Introduction
In the realm of intellectual property law, patent disputes often serve as battlegrounds where innovation meets commercial interests. The case of Merck Sharp & Dohme Corporation (MSD) versus Glenmark Pharmaceuticals, adjudicated by the Delhi High Court, stands as a pivotal example of such a conflict. This case, centered on the alleged infringement of MSD’s patent for Sitagliptin, a drug used to manage Type 2 Diabetes Mellitus (T2DM), encapsulates the intricate interplay between patent rights, public interest, and equitable principles. It raises critical questions about the scope of patent claims, the necessity of full disclosure, and the balance between protecting innovation and ensuring access to essential medicines. This case study delves into the factual and procedural intricacies, the legal issues, the parties’ submissions, the judicial reasoning, and the final decision, offering a comprehensive analysis of a landmark ruling that shaped India’s patent jurisprudence.
Detailed Factual Background
Merck Sharp & Dohme Corporation, a New Jersey-based pharmaceutical giant, held Indian Patent No. 209816 for Sitagliptin, a Dipeptidyl Peptidase-IV (DPP-IV) inhibitor used to lower blood sugar levels in T2DM patients. Marketed under the trademarks Januvia and Janumet, and licensed to Sun Pharmaceutical Industries Ltd. for sale as Istavel and Istamet, Sitagliptin was a cornerstone of MSD’s diabetes treatment portfolio. The patent, granted on September 6, 2007, covered Sitagliptin and its pharmaceutically acceptable salts, with Claim No. 19 specifically addressing Sitagliptin and its salts, including the phosphate monohydrate form. MSD claimed that Sitagliptin was a groundbreaking innovation, developed after nine years of research and significant investment, offering a novel mechanism to manage T2DM without the risk of hypoglycemia associated with older drugs like Metformin.
Glenmark Pharmaceuticals, a global pharmaceutical company, entered the Indian market with its products Zita (Sitagliptin Phosphate Monohydrate) and Zitamet (a combination of Sitagliptin Phosphate Monohydrate and Metformin Hydrochloride). MSD alleged that these products infringed its patent, as the production of Sitagliptin Phosphate Monohydrate necessarily involved the use of the patented Sitagliptin molecule. MSD highlighted that its patent was granted in 102 countries and was unopposed in India, underscoring its validity and commercial success. The company also emphasized its efforts to make Januvia affordable in India, pricing it at one-fifth of its U.S. price, and investing in patient education and access programs.
Glenmark, however, contended that its products did not infringe MSD’s patent. It argued that Sitagliptin Phosphate Monohydrate was a distinct compound, not covered by MSD’s patent, and pointed to MSD’s abandoned patent applications for the phosphate salt as evidence of its novelty. Glenmark further challenged the validity of MSD’s patent, alleging non-disclosure of related patent applications and insufficient specification, and claimed that Sitagliptin and its hydrochloride salt were unstable and industrially inapplicable.
Detailed Procedural Background
The dispute commenced when MSD filed a suit in the Delhi High Court on April 1, 2013, seeking a permanent injunction to restrain Glenmark from manufacturing, selling, or distributing Zita and Zitamet, along with damages, rendition of accounts, and delivery up. Concurrently, MSD applied for an ad interim injunction (IA 5167/2013) to immediately halt Glenmark’s activities. Glenmark, on caveat, appeared at the first hearing on April 2, 2013, before a Single Judge. MSD relied on its patent claims and judicial precedents, while Glenmark opposed the injunction, alleging suppression of material facts by MSD, particularly the abandonment of patent applications for Sitagliptin Phosphate Monohydrate. Glenmark also submitted documents to support its claim that its products were distinct from MSD’s patented compound.
On April 5, 2013, the Single Judge dismissed MSD’s application for an interim injunction. The judge acknowledged that minor variations in Glenmark’s product did not necessarily negate infringement but found that MSD failed to plead how Sitagliptin Phosphate Monohydrate was medically equivalent to Sitagliptin or merely a new form without enhanced efficacy. The judge also noted MSD’s abandoned patent applications, suggesting that MSD itself treated the phosphate salt as a distinct invention.
MSD appealed the decision (FAO (OS) 190/2013) before a Division Bench of the Delhi High Court, comprising Justices S. Ravindra Bhat and Najmi Waziri. On April 12, 2013, the court allowed Glenmark to file a substantive reply and additional documents, with MSD permitted to respond. The appeal was heard extensively, with arguments concluded on January 6, 2014, and the judgment reserved on January 9, 2015, pronounced on March 20, 2015. The Division Bench conducted a detailed examination of the patent claims, infringement allegations, and equitable considerations, ultimately overturning the Single Judge’s order.
Issues Involved in the Case
The case presented several critical legal and technical issues:
Whether Glenmark’s products, Zita and Zitamet, infringed MSD’s patent for Sitagliptin by using the patented molecule or its salts.
Whether MSD’s patent was valid, or if it was liable for revocation due to non-disclosure of related patent applications, insufficient specification, lack of inventive step, or industrial inapplicability.
Whether MSD’s non-disclosure of abandoned patent applications for Sitagliptin Phosphate Monohydrate and other compounds constituted suppression of material facts, warranting denial of interim relief.
Whether the balance of convenience and public interest favored granting an interim injunction to MSD, considering the accessibility of diabetes treatment.
Whether the court should mandate disclosure of X-ray Diffraction (XRD) data to compare the compounds, and if its absence affected MSD’s case.
Detailed Submission of Parties
MSD’s Submissions
MSD argued that its patent (IN 209816) comprehensively covered Sitagliptin and its pharmaceutically acceptable salts, including the phosphate monohydrate form used by Glenmark. The company emphasized that Sitagliptin was the active ingredient in both its and Glenmark’s products, and producing Sitagliptin Phosphate Monohydrate required using the patented Sitagliptin molecule, thus constituting infringement under Section 48 of the Patents Act, 1970. MSD cited Glenmark’s U.S. Patent No. 8334385, which acknowledged Sitagliptin as the active free base, as evidence of infringement.
MSD contested Glenmark’s claim that the patent was limited to Sitagliptin Hydrochloride, arguing that Example 7 in the patent specification was merely illustrative, not exhaustive. The company relied on legal precedents such as Edward H. Phillips v. AWH Corporation (415 F.3d 1303) and F.H and B Corporation v. Unichem Laboratories (AIR 1969 Bom 255) to assert that patent claims define the invention’s scope, not specific examples. MSD also argued that its abandoned applications for Sitagliptin Phosphate Monohydrate were inessential details, abandoned due to Section 3(d) of the Patents Act, which restricts patents for new forms without enhanced efficacy. The company cited Novartis AG v. Union of India (2013 (6) SCC 1) to support its position that non-disclosure of such applications did not invalidate the patent.
MSD underscored the public interest in protecting its patent rights, noting its efforts to make Januvia affordable and its investment in patient education. It argued that allowing Glenmark to operate would lead to irreparable market harm, as price reductions by an infringer could permanently depress prices, citing SmithKline Beecham v. Generics ((2002) 25(1) IPD 25005) and SmithKline Beecham Plc v. Apotex ([2003] EWCA Civ L37).
Glenmark’s Submissions
Glenmark vehemently opposed MSD’s claims, asserting that its products did not infringe the patent because Sitagliptin Phosphate Monohydrate was a distinct compound, not covered by MSD’s patent. It pointed to MSD’s abandoned application (5948/DELNP/2005) for the phosphate salt, where MSD described it as a “newly discovered” invention with superior stability, as evidence that it was not subsumed under the suit patent. Glenmark argued that accepting MSD’s broad claims would nullify Section 3(d), allowing patent protection for unpatentable derivatives.
Glenmark challenged the patent’s validity on multiple grounds: non-disclosure of foreign and Indian patent applications under Section 8, insufficient specification under Section 10(4), lack of inventive step, and industrial inapplicability due to the instability of Sitagliptin and its hydrochloride salt. It cited cases like Teva Canada v. Pfizer Canada (2012 SCC 60) and Abraham Esau’s & C. Lorenz Application (1932 (49) RPC 85) to argue that inadequate disclosure invalidated the patent. Glenmark also relied on F. Hoffmann-La Roche Ltd. v. Cipla (2009 (40) PTC 125) to underscore the mandatory nature of Section 8 disclosures.
Glenmark further contended that MSD failed to provide XRD data to prove that its products used the patented compound, citing Hoffmann-La Roche (2012 (52) PTC 1) for the necessity of such data in pharmaceutical patent cases. It argued that public interest favored denying the injunction, as diabetes treatment accessibility should not be curtailed, and highlighted that MSD’s high prices limited access compared to its lower-priced generics.
Detailed Discussion on Judgments Cited by Parties
The parties cited numerous judicial precedents to bolster their arguments, each serving a specific context in the case:
Edward H. Phillips v. AWH Corporation, 415 F.3d 1303 (Federal Circuit, 2005): MSD cited this U.S. case to emphasize that patent claims define the invention’s scope. The court held that claims are interpreted based on their plain meaning as understood by a person skilled in the art, supporting MSD’s argument that its patent covered all pharmaceutically acceptable salts, not just the hydrochloride salt in Example 7.
F.H and B Corporation v. Unichem Laboratories, AIR 1969 Bom 255: MSD relied on this Indian case to reinforce that the claims, not illustrative examples, determine a patent’s scope. The Bombay High Court held that the patent’s protection extends to the claimed invention, aligning with MSD’s contention that Glenmark’s use of Sitagliptin infringed its patent.
Novartis AG v. Union of India, 2013 (6) SCC 1: MSD cited this Supreme Court decision to argue that non-disclosure of abandoned applications was not fatal. The court clarified that patent coverage can exceed disclosure and upheld Section 3(d)’s restriction on new forms without enhanced efficacy, explaining MSD’s abandonment of the phosphate salt application.
CFMT Inc. v. YieDup International Corporation, 349 F.3d 1333 (Federal Circuit, 2003): MSD referenced this case to argue that improvement patents (like the phosphate salt) do not negate the validity of a basic patent. The court recognized that subsequent improvements could be patented separately without undermining the original patent’s scope.
F. Hoffmann-La Roche Ltd. v. Cipla, 2009 (40) PTC 125 (Delhi High Court, Division Bench): Glenmark cited this case to argue that non-disclosure of patent applications violated Section 8, warranting revocation. The court held that Section 8 mandates disclosure of foreign applications, but the Division Bench’s view that Indian applications must also be disclosed was contested by the court in this case.
F. Hoffmann-La Roche Ltd. v. Cipla, 2012 (52) PTC 1 (Delhi High Court, Single Judge): Glenmark relied on this decision to assert that non-disclosure of related applications justified denying an injunction. The Single Judge emphasized the mandatory nature of Section 8 disclosures, but the Division Bench clarified that revocation is discretionary.
Teva Canada v. Pfizer Canada, 2012 SCC 60 (Supreme Court of Canada): Glenmark cited this case to argue that insufficient disclosure invalidated the patent. The Canadian court held that patents must enable a skilled person to practice the invention, supporting Glenmark’s claim that MSD’s patent lacked details on Sitagliptin’s isolation.
Abraham Esau’s & C. Lorenz Application, 1932 (49) RPC 85: Glenmark referenced this UK case to argue that inadequate disclosure rendered a patent invalid. The court held that patents must provide clear instructions for practicing the invention, aligning with Glenmark’s challenge to MSD’s specification.
SmithKline Beecham v. Generics, (2002) 25(1) IPD 25005 (UK High Court): MSD cited this case to argue that allowing an infringer to operate could cause irreparable market harm. The court granted an injunction, noting that price reductions by infringers could permanently depress prices, a concern echoed in MSD’s submissions.
SmithKline Beecham Plc v. Apotex, [2003] EWCA Civ L37 (UK Court of Appeal): MSD relied on this case to reinforce the market harm argument. The court upheld an injunction, emphasizing that the patentee’s sole supplier status warranted protection against price erosion.
Maj. (Retd.) Sukesh Behl v. Koninklijke Phillips Electronics, FAO 16/2014 (Delhi High Court, decided on 07-11-2014): The court cited this recent Division Bench ruling to clarify that Section 8 violations do not automatically lead to revocation, as Section 64(1) grants discretionary power, supporting MSD’s position on non-disclosure.
Anand Prasad Agarwalla v. Takeshwar Prasad and Ors., (2001) 5 SCC 568: The court referenced this Supreme Court decision to caution against conducting a mini-trial at the interim stage, emphasizing that detailed factual inquiries should await the full trial.
American Cyanamid v. Ethicon Ltd., [1975] AC 396 (UK House of Lords): The court cited this seminal case to outline the triple test for interim injunctions: prima facie case, balance of convenience, and irreparable injury, guiding its equitable analysis.
Bayer Corporation v. Cipla, 162 (2009) DLT 371 (Delhi High Court): The court relied on this case to underscore the public interest in maintaining patent integrity, noting that allowing unauthorized use undermines the Patents Act’s objectives.
K. Ramu v. Adayar Ananda Bhavan, 2007 (34) PTC 689 (Madras High Court): The court cited this case to support granting an injunction when the patentee is already in the market, a factor favoring MSD.
Bajaj Auto Ltd. v. TVS Motor Company Ltd., 2008 (36) PTC 417 (Madras High Court): This case reinforced the relevance of the patentee’s market presence in granting interim relief.
National Research Development Corporation of India v. The Delhi Cloth and General Mills Co. Ltd., AIR 1980 Del 132: The court cited this decision to emphasize that the patentee’s established market operations weigh in favor of an injunction.
Detailed Reasoning and Analysis of Judge
The Division Bench, comprising Justices S. Ravindra Bhat and Najmi Waziri, conducted a meticulous analysis, overturning the Single Judge’s dismissal of the interim injunction. The court’s reasoning focused on three pillars: the prima facie case of infringement, the balance of convenience, and the potential for irreparable injury.
The court found that MSD established a strong prima facie case for patent validity and infringement. It held that MSD’s patent covered Sitagliptin and its pharmaceutically acceptable salts, including the phosphate monohydrate form, as evidenced by Claim No. 19 and the patent specification. The court rejected Glenmark’s argument that the patent was limited to Sitagliptin Hydrochloride, citing Edward H. Phillips and F.H and B Corporation to affirm that claims, not examples, define the patent’s scope. Glenmark’s U.S. Patent No. 8334385, which acknowledged Sitagliptin as the active component, further supported MSD’s infringement claim. The court dismissed Glenmark’s contention that it produced Sitagliptin Phosphate Monohydrate without using Sitagliptin, noting the absence of evidence and the logical necessity of using the patented molecule.
On patent validity, the court addressed Glenmark’s challenges under Sections 8, 10(4), and 64 of the Patents Act. It clarified that Section 8 mandates disclosure of foreign, not Indian, patent applications, aligning with the Single Judge’s interpretation in Hoffmann-La Roche (2012 (52) PTC 1) and the Justice Ayyangar report. The court found that MSD’s Form 3 disclosures and subsequent updates satisfied Section 8, and the non-disclosure of Indian applications (e.g., 5948/DELNP/2005) was not fatal. Citing Maj. Sukesh Behl, the court emphasized that Section 64(1)(m) revocation is discretionary, and non-disclosure alone did not justify denying interim relief at this stage.
The court also rejected Glenmark’s argument on insufficient specification, finding that the patent provided detailed instructions for producing Sitagliptin, as confirmed by Glenmark’s own U.S. patent claims. Allegations of obviousness and industrial inapplicability were deemed premature without a full trial, per Anand Prasad Agarwalla. Regarding XRD data, the court clarified that Hoffmann-La Roche did not mandate its disclosure in all cases, as it depends on the drug’s nature, and no polymorph differentiation was at issue here.
On equitable considerations, the court applied the triple test from American Cyanamid. It found the balance of convenience favoring MSD, as Glenmark’s operation could lead to irreversible price erosion, citing SmithKline Beecham cases. The court noted that MSD’s price reduction to one-fifth of the U.S. price and the absence of a significant price differential with Glenmark’s products mitigated public interest concerns about access. Unlike Hoffmann-La Roche, where a 300% price difference for a life-saving drug justified denying an injunction, diabetes was deemed a manageable condition, not life-threatening, and WHO’s essential medicines list excluded Sitagliptin combinations.
The court also considered Glenmark’s failure to challenge the patent before launching Zita, citing SmithKline Beecham and Pharmacia Italia to highlight that such conduct weighs against the infringer at the interim stage. To mitigate harm to Glenmark, the court imposed conditions, including MSD’s undertaking to compensate Glenmark if the suit failed and Glenmark’s obligation to account for earnings.
Final Decision
The Division Bench allowed MSD’s appeal, set aside the Single Judge’s order, and granted the interim injunction (IA 5167/2013) on March 20, 2015. The court issued the following directions:
MSD to file an affidavit undertaking to compensate Glenmark for losses if the suit is dismissed, within two weeks.
Glenmark to undertake compliance with the injunction within two weeks.
Glenmark to file a detailed account of earnings from Zita and Zitamet since the suit’s filing, verified by a chartered accountant, within four weeks.
Glenmark permitted to sell existing stock in the market but prohibited from further production or distribution of Zita and Zitamet.
Parties to appear before the Single Judge on April 10, 2015, with directions to expedite the trial using limited expert evidence and a technical expert under Section 115 of the Patents Act.
Law Settled in This Case
This case clarified several aspects of Indian patent law:
Scope of Patent Claims: Patent claims, not illustrative examples, define the invention’s scope, and broad claims covering pharmaceutically acceptable salts are enforceable if supported by the specification.
Section 8 Disclosure: Section 8 mandates disclosure of foreign, not Indian, patent applications. Non-disclosure of Indian applications does not automatically invalidate a patent or deny interim relief, and revocation under Section 64(1)(m) is discretionary.
Public Interest in Pharmaceuticals: Accessibility concerns are significant but not absolute. For non-life-threatening conditions like diabetes, patent enforcement may take precedence if price differentials are not substantial.
Date of Order:March 20, 2015
Case No.FAO (OS) 190/2013
Citation:MANU/DE/0852/2015
Name of Court:High Court of Delhi at New Delhi
Name of Judges:Hon’ble Mr. Justice S. Ravindra Bhat and Hon’ble Mr. Justice Najmi Waziri
Disclaimer: The information shared here is intended to serve the public interest by offering insights and perspectives. However, readers are advised to exercise their own discretion when interpreting and applying this information. The content herein is subjective and may contain errors in perception, interpretation, and presentation.
Written By: Advocate Ajay Amitabh Suman, IP Adjutor [Patent and Trademark Attorney], High Court of Delhi
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