Notes

Patent Law Basics - Overview

• Historical Background
• What a patent is - definition and examples
• Justification/Rationale for patent rights
• Subject Matter
• Requirements for Patentability
• Ownership
• Term(s) of Protection
• Rights conferred by a patent (e.g.: scope of patent protection)
• Limitations to patent protection
• Institutional players and national/regional/international patents
• News from Europe: The "Unitary Patent" Package.

First Known Patent Open letter of Privilege issued by the Florence City Council in 1412

• Inventor: Filippo Brunelleschi.
• Invention: Boat for loading and transporting marble blocks.
• Privilege: Exclusive right to manufacture and use the invention for 3 years.

Galileo's Water Pump (Venetian's Senate: 1593/1594)

What is a Patent?

• Patent = title (document) issued by an administrative authority, conferring the exclusive right of commercial exploitation of an innovation for a limited period of time (generally, 20 years starting from the filing of the application).
• The rights are conferred after substantial and formal examination and evaluation of the patent requirements.

Patent applications can be filed by the inventor or the inventor's employer (see later slide on ownership!) as inventions are usually the property of the company that employs the inventor. This is also the case for university researchers in many countries. A European patent application contains a full and detailed description of the invention so that others can understand and replicate it, one or more claims which define the technical features of the invention for which protection is sought - this is called the "scope of protection" - and optional drawings which help with understanding and interpreting the claims and description. The cover sheet contains bibliographic information about the applicant and the inventor. It also contains an abstract, one of the drawings, and details of the technical class. The abstract and the technical class are useful when it comes to searching for patents.

What does the description contain?

• Prior Art, it shows the situation at the moment of registration, demonstrating that the invention is yours and has not been invented before by anyone else.
• Problem to be Solved.
• Solution.
• Advantage of the Invention.

Why granting a Patent? Patents as a social contract (contract theory).

[The inventor is granted the exclusive right on the invention as long as he discloses the invention through the patent application, for the period of duration of the patent. Granting the patent means stimulating inventions, most of the ideas would otherwise remain secret or never exploited.] As we have already seen, patents are sometimes considered as a kind of contract between the applicant and society. Applicants and patent owners are interested in benefiting from their inventions. Owning a patent gives them the right to prevent others from making, using, offering for sale, selling or importing a product that infringes the patent, for a limited amount of time and the country for which the patent has been granted. The exceptions to this are use of the patent for non-commercial purposes, including private use and academic research. Society is interested in:

• Encouraging innovation so that better products can be made and better production methods can be used for the benefit of all;
• Protecting new and innovative companies so that they can compete with larger established companies, in order to maintain a competitive economy;
• Finding out the details of new inventions so that other engineers and scientists can further improve them; and
• Promoting technology transfer, that is from universities to industry.

In return for this protection, applicants must reveal their inventions to the public, so others can build on them. This takes the form of publication of the application by the relevant patent office. This social contract is institutionalised in the form of patent law.

The role of the patent system

• To encourage technological innovation.
• To promote competition and investment.
• To provide information on the latest technical developments.
• To promote technology transfer.

The patent system encourages technological innovation by rewarding intellectual creativity. In providing patent owners with protection for their inventions, patents offer them recognition for their creativity. and the possibility of obtaining financial reward if they commercialise or exploit their inventions. The patent system can also promote competition and investment in developing new or improved products or processes by encouraging research and development. Investors are more likely to provide financial backing if there is the potential for a return on their investment from inventions that can be patented. Because the information disclosed in patents is published, the patent system encourages the dissemination of information that may be of benefit to society.

It can promote technology transfer by way of the publicly available information in patent databases.

What is an invention?

• There is no formal definition of "invention" (anywhere)
• In the EPC: "European patents shall be granted for any inventions, in all fields of technology, provided that they are new, involve an inventive step and are susceptible of industrial application".
• Scholars: new and original solution to a technical problem, that is suitable for industrial application.
• As long as it meets the mandatory requirements + subject-matter not excluded from patentability = patentable invention.

Main "types" of invention

• Product Invention, Old way of producing something new.
• Process Invention, New way of producing something old.
• Invention of USE, New use of an old product or process.

Patentable Subject Matter EPC gives twofold "negative" definition of patentable subject matter, in terms of:

• Intellectual creations that shall NOT be regarded as inventions (art. 52(b,c,d)).
• Inventions that shall NOT be regarded as patentable (art. 53).

Two different grounds:

• Excluding from patentability creations that are subject matter of different IPRs (copyright, sui generis right, etc.)
• Excluding from patentability intellectual creation that must be left in the public domain.

Patentable Subject Matter (EPC)

Negative definition of patentable subject matter (art. 52 and 53 EPC)

• Ideas.
• Laws of Nature, Physical Phenomena.
• Living Organism (but within BioTech limitations).
• Methods of Doing Business.
• Surgery or Therapy Methods.
• Computer Programs.

Patentability Requirements

Three "substantive requirements"

• EU:
  • Novelty
  • Inventiveness
  • Industrial Applicability
• US:
  • Novelty
  • Non Obviousness
  • Usefulness

+ Sufficient Disclosure ("Formal" requirement)

Patents can be granted only if the invention matches All the requirements:

• Patentable Subject Matter
• Novelty
• Inventiveness/Non-Obviousness
• Industrial Applicability/Utility
• Sufficient Disclosure

Patent offices can reject applications failing ONE of these requirements. Courts can invalidate a patent for lacking ONE of these requirements.

Novelty

• An invention shall be considered to be new if it does not form part of the state of the art.
• The state of the art shall be held to comprise everything made available to the public by means of a written or oral description, by use, or in any other wat, before the date of filing of the European patent application.
• Including from the patent applicant itself (prior disclosure!)

State of the art (Prior Art)

• Prior Art is any evidence that your invention is already known.
• It is enough that someone, somewhere, sometime previously had described or shown or made something that contains a use of technology that is very similar to the invention.
• A prehistoric cave painting can be prior art. A piece of technology that is centuries old can be prior art. A previously described idea that cannot possibly work can be prior art. Anything can be prior art.
• Novelty requirement entails ABSOLUTE novelty, that is, the invention must be non-anticipated anywhere (worldwide) and anyway (in any form).

Do's and Don'ts for safeguarding novelty Don'ts

• Do not publish any articles, press releases, conference presentations/posters/proceedings, lectures or blog posts, etc. before you file.
• Do not sell any products incorporating the invention before you file.

Do's

• Sign a non-disclosure agreement (NDA).
• Seek professional advice at an early stage.
• File before anyone else does!

If you disclose your invention before the filing date you risk invalidating your patent application. Remember the social contract? If you have already revealed your invention to the public, you will have nothing to "trade", so you won't get a patent, even if it was you who made the invention public! Under the EPC, the first to file the patent application will be entitled to the grant of a patent on a particular invention. If you disclose your invention before filing, it will no longer be considered "new", regardless of the form the disclosure took, including written form (even in a publication that no-one might have read), oral disclosure (such as in a presentation or lecture), actual use or sale, and regardless of the place. In other words, all material made available to the public anywhere in the world forms part of the state of the art. So, the key message is keep it confidential! Do not disclose your invention to anyone, not even orally, until you have filed your patent application. If you need to talk to potential customers or investors before you file, make sure you sign a non-disclosure agreement with them first. Once you have filed your application, you are free to present, publish or sell your invention as you wish.

Inventive Step/Non-Obviousness Invention must not only be "new" with respect to the state of the art, but must make a step forward from the prior art. An invention shall be considered as involving an inventive step if, having regard to the state of the art, it is not obvious to a person skilled in the art.

Person skilled in the art:

• Abstract model that is only aware of the state of the art in the technical field of the invention (not "medicine", but "oncology", or - if applicable - "Pediatric oncology") + common general knowledge (text books).
• May be a team, and thus be aware of multiple technical fields ("chemistry"+ "oncology").
• May know other fields, if neighboring or even remote (respectively, if common to know or if prompted to do so).

The Problem-Solution Approach (EPO) In order to assess inventive step in an objective and predictable manner, the so-called "problem-solution approach". In the problem-solution approach, there are three main stages:

• Determining the "closest prior art".
• Establishing the "objective technical problem" to be solved.
• Considering whether or not the claimed invention, starting from the closest prior art and the objective technical problem, would have been obvious to the skilled person.

Secondary Considerations in Inventive Step

• Long-felt but unsolved need.
• Commercial Success
• Failed efforts of others
• Copying by others
• Unexpected results

Increases in speed, accuracy or definition do not generally result from an inventive step.

Industrial Application (EPO Utility US) EPC art. 57, Invention must be susceptible of industrial application:

• Something which can be made industrially or related to an industrial process.
• Something which can be made or used in any kind of industry (including agriculture).

35 U.S.C. 101, Industrial application implies that the invention is useful (some identifiable benefit and is capable of use), that is, it must produce (at least some) tangible and physical effect.

Sufficient Disclosure EPC 138 (1 b)/ 35 U.S.C. 112 The patent must disclose the invention in a manner sufficiently clear ad complete for it to be carried out by a person skilled in the art. Sufficiently clear and complete:

• The invention must be entirely disclosed in all detail.
• The disclosure shall not merely describe the new product or process, but must enable others to carry it out.

Rationale for patent grant (the "contract") is contribution to human knowledge: therefore the inventor must inform the public what he or she believes is the best way to practice the invention.

Ownership Any natural (human beings) or legal (legal entities such associations, corporations, estates, NGO, etc.) person is entitled to apply for both individually and jointly.

Term(s) of Patent Protection International harmonization of patent term across national laws under TRIPs Agreement (Art. 33):

• The term of protection available [for patents] shall not end before the expiration of a period of twenty years counted from the filing date".

Rights conferred by a patent (e.g. Scope of Patent Protection) The scope of patent protection is determined by the terms of the claim. The patent document confers a temporary right to exclude others from making, using or selling the invention described and claimed in the document. It's a NEGATIVE RIGHT.

Limitations of the Exclusive Right

• Private and/or non commercial use;
• Experimental use and/or scientific research;
• Extemporaneous preparation of medicines;
• Prior use;
• Use of articles on foreign vessels, aircrafts and land vehicles;
• Acts for obtaining regulatory approval from authorities;
• Exhaustion of patent rights;
• Compulsory licensing and/or government use; and
• Certain use of patented inventions by farmers and breeders.

The above list has been elaborate by the Standing Committee on the Law of Patents (SCP) The SCP was created in 1998 to serve as a forum to discuss issues, facilitate coordination and provide guidance concerning the progressive international development of patent law. By dealing with clusters of interlocking issues rather than working in isolation on single issues, it is intended to provide member states with an effective mechanism for setting priorities and allocating resources, and ensure the coordination and continuity of interrelated, on-going work.

Institutional Players Patent (and Trademark) Offices:

• National Offices, National patent
• Regional Office (European Patent office), European patent
• WIPO (through national POs), International patent.

European Patent System European Patent Convention (EPC) = International agreement in 1973 that has nothing to do with the European Union (now: 38 member states, but protection can be extended to up to 42 states). Allows for a centralized procedure to file and have the patent examined before the European Patent Office (EPO). Through ONE application you can get patents in all the countries unless you opt out from some countries. Once granted, the patent actually becomes a "bundle" of patents, one for each territory where it was requested (and paid for). Many states then require the owner to file a translation in their national language to become effective in the country (e.g. Italy). Therefore, the "European patent" does not mean a unitary title across Europe. Validation requirements differ between countries and can lead to high direct and indirect costs, including translation costs, validation fees (i.e. fees due in some member states for publication of the translations) and associated representation costs, such as the attorney fees charged for the administration of the patent (i.e. payment of national renewal fees).

How to obtain patent protection in Europe The national route:

• Separate procedure for each state
• Procedures differ according to national law

The regional route: European Patent Convention:

• One application filed at one office for up to 42 states.
• One procedure.
• Applicant selects the desired states.
• Results in a bundle of national patents.

At the international level: PCT System The Patent Cooperation Treaty (PCT) is an international convention that was signed in 1970. One single application for up to 152 countries (as of June 2019). The PCT established a system that makes it possible to seek patent protection for an invention simultaneously in a large number of countries by filing a single "international" patent application instead of filing several separate national or regional patent applications. However, the granting of patents remains under the control of the national or regional patent Offices in what is called the "national phase". It is a matter of a centralized procedure, but still very relevant due to the strict novelty/inventive step rules we have seen (secure timing, once and for all).

European "Unitary Patent" Package Regulations 1257/2012 and 1260/2012. A European patent with unitary effect. Further option in addition to European patents and national patents. Protection in a single step for 26 participating EU member states Unitary character for said 25 states: limitation, transfer, revocation, lapse (only in respect of all states). One-stop shop with centralized post-grant administration by the EPO (single renewal fee, register entries). This will be a very big change in the EU as, like in the case of the community trademark, through one application you have ONE patent that is valid within the internal market, skipping the validation phase and the maintenance costs of the European Patent System. Moreover, there will be European courts specialized in addressing patent issues.

European "Unitary Patent" package

• European patent with unitary effect
• Unified Patent Court

This would be a very big change as, like in the case of the community trademark, through one application you have a patent that is valid within the internal market, skipping the validation phase and the maintenance costs of the European patent system. The law of the Unitary Patent would be in a Regulation (see slide) that directly applies within all Member States. The patent would be litigated at European level, in front of the Unified Patent Court, instead of being litigated at national level as in the case of international and European patents.

• A European patent with unitary effect. Further option in addition to European patents and national patents. Protection in a single step for 26 participating EU member states. Unitary character for said 25 states: limitation, transfer, revocation, lapse (only in respect of all states). One-stop shop with centralized post-grant administration by the EPO (single renewal fee, register entries). This will be a very big change in the EU as, like in the case of the community trademark, through one application you have ONE patent that is valid within the internal market, skipping the validation phase and the maintenance costs of the European patent system. Moreover, there will be European courts specialized in addressing patent issues.
• The process:
  • The "European Unitary Package" was meant to be launched in February 2017
  • But delayed due to Brexit and due to a constitutional complaint filed in Germany on the Unified Patent Court (on sovereignty issues).
  • The new "date" is currently expected for the beginning in 2022.