Patents I. What are they?

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Patents

Introduction

A large and growing amount of money is invested worldwide in "intellectual property", so the establishment and enforcement of patents has become a major concern. Where a chemical substance such as a drug is involved in the patent, powder diffraction can play a major role. Cases involving many billions of U.S. dollars may hinge on the words of powder X-Ray diffraction experts. This page provides a simple background to patents, and some advice on how to best conduct patent powder diffraction work, illustrated by a few examples. Most of the comments will be made with implicit reference to North American and European legal systems, but many other countries use a similar basis for their patent laws.

The Constitution of the United States of America, Article 1, Section 8 says: "The Congress shall have power... To promote the progress of science and useful arts, by securing for limited times to authors and inventors the exclusive right to their respective writings and discoveries"

A patent is a deal between an inventor and the people. In exchange for the details of an invention (and payments) the inventor receives a temporary monopoly on the invention. Patents on new chemical entities (such as drugs or food additives) are highly valued by research-driven companies. As an aside follow this link for an example of how much a patent is worth.

What is a Patent?

A patent must have "absolute novelty". That is, it must not be available to the public in any form in any country before the priority date. Clearly the people would not grant exclusive rights to anyone for something they could already find out. Hence the general rule that if you want a patent you do NOT publish first. There are many possible complications, including the U.S. concept of "first to invent", which means properly dated and signed laboratory books are important. (In the U.K., on the other hand, "first to file" has more legal significance.) This is the basis of the commonly held belief that you cannot patent something twice, which is essentially correct, although, for instance, it may be possible to establish a second patent on a substance if a previously unknown use is found for it.

The patent must not be obvious; it must contain an inventive step, such that it could clearly not have been devised by a hypothetical person "skilled in the art" but without imagination. The people would clearly gain nothing by granting exclusive rights to an inventor in exchange for something that is perfectly obvious to anyone working in the field.

The patent must have commercial application. Patents on drugs and (except in the U.K.) methods of medical diagnosis or treatment are subject to this requirement, which can be problematic and so is often less stringently applied than the others. This is because a truly novel invention is likely not to have been used yet. Even so, after the grant of a patent it must be used or "worked".

How to Obtain and Maintain a Patent

Obtaining a patent in the U.K. (five basic steps):

• Filing: The application form and fee are sent to the Patent Office, or for a European Patent under the auspices of the European Patent Office (EPO) to Munich, The Hague or a national member office.
• Preliminary Examination and Search: Within 12 months the inventor supplies more details and additional fees, following which the examiner checks the patent for novelty and obviousness and provides a list of findings but no comment.
• Publication: The patent can be quickly amended and is then published.
• Substantive examination: More fees must be paid within six months of publication. Based on prior art, and anything that anyone else has brought to the examiner's attention, a letter is sent to the inventor with a list of any objections. The inventor can then either amend, appeal or withdraw.
• Grant: If the above issues are all resolved by 4.5 years from the original filing, the patent is granted, and published from the applicant's original submission.

Obtaining a patent in the USA and the European Patent Office (EPO):

Most details in the USA and EPO are similar, but note:

• In the USA there a "first to invent" principle applies. The inventor must apply in person and declare that the invention is novel. Examination follows, with a procedure for Appeal and/or Refiling (which may contain new subject matter)
• For an EPO patent the application must be filed at Munich, The Hague or the office of a member state, and a copy must be provided in English, French or German. This is followed by filing, an examination and search and a substantive examination. There is a further opposition procedure whereby any third parties may oppose the grant within nine months of final publication on the grounds that the invention was not patentable.

Continuing a patent:

• Renewal fees: These must be paid promptly and increase over time, so patents which have failed to create substantial revenue are often not considered worth renewing, and are allowed to lapse.
• "Working" the patent: the inventor should use the patent. The purpose of this rule, which can be difficult to enforce, is to prevent the situation which is often described erroneously by urban legends where someone has a wonderful patent but is not using it to protect their business. [I've often heard a story which tells of a large petrochemical that bought a patent for a much cheaper form of fuel (gas, petrol) but does not use, because of their investment in the current processes and the profits they are making. For legal reasons, this cannot be true.]
• Infringement: A patent is the right to sue for infringement, which is classified as a civil wrong or tort. Others may not make, use, exercise or vend what is covered by the patent. For imported drugs it is the import, not the manufacture elsewhere that constitutes infringement. The defendant in a patent lawsuit may be required to prove non-infringement of the patent in question.

Patent Infringement and Litigation

UK: Chancery Division. Here the judge is a specialist in patent cases. There is no jury, but a scientific advisor may be present. The usual procedure consists of writ, pleadings, summons for directions, and 'discovery' of all relevant documents (except those privileged). The subsequent hearing includes examination and cross-examination of company witnesses and expert witnesses, following which the barristers give their summaries, and judgement comes a few weeks later. Appeal is to the Court of Appeal and then to the House of Lords. Where it is found that the patent has been infringed, possible outcomes include injunctions, claims for damages (though not against an innocent infringer), surrender or destruction of the infringing goods, declaration of validity of the patent, and claims for costs.

USA Federal District Court (or the International Trade Commission in Washington D.C.) for international cases such as those involving importation. In these cases there may be longer pleadings and a pre-trial conference. The hearing itself may be shorter, and carried out in the presence of a jury where a claim for damages is involved. In general there is more discovery and less privilege (right of confidentiality).

Reports and declarations etc. A powder diffractionist participating in a patent case needs to be aware of certain requirements. As part of the discovery process, laboratory books relevant to the matter at hand, letters, notes, copies of the patent in question or any related scientific papers, all electronic files (of collected powder diffraction data for instance) and output, graphs, plots, machine log books, etc. may have to be produced. It may also be necessary to keep any samples and clearly establish where they came from (when you received them, where you stored them etc. - often known as a "chain of custody" and "provenance").

Deposition. Discovery may require an expert witness to be a deponent. This means acting as a witness testifying under oath, not in court or in front of a judge or jury, but usually at a lawyers' offices with perhaps a couple of lawyers from each side. All transactions are recorded word for word by a court reporter, and the transcript becomes part of the court evidence. There may be other people present, such as company officials from patenting departments or opposing expert witnesses. Usually they may not speak, but common practice seems to be for them to pass notes to the lawyers with course have briefed the lawyers.

Witnesses generally come in two varieties: (a) In house witnesses. These may give plain factual evidence, for instance: "I made this discovery as detailed in my laboratory book...", "I prosecuted the original patent on...", "Our sales have fallen by..." (b) Expert witnesses. These are often external to the company, so as to provide (or appear to provide) an independent viewpoint. These can offer opinion as well as fact (in practice opposing sides often retain expert witnesses who disagree); they may make such statements as "I collected powder diffraction data on Company Y's sample and examined it for evidence of infringement of X's patent..." (but read the declaration in the final case study).

Usual procedure for a witness in the witness box:

• Establish credentials. Questions asked might include:- How long have you worked for Company Y? What qualifications do you have in this field? Have you acted as an expert witness in any similar cases?
• Direct Examination. This is often coached and planned, but not led; i.e. Did there come a time when you discovered a new... What did these tests show?
• Cross examination. This is often an attempt to discredit the scientific evidence presented by the witness. Failing this, the cross examiner may try to discredit the person, their scientific discipline, their standards and procedures such as calibration and controls, etc. etc. It has been said that the best way to deal with cross examination is: Always count to three before you answer to give your lawyer a chance to object, and then try to truthfully answer "Yes", "No", "I don't know" or "I can't remember"!

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