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Applying for a patent

Patentability

What are the criteria for patentability in your jurisdiction?

The basic criteria for patentability of an invention in India are as follows:

  • Absolute novelty – the invention should be new and not disclosed to the public anywhere in the world in any form or through any medium.
  • Inventive step/non-obviousness – the invention should not be obvious to a person skilled in the art in the relevant area of technology and should involve an inventive feature which is distinctive in nature from the previous inventions made in the same field.
  • Industrial application – the new product or process should be capable of being made or used in an industry and it should have economic significance.

What are the limits on patentability?

The following are not considered as inventions and are not patentable under Sections 3 and 4 of the Patents Act 1970:

  • an invention which is frivolous or which claims anything obviously contrary to well-established natural laws;
  • an invention whose primary or intended use or commercial exploitation is contrary to public order or morality or which causes serious prejudice to human, animal or plant life, health or the environment;
  • the mere discovery of a scientific principle or the formulation of an abstract theory;
  • the discovery of a living thing or a non-living substance occurring in nature;
  • the mere discovery of a new form of a known substance which does not enhance the known efficacy of that substance, the mere discovery of a new property or new use for a known substance or the mere use of a known process, machine or apparatus unless the known process results in a new product or employs at least one new reactant (wherein salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance will be considered to be the same substance, unless they differ significantly in properties with regard to efficacy);
  • a substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance;
  • the mere arrangement, rearrangement or duplication of known devices which function independently of one another in a known way;
  • a method of agriculture or horticulture;
  • any process for the medicinal, surgical, curative, prophylactic, diagnostic, therapeutic or other treatment of human beings, or any process for a similar treatment of animals to render them free of disease or to increase their economic value or that of their products;
  • plants and animals in whole or any part thereof other than microorganisms, including seeds, varieties and species and essentially biological processes for production or propagation of plants and animals;
  • a mathematical or business method, a computer programme per se or algorithms;
  • a literary, dramatic, musical or artistic work or any other aesthetic creation, including cinematographic works and television productions;
  • a mere scheme, rule or method of performing a mental act or playing a game;
  • a presentation of information;
  • the topography of integrated circuits;
  • an invention which, in effect, is traditional knowledge or an aggregation or duplication of known properties of traditionally known component or components; and
  • inventions relating to atomic energy.

To what extent can inventions covering software be patented?

The patentability of software inventions in India can be understood in light of Section 3(k) of the Patents Act 1970 and the Guidelines for Examination of Computer Related Inventions (CRIs) published by the Office of the Controller General of Patents, Designs and Trademarks.

Section 3(k) of the act bars the patentability of a computer program per se. However, recent patent grants to CRIs by the Indian Patent Office indicate that software inventions may be patentable if:

  • there is technical advancement in the invention over the existing prior arts; and
  • the invention provides a technical solution to a technical problem by providing a practical application or an improved technical effect of the underlying software.

Further, the latest guidelines state that while examining a computer-related invention, the patent examiner would focus on the underlying substance of the invention and not the particular form in which it is claimed.

To what extent can inventions covering business methods be patented?

According to Section 3(k) of the Patents Act 1970, business methods are not patentable. Further, the Manual of Patent Office Practice and Procedure in India provides that business methods claimed in any form are not patentable subject matter. Moreover, the manual emphasises that this exclusion applies to all business methods; therefore, even if business methods are claimed alongside technical features such as the Internet, networks, satellites and telecoms, they do not qualify as patentable subject matter and may fall under the purview of Section 3(k) of the act.

To what extent can inventions relating to stem cells be patented?

Section 3(j) of the Patents Act 1970 states that “plants and animals in whole or any part thereof other than micro-organisms but including seeds, varieties and species and essentially biological processes for production or propagation of plants and animals" are not inventions as per the act and hence not patentable.

Stem cells are considered to fall under the phrase “any part thereof” and hence are excluded from patentability. However, in vitro methods of differentiating, isolating/purifying and culturing of stem cells may qualify as patentable subject matter, provided that the method is novel, involves an inventive step and has industrial applicability.

In addition, inventions pertaining to stem cells may also be opposed under Section 3(b) of the Act, which prohibits the grant of patent to:

an invention the primary or intended use or commercial exploitation of which could be contrary to public order or morality or which causes serious prejudice to human, animal or plant life or health or to the environment.

Are there restrictions on any other kinds of invention?

No. Sections 3 and 4 of the Patents Act, 1970 stipulate inventions that are not patentable under the act.

Grace period

Does your jurisdiction have a grace period? If so, how does it work?

Section 31 of the Patents Act, 1970 provides a grace period of 12 months for filing a patent application from the date of its:

  • publication in a journal;
  • public display (with the inventor’s consent) in an exhibition organised by the government; or
  • disclosure in a paper read by the inventor before a learned society or published with their consent by such society.

This applies only to exhibitions to which Section 31 has been extended by the government by notification in the Official Gazette.

In addition, Section 32 of the act also provides a 12-month grace period in case of anticipation by public working. The invention cannot be anticipated by public working in India within one year before the priority date of the invention by the patentee, the applicant or any person deriving title therefrom, provided that the working was effected for the purpose of reasonable trial only and it was necessary, having regard to the nature of the invention, for the working to be effected in public.

Oppositions

What types of patent opposition procedure are available in your jurisdiction?

The Patents Act 1970 stipulates the provisions and grounds for filing two types of opposition:

  • pre-grant opposition; and
  • post-grant opposition.

Pre-grant opposition Section 25(1) of the act provides that any person may file a pre-grant opposition against a patent application, provided that the patent application has been published but has not been granted at the time of filing such opposition. A pre-grant opposition may be filed on any of the following grounds:

  • The invention has been wrongfully obtained by the applicant or the person under or through whom they claim.
  • The invention is anticipated by a prior publication in India or elsewhere.
  • The invention is anticipated by a claim in a complete specification where such claim has an earlier priority date and said specification has also been filed in India as a patent application.
  • The invention is publicly known or used in India.
  • The invention is obvious and lacks inventive step.
  • The invention comprises non-patentable subject matter.
  • The invention is insufficiently disclosed.
  • The invention is anticipated by the knowledge (oral or otherwise) available in any local or indigenous community in India or elsewhere.
  • The applicant has failed to disclose information in respect of corresponding foreign applications as required by the act or has furnished false information.
  • The application, being a conventional application, was not filed within 12 months of the date of the first application.
  • The application makes false mention of or fails to disclose the source or geographical origin of biological material used for the invention.

Post-grant opposition Section 25(2) of the act provides that any person interested may file a post-grant opposition against a granted patent at any time after the grant of patent but before the expiry of one year from the date of publication of the grant of patent.

A ‘person interested’ is defined under the act to include a person engaged in, or in promoting, research in the same field as that to which the invention relates. A post-grant opposition can also be filed on the same grounds as a pre-grant opposition. 

Apart from oppositions, are there any other ways to challenge a patent outside the courts?

A patent granted before or after the commencement of the Patents Act 1970 may be revoked:

  • by the Intellectual Property Appellate Board on the petition of any person interested or the government; or
  • by the High Court on a counterclaim in a suit for infringement of the patent.

Under Section 64 of the act, a patent may be revoked based on any of the following grounds:

  • The invention has been validly claimed in the complete specification of another granted patent in India with an earlier priority date.
  • The patent has been granted on the application of a person not entitled to apply under the act.
  • The patent contravenes the rights of the petitioner or any person under or through whom they claim.
  • The subject matter of any claim in the specification is not an invention under the act.
  • The invention is not novel.
  • The invention is obvious or involves no inventive step.
  • The invention is not useful.
  • The complete specification does not sufficiently and fairly describe the invention and the method by which it is to be performed.
  • The scope of any claim of the complete specification is not sufficiently and clearly defined or that any claim of the complete specification is not Fairly based on what is disclosed in the specification.
  • The patent was obtained on a false suggestion or representation.
  • The patent covers non-patentable subject matter under the act.
  • The invention was secretly used in India before the priority date of the claim.
  • The applicant has failed to disclose information in respect of corresponding foreign applications as required by the act or has furnished false information.
  • The applicant contravened a direction for secrecy passed or applied for grant of a patent outside India without prior permission.
  • The applicant’s leave to amend the complete specification was obtained by fraud.
  • The application mentioned an incorrect source or geographical origin of biological material or failed to mention the source or origin.
  • The invention is anticipated by the knowledge (oral or otherwise) available in any local or indigenous community in India or elsewhere.

How can patent office decisions be appealed in your jurisdiction?

An appeal will result from the decision of the controller of the patent office or the government by orders issued under Sections 15, 16, 17, 18, 19, 20, 25(4), 28, 51, 54, 57, 60, 61, 63, 66, 69(3), 78, 84(1)-(5), 85, 88, 91, 92 and 94 for:

  • matters involving the amendment of applications;
  • matters involving patents of addition;
  • matters involving the division of applications;
  • matters involving the dating of applications;
  • cases involving decisions pertaining to the refusal of applications for failure to comply with the act;
  • matters involving decisions related to anticipation;
  • cases involving decisions pertaining to potential infringement;
  • cases involving decisions pertaining to the substitution of applicants;
  • decisions involving the maintenance, amendment or revocation of a patent;
  • matters involving the names of inventors;
  • matters involving directions given by the controller to the patent’s co-owners;
  • matters involving restoration of a lapsed patent;•
  • matters involving the surrender of patents;
  • cases involving decisions pertaining to the revocation of patents in the public interest;
  • cases involving decisions pertaining to the revocation of patents for non-working;
  • matters involving the registration of assignments and transmissions;
  • matters involving the correction of clerical errors;
  • matters involving compulsory licences; and
  • cases involving decisions pertaining to the licensing of related patents.

Appeals from any decision of the Intellectual Property Appellate Board can be appealed to the High Court in the form of a writ petition filed under Article 226 of the Constitution.

Timescale and costs

How long should an applicant expect to wait before being granted a patent and what level of cost should it budget for?

Time In India, a patent may be granted between three to five years from the date of filing the application in India (provided that the request for examination was filed along with the application).

An applicant in India can start commercialising the patent as soon as the patent application has been filed.

Cost The approximate costs involved in prosecuting a patent application through to registration in India range from $3,000 to $5,000 (excluding annuity fees) – each application contains one priority, 10 claims and 30 pages of specification. 

Enforcement through the courts

Strategy

What are the most effective ways for a patent owner to enforce its rights in your jurisdiction?

In recent years, the Indian courts have shown zeal and dynamism for the effective protection of IP rights, particularly in respect of patents. The most effective way to enforce patent rights includes a civil action in case of infringement of a patent, seeking any or all of the following remedies:

  • an interlocutory/temporary/ad interim injunction –  an order prohibiting an action (specifically infringement) by the defendant(s) until disposal of the suit;
  • a permanent or perpetual injunction – a final order of the court restraining the defendant(s) from carrying out activities constituting infringement in India;
  • damages or account of profits;
  • delivery up or destruction of infringing articles; and
  • costs.

A patent owner also has the following options to enforce its rights in India:

  • an Anton Piller order – a plaintiff may make an ex parte in camera application to the court to direct the defendant(s) to permit the plaintiff to enter the defendant’s premises, inspect relevant documents and articles and take copies thereof or remove them for safe custody. The necessity for such an order arises when there is grave danger of relevant documents and infringing articles being removed or destroyed;
  • a Mareva injunction – a plaintiff may make an application to the court to restrain the defendant(s) from disposing of its assets within India until the trial ends or judgment in the civil suit is passed; or
  • a John Doe order – a plaintiff may make an application to the court to order search and seizure in respect of an unknown or unnamed defendant(s) with the cooperation of the court-appointed local commissioner and police, if required, to raid any premises where infringing activities are suspected of being carried out.

What scope is there for forum selection?

A patent infringement suit may be filed in India at the district level or the high court level, subject to the pecuniary jurisdiction and territorial jurisdiction.

The Commercial Courts, Commercial Division and Commercial Appellate Division of High Courts Act 2015 constituted commercial courts at the district level, the Commercial Division of the High Court and Commercial Appellate Division of the High Court, which deal with patent infringement matters.

In territories where the High Court has original civil jurisdiction (ie, Delhi, Mumbai, Kolkata and Madras), plaintiffs can file a patent infringement suit in either a commercial court at the district level or the Commercial Division of the High Court.

Pecuniary jurisdiction The pecuniary value of patent infringement disputes to be adjudicated at the district level is approximately $4,500 or more.

The pecuniary value of patent infringement disputes to be adjudicated at the High Court level is approximately $282,000 or more.

Territorial jurisdiction The territory of the court in which a patent infringement suit is to be filed is decided after taking into account the following factors:

  • the place where the defendant resides or carries on business; and
  • the place where the cause of action has arisen (ie, where the infringement took place).

Further, if a defendant files a counterclaim for revocation of the patent, the suit and the counterclaim are transferred to the High Court of the concerned territory. As defendants invariably counterclaim for revocation, patent infringement suits are typically heard by the High Court.

Pre-trial

What are the stages in the litigation process leading up to a full trial?

The following stages lead to a full patent trial:

Pleadings A suit is instituted before the court in the appropriate jurisdiction by the plaintiff, including a plaint (containing the facts, grounds, claims, arguments and relief claimed) and supporting documentary evidence. The plaint must comply with Orders IV (institution of suits), VI (pleadings) and VII (plaint) of the Code of Civil Procedure, 1908.

In addition to the plaint, the plaintiff often files separate interim applications seeking:

  • a temporary injunction in conjunction with an ex parte ad interim injunction;
  • the appointment of a local commissioner; or
  • the appointment of a scientific adviser.

The court will consider the interim applications and issue any necessary orders. In exceptional cases an ex parte ad interim injunction order can be passed on the first day of the hearing, if the plaintiff is able to establish the following:

  • a prima facie case;
  • irreparable loss and injury; and
  • the balance of convenience in its favour.

Pursuant to institution of the suit, if a court prima facie finds merit in the plaintiff’s claims, it can issue a court notice to the defendant to appear before the court on a given date. The plaint is then also served on the defendant. On receiving the notice, the defendant can appear before the court to seek time to file a written statement. The plaintiff may then file a rejoinder reply to the defendant’s written statement.

Admission and denial of documents At this stage, the parties must produce before the court all of the documents in their possession on which they intend to rely. Thereafter, the parties must notify the court as to whether they admit or deny the documents filed by the other side. The court marks the exhibits accordingly.

Framing of issues Based on the pleadings filed by both the parties, the documents and the preliminary hearing, the court frames the main issues to be heard during the course of the proceedings.

Discovery (optional) Discovery is the process by which a party may obtain information or documents from the opposing party before trial, through a request from the court. At this stage, depositions, requests for admission and requests for the production of documents, objects and entry may be filed.

Evidence At the evidence stage, the parties must provide evidence and confirm the veracity and genuineness of the evidence filed by an affidavit under oath. In order to prevail in a civil trial, the plaintiff may introduce competent evidence with respect to each disputed allegation, if not filed already.

Examination and cross-examination of witnesses The parties’ witnesses give statements under oath which may be questioned by the other party’s counsel. At this stage, an expert witness may be asked to appear before the court to validate the parties’ arguments or their own report.

Final arguments At this stage, each party’s counsel presents its case, with supporting arguments, evidence and precedents. Written arguments or submissions may also be given to the court at its discretion.

Judgment The court then pronounces its judgment.

How easy is it for defendants to delay proceedings and how can plaintiffs prevent them from doing so?

Ordinarily, the IP courts are reluctant to grant adjournments due to the time-sensitive nature of such matters. Therefore, in order to obtain an adjournment the defendant must prove beyond reasonable doubt the reason for adjournment. As a matter of practice, the courts grant adjournments subject to the payment of costs unless the reasons or circumstances are such that an adjournment is necessary in the interest of justice.

The plaintiff may prevent the other side from seeking frequent, unnecessary adjournments by raising formal objections before the court and pressing for the refusal of adjournment requests. Further, the plaintiff may press for costs so that any loss caused due to delay may be compensated. The best way to proceed is to request the court to fix a timeline for adjudication of the matter – this may be allowed depending on the court’s discretion and the urgency of the case. 

How might a party challenge the validity of a patent through the courts in anticipation of a potential suit for infringement being issued against it?

In anticipation of a potential patent infringement suit, the validity of a patent can be challenged by filing a revocation petition before the Intellectual Property Appellate Board.

At trial

What level of expertise can a patent owner expect from the courts?

The judges handling IP cases are highly proficient and fully conversant with the relevant IP laws applicable in the country. Only judges with experience or expertise in the field handle IP cases, and hence a reasonable level of expertise may be expected from the courts.

Are cases decided by one judge, a panel of judges or a jury?

The first-instance civil action is decided by a single judge in India. However, the appellate courts are often the division bench or a bench comprising of two or more judges. 

If jury trials do exist, what is the process for deciding whether a case should be put to a jury?

Not applicable. 

What role can and do expert witnesses play in proceedings?

Expert witnesses or scientific advisers (as per the Patents Act 1970) are extremely important as far as their evidentiary value is concerned. They assist the court with the technical aspects of inventions in order to decide complex patent litigation, fairly and properly. The Indian legislature is cognisant of the fact that patent law may deal with extremely intricate inventions in scientific, technological, pharmaceutical and other fields with which the courts may be unfamiliar. For this reason, Section 115 of the Patents Act 1970 provides for the appointment of a scientific adviser to provide expert assistance. In addition, Rule 103 of the Patent Rules provides the requisite qualifications for a person to qualify as a scientific adviser:

  • a degree in science, engineering or technology;
  • at least 15 years’ practical or research experience; and
  • a responsible post in a scientific or technical department of the central or state government or in any organisation.

In addition, the Indian judiciary also accepts and recognises that a person can be an expert in an area of specialised knowledge by experience and they need not hold a degree in that field. A person can also become an expert by virtue of their occupation.

Does your jurisdiction apply a doctrine of equivalents and, if so, how?

The Indian courts do not strictly follow the literal construction of claims and values the doctrine of equivalents based on the interpretation that claims must be “fairly based” on the matter disclosed in the specification (in line with Article 69 of the European Patent Convention). But, no decision has provided clear guidelines on the interpretation of the phrase 'fairly based' so far. Though non-literal infringement was discussed and addressed by the Indian judiciary as early as 1987, the doctrine of equivalents was applied for the first time by the judiciary in 2008, in the case of Ravi Kamal Bali v Kala Tech.

Is it possible to obtain preliminary injunctions? If so, under what circumstances?

The Indian courts can grant a preliminary or temporary injunction provided that the plaintiff can establish a prima facie case. In India, courts of appropriate jurisdiction can also grant ex parte injunctions to the plaintiff. A plaintiff seeking a temporary injunction must establish the following quintessential ingredients:

  • a prima facie case;
  • irreparable loss and injury to the plaintiff if such injunction is not granted; and
  • the balance of convenience in favour of the plaintiff.

How are issues around infringement and validity treated in your jurisdiction?

In India, caution and stringency are observed in patent infringement and validity cases. The Indian patent judicial regime seeks to reduce the menace of IP infringement by adopting a strict approach while determining questions of infringement and has also adopted measures that enunciate its stringent and effective deterrence policy. Due consideration is given to:

  • the protection and promotion of innovation;
  • creativity;
  • balancing parties’ interests parties; and
  • public interest.

Deterrent measures taken under the Indian legal regime include not confining the scope of protection conferred on a claim to the literal language of the claim. 

With respect to presumption of validity, there is neither a set parameter in the provisions nor does the grant of a patent award such presumption. However, judicial precedents align to suggest that if a patent is more than six years old and has been used, it would be safe for the court to proceed with the presumption that the patent is valid. 

Will courts consider decisions in cases involving similar issues from other jurisdictions?

Yes, provided that the cited facts apply to the facts brought before the court. While foreign decisions may not be binding on the Indian courts, they have strong persuasive value and due consideration is given to them by the Indian courts. 

Damages and remedies

Can the successful party obtain costs from the losing party?

Yes, the successful party may seek a relief of costs from the losing party in a matter. In particular, if the plaintiff prevails to establish infringement to the court’s satisfaction, it may seek to receive such costs from the defendant(s) in addition to the damages or the account of profits.

What are the typical remedies granted to a successful plaintiff?

If the plaintiff is successful in establishing infringement by the defendant(s) to the court’s satisfaction, the court may grant any or all of the following reliefs (provided that the same have been requested by the plaintiff):

  • a permanent or perpetual injunction (subject to such terms as the courts think fit);
  • damages or an account of profits;
  • delivery up or destruction of infringing articles; and
  • costs. 

How are damages awards calculated? Are punitive damages available?

Three types of damage are granted under the Indian patent law regime:

  • direct;
  • indirect; or
  • punitive or exemplary.

Damages are recoverable from the date of publication of a patent application under Section 11A of the Patents Act 1970. The actual profit or loss made is of no consequence when calculating damages – thus, damages can exceed the actual profits made by an infringer, unlike in the case of account of profits.

Direct damages Direct damages are awarded to put the patentee in the position that it would have been in had the infringement not taken place. Ideally, they are the pecuniary equivalent of the injury caused. Damages calculations are generally based on the normal rate of profit or established and reasonable royalty rates. The court may award interest on damages at its discretion.

Indirect damages In general, indirect damages are not recoverable. However, in special cases, a patent owner may obtain damages based on the value of an “entire infringing device”, even if that device contains multiple features and only one feature is found to be infringing.

Punitive damages

Yes, punitive damages are granted as exemplary damages, which are awarded in addition to actual damages. They are intended to act as a deterrent and are considered as a way of punishing the defendant and based on the theory that the interests of society and the individual harmed can be met by imposing additional damages on the defendant.

Three factors guide the decision of whether to award punitive or exemplary damages:

  • whether the infringement was wilful or deliberate;
  • whether the infringer had a good-faith belief that the patent was invalid; and
  • the party’s conduct during the litigation.

Royalty rates are calculated based on the following factors:

  • the strength of patent portfolio;
  • the ratio of the patent ownership;
  • the total royalty rate payable on a particular product; and
  • the share of the patent owner. 

How common is it for courts to grant permanent injunctions to successful plaintiffs and under what circumstances will they do this?

The Indian courts do not hesitate to grant a permanent injunction to successful plaintiff(s) against the defendant(s) infringing the suit patent(s), at the stage of conclusion of the proceedings. The Indian courts usually consider the US decision of eBay Inc v Merc Exchange LLC (547 US 388 (2006)), which set out a four-factor test for injunctive relief:

  • The patentee has suffered an irreparable injury.
  • Remedies available through the law (eg, monetary damages) are inadequate to compensate for that injury.
  • Considering the balance of hardships between the plaintiff and defendant, an injunction is warranted.
  • The public interest is not damaged by a permanent injunction.

The eBay decision was considered by the Delhi High Court in F Hoffmann-La Roche Ltd v Cipla Limited (148 (2008) DLT 598). There have also been several recent cases in which the Indian courts have passed injunction orders based on the merits.

Timescale and costs

How long does it take to obtain a decision at first instance and is it possible to expedite this process?

A fully contested suit may take three to five years to reach a conclusion before the appropriate court.

An order for an interim injunction may take around six to eight months. However, in exceptional circumstances and on proof of a prima facie case, irreparable damage or injury to the plaintiff and balance of convenience in favour of the plaintiff – the Indian courts do not hesitate to grant ex parte ad interim injunction at the first hearing.

How much should a litigant plan to pay to take a case through to a first-instance decision?

The costs in a patent infringement suit depends on the length and complexities of the case. Further, the official costs depend on the damages sought and the court fee applicable to each type of relief claimed in the suit, which varies from court to court.

On average, an interim decision costs up to $25,000 and a complete trial up to $60,000. However, this may vary depending on the court, the damages sought and the length and complexities of the case. Highly complex cases could cost between $100,000 and $150,000 for an interim decision and $200,000 and $350,000 for a full decision.

Appeal

Under what circumstances will the losing party in a first-instance case be granted the right to appeal? How long does an appeal typically take?

As per the applicable laws and practices prevailing in India, a first-instance decision can be appealed where:

  • the impugned order was illegal, arbitrary and against the facts of the case, as well as the established principles of law;
  • the first-instance court failed to appreciate or assess material facts, arguments or documents with significant bearing on the matter or necessary for fair and proper adjudication of the dispute;
  • the impugned order is contrary to the principles of natural justice, justice, equity and good conscience or the public interest; or
  • the impugned order fails to appreciate or recognise the irreparable loss and injury that it may cause the aggrieved party.

A fully contested appeal may take two to four years to reach a conclusion before the appropriate court. 

Options away from court

Are there other dispute resolution options open to parties that believe their patents to be infringed outside the courts?

Yes, other out of court dispute resolution options are available to parties that believe their patents have been infringed – for example, negotiations and settlement by way of licensing, a consent agreement or discontinuation of use.