Claimed Mice

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The keyword claimed mice has 1 sections. Narrow your search by selecting any of the keywords below:

• biotechnological inventions (4)
• inventive step (4)
• patent eligibility (2)
• ethical issues (2)
• inventive skill (2)
• patent application (2)
• patentable subject matter (2)
• prior art (2)
• key considerations (2)
• grace period (2)

1.Key Considerations for Biotechnological Inventions[Original Blog]

Biotechnology is a rapidly evolving field that offers many opportunities for innovation and invention. However, biotechnological inventions also pose some unique challenges when it comes to patent protection. In this section, we will discuss some of the key considerations that biotechnology inventors should be aware of before filing a patent application. We will cover topics such as patent eligibility, novelty, inventive step, disclosure, enablement, and ethical issues. We will also provide some examples of biotechnological inventions that have been granted or denied patents in different jurisdictions.

Some of the key considerations for biotechnological inventions are:

1. Patent eligibility: Biotechnological inventions must meet the criteria of patent eligibility, which means that they must fall within the scope of patentable subject matter and not be excluded by law or policy. Patentable subject matter generally includes any product, process, or use that is new, useful, and non-obvious. However, some biotechnological inventions may be excluded from patentability for various reasons, such as being contrary to public order, morality, or health; being part of the natural world; or being mere discoveries without any technical contribution. For example, in the US, the Supreme Court has ruled that isolated DNA sequences, natural phenomena, and laws of nature are not patent eligible, while in the EU, the Biotechnology Directive has excluded human embryos, animal varieties, and plant varieties from patentability.

2. Novelty: Biotechnological inventions must be novel, which means that they must not have been disclosed to the public before the filing date of the patent application. Disclosure can occur in various ways, such as publication, presentation, sale, use, or offer for sale. However, some jurisdictions may provide a grace period for certain types of disclosures, such as those made by the inventor or those made in official exhibitions or scientific conferences. For example, in the US, the inventor has a one-year grace period to file a patent application after making a public disclosure, while in the EU, there is no grace period and any disclosure will destroy the novelty of the invention.

3. Inventive step: Biotechnological inventions must involve an inventive step, which means that they must not be obvious to a person skilled in the art at the filing date of the patent application. The person skilled in the art is a hypothetical person who has the common general knowledge and the relevant technical background in the field of the invention. The inventive step is assessed by comparing the invention with the prior art, which is the state of the art that is publicly available before the filing date. The prior art may include patents, publications, databases, or any other source of information. The invention must provide a technical advantage or a surprising or unexpected result over the prior art. For example, in the US, the Federal Circuit has held that the invention of a recombinant DNA molecule encoding erythropoietin (EPO) involved an inventive step, because it was not obvious how to isolate and clone the gene for EPO from human cells, while in the EU, the European Patent Office (EPO) has rejected the patent application for the same invention, because it was obvious to try to isolate and clone the gene for EPO using the known techniques of molecular biology.

4. Disclosure: Biotechnological inventions must be sufficiently disclosed in the patent application, which means that they must provide enough information to enable a person skilled in the art to carry out the invention without undue burden or inventive skill. The disclosure must also support the claims, which are the legal definition of the invention and the scope of protection. The disclosure may include a written description, drawings, examples, experimental data, and references to deposited biological material. The disclosure must be clear, complete, and concise, and must not contain any contradictions, ambiguities, or inconsistencies. For example, in the US, the Federal Circuit has invalidated a patent for a method of producing transgenic mice, because the disclosure did not enable a person skilled in the art to make the claimed mice without undue experimentation, while in the EU, the EPO has granted a patent for the same invention, because the disclosure provided sufficient guidance and examples to enable a person skilled in the art to make the claimed mice.

5. Enablement: Biotechnological inventions must be enabled, which means that they must be capable of being made or used in practice. Enablement is closely related to disclosure, but it also depends on the technical feasibility and reproducibility of the invention. The invention must be enabled across the whole scope of the claims, which means that it must not cover any embodiments that are not enabled or that require further inventive skill. The enablement requirement may vary depending on the type and complexity of the biotechnological invention. For example, in the US, the Federal Circuit has upheld a patent for a method of producing monoclonal antibodies, because the invention was enabled by the disclosure and the common general knowledge in the art, while in the EU, the EPO has revoked a patent for a method of producing human antibodies, because the invention was not enabled across the whole scope of the claims, which covered any human antibody against any antigen.

6. Ethical issues: Biotechnological inventions must comply with the ethical standards and principles that are recognized by the society and the law. Ethical issues may arise from the nature, origin, or use of the biotechnological invention, such as its impact on human dignity, animal welfare, environmental protection, or public health. Ethical issues may also affect the patentability, validity, or enforceability of the biotechnological invention, depending on the legal and policy framework of the jurisdiction. For example, in the US, the Patent Office has issued a patent for a method of cloning human beings, but the patent is likely to be unenforceable, because human cloning is prohibited by federal and state laws, while in the EU, the Biotechnology Directive has explicitly excluded methods of cloning human beings from patentability, because they are contrary to human dignity.