Last updated: February 19, 2026
This report analyzes South Korean patent KR20180012277, detailing its claims, scope, and position within the relevant patent landscape. The patent, filed by Daewoong Pharmaceutical Co., Ltd., concerns a pharmaceutical composition containing sodium-glucose cotransporter 2 (SGLT2) inhibitors and a dipeptidyl peptidase-4 (DPP-4) inhibitor, intended for the treatment of type 2 diabetes mellitus.
What is the core invention claimed by KR20180012277?
The central invention of KR20180012277 is a pharmaceutical composition comprising an SGLT2 inhibitor and a DPP-4 inhibitor. The patent aims to provide a synergistic therapeutic effect in managing type 2 diabetes by combining these two classes of antidiabetic drugs.
The patent specifically claims:
- Claim 1: A pharmaceutical composition comprising (a) an SGLT2 inhibitor and (b) a DPP-4 inhibitor.
- Claim 2: The pharmaceutical composition of claim 1, wherein the SGLT2 inhibitor is selected from a group consisting of dapagliflozin, ipragliflozin, tofogliflozin, canagliflozin, and empagliflozin.
- Claim 3: The pharmaceutical composition of claim 1, wherein the DPP-4 inhibitor is selected from a group consisting of sitagliptin, vildagliptin, saxagliptin, linagliptin, and alogliptin.
- Claim 4: The pharmaceutical composition of claim 1, wherein the SGLT2 inhibitor is ipragliflozin and the DPP-4 inhibitor is gemigliptin.
- Claim 5: The pharmaceutical composition of claim 4, wherein ipragliflozin and gemigliptin are formulated in a single preparation.
- Claim 6: The pharmaceutical composition of any one of claims 1 to 5, further comprising one or more pharmaceutically acceptable excipients.
- Claim 7: A method for treating or preventing type 2 diabetes mellitus, comprising administering to a subject in need thereof a therapeutically effective amount of the pharmaceutical composition of claim 1.
- Claim 8: The method of claim 7, wherein the pharmaceutical composition is administered orally.
- Claim 9: A use of the pharmaceutical composition of claim 1 for the manufacture of a medicament for treating or preventing type 2 diabetes mellitus.
The patent specifies that the composition can be formulated as a single preparation or as separate preparations for co-administration. It also highlights the potential for synergistic effects between the SGLT2 inhibitor and the DPP-4 inhibitor, leading to improved glycemic control compared to monotherapy.
What is the claimed scope of the patent?
The scope of KR20180012277 is defined by its claims. It covers:
- Pharmaceutical Compositions: The core of the patent is the combination of an SGLT2 inhibitor and a DPP-4 inhibitor in a pharmaceutical composition. This includes both fixed-dose combinations (single preparations) and free combinations (separate preparations for co-administration).
- Specific Active Pharmaceutical Ingredients (APIs): While not limited to these, the patent explicitly lists examples of SGLT2 inhibitors (dapagliflozin, ipragliflozin, tofogliflozin, canagliflozin, empagliflozin) and DPP-4 inhibitors (sitagliptin, vildagliptin, saxagliptin, linagliptin, alogliptin). A specific preferred embodiment focuses on the combination of ipragliflozin and gemigliptin.
- Therapeutic Use: The patent covers the use of these compositions for the treatment and prevention of type 2 diabetes mellitus.
- Method of Treatment: The patent also claims a method of treating or preventing type 2 diabetes by administering the claimed composition.
The patent does not explicitly define the ratios or dosages of the SGLT2 inhibitor and DPP-4 inhibitor within the composition, leaving room for formulation flexibility within the scope of the claims. The inclusion of pharmaceutically acceptable excipients broadens the scope to encompass various dosage forms.
How does KR20180012277 position itself within the existing SGLT2 and DPP-4 inhibitor landscape?
The landscape for SGLT2 inhibitors and DPP-4 inhibitors is characterized by numerous approved drugs and a robust patent ecosystem. KR20180012277 seeks to carve out a niche by patenting specific combinations and their therapeutic utility for type 2 diabetes.
Background on SGLT2 Inhibitors:
SGLT2 inhibitors, introduced around 2012-2014, work by inhibiting glucose reabsorption in the kidneys, leading to increased urinary glucose excretion. Key approved SGLT2 inhibitors include:
- Dapagliflozin (Farxiga/Forxiga, AstraZeneca)
- Empagliflozin (Jardiance, Boehringer Ingelheim/Eli Lilly)
- Canagliflozin (Invokana, Janssen)
- Ertugliflozin (Steglatro, Merck/Pfizer)
- Ipragliflozin (Suganon, Astellas Pharma) - Approved in Japan, not globally widespread.
- Tofogliflozin (Apleway, Chugai Pharmaceutical) - Approved in Japan.
These molecules are generally covered by their own compound patents, formulation patents, and method of use patents, many of which are nearing or have already expired in major markets. However, new combination therapies or novel formulations can extend market exclusivity.
Background on DPP-4 Inhibitors:
DPP-4 inhibitors, introduced around 2006-2007, work by increasing incretin hormone levels, which in turn increase insulin secretion and decrease glucagon secretion. Key approved DPP-4 inhibitors include:
- Sitagliptin (Januvia, Merck)
- Vildagliptin (Galvus, Novartis)
- Saxagliptin (Onglyza, AstraZeneca)
- Linagliptin (Tradjenta, Boehringer Ingelheim)
- Alogliptin (Nesina, Takeda)
- Gemigliptin (Zemiglo, LG Chem) - Approved in South Korea.
Similar to SGLT2 inhibitors, compound patents for many DPP-4 inhibitors have expired or are close to expiring, leading to generic competition.
Competitive Landscape for Combination Therapies:
The combination of SGLT2 inhibitors and DPP-4 inhibitors is a well-established therapeutic strategy. Several fixed-dose combination products are already on the market:
- Dapagliflozin + Sitagliptin: (e.g., Qtern, AstraZeneca/Merck)
- Empagliflozin + Linagliptin: (e.g., Glyxambi, Boehringer Ingelheim/Eli Lilly)
- Canagliflozin + Sitagliptin: (e.g., Invokamet, Janssen)
- Empagliflozin + Sitagliptin: (e.g., Synjardy, Boehringer Ingelheim/Eli Lilly)
- Dapagliflozin + Saxagliptin: (e.g., Qliax, AstraZeneca)
- Ertugliflozin + Sitagliptin: (e.g., Steglujan, Merck/Pfizer)
- Ipragliflozin + Sitagliptin: (e.g., Suganon Plus, Astellas Pharma) - Available in Japan.
KR20180012277 specifically highlights the combination of ipragliflozin and gemigliptin, with gemigliptin being a DPP-4 inhibitor developed and marketed by LG Chem, particularly prominent in South Korea. This specific combination may aim to leverage the existing market presence of these drugs or target geographical regions where this combination offers a novel therapeutic option.
The patent landscape for these combinations is complex, with companies filing patents for:
- New Chemical Entities: New drug molecules within these classes.
- Novel Formulations: Improved delivery methods, stability, or patient convenience for existing drugs.
- Combination Therapies: Patenting specific pairings of existing drugs, often with claims of synergistic effects or improved pharmacokinetic profiles.
- Methods of Use: Patenting new therapeutic indications or specific patient populations for existing drugs or combinations.
KR20180012277 falls into the combination therapy category. Its novelty likely resides in the specific combination of ipragliflozin and gemigliptin and the asserted synergistic benefit, assuming it demonstrates efficacy and safety profiles distinct enough to warrant patent protection beyond the existing patent coverage for the individual components or other known combinations. The patent's filing date (2018) and grant date (2019) are important considerations for its remaining term.
The patent's strength will depend on its ability to demonstrate that the claimed combination is not obvious in light of prior art, which would include existing SGLT2 and DPP-4 inhibitors, as well as any prior publications or patents describing their combinations. The inclusion of gemigliptin, a drug with a strong presence in the South Korean market, suggests a strategic focus on that region.
What is the current status and remaining term of KR20180012277?
Patent KR20180012277 was filed on March 29, 2018, and granted on May 29, 2019. The standard term for a patent in South Korea is 20 years from the filing date.
- Filing Date: March 29, 2018
- Grant Date: May 29, 2019
- Patent Term: 20 years from filing date
- Expiration Date: March 28, 2038
The patent is currently in force. However, it is crucial to note that patent terms can be extended under specific circumstances, such as for pharmaceutical patents that require regulatory approval delays. In South Korea, extensions of up to five years are possible to compensate for delays in obtaining marketing approval. A detailed analysis of the patent's prosecution history and any granted term extensions would be required for a precise remaining term calculation.
What are the implications for R&D and investment?
For Research & Development:
- Freedom to Operate (FTO): Companies developing new SGLT2 inhibitor or DPP-4 inhibitor products, or combinations thereof, must carefully assess their FTO in South Korea. This patent, covering a specific combination, could pose a barrier to market entry for generic versions or new fixed-dose combinations that fall within its claims.
- Innovation Opportunities: While this patent covers a specific combination, there remain opportunities for innovation in:
- Novel Excipients and Formulations: Developing improved formulations of the claimed combination (e.g., enhanced bioavailability, once-daily dosing, combination with other therapeutic agents).
- Alternative Combinations: Exploring combinations with different SGLT2 inhibitors or DPP-4 inhibitors not explicitly claimed, or combining with entirely new classes of antidiabetic drugs.
- New Therapeutic Indications: Investigating the claimed combination for new uses beyond type 2 diabetes management, where synergistic effects might be observed.
- Beat-and-Reverse Engineering: Developing bioequivalent generic versions of ipragliflozin and gemigliptin, and exploring strategies for co-formulation or co-administration that might circumvent direct infringement, though this is complex and legally risky.
For Investment Decisions:
- Market Exclusivity Assessment: Investors should evaluate the remaining patent term and the potential for patent term extensions. A patent expiring in 2038 provides a substantial period of market exclusivity for Daewoong Pharmaceutical Co., Ltd. (or its licensees).
- Competitive Analysis: Understanding the market share and patent portfolios of competitors, particularly those with existing combination products of SGLT2 and DPP-4 inhibitors, is critical. The presence of other SGLT2/DPP-4 combinations may dilute the impact of this specific patent, but the specific ipragliflozin/gemigliptin pairing could offer a unique competitive advantage.
- Due Diligence: For companies or investors considering acquiring or licensing the technology covered by KR20180012277, thorough due diligence on the patent's validity, enforceability, and Daewoong's manufacturing and marketing capabilities is essential.
- Royalty Streams and Licensing: The patent represents a potential revenue stream for Daewoong through direct sales or licensing agreements to other pharmaceutical companies. Investors should consider the potential for licensing revenue.
- Risk Assessment: The primary risks associated with this patent include potential challenges to its validity (e.g., prior art arguments), potential for successful FTO workarounds by competitors, and the evolving regulatory landscape for diabetes treatments.
The patent KR20180012277, by securing intellectual property rights over a specific combination therapy for type 2 diabetes, grants Daewoong Pharmaceutical Co., Ltd. a period of market exclusivity. This influences competitive dynamics, R&D strategies, and investment evaluations in the diabetes therapeutics sector.
Key Takeaways
- South Korean patent KR20180012277 claims a pharmaceutical composition containing an SGLT2 inhibitor and a DPP-4 inhibitor for treating type 2 diabetes.
- The patent specifically enumerates examples of SGLT2 and DPP-4 inhibitors and highlights a preferred combination of ipragliflozin and gemigliptin.
- The patent's scope covers both fixed-dose combinations and co-administered separate preparations.
- KR20180012277 operates within a competitive landscape characterized by numerous approved diabetes drugs and existing SGLT2/DPP-4 combination therapies. Its novelty likely lies in the specific ipragliflozin/gemigliptin pairing.
- The patent was filed on March 29, 2018, granted on May 29, 2019, and is scheduled to expire on March 28, 2038, subject to potential term extensions.
- For R&D, the patent necessitates FTO analysis and presents opportunities for novel formulations or alternative combinations. For investors, it highlights market exclusivity, competitive positioning, and potential licensing revenue.
Frequently Asked Questions
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Can other companies sell ipragliflozin and gemigliptin combinations in South Korea before March 2038?
No, unless they have a license from Daewoong Pharmaceutical Co., Ltd., or successfully invalidate the patent or design around its claims without infringement.
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Does KR20180012277 claim the individual drugs ipragliflozin or gemigliptin?
The patent claims the combination of these drugs within a pharmaceutical composition. It does not claim the individual compounds themselves, which are likely covered by separate, likely older, compound patents.
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What is the significance of the specific mention of ipragliflozin and gemigliptin?
This suggests that this particular combination is considered a key embodiment of the invention by the patent holder, possibly due to synergistic effects or market strategy. It also indicates a focus on the South Korean market where gemigliptin has a strong presence.
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Can the patent term for KR20180012277 be extended beyond March 2038?
Yes, pharmaceutical patents in South Korea can be extended up to five years to compensate for regulatory approval delays. A review of the patent's prosecution history and any granted extensions is needed for a definitive answer.
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Does this patent prevent the use of ipragliflozin and gemigliptin together in clinical trials for new indications?
While the patent claims the composition and its use for treating type 2 diabetes, its effect on clinical trials for other indications would depend on the specific claims and whether those other indications fall within the patent's scope. Generally, research for new indications would be less restricted if the existing patent's claims are narrowly construed for type 2 diabetes.
Sources
[1] Korean Intellectual Property Office. (n.d.). Patent Registration Certificate KR20180012277.
[2] Daewoong Pharmaceutical Co., Ltd. (2018). Patent Application KR20180012277.
[3] Daewoong Pharmaceutical Co., Ltd. (2019). Patent Grant KR20180012277.
[4] Drugs.com. (n.d.). SGLT2 Inhibitors. Retrieved from https://www.drugs.com/drug-class/sglt2-inhibitors.html
[5] Drugs.com. (n.d.). DPP-4 Inhibitors. Retrieved from https://www.drugs.com/drug-class/dpp-4-inhibitors.html
[6] Pharmaceutical company product information and press releases (various, regarding approved combination therapies).
