mittal seems to approximate a middle path in defending innovation through a reasoned order that finds the balance of convenience in favour of the Plaintiff by citing the ‘time and money of the inventor’ and the urgency of industry demands.