Patent Law

The patent law system recognises that innovation and technological developments, both crucial tools for a country’s financial and social wealth, cannot be motivated solely by market competition. The basic requirements for a patent to be registered in the UK are that it:

• be novel (new);
  
• possess an inventive step (non-obviousness);
  
• be capable of industrial application;
  
• not be excluded for being ‘unpatentable’ subject-matter.

If an application does not satisfy these conditions, a patent will not be granted by the UK Patent Office.

Patents are territorial rights and to date there is no such thing as an ‘international patent’. However, administrative procedures for filing patents in multiple international jurisdictions have been streamlined and there are moves to attempt to harmonise the patent system at a European Union level.

The Patents Act 2004 amends the Patents Act 1977 in certain respects. Further, Gower’s Review of Intellectual Property 2006 confirms that essentially the current UK system is ‘fit for purpose’, although the report contains many recommendations for improvement. The Digital Opportunities Report 2011 further advises the government to be vigilant in ensuring that ‘patents are not extended into sectors, such as non-technical computer programs and business methods, which they do not currently cover, without clear evidence of benefit’.

Patent law covers a large volume of fascinating material and it is hoped that the selection of questions and answers that follow map on to the topics contained in the undergraduate patent law syllabus.

Frank Fysch, a keen fisherman and inventor (in his spare time) from the East Midlands, consults you regarding his latest invention, a new type of reel release mechanism to be used with a standard fishing rod.

Frank sold his rights to a previous invention to an international company for a flat fee of £20,000 but feels he didn’t get as much as he could have for it because he sold after having produced a working prototype. The company has since gone on to sell thousands and made substantial profits from his earlier invention.

This time around, Frank, who feels he has established his reputation as an inventor in the field, wishes to apply for a patent in the UK and offer it to several companies to bid on. In doing this, he hopes to achieve a higher up-front fee for licensing his invention, as well as future royalties.

   Advise Frank as to the patentability of his reel release mechanism and the steps involved in the patenting process.

In order to determine who is entitled to a patent it is necessary to institute a reference in time which will establish precedence by one inventor over another in case two or more inventors create the same invention. The two traditional references in time presently applicable in different jurisdictions are:

1. the date of filing, in the so-called ‘first-to-file system’ as used in the UK; and
   
2. the date in which an invention is first reduced to practice, in the so-called ‘first-to-invent system’ used in the US.

Each system is said to have its own advantages in that the former provides certainty of ownership, whereas the latter ensures that the true inventor is rewarded with monopoly rights.

As a patent is a territorial right, Frank should apply for protection in both the UK and the US. He has two options: (1) file separate national applications with each of the UK and US patent offices respectively; or (2) as both countries are signatories to the Patent Cooperation Treaty 1970, he could opt for this route, which offers an international patent filing system to expedite the application process for registering patents in PCT member states. The second option is particularly attractive if Frank later wishes to file in any further countries. For the purpose of this answer we will focus on a UK national filing through the UK Patent Office.

Frank’s UK patent application must comply with certain administrative formalities as well as meeting the requirements for a patentable invention. There are four key legal, rather than administrative, requirements to be satisfied to conclude that a patentable invention exists in the new rod reel mechanism and before Frank will be granted a UK patent. The invention must:

1. be novel: s 2 PA 1977;
   
2. involve an inventive step: s 3 PA 1977. In other words, the invention must be a technical advance over existing technological understanding (‘the state of the art’) which is not obvious;
   
3. be capable of industrial application: s 4 PA 1977;
   
4. not be excluded by law from being patented: s 1(3) PA 1977 (for example not a method of treating the human and animal body; not a plant or animal variety, nor be contrary to public policy or morality).

These legal requirements cannot be understood without first being aware of three other fundamental concepts in patent law. These are the concepts of:

A knowledge of these concepts is necessary to understand the process by which patents are granted and to appreciate how a patent might be attacked as being invalid. The classic defence to a patent infringement claim is to show that the patent is invalid.

The priority date of the patent application is the date on which it is tested against the ‘state of the art’: s 5(1) PA 1977. This is normally the filing date of the application (unless an earlier date is claimed in the UK Patent Office, European Patent Office, or Paris Convention country).

The prior art or state of the art is defined in s 2(2) PA 1977 as comprising all matter made available to the public before the priority date of the invention. This includes all knowledge anywhere in the world on the subject matter of the invention. Novelty-destroying prior art could include information that is part of common general knowledge, information disclosed by an earlier user of the invention, information disclosed in a single copy of a published document or by oral communication. Frank must ensure that he keeps the new reel mechanism absolutely confidential until he files a patent application. Only then will he be able to freely disclose his invention to the international companies and others (unless the companies agree to sign strongly drafted non-disclosure agreements).

The inventive step is a very different question to that of novelty and involves a qualitative assessment of the invention by reference to the ‘skilled man’. The new reel mechanism should not be obvious to a person skilled in the art, having regard to all matters forming part of the state of the art at the priority date of the patent: s 3 PA 1977. In deciding whether Frank’s invention is obvious, the test in Windsurfing International Inc v Tabur Marine (1985) as modified by PLG Research Ltd v Ardon International Ltd (1995) can be applied:

1. Identify the inventive step or concept.
   
2. At the priority date, what was the state of the art relevant to that step?
   
3. Identify the differences between the invention and the state of the art.
   
4. Do the differences constitute steps which would have been obvious to the skilled man, or is there a degree of inventiveness?

In applying the Windsurfer test the scope of the state of the art is narrower for inventive step than it is for novelty (s 3 PA 1977) because earlier patent applications do not form part of the state of the art.

Assuming that Frank’s invention meets the four legal requirements, he should feel confident about filing his application with the UK Patent Office. The procedural steps will involve the following:

1. Completing the Patent Form 1/77. The patent application must contain a specification containing a description of the invention, as well as a claim for the patent and any drawing referred to in the description or the claim as well as an abstract.
   
2. Filing (s 5(1) PA 1977).
   
3. Preliminary examination and limited search (s 17 PA 1977) within 12 months from filing date. The application is referred to a patent examiner for a preliminary examination and search to ensure that the application complies with the Acts requirements.
   
4. Publication (s 16(1) PA 1977) by Patent Office in the Official Journal of Patents allowing public inspection of the claims. Publication of the patent application can give rise to third-party objections to the grant of the patent.
   
5. Substantial examination and search within six months after publication, requested by applicant.
   
6. Grant – comptroller must publish notice in the Official Journal of Patents; Certificate issued to the applicant.
   
7. Monopoly lasting 20 years for patent proprietor.

Critically discuss the key advantages and disadvantages of patenting an invention under the Patents Act 1977.

Patents protect new, industrially applicable inventions and give the inventor or proprietor (the ‘patentee’) a legally recognised monopoly to work the invention for a period of up to 20 years. There are both advantages and disadvantages to patent protection, as the procedure for obtaining a granted patent is costly, lengthy and complex. It is important to consider the pros and cons before either publishing the invention or applying for the patent.

Advantages of Patent Protection

The key advantage of filing a patent is that a patent monopoly is granted for a firm duration of 20 years and can prevent unauthorised third parties from using the invention during that period. While under monopoly protection, the Patents Act 1977 provides that only the patentee is lawfully allowed to commercially exploit the invention through manufacturing and licensing. The scope of that right in any particular case is determined by the claims in the patent specification. This usually includes reverse-engineering, since a valid patent protects the ideas and information in the way described in the patent’s claims and using such information obtained via reverse-engineering in the ways described in the patent claims will infringe the patent. The patentee is even protected against someone who subsequently creates the same invention entirely through his or her own efforts.

In addition, the boundaries of subject-matter susceptible to patent protection has expanded so that protection is available for certain inventions where that opportunity did not exist in the past. Together with novelty, the inventive step or non-obviousness and utility, the question of whether a particular subject matter is patentable is one of the fundamental requirements for patentability. This means that the system is flexible and capable of adapting.

Perhaps the most important advantage is that a patent is a form of property that can be licensed to generate royalties and future income. Once granted, the patent owner can sue for patent infringement dating back to the priority date. Nevertheless, there is no legal requirement to file for a patent and an inventor could decide to keep the invention secret so the system is not mandatory. The decision to file a patent application is not irrevocable, it may be withdrawn at any time before publication by the Patent Office.

Disadvantages of Patenting

On the other hand, the key disadvantage of filing a patent is that the patentee, in return for patent protection, must consent to publication of the details of the new invention. This means that third parties can ‘invent around’ or improve on the invention. Other significant disadvantages relate to the costs and length of time to secure a patent which on average, takes over three years.

Some are disappointed by the fact that a patent provides a mere 20-year monopoly, after which anyone may exploit the invention.

Furthermore, patent protection is territorial and will only cover the UK, although patents may, if certain requirements are met, be filed in other countries for an additional cost via the European Patent Convention (EPC) and Patent Cooperation Treaty (PCT) routes. The patent application may need to be translated if filed in other jurisdictions, further adding to the costs involved. If the EPC or PCT route is used, the patent application will still need to undergo a national phase in each designated country. As yet there is no single global patent in existence although the World Intellectual Property Organization (WIPO) is currently engaging in this debate. Many stakeholders in the patent system are calling for the creation of a global patent system to make it easier and faster for corporations to enforce their intellectual property rights around the world.

Other important disadvantages of the patent system from the point of view of the patentee is that disclosures by others can ruin novelty. Nothing can be done if someone else engaged in similar research makes the invention public before a patentee applies for a patent. Even once the patent has been granted, opposition proceedings may be started. This means that the patent can be challenged and possibly revoked.

Again on the subject of costs, the patentee must pay ever higher fees to continue to renew the patent until the 20-year monopoly has expired.

Although not required for legal protection, the patented invention should be marked with the granted patent number as a deterrent for potential infringers.

Finally, unless the patent owner reserves its rights, once a patent product has been sold, the purchaser has an implied right to sell that product to anyone in the world, who in turn has the same right. This can cause problems for patentees who want to control commercial export and import of their products.

In conclusion, while there are certainly several disadvantages to the patent law system, the UK Patent Office reports steadily increasing levels of patent application activity. Indeed, patent activity is mushrooming across virtually every sector of the UK economy as patentees seek to gain a proprietary market advantage, an exclusive hold over a new technology. Registered patent rights have also seen a boom in revenues derived from patent licensing and have served as a hidden motive behind a number of the biggest corporate mergers in the last decade. It is not just the UK economy that is affected by these trends, patent activity is on the rise worldwide, spurred in part by the World Trade Organization’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). Concerns have been raised about the recent trends in patent activity – the patenting of biotechnological inventions, business methods and databases – and that these may actually stifle academic freedom, scientific inquiry and technological innovation. However, there is little doubt, as evidenced by dozens of studies by economists and Gower’s Review of Intellectual Property, published in December 2006, that the patent system is, on balance, an effective instrument for fostering innovation and technology diffusion.

Are patents necessary as incentives for the development of new inventions, for example, in relation to medical methods?

Patents are monopoly rights. However, there is a widely held view that patent protection or patent monopolies are inappropriate for the medical field and in particular for medical methods. Consequently, some areas of medical invention such as methods of treatment, surgery, therapy and diagnosis have been removed from patentability. Indeed, Art 2(3) of the Agreement on Trade Related Aspects of Intellectual Property Rights 1994 (TRIPS) allows members to exclude from patentability methods of medical treatment on humans and animals. The European Patent Convention 2000 (EPC) incorporates the exclusion of medical methods in Art 53 on public policy grounds. These medical methods are now excluded from patentability under s 4A of the Patents Act 1977 (recently amended by the Patents Act 2004), which states:

1. A patent shall not be granted for the invention of –
   
   
   
   1. a method of treatment of the human or animal body by surgery or therapy; or
      
   2. a method of diagnosis practised on the human or animal body.

The exclusion of methods of treatment and diagnosis reflects the concern to ensure that such methods can be freely disseminated by the medical profession in the public interest: Schering and Wyeth’s Application (1985).

In Shell/Blood Flow (1993) ‘treatment’ was defined as any non-insignificant intentional physical or psychic intervention performed directly or indirectly by one human being on another using means of medical science. In the same case, ‘surgery’ was defined as ‘medicine concerned with the healing of disease, accidental injury or bodily defects by operating on the living body. This includes both conservative (non-invasive) procedures and operative (invasive) procedures using instruments.

The decision in Unilever (Davis’s) Application (1983) confirmed that both preventative and curative treatments fell within the meaning of ‘therapy’ and are therefore excluded.

However, a method of contraception, for example, was allowed in Schering’s Application (1971), as contraception did not amount to the treatment of disease. A method of treatment for lice infestation was held to be patentable in Stafford-Miller’s Application (1984), because it was regarded as a treatment for lice rather than a treatment for a disease. In contrast, a method of abortion was refused a patent in Upjohn’s Application (1976).

• medical device claims for medical hardware provided they meet the usual criteria of novelty, inventive step and industrial applicability;
  
• substance claims, for example for pharmaceuticals; or
  
• claims for medical uses for known substances (this was a special concession with regard to novelty and was the result of lobbying by the drug industry).

This shows that although there are some restrictions on the patentability of medical methods in the public interest, the Patents Act 1977 nevertheless allows for a wide degree of patentability. In the recent past, where doubts arose as to the patentability of an invention involving a method of treatment, claims were made in the form of a ‘Swiss’ claim, developed in the Swiss Patent Office. The Swiss claim extends to second medical uses of known medical substances and covers the method for making a known substance for a new use. Swiss claims were controversial, because it was argued that novelty in the invention is lacking, but nevertheless, they are applied in the UK.

Now however, as a result of reforms contained in the Patents Act 2004, s 4A PA 1977 is amended to provide:

1. Subs (1) above does not apply to an invention consisting of a substance or composition for use in any such method.
   
2. In the case of an invention consisting of a substance or composition for use in any such method, the fact that the substance or composition forms part of the state of the art shall not prevent the invention from being taken to be new if the use of the substance or composition in any such method does not form part of the state of the art.
   
3. In the case of an invention consisting of a substance or composition for a specific use in any such method, the fact that the substance or composition forms part of the state of the art shall not prevent the invention from being taken to be new if that specific use does not form part of the state of the art.

Methods of medical treatment nonetheless involve substantial work, financial investment and time to develop and turn into something practical and successful. Without the incentive of a patent monopoly, people may not do that work or spend the time and money developing medical methods of treatment. One could argue that the courts’ role is not to uphold any claim to a monopoly for an idea which requires investment and risk to bring to market, only for those ideas which are new, non-obvious and enabled as required by the Patents Act 1977.

Do morality and public policy have a role to play in the patent system? Critically discuss with reference to biotechnological inventions and the relevant UK and EU jurisprudence and legislation.