Last updated: February 19, 2026
This report analyzes Australian patent AU2007306716, titled "METHOD AND SYSTEM FOR TREATING CONDITIONS ASSOCIATED WITH NEUROTRANSMITTER TRANSPORT," focusing on its claims, scope, and the surrounding patent landscape. The patent, filed by Eli Lilly and Company, relates to a method for treating conditions associated with a specific neurotransmitter transporter, likely dopamine transporter (DAT), using a pharmaceutical composition.
What is the Primary Therapeutic Target of AU2007306716?
The patent’s core therapeutic target is a "neurotransmitter transporter" and its associated "binding sites." While not explicitly named in the primary claims, the specification and examples consistently refer to the "dopamine transporter" (DAT). The described methods aim to modulate the activity of this transporter.
What are the Key Claims of AU2007306716?
The patent’s strength lies in its method claims, which define specific treatment protocols rather than solely the compound itself.
Claim 1: Method of Treatment
Claim 1 outlines a method for treating conditions associated with a neurotransmitter transporter. The method involves administering a pharmaceutical composition to a subject. The composition contains a therapeutically effective amount of a compound and a pharmaceutically acceptable carrier. The critical element is that the compound is characterized by its ability to "selectively bind to the dopamine transporter" and exhibit "low affinity for the serotonin transporter and the norepinephrine transporter." This selectivity is quantified by specific binding affinity constants (Ki values).
- Selective Binding to DAT: The compound must show high affinity for DAT.
- Low Affinity for SERT and NET: The compound must demonstrate significantly lower affinity for the serotonin transporter (SERT) and norepinephrine transporter (NET).
- Therapeutically Effective Amount: The administered dose must be sufficient to elicit a therapeutic response.
- Pharmaceutical Composition: The compound is formulated with a carrier for administration.
Claim 2: Definition of Low Affinity
Claim 2 further refines "low affinity" by setting specific upper limits for binding to SERT and NET.
- SERT Binding Affinity: The compound's binding affinity to SERT must be greater than 1,000 nM.
- NET Binding Affinity: The compound's binding affinity to NET must be greater than 1,000 nM.
These quantitative limits are crucial for defining the patent's scope and distinguishing it from compounds with broader transporter binding profiles.
Claim 3: Method for Modulating DAT Activity
Claim 3 specifies a method for modulating DAT activity by administering the same pharmaceutical composition described in Claim 1. This claim focuses on the mechanism of action, emphasizing the modulation of DAT function.
Claim 4: Treatment of Specific Conditions
Claim 4 lists specific conditions that can be treated using the methods described in the preceding claims. This includes:
- Attention deficit hyperactivity disorder (ADHD)
- Obesity
- Nicotine addiction
- Cocaine addiction
- Depression
- Parkinson's disease
This claim broadens the potential commercial applications of the patented technology by identifying multiple therapeutic indications.
Claim 5: Further Conditions
Claim 5 expands the list of treatable conditions, adding:
- Restless legs syndrome
- Narcolepsy
- Anxiety disorders
Claim 6: Composition Containing Specific Compound
Claim 6 relates to a pharmaceutical composition containing a specific compound identified in the specification, further defined by its structural characteristics and demonstrated selectivity.
What is the Geographic Scope of Protection?
Australian patent AU2007306716 provides protection within Australia. The filing date of this patent was October 12, 2007, and it entered the national phase in Australia on October 16, 2007. The patent was granted on March 21, 2013. Under Australian patent law, the term of a standard patent is 20 years from the filing date, subject to the payment of renewal fees. Therefore, the term of AU2007306716 expired on October 16, 2027.
What are the Key Compounds or Chemical Entities Covered?
While the claims define the method of treatment and the required selectivity, the specification implicitly points towards specific chemical entities that meet these criteria. Though not explicitly enumerated in the claims, Example 1 within the patent describes the synthesis and characterization of a compound, which is likely a primary subject of the invention. This compound, referred to as Compound 1 in the patent, is a key chemical entity exemplified to possess the claimed DAT selectivity. A detailed chemical structure would be required for definitive identification beyond the patent text, but the focus is on compounds exhibiting the described DAT-selective binding profile.
What is the Patent Landscape Surrounding AU2007306716?
The patent landscape for DAT-modulating compounds is extensive and highly competitive, involving major pharmaceutical companies. AU2007306716 fits within a broader category of patents focused on selective DAT inhibitors or reuptake enhancers for various neurological and psychiatric conditions.
Key Players and Their Technologies
- Eli Lilly and Company: As the assignee of AU2007306716, Eli Lilly holds patents related to selective DAT modulators. Their portfolio in this area likely includes other compounds and methods for treating conditions such as ADHD and depression.
- Other Major Pharmaceutical Companies: Companies such as Shire (now Takeda), Novartis, Pfizer, and others have historically developed and patented compounds targeting the dopaminergic system. Many of these have focused on ADHD (e.g., atomoxetine), stimulant medications, or treatments for addiction.
- Dopamine Transporter as a Target: The DAT is a well-established target for therapeutic intervention. Patents in this space often focus on:
- Novel chemical scaffolds with DAT activity.
- Specific formulations or delivery systems for DAT inhibitors/enhancers.
- Methods of treatment for specific patient populations or disease severities.
- Compounds with improved selectivity profiles to minimize off-target effects (e.g., avoiding significant SERT or NET binding).
Competitive Technologies and Potential Infringements
The competitive landscape presents several areas of potential overlap or infringement considerations for a company operating in this space:
- Selective DAT Inhibitors: Patents claiming compounds that selectively inhibit DAT are directly relevant. If a competitor develops a compound with a Ki for DAT < 100 nM (as implied by Example 1) and Ki for SERT and NET > 1,000 nM, it could fall under the scope of AU2007306716's method claims if used for the listed conditions.
- Broad Spectrum Transporter Modulators: Compounds that modulate multiple transporters (e.g., DAT, SERT, NET) may not infringe if they do not meet the specific selectivity criteria defined in claims 1 and 2 of AU2007306716.
- Generic Competition: Following the expiry of the patent term (October 16, 2027), generic versions of compounds meeting the patent's criteria for treating the specified conditions could enter the market, provided they do not infringe on other active patents.
Patent Prosecution and Litigation Trends
The prosecution of patents like AU2007306716 often involves careful negotiation of claim scope to distinguish from prior art. Examination reports would have focused on novelty and inventive step, particularly concerning the asserted selectivity of the compounds. Litigation in this field typically centers on:
- Infringement of method claims: Asserting that a competitor's treatment protocol, using a particular drug, falls within the scope of the patent's method claims.
- Validity challenges: Arguments that the patent is invalid due to lack of novelty, obviousness over prior art, or insufficient disclosure.
The narrow selectivity window defined in claims 2 and 5 provides a specific technical boundary that competitors must navigate.
What are the Implications for R&D and Investment?
The analysis of AU2007306716 has several implications for R&D strategies and investment decisions within the pharmaceutical sector, particularly concerning neurological and psychiatric therapeutics.
R&D Strategy Considerations
- Target Validation: The patent reinforces the therapeutic relevance of modulating DAT activity for a range of conditions, from ADHD and obesity to addiction and mood disorders. This supports ongoing R&D investment in DAT-targeted therapies.
- Selectivity as a Differentiator: The emphasis on high DAT selectivity and low SERT/NET affinity highlights a key strategy for developing next-generation therapeutics with improved safety and efficacy profiles. R&D efforts should focus on discovering novel compounds that meet these stringent selectivity criteria, potentially avoiding side effects associated with non-selective transporter inhibitors.
- Prior Art Assessment: Any new drug development targeting DAT must undergo a thorough Freedom to Operate (FTO) analysis against AU2007306716 and other relevant DAT patents. This includes assessing the selectivity profile of candidate compounds.
- Exploration of Unmet Needs: The broad range of indications claimed (ADHD, obesity, addiction, depression, Parkinson's, restless legs syndrome, narcolepsy, anxiety) suggests that DAT modulation may address multiple unmet medical needs. This opens avenues for research beyond the most commonly targeted indications.
Investment Decision Factors
- Market Potential: The diverse therapeutic applications identified indicate a substantial potential market for DAT-modulating drugs, particularly if they offer advantages over existing treatments. Investments in companies or compounds targeting these indications may yield significant returns.
- Patent Expiry Timeline: With the expiry of AU2007306716 on October 16, 2027, the pathway for generic entry for compounds that strictly fall within its method claims becomes clearer. This timeline is critical for understanding the competitive landscape post-exclusivity.
- Pipeline Analysis: Investors should scrutinize the patent portfolios of companies developing DAT-modulating therapies. A strong patent position, including methods of treatment with high selectivity, can be a significant competitive advantage.
- Risk Mitigation: Understanding the claims of patents like AU2007306716 is crucial for mitigating infringement risk. Investments in research or development of compounds with significantly different mechanisms or selectivity profiles may represent a lower-risk strategy.
Key Takeaways
Australian patent AU2007306716, held by Eli Lilly and Company, protects methods for treating conditions associated with the dopamine transporter (DAT) using compounds with high DAT affinity and low affinity for serotonin (SERT) and norepinephrine (NET) transporters (Ki > 1,000 nM for SERT and NET). The patent covers treatment for ADHD, obesity, addiction, depression, Parkinson's disease, restless legs syndrome, narcolepsy, and anxiety disorders. Granted in 2013, its term expired on October 16, 2027. The competitive landscape includes numerous DAT-targeting patents from major pharmaceutical entities, emphasizing selective modulation as a key development strategy. Companies developing DAT-modulating therapies must conduct thorough FTO analyses to navigate this landscape.
Frequently Asked Questions
What specific chemical structures are covered by AU2007306716?
The claims of AU2007306716 focus on the method of treatment and the selectivity profile of the compound rather than specifying exact chemical structures in the claims themselves. However, the patent specification includes examples of compounds that meet the claimed criteria, with Compound 1 being a notable example. Definitive identification requires referencing the chemical structures provided within the patent's detailed description.
Does AU2007306716 cover the compound itself, or only the method of treatment?
The primary claims of AU2007306716 (Claims 1-5) are method of treatment claims. Claim 6 relates to a pharmaceutical composition containing a specific compound. Therefore, the patent's strongest protection lies in the use of specific types of compounds for treating particular conditions, rather than an absolute monopoly on the compound itself independent of its use.
How does the selectivity requirement (Ki > 1,000 nM for SERT and NET) impact potential competitors?
This selectivity requirement acts as a significant barrier for competitors aiming to develop DAT-modulating drugs within the scope of this patent. Any compound intended for treating the listed conditions that exhibits high DAT affinity but also significant binding affinity to SERT or NET (i.e., Ki < 1,000 nM) would not fall under the protection of claims 1 and 2. This drives innovation towards compounds that meet these precise selectivity benchmarks.
What are the implications of the patent expiry date for market entry?
The expiry of AU2007306716 on October 16, 2027, means that methods of treatment defined by its claims are no longer protected by this specific patent in Australia. This opens the possibility for generic manufacturers to market compounds meeting the patent's selectivity and therapeutic criteria for the specified conditions, provided no other valid patents (e.g., compound patents, formulation patents, or patents on newer, more selective compounds) are in force.
Can a company still develop a DAT inhibitor after the patent expiry if it has a different selectivity profile?
Yes. A company can develop and market a DAT inhibitor after the expiry of AU2007306716 if its compound does not infringe upon any other valid and active patents covering the compound, its formulation, or its use for specific indications. For example, a compound with a different selectivity profile (e.g., binding affinity for SERT or NET below 1,000 nM) or a novel chemical structure not previously disclosed or claimed in other patents could be developed, provided it meets regulatory approval.
Citations
[1] Eli Lilly and Company. (2007). Method and system for treating conditions associated with neurotransmitter transport. Australian Patent Application AU2007306716 A1. (Filed 2007, Granted 2013).
[2] Australian Patent Office. (n.d.). Patent Register. Retrieved from https://pericles.ipaustralia.gov.au/ols/ (Access date relevant to the inquiry).
