INDIA VS. US : REGULATIONS ON PATENT INFRINGEMENT

Introduction

Infringement of any Intellectual Property Right or Patent has a nearly universal definition; nevertheless, some components or reasons for infringement of rights or patent may change from country to country depending on their particular laws. Similarly, while the laws and rules regulating patent infringement in India and the United States are very similar, there are specific provisions, procedural features, and determinants that distinguish the filing and process for patent infringement in both countries.

Defining patent infringement:-

Patent infringement is defined as the unauthorised making, using, offering for sale, selling, or importing into India of any patented invention during the term of the patent. Although patent infringement is not specifically mentioned in the Patent Act, the governing provisions in this regard are Sections 104 to 114 of the Patents Act[i], 1970.

As patents are public documents with easily available information, if the patent holder sues, the court can order the defendant to halt the patent’s illegal conduct. The patent holder can also obtain monetary damages for the patent’s unauthorised use. A patentee has rights under Section 48[ii] of the Act. When the subject matter of a patent is a product (product patent), the patentee has an exclusive right to restrict third parties who do not have this consent from producing, selling, using, making offers for sale, or importing the product in India.

As a result, infringement of this right would be considered or constitute patent infringement. The Patent Act regulates the awarding of patents in the United States, and also the operations of the US Patent and Trademark Office (USPTO). Patent infringement is covered under Title 35 of the United States Code, Section 271[iii] of the Patents Act, which states:

(a) Except as otherwise provided in this title, whoever without authority makes, uses, offers to sell, or sells any patented invention, within the United States or imports into the United States any patented invention during the term of the patent therefor, infringes the patent.

(b) Whoever actively induces infringement of a patent shall be liable as an infringer.

(c) Whoever offers to sell or sells within the United States or imports into the United States a component of a patented machine, manufacture, combination or composition, or a material or apparatus for use in practicing a patented process, constituting a material part of the invention, knowing the same to be especially made or especially adapted for use in an infringement of such patent, and not a staple article or commodity of commerce suitable for substantial non-infringing use, shall be liable as a contributory infringer.

The main distinction between the patent laws of the two nations is how they are enforced and expressed. The United States takes a more demonstrative approach, stating what may be patented under the Patent Act, but India’s patent rules are more focused on what cannot be patented.

How to check if patent has been infringed & prosecuted:-

In order to exercise due diligence on the rights granted to a patentee, he or she must exert for or perform periodic monitoring of patented items or processes to verify that rivals are not engaging in infringing actions. It is recommended that the patentee keep a market watch on competitor products or processes, as well as use patent analytics to monitor patent publications of potential competitors to see if they are coming up with any inventions that are dangerously similar or substantially similar to the patented inventions that the patentee must-have.

In the United States, a patent holder will often sue the infringer in a civil suit to enforce a patent against encroached or infringed goods. The court conducts a two-step investigation to determine whether there is any violation. The first stage is to create a claim in light of the case language, the textual description of the precise specification, the patent’s prosecution history, and any extrinsic proof that is relevant to understanding the invention.

To determine if infringement has occurred, a highly detailed and specialised study of the patents is performed. Each aspect of the patentee’s infringement claim is compared to all components of the defendant’s product/process. Infringement arises when the functionality and operations of the parts of both parties are identical or substantially similar, which is known as the doctrine of equivalents.

Patent Infringement disputes in India:-

Until a patent is granted, there may be no infringement actions. There are a few elements that the patentee must demonstrate in order to receive damages:

• That the infringement happened after the patent application is published;
• The claims specified in the patent specifications should be equivalent to the allegedly infringing product/process;
• Actual notice of publishing is required for the infringement.

In Biswanath Prasad Radhey Shyam v. Hindustan Metal Industries[iv], the Supreme Court established standards for determining patent infringement. The following is the guideline:

1. Read the description before moving on to the claims.
2. Identify what is known as prior art;
3. To identify what is, in fact, an improvement over the prior art;
4. Make a list of the major characteristics of the improvement;
5. Features of the defendant’s process or apparatus in general;
6. Infringement occurs when the defendant’s process or equipment is either identical to or falls within the scope of the plaintiff’s method or apparatus.

Section 104[v] of the Act governs the jurisdiction of starting a suit for infringement, where a patentee may bring a complaint for patent infringement in a court not lower than the District Court, and can file a suit in either the District Court or the High Court, which has original jurisdiction.

When the defendant files a counterclaim, the case, together with the counterclaim, is moved to the High Court for decision, as only the High Court has jurisdiction over counterclaims.

It’s worth noting that, under Section 19[vi] of the Civil Procedures Code, a patentee has the right to file a complaint for infringement in the court where he lives or does business, or in a court that has jurisdiction over the region where the cause of action or infringement originated.

Patent Infringement cases in India:-

(1) Bayer Corporation v. Union of India[vii]

Facts-

• The Indian Patent Office granted Bayer Corporation (Plaintiff) a patent in 2008 for its drug ‘Sorafenib Tosylate,’ which is used to treat liver and kidney cancer.
• In 2012, the Drug Controller of India (Defendants) approved Natco Pharma the first ever Compulsory License to produce a generic version of this drug.
• Plaintiff was selling the drug for Rs. 2,80,000 each month for a course, whereas Defendant claimed to supply it for just Rs. 8,800.
• Plaintiff was offended by the fact that Natco was given a Compulsory License and requested a stay from the Intellectual Property Appellate Board (IPAB), claiming that the License issued by the DGCI was unlawful, illegitimate, and unsustainable.
• The IPAB, on the other hand, dismissed Plaintiff’s appeal, concluding that the License was issued in the public interest because of its reduced rates, making it more accessible to the general population.
• The judgement was subsequently challenged at Bombay High Court by the plaintiff (HC).

Issues-

The case featured a number of subsidiary concerns, but the primary one pertaining to patent infringement was:

• Whether the DGCI’s License been given in compliance with the Patent Act’s provisions?

Decision-

• The HC denied the petition once more, stating that the public interest must always take precedence. The purpose of the Patent Act, according to the court, is to promote invention and protect the creator from infringement.
• The High Court ruled that reading Section 156 of the Patent Act, which provides the Central Government the ability to set rules, to say that DCGI cannot approve the sale of a medicine patent to someone else would be incorrect.
• It was decided that the DGCI could allow generic drugs to be commercialised even if they were already patented in the public interest under Section 90 of the Patents Act. It was clarified that by doing so, DGCI would not be supporting or committing patent infringement, but rather would be responsible for avoiding infringement because it has appropriate licences.
• It also held that the acceptance of the generic drugs would not amount to patent infringement.

(2) Novartis vs. Cipla,[viii]

Facts-

• Cipla (Defendant) was sued by Novartis (Plaintiff) for infringing on patents protecting Onbrez (Indacaterol, a drug used to treat chronic obstructive pulmonary disease) and was awarded damages.
• In India, the drug is covered by five patents, including product composition and process patents.
• The Defendant released a generic version of Onbrez in 2014 and filed a petition to have the Plaintiff’s patents invalidated in the process. It claimed that the condition had progressed to the point of becoming a “epidemic,” and that the Plaintiff’s monopoly was limiting the drug’s distribution.
• In light of this, the Central Government was asked to cancel the patent under the Patents Act’s Sections 92 (3) (compulsory licence under extraordinary circumstances) and 66 (patents that are harmful to the public).
• Plaintiff was not producing the drug locally, according to the defendant, and only imported small quantities through a licensee.
• Plaintiff then filed a claim for patent infringement and damages in the Delhi High Court.

Court Decision-

• By issuing an interim injunction to the Plaintiff, the Delhi High Court banned the Defendant from producing or distributing generic copies of the Plaintiff’s drug.
• The HC found that Plaintiff had a strong prima facie case, and that because the patent’s validity is not substantially questioned, there is a straightforward path to an injunction being granted.
• Defendant has earlier indicated that there was a medication scarcity and that it was insufficient. The Defendant, on the other hand, failed to produce any proof or numbers to support such allegations, according to the HC.

Period of Limitation:-

The Limitation Act[ix], 1963 governs the limitation period in India. The time limit for filing a patent infringement lawsuit is three years from the date of infringement. The defendant bears the burden of proof (Sec.104A)[x] when the court orders the defendant to establish that the process employed by the defendant to get at the process in issue is different from the patented method if:

1. The subject matter of the process for obtaining a new product;
2. The patentee has proven that the product generated by the accused infringer is similar to the product directly produced by the patented process; nevertheless, the patentee is unable to establish the process actually used.

In the United States, Section 286 allows a patent owner to file a lawsuit for infringement of his patent within six years after the date of the infringer’s infringement action. If the owner and the infringer mutually agree during their settlement talks, this time period may be extended. The patent must be active at the time of the infringement action in order for it to be used as a foundation for a lawsuit. Under the Act, a utility patent has protection duration of roughly 20 years, whereas plant and design patents have a protection period of less than 20 years.

Powers and role of the court:-

The power of the court to issue a declaration of non-infringement is set out in Section 105 of the Act, and an aggrieved person may bring an action for non-declaration of non-infringement. The plaintiff’s request for written acknowledgements of non-infringement from the patentee and the patentee’s refusal to grant or furnish such acknowledgment would be the conditions.

The court in the United States makes the final judgement on whether a patent has been infringed. If an infringement is proven during the trial, the infringer is obligated to reimburse the patent owner for the losses incurred as a result of the infringement. The court may also give injunctions in specific circumstances, such as a preliminary injunction or a temporary restraining order.

Exceptions for Patent Infringement:-

In India, the patent act also provides for infringement exclusions. Any act of making, constructing, using, selling, or importing a patented invention solely for the development and submission of information required by law, whether in India or in a country regulating the manufacture, construction, use, sale, or import of such product, will not be considered patent infringement, according to Section 107A (a)[xi] of the Act. Parallel import of patented items by any person from a legally authorized person under the law to make, sell, and distribute the product does not constitute patent infringement in India, according to Section 107A (b)[xii].

Conclusion

The patent laws in India and the United States are identical, but the processes and filing procedures are drastically different. In India, the date on which a person files an invention establishes who the inventor of a product or technique is. The inventor is stated to be the first individual who files a patent application. In the United States, however, the individual who created a product or technique first is regarded the inventor in the situation of multiple patent applications. Infringement analysis is carried out in India to establish if a patent claim falls within the limits of the claim’s “literal” language.

[i] Suits Concerning Infringement of Patents.

[ii] The Patents Act, 1970, Act no. 39, Section 48: Rights of patentees.

[iii] https://www.bitlaw.com/source/35usc/271.html

[iv] Biswanath Prasad Radhey Shyam v. Hindustan Metal Industries, AIR 1982 SC 1444.

[v] The Patents Act, 1970, Act no. 39, Section 104: Jurisdiction.

[vi] The Code of Civil Procedure,( 1908), Act No. 05,  Section 19: Suits for compensation for wrongs to person or movables.

[vii] Bayer Corporation v. Union of India, 162 (2009) DLT 371.

[viii] Novartis vs. Cipla  (2015), I.A. No.24863/2014 IN CS(OS) 3812/2014.

[ix] The Limitation Act, 1963, Act no. 36.

[x] The Patents Act, 1970, Act No. 39, Section 104A: Burden of proof in case of suits concerning infringement.

[xi] The Patents Act, 1970, Act No. 39, Section 107A (a): Certain acts not to be considered as infringement.

[xii] Id at 11.

References

1) Justia , First Steps in a Patent Infringement Case, (may 19), https://www.justia.com/intellectual-property/patents/infringement/first-steps-in-a-patent-infringement-case/,

2) Kathlene Ingham, Patent Infringement: It’s more Common than You Think, (Aug. 18, 2012), https://www.industryweek.com/innovation/intellectual-property/article/21958141/patent-infringement-its-more-common-than-you-think.

3) Tushar Kohli, Patent Infringement In India, (Mar. 09, 2020), https://www.mondaq.com/india/patent/900676/patent-infringement-in-india.

4) Legal information institute, https://www.law.cornell.edu/uscode/text/35/271.

5) Rachit Garg, Patent infringement cases in India, (Apr. 27, 2021), https://blog.ipleaders.in/patent-infringement-cases-india/

6) Shoronya Banerjee, Patent infringement in India v. patent infringement in the US, (Jul. 18, 2021), https://blog.ipleaders.in/patent-infringement-in-india-v-patent-infringement-in-the-us/.