United States

How do you get a patent in your jurisdiction?

Q: What types of patent are granted in your jurisdiction, and what rights do they confer on owners?

Three types of patent are obtainable in the United States. Utility patents are the most common and are awarded for “any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement” of one of those categories (35 USC Section 101). Design patents are also available and protect “any new, original and ornamental design for an article of manufacture” (35 USC Section 171(a)). Plant patents are rare but obtainable to protect “any distinct and new variety of plant” that is not “tuber propagated” (eg, a potato) and not found in an “uncultivated state” (35 USC Section 161).

Each patent owner has the right to “exclude others from making, using, offering for sale, or selling the invention” in the United States and from importing the invention into the United States (35 USC Section 154(a)(1)). Notably, a patent owner is granted only the right to exclude others from practising the invention, not the right to practise the patented invention. This is because practising one invention could infringe another patent owner’s right. For example, patent owner 1 could have a patent to feature A, and patent owner 2 could have a patent to features A and B. If patent owner 2 practised the invention in their patent, they would infringe patent owner 1’s patent. Patent owner 1 was granted only the right to exclude patent owner 2 (and everyone else) from practising feature A.

Q: What inventions are eligible for patent protection in your jurisdiction?

Inventions falling within the scope of the subject matter eligible for protection by a utility, design or plant patent are eligible for protection (35 USC Sections 101, 161 and 171(a)). In addition to being directed to a protectible type of subject matter, the invention must also be “useful” (Section 101). This requirement is found in US statutes and has its roots in the US Constitution, which provides that the legislature may grant patents “to promote progress of… useful arts” (US Constitution, Article 1, Section 8(8)).

Q: Are there any specific exemptions to patent eligibility?

Certain types of subject matter have been determined by US courts to be exceptions to the statutorily defined patentable subject matter, including laws of nature, natural phenomenon and abstract ideas (Alice Corp Pty v CLS Bank Int’l, 573 US 208, 217 (2014)). Claims that recite one of these ineligible concepts without something more to transform the claim into patent-eligible subject matter are not eligible for a US patent.

Q: Are there technology-specific eligibility issues that applicants need to navigate (eg, in software, business methods, AI, medical diagnostics, pharmaceuticals, medical procedures, etc)?

Certain technology areas are affected more than others by the categories of patent-ineligible subject matter set forth by the courts.

For example, claims directed to medical diagnosis, by itself (ie, without being incorporated, for example, into a method of treatment claim), have repeatedly been struck down as patent ineligible (Athena Diagnostics Inc v Mayo Collaborative Servs LLC, 927 F.3d 1333, 1363, 1370 (Fed Cir 2019)). Similarly, the laws of nature exception affects the life sciences industry because it prohibits patenting products of nature, such as Dolly the cloned sheep, which is genetically too similar to her naturally occurring donor parent to be patentable (In re Roslin Inst, 750 F.3d 1333, 1337 (Fed Cir 2014)).

Further, the abstract ideas exception has been interpreted in a way that affects software patents because processes that can be performed mentally – even if the claim requires a processor implementation – have been found ineligible for patent protection. For example, the process of selecting a hook for fishing based on light intensity observed in the water was found to be patent ineligible because it included a mental process (In re Rudy, 956 F.3d 1379 (Fed Cir 2020)). Navigating patent eligibility relating to the abstract ideas exception can be quite difficult due to the fluidity of the law in this area.

Q: What are the time and costs involved in securing a granted patent? Is expedited examination available? Are reduced fees available for certain applicants?

Because the USPTO has numerous art units, each dedicated to different technology areas, and the merits of each case differ, the time it takes to obtain a patent varies significantly between cases. However, as of July 2021, the USPTO reports a traditional total pendency of 23 months from the initial filing of a patent application (www.uspto.gov/dashboard/patents/). Expedited examination is available through a few USPTO programmes. One commonly used programme is Track One Prioritised Examination under which the USPTO aims to provide a final disposition within 12 months of granting the request for prioritised examination (www.uspto.gov/patents/initiatives/usptos-prioritized-patent-examination-program). The programme fee varies based on the entity size of the applicant, and the USPTO caps the total number of requests that it will grant each year (typically about 10,000).

The fees associated with obtaining a patent also vary from case to case but typically include pre-filing fees (eg, attorney preparation fees and patentability search fees), filing fees (eg, USPTO search and examination fees, and fees if Track One Prioritised Examination is requested) and post-filing fees (eg, costs for extensions of time in responding to office actions). The USPTO fee schedule sets forth different fees for large entities (undiscounted), small entities (half the large entity fees) and micro entities (half the small entity fees) (www.uspto.gov/learning-and-resources/fees-and-payment/uspto-fee-schedule).

Q: What are any specific requirements that a patent specification must meet in your jurisdiction?

The specification has numerous formal and substantive requirements, but a few arise frequently during patent application examination. One such requirement is the enablement requirement, which requires that an inventor provide a description of the claimed invention that enables another person of ordinary skill in the art to make and use what is claimed (35 USC Section 112(a)). Another requirement is that the inventor provide a written description that supports the claims (id). While the two requirements are related, they are distinct. For example, an inventor could disclose a chemical compound itself (therefore satisfying the written description requirement) but not describe how to make or use it (therefore not satisfying the enablement requirement) (Univ Of Rochester v GD Searle & Co, 358 F.3d 916, 921 (Fed Cir 2004)).

Q: What rules govern the filing of provisional applications, continuations or continuations-in-part, divisionals or any other special type of application?

Each of these application types has its own set of unique rules. Provisional applications allow an applicant to obtain an early filing date with limited requirements (ie, just a specification and drawing) while delaying the cost of a full utility patent application (35 USC Section 111(b)). However, a provisional application becomes abandoned 12 months after its filing date and will not be examined by the USPTO (Section 111(b)(5)). Therefore, a non-provisional application claiming priority to the provisional application must be filed within a year if the applicant wishes to secure exclusionary rights.

Continuations, continuations-in-part and divisional applications claiming priority to a parent application must be filed while the parent application (or an intermediate application properly claiming priority to the parent application) is still pending (35 USC Section 120). These continuing applications are often filed after the parent application has been allowed by the USPTO. The statute requires that continuing applications be filed “before the patenting” (ie, the issue date) of the parent application (id, MPEP Section 211.01(b)(I)).

Q: What do applicants need to know about office actions and patent examiner interviews?

The USPTO encourages interviews with the examiner to “improve the mutual understanding of specific issues in the application” and advance prosecution by helping to “identify patentable subject matter” (MPEP Section 713). Interviews generally last no more than 30 minutes (Section 713.01(IV)). It is important to stick to this limit because examiners are given only an hour of credit for preparation and participation in the interview. Interviews tend to be most helpful after an initial office action on the merits is issued because the applicant and examiner have both had an opportunity to consider the prior art.

Q: Are there any recent examination trends that patent applicants need to be aware of?

The USPTO has been working to reduce the time from filing a patent application to a final decision (ie, allowance or a final rejection) (www.uspto.gov/about-us/news-updates/uspto-year-review-new-search-tool-shorter-examination-times-and-unexpected). The agency is also working to improve the quality of patent application examinations by, for example, improving the search tools available to examiners and routing applications to examiners based on the technological profile of the application in combination with the examiner’s prior work experience (id).

Q: Is there anything else about the patent filing process that applicants should know?

Everyone associated with the prosecution of a patent application, including the inventors, has a duty to disclose to the USPTO information relevant to the patentability of the pending claims in the application (eg, known prior art) (37 CFR Section 1.56). This duty is ongoing and continues throughout prosecution of the application (id).

What are the major administrative procedures in your jurisdiction?

Q: How can applicants appeal a patent office decision?

An applicant whose claims have been rejected twice (eg, in non-final and final office actions) may initiate an appeal to the PTAB by filing a notice of appeal with the appropriate fee (35 USC Section 134(a)). The applicant must follow up with an appeal brief within two months of filing the notice of appeal (37 CFR Section 41.37(a); MPEP Section 1205.01).

Q: Are oppositions available pre-grant or post-grant? What rules govern standing to oppose a patent and the opposition process?

The three most common mechanisms used in the United States to challenge issued patents at the USPTO are post-grant review, inter partes review and covered business method proceedings. Post-grant review proceedings are available for the first nine months after issuance of the patent. In a post-grant review, the petitioner can challenge the validity of the patent on any basis (eg, patent eligibility, on-sale activity and indefiniteness) except best mode. After the nine-month period expires, an inter partes review can be filed, but the validity challenges are limited to those based on patents and printed publications (35 USC Section 311). A covered business method review is available only for patents directed to certain financial products and services and, like a post-grant review, allows challenges on more bases than inter partes review.

A post-grant review petitioner cannot be the patent owner or have previously filed a civil action challenging the patent’s validity. An inter partes review petitioner has the same requirements as the post-grant review petitioner and also cannot have been served with a complaint alleging infringement of the patent one year prior to filing the petition. A covered business method review petitioner must have been sued or charged with infringement of the patent. All three proceedings require that the petitioner identify all real parties in interest.

A third party can also submit patents and printed publications for consideration by the office during prosecution of a patent application if the submission contains a description of each reference and meets certain timing and fee requirements (35 USC Section 122(e)).

Q: What are the processes for re-examination of a patent?

Ex parte re-examination can be requested by anyone at any time while a patent is in force based on a substantial new question of patentability (35 USC Section 302). However, because this proceeding is ex parte (ie, the petitioner will not get to participate if not the patent owner) in nature, most patent challenges are presented as inter partes reviews, post-grant reviews or covered business method reviews, despite the significantly lower cost of re-examination.

Q: What is the process for invalidation or revocation of a patent? Who has standing to request invalidation? How long do inter partes invalidation cases take? 

At the USPTO, the inter partes review and post-grant review mechanisms with the petitioner requirements previously described are the most commonly used procedures to invalidate patents at the USPTO. The USPTO must determine whether to institute the proceeding within three months of the filing of a preliminary response to the petition or, if one is not filed, the last date when one could be filed (35 USC Sections 314(b) and 324(c)). This institution decision is made typically about six months from the filing of a petition for inter partes review or post-grant review. If the proceeding is instituted, a final determination must be made within one year of institution or 18 months for good cause shown (35 USC Sections 316(a)(11) and 326(a)(11)). Thus, it usually takes about 12 to 18 months to receive a final determination from the USPTO.

Q: How can opposition, re-examination or invalidation decisions be appealed?

After the PTAB issues a final decision, a party can appeal to the United States Court of Appeals for the Federal Circuit (35 USC Sections 141, 319 and 229). To do so, the party must file a notice of appeal with the USPTO director within 63 days of the unfavourable decision (35 USC Section 142; 37 CFR Section 90.3(a)(1)).

Q: Is administrative enforcement of patents possible?

Patents can be enforced at the International Trade Commission (ITC), but the only available remedy is blocking the import of infringing goods; monetary damages are not available (19 USC Section 1337). Further, a patent owner must prove that it has or is in the process of establishing an economic and technical domestic industry in the United States to be able to use this forum (id). To meet this additional requirement, the complainant must show that the patent claims cover both the allegedly infringing product and the complainant’s own product or a licensed product. One of the hallmarks of this forum is speed, as the ITC is statutorily mandated to complete its investigation “at the earliest practicable time” (19 USC Section 1337(b)(1)). In practice, “the earliest practicable time” is typically about 12 to 16 months. Another hallmark of the ITC that differs from patent enforcement in US federal courts is that no jury is involved; an administrative law judge is the factfinder.

Q: Does your jurisdiction grant patent-term extensions?

Patent term adjustment extends the term of a patent based on delays caused by the USPTO during the prosecution of a utility or plant patent (35 USC Section 154(b)). If the applicant causes delays (eg, by taking extensions of time to reply to office actions), the applicant delays are used to offset the USPTO delays when calculating the patent term adjustment (id).

Patent term extensions are also available in rarer cases based on delays in regulatory review resulting from, for example, regulatory approval of certain medical drugs and devices (35 USC Section 156).

Q: Is there anything else about patent administrative procedures that patent owners and challengers should know?

Institution of inter partes review and post-grant review proceedings at the USPTO is at the discretion of the director, who has delegated this authority to the PTAB (35 USC Sections 304, 314(a) and 324(a)). That is, the PTAB decides which petitions to deny, effectively ending a petitioner’s attempt to get the USPTO to review the challenged patent and which to grant, resulting in a trial before the PTAB. Recently, the PTAB has been exercising its discretion to deny institution more often in circumstances where more than one petition is filed to challenge the same patent, a proceeding is already underway in another forum (eg, a US district court or the ITC) involving the same patent, and/or the prior art in the petition is the same as or cumulative of the prior art considered by the examiner during examination of the patent application.

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