On December 4, 2018, India’s Department of Industrial Policy and Promotion, Ministry of Commerce and Industry published Draft Patent (Amendment) Rules, 2018 (Draft Rules) for comment. These Draft Rules seek to amend the Patent Rules, 2003. Key highlights of the of the Draft Rules include:
Encouraging Electronic Filing of Patent Cooperation Treaty (PCT) Applications by Indian Nationals
The Draft Rules propose to waive the transmittal fee required when a PCT application is filed electronically using e-PCT SAFE. Currently, the transmittal fee for filing a PCT application electronically in the Indian Patent Office (IPO) is INR 16000 (approximately $US 230) for a large entity and INR 4200 (approximately $US 60) for individuals. Waiver of this transmittal fee will reduce the overall costs of filing PCT applications at the IPO.
Additionally, India joined the World Intellectual Property Organization’s (WIPO) Digital Access Service (DAS) which allows priority and other relevant documents to be securely exchanged via electronic means between participating intellectual property offices worldwide. The Draft Rules propose to waive the IPO’s fee of INR 5000 (approximately $US 71) to prepare and transmit certified copies of priority documents (e.g., Indian patent applications) though the DAS. Waiver of this fee will benefit applicants who plan to file one or more PCT applications claiming priority from one or more Indian patent applications.
Further, the Draft Rules also provide that all PCT applications filed by registered patent agents must be filed on-line, by submission of scanned copies of the relevant documents. Original documents, when required, must be submitted within 15 days from the date of the filing of the scanned copy.
Broadening the Availability of Expedited Examination
In the Patent Rules 2016, the Indian Government introduced expedited examination to speed up the patent process for two categories of applicants: (i) start-ups (including domestic (Indian) and foreign); and (ii) applicants choosing India as the International Searching Authority. In some instances, applications in which expedited examination was requested were examined and patents granted in as little as about 6 months (compared with 2 to 4 years under the normal examination process).
The Draft Rules further expand the categories of applicants that can request expedited examination to include:
- Small entities (for Indian applicants, evidence of registration under the Micro, Small and Medium Enterprises Act, 2006 is required; for a foreign entity, any document evidencing eligibility can be used);
- Female applicants (applying either alone or jointly with other applicants, where all the other applicants are individuals (namely natural persons; it does not appear that a female applicant applying along with a corporate entity would be permitted);
- Indian and foreign government undertakings (The Draft Rules do not define foreign government undertakings but indicate that foreign entities that are “similar” to Indian government undertakings are entitled to the benefits of this provision. Section 2(h) of the Patents Act, 1970, defines “Government undertaking” to mean any industrial undertaking carried on by a(n) (a) department of the Government, or (b) corporation established by a Central, provincial or State Act, which is owned or controlled by the Government; or (c) Government company (which is a company in which not less than fifty-one percent of the paid up share capital is held by Central or State Governments, either singly or jointly, and includes subsidiaries of Government companies (per Section 617 of the Companies Act, 1956)); or (d) institution wholly or substantially financed by the Government (an institution is considered to be “substantially financed” by the Government if it receives a grant or loan of not less than INR twenty-five lakhs (about $US 35,000) and the grant or loan is not less than 75% of the total expenditure of that body or authority (per section 2(1)(h)(iv) of the Comptroller and Auditor-General’s (Duties, Powers and Conditions of Service) Act, 1971))); and
- Applicants eligible for the patent prosecution highway (PPH) based on a mutual agreement between the IPO and the participating Patent Office.
Under the Draft Rules, an applicant must provide documentation demonstrating that it meets the requirements for expedited examination at any time before the First Examination Report is issued. This is an important change over the current rule which provides that if an applicant does not provide the necessary documentation demonstrating that it meets the requirements for expedited examination at the time of the filing of the request, the application will be examined in the normal examination process.
Amendments to pre-grant opposition proceedings
Currently, pre-grant oppositions are handled by a single Controller. Under the Draft Rules, pre-grant oppositions will be handled by a bench comprising two members. Additionally, in the event that the two members of the bench have a difference of opinion on any issue, a third member can be added, and a majority decision rendered. When such a situation arises, the third member will be nominated by the Controller. This proposal to have a two or three member bench is significant because it reduces the subjectivity of opposition decisions and also increases the accountability of the members to each other as well as to applicants.
The comment period is open until January 3, 2019.
This post was written by Lisa Mueller.
On Friday, December 7, 2018, the Federal Circuit issued two important decisions involving obviousness-type double patenting. In the first decision, Novartis Pharmaceuticals Corporation v. Breckenridge Pharmaceutical Inc., the Court addressed the question of whether a patent filed after June 8, 1995 (post-Uruguay Round Agreements Act of 1994 (URAA)) but expires before a pre-URAA patent can qualify as a double patenting reference against the pre-URAA patent. In the second decision, Novartis AG v. Ezra Ventures LLC, the Court addressed the interplay between patent term extension (PTE) under 35 U.S.C. § 156 and obviousness-type double patenting. Judge Chen was the author of both decisions.
Novartis Pharmaceuticals Corporation v. Breckenridge Pharmaceutical Inc., No. 2017-2173, 2017-2175, 2017-2176, 2017-2178, 2017-2179, 2017-2180, 2017-2182, 2017-2183, 2017-2184 (Fed. Cir. Dec. 7, 2018)
Novartis sells everolimus, which is the active ingredient in Zortress® and Afinitor®, for treating certain cancers and preventing rejection in patients that have received kidney and liver transplants. Novartis owns several patents covering everolimus, including: (1) U.S. Patent No. 5,665,772 (the ‘772 patent) which claims the compound everolimus; and (2) U.S. Patent No. 6,440,990 (the ‘990 patent) which claims methods of treatment using everolimus and specific pharmaceutical compositions comprising everolimus. Both the ‘772 and ‘990 patents have the same priority date of September 24, 1993. The ‘990 patent was filed on May 23, 1997 (after the June 8, 1995 effective date of the URAA) and expired on September 23, 2013 (20 years from its earliest effective filing date), prior to the expiration date of the ‘772 patent. The ‘772 patent was filed on April 7, 1995 (before the effective date of the URAA) and was set to expire on September 9, 2014 (17 years from issuance). However, Novartis obtained five years of PTE under 35 U.S.C. § 156. With the PTE, the ‘772 patent expires on September 9, 2019. The diagram below illustrates the relevant dates for each patent, and how, because of the URAA, the ‘990 patent expires earlier than the ‘772 patent:
Novartis sued Breckenridge Pharmaceutical Inc., Par International Ltd. (collectively, Defendants) for infringing claims 1-3, 7, and 10 of the ‘772 patent after the Defendants filed Abbreviated New Drug Applications (ANDAs) to market generic versions of Zortress® and Afinitor®. In district court, the Defendants conceded that their proposed products infringed the asserted claims of the ‘772 patent. The parties stipulated that: (1) the ‘772 and ‘990 patents were assigned to the same entity and shared common inventors; and (2) if the district court found the ‘990 patent to be a proper double patenting reference to the ‘772 patent, then the claims of the ‘990 patent would render the asserted claims of the ‘772 patent invalid for obviousness-type double patenting. Therefore, the only question before the district court was whether the ‘990 patent could serve as an obviousness-type double patenting reference against the ‘772 patent. Relying on the Federal Circuit’s decision in Gilead Sciences, Inc. v. Natco Pharma Ltd., 753 F.3d 1208 (Fed. Cir. 2014), the district court found that the ‘990 patent was a proper double patenting reference against the ‘772 patent and found the asserted claims of the ‘772 patent invalid for obviousness-type double patenting (as not patentably distinct from the claims of the ‘990 patent). Interestingly, the district court acknowledged that there was no binding precedent addressing the precise issue of whether a post-URAA patent could serve as a double patenting reference against a pre-URAA patent; however, it concluded that the Federal Circuit’s rational regarding the public’s right to practice an invention after a patent expires, as discussed in Gilead, applied.
With respect to Novartis’s arguments, the district court:
- Rejected Novartis’s argument that there was no unjustified extension of patent rights or public harm because the expiration date of the ‘772 patent was the same as it would have been if the ‘990 patent had never issued;
- Dismissed Novartis’s argument that, unlike the patent owners in Gilead and AbbVie Inc. v. Mathilda & Terence Kennedy Institute of Rheumatology Trust., 764 F.3d 1366 (Fed. Cir. 2014), Novartis did not engage in any gamesmanship such as the structuring of priority claims among related patents to obtain the benefit of one patent gaining a later expiration date (the district court held that a patentee need not engage in gamesmanship in order to violate the principles of double patenting because neither Gilead nor AbbVie held that gamesmanship is required);
- Was unpersuaded by Novartis’s argument that allowing an earlier-expiring post-URAA patent to serve as a double patenting reference for a later-expiring, pre-URAA patent would effectively shorten the statutorily mandated 17-year term of the pre-URAA patent (the district court found that Novartis ran this risk by seeking a second patent on an obvious variant of its invention claimed in the first issued patent); and
- Acknowledged that although Novartis’s arguments that the patent term extension it received for the ‘772 patent was not an unjustified extension of patent rights and effectively immunized its patent from a double patenting challenge was correct in the abstract, Novartis’s patent term extension grant was not at issue in the case and, moreover, it had not cited any case law supporting its proposition that patent term extension immunizes a patent from a double patenting challenge (The Federal Circuit noted in footnote 2 of the decision that this issue was being addressed in the concurrently issued opinion Novartis AG v. Ezra Ventures LLC, 2017-2284 (Fed. Cir. Dec. 7, 2018) which is discussed below).
The Federal Circuit (Prost, Wallach and Chen) narrowly framed the issue on appeal as follows: “[C]an a post-URAA patent that issues after and expires before a pre-URAA patent qualify as a double patenting reference against the pre-URAA patent?” The Federal Circuit held that “…under the circumstances of this case that it cannot” and reversed the district court.
In its decision, the Federal Circuit acknowledged that Gilead addressed a question that was not applicable in this case. Specifically, Gilead involved two post-URAA patents having the same inventors and a common owner (Gilead). In this case, Novartis owned one pre-URAA patent (the ‘772 patent) and one post-URAA patent (the ‘990 patent), and that the 17-year term granted to the ‘772 patent did not pose the unjustified time extension problem that was the case for patent invalidated in Gilead.
Readers will recall that the issue in Gilead was whether a patent that issues after but expires before another patent (U.S. Patent No. 5,952,374 (the ‘375 patent)) can qualify as a double patenting reference against an earlier-issuing, but later expiring patent (U.S Patent No. 5,673,483 (the ‘483 patent)) as shown by the below diagram:
The Federal Circuit clarified in this decision that even though it held in Gilead that the ‘375 patent could serve as a double patenting reference against the ‘483 patent (even though the ‘483 patent issued first and expired 22 months after the ‘375 patent), its holding was limited to the post-URAA context. Specifically, the Court stated:
“Throughout Gilead, we repeatedly noted that our analysis was rooted in the consequences that flow from the implementation of the URAA’s new patent term rule under which a patent expires 20 years from the effective filing date:
[F]or double patenting inquires, looking to patent issue dates had previously served as a reliable stand-in for the date that really mattered – patent expiration. But as this case illustrates, that tool does not necessarily work properly for patents to which the URAA applies, because there are now instances, like here, in which a patent that issues first does not expire first.”
The Court further noted that the facts of this case did not give rise to the patent prosecution gamesmanship that it worried about in Gilead because here, the later expiration of the ‘772 patent after the ‘990 patent occurred as a result of an intervening change in patent term law. The Court noted that both the ‘772 and ‘990 patents shared the same effective filing date (September 24, 1993) and that if both had been pre-URAA patents, the ‘990 patent would have expired on the same day as the ‘772 patent by operation of the terminal disclaimer Novartis filed on the ‘990 patent (tying its expiration to that of the ‘772 patent). Thus, had both patents been post-URAA patents, both would have expired on the same day. Therefore, in view of the different circumstances in this case, the Federal Circuit held that its holding in Gilead did not resolve the narrow question presented on appeal in this case.
The Federal Circuit disagreed with the Defendants that AbbVie was controlling in this case. The below diagram illustrates the relevant dates for the two patents at issue in AbbVie, U.S. Patent Nos. 7,846,442 (the ‘442 patent) and 6,270,766 (the ‘766 patent).
The Court noted that AbbVie was distinguishable because (1) it involved two post-URAA patents; and (2) the ‘766 patent had an earlier issuance and earlier expiration date than the ‘422 patent.
The Court concluded by stating:
“In this particular situation where we have an earlier-filed, earlier-issued, pre-URAA patent that expires after the later-filed, later-issued, post-URAA patent due to a change in statutory patent term law, we decline to invalidate the challenged pre-URAA patent by finding the post-URAA patent to be a proper obviousness-type double patenting reference (citing footnote 3). Instead, we apply our traditional, pre-URAA obviousness-type double patenting practice, see supra, to Novartis’s challenged pre-URAA patent. That is, we use the ‘772 patent’s issuance date as the reference point for our obviousness-type double patenting analysis. As we recognized in Gilead, looking to the patent issuance dates pre-URAA serves as a reliable guide for assessing whether a patent may serve as a double patenting reference against another patent. See 753 F.3d at 1215. Under this analysis, the ‘990 patent is not a proper obviousness-type double patenting reference for the ‘772 patent. When the ‘772 patent issued, the ‘990 patent had not yet issued and thus did not exist as a double patenting reference against the ‘772 patent.”
Finally, the Court noted that Novartis did not seek to extend its patent rights over everolimus beyond one patent term (namely, beyond 17 years from issuance). According to the Court, had the law not changed, regardless of whether Novartis had obtained the ‘990 patent, the ‘772 patent would have expired on September 9, 2014 (September 9, 2019 with the patent term extension). The fact that the law for patent term changed, resulting in the later-issued ‘990 patent having an earlier expiration date than it would have pre-URAA, should not affect the statutorily granted 17-year patent term for the ‘772 patent. The Court noted that Novartis did not receive a windfall with the 17-year term for the ‘772 patent because the term of the ‘990 patent was truncated by the intervening change in law.
Novartis AG v. Ezra Ventures LLC, No. 2017-2284 (Fed. Cir. Dec. 7, 2018).
Novartis sells fingolimod, which is the active ingredient in Gilenya®, for the treatment of relapsing forms of multiple sclerosis. Novartis owns a number of patents covering Gilenya® including: (1) U.S. Patent No. 5,604,229 (the ‘229 patent) which claims a large group of compounds, including fingolimod; and (2) U.S. Patent No. 6,004,565 (the ‘565 patent), which claims a method of administering fingolimod.
Because the ‘229 patent was filed before the effective date of the URAA, it was set to expire on February 18, 2014 (17 years from its issue date). However, Novartis obtained a PTE of five years pursuant to 35 U.S.C. § 156. With the PTE, the ‘229 patent expires on February 18, 2019. The ‘565 patent issued from a patent application filed after the effective date of the URAA, thus its term expired on September 23, 2017 (20 years from its earliest effective filing date). Thus, because the ‘229 patent is a pre-URAA patent and the ‘565 patent is a post-URAA patent, each is governed by different statutory patent term regimes as shown by the graphic below:
Ezra Ventures (Ezra) filed an ANDA for a generic version of Gilenya®. Novartis filed an infringement suit against Ezra in response asserting claims 9, 10, 35, 36, 46 and 48 of the ‘229 patent.
On September 22, 2016, the district court denied Ezra’s Federal Rule of Civil Procedure 12(c) motion for judgment on the pleadings. Specifically, Ezra argued that the ‘229 patent should be ruled invalid, or otherwise terminally disclaimed for the patent term of the expiration date of the ‘565 patent. Ezra argued that the granted extension of the ‘229 patent term beyond the life of the ‘565 patent was impermissible because it:
- De facto extended the life of the ‘565 patent, and violated § 156 (c)(4)’s requirement that only “one patent be extended” (namely, by extending “two” patents);
- Violated the “bedrock principle” that the public may practice an expired patent; and
- Rendered the ‘229 patent invalid for statutory and obviousness-type double patenting because Novartis’s ‘229 patent claims were not patentably distinct from the ‘565 patent claims.
The district court denied Ezra’s Rule 12(c) motion:
- Concluding that Ezra’s argument regarding the de facto extension of the ‘565 patent required reading “effectively” into the statute as a modifier of “extended” and this a reading did not make sense, particularly when compared to other uses of the word “extend” in the statute.
- Relying on the Federal Circuit’s holding in Merck & Co. v. Hi-Tech Pharmacal Co., 482 F.3d 1317 (Fed. Cir. 2007) that a terminally disclaimed patent could still have its term extended with a PTE because “Congress chose not to limit the availability of a patent term extension to a specific parent or continuation patent but instead chose a flexible approach which gave the patentee a choice.” The district court reasoned that “[e]xtension of the term of a patent that has been terminally disclaimed [as allowed in Merck] ‘de facto’ or ‘effectively’ extends the life of the patent over which it is terminally disclaimed,” much like the extension of the ‘229 patent’s term effectively extended the life of the related ‘565 patent in this case. Thus, the district court concluded that the ‘229 patent’s term extension was permitted under § 156.
- Explaining that the expiration of a patent does not grant the public an affirmative right to practice a patent, rather, it merely ends the term of the patentee’s right to exclude others from practicing the patent. In fact, the district court pointed to other ways that the ‘565 patent could be blocked from public use, such as by other patent rights or contractual obligations.
- Found that judgment on the pleadings was improper for a double patenting challenge because the analysis included factual issues underlying a “construction of the claims in [the] earlier patent and later “patent” and a “determination of whether differences between claims rendered them patentably distinct”.
Five months after the district court denied Ezra’s Rule 12(c) motion, Ezra stipulated that its ANDA product infringed claims 9, 10, 35, 36, 45 and 48 of the ‘229 patent if the claims were not invalid, expired, or unenforceable. Shortly thereafter, Ezra sent a letter to the district court stating it would not present any further evidence on the issue of statutory and obviousness-type double patenting and withdrew its other pending defenses stating its decision disposed of all pending triable issues and rendered a trial moot. On June 9, 2017, the district court entered judgment finding the ‘229 patent valid, unexpired and unenforceable with the PTE, found infringement of the ‘229 patent and imposed an injunction on Ezra’s product until the expiration of the ‘229 patent in 2019.
Ezra appealed and the Federal Circuit (Judges Moore, Chen and Hughes) affirmed the District Court.
Validity of the ‘229 Patent’s Term Extension
- Section 156’s “One Extended Patent” Rule
The “one extended patent” rule found in section 156(c)(4) provides that “in no event shall more than one patent be extended under subsection (e)(1) for the same regulatory review period for any product”. The Federal Circuit agreed with the district court that there was no reason to read “effectively” as a modifier to “extend” in the language of § 156(c)(4). Additionally, it noted, as the district court had found, “throughout the rest of § 156, ‘extend,’ ‘extension,’ and ‘extending’ refer to the legal status conferred upon a patent chosen to benefit from PTE.” Thus, this “legal status was the literal changing of the patent’s expiration date by the Director under § 156, ensuring a government-granted de jure exclusionary right for an extended time period as opposed to an “effective” or “de facto” exclusion. According to the Court, only the ‘229 patent was selected and legally extended and the fact that the ‘565 patent could not be practiced during the extended term of the ‘229 patent was a permissible consequence of the legal status conferred upon the ‘229 patent by § 156.
Ezra contended that to comply with § 156 Novartis had to choose a patent to extend and ensure that no more than one patent was extended. The Federal Circuit rejected this argument stating that they saw nothing in the text, structure, or history of § 156 that imposed such a requirement on patent owners. Instead, it stated that Congress chose not to limit the availability of patent term extension to a specific patent but chose a flexible approach which gave the patentee a choice. Therefore, the Court concluded that Novartis’s selection of the ‘229 patent for extension did not violate § 156(c)(4).
- Interaction Between Section 156 and Obviousness-Type Double Patenting
The Federal Circuit rejected Ezra’s argument that the ‘229 patent was invalid due to obviousness-type double patenting because the patent term extension of the ‘229 patent caused it to expire after the ‘565 patent. Specifically, the Court concluded that such a conclusion was a logical extension of its holding in Merck. The Federal Circuit agreed with the district court’s observation that if a patent was terminally disclaimed to another patent to overcome an obviousness-type double patenting rejection and then term-extended under § 156 (as in Merck), it will expire after the patent to which it had been subject to a double patenting rejection. According to the Court, “[S]uch an extension would result in the situation, as here, where the term of patent protection afforded to the patentably indistinct patent to which the extended patent was terminally disclaimed is – in Ezra’s words – ‘effectively’ extended because of a PTE granted pursuant to § 156.”
Ezra argued that a PTE “must not be granted if such an extension violates other provisions of law, such as invalidity under 35 U.S.C. §§ 102 and 103 or obviousness-type double patenting. The Federal Circuit agreed to the extent of considering a patent’s validity without a § 156 extension. Specifically, the Court stated that “…if a patent, under its original expiration date without a PTE, should have been (but was not terminally disclaimed because of obviousness-type double patenting, then this court’s obviousness-type double patenting case law would apply, and the patent could be invalidated. However, if a patent, under its pre-PTE expiration date, is valid under all other provisions of law, then it is entitled to the full turn of its PTE.”
The Court concluded by noting that this case did not raise the traditional concerns with obviousness-type double patenting of a patent owner trying to extend his exclusive rights through claims in a later-file patent that are not patentably distinct from claims in an earlier patent. Here, the ‘229 patent was earlier-filed and earlier issued but had a later expiration date due to the PTE. The ‘565 patent was later-filed and later-issued. Additionally, the Federal Circuit found that this case did not present the concerns that resulted in previous decisions regarding obviousness-type double patenting in the post-URAA context. Namely, there was no potential gamesmanship issues here through the structuring of priority claims like in Gilead. Instead, in this case, the ‘229 patent would have expired before the ‘565 patent but for the patent term extension. Thus, there was no concern here that once Novartis had obtained the ‘229 patent that it sought to obtain a second, later expiring patent for the same invention as in AbbVie.
This post was written by Lisa Mueller.
In August 2016, a new amended patent law took effect in Indonesia which removed the obligation of patent owners to pay annuities on patents that lapsed through non-payment of earlier annuities. However, despite this change, patent owners in Indonesia remain liable for any “annuity debt” that accrued under the old law. Unless any such debts are settled in full by February 16, 2019, the Directorate General of Intellectual Property (DGIP) will refuse to accept any new patent applications from that patent owner.
In many jurisdictions it is possible to abandon a patent simply by stopping annuity payments. However, under the old Indonesian patent law (pre-2016), a patent could only be deemed abandoned, and no longer subject to annuity payments, if a patent owner submitted a request of abandonment to the DGIP. As such, patent owners who attempted to abandon their patents by non-payment of annuities without submitting an abandonment request still owe an obligation of annuity payment to the DGIP.
Indonesia’s New Patent Law Does Not Eliminate the Obligation of Annuity Payment Under the Old Law
On August 16, 2018, the DGIP issued a circular providing guidance with respect to the payment of outstanding patent annuities accrued under the old law. The circular mandates that all patent owners should pay any outstanding annuities that have accrued by February 16, 2019. Patent owners who fail to do so will face significant consequences. Specifically, the DGIP has stated its intention to refuse any new patent application filings from patent owners who fail to satisfy their annuity payment obligation. Essentially, such patent owners will be barred from obtaining patent protection in Indonesia from February 2019 on.
Additionally, it appears that the August 16th notice serves to clarify an earlier notice by the DGIP issued on December 28, 2017 which related to the revival of patents that were abandoned due to non-payment of annuities. In view of this latest notice, it appears that old patents can be revived if the payment of outstanding annuities is accompanied by a request to revive the patent and a declaration by the patent owner stating that they will not take any legal action against any parties that infringed the patent rights during the lapsed period. Patent owners will be able to take legal action against any parties infringing any patent rights after restoration.
Thus, although the DGIP approach may be a burden for patent owners, it could equally represent a win-win, whereby payment of outstanding annuities will secure future filing rights, and, if desired, restore lapsed patent rights.
Next Steps for Patent Owners
Guidance is not yet available on how the DGIP will screen new applications for outstanding annuities from an applicant, the process for refusal of a new filing, and what (if any) grounds an applicant has to object to the refusal (particularly if the filing deadline has passed). As a result, patent owners should carry out a review of their Indonesian patent portfolio to minimize the risk of a refusal in the future by confirming:
- The status of all Indonesian patents in the patent register in the name of the patent owner;
- Whether abandonment requests were submitted for abandoned patents;
- That the Indonesian patent register is up to date and correct in respect of their patents; and
- Whether any abandoned patents are worth reviving.
For patent owners with high amounts of unpaid annuities, it may be prudent to undertake a cost-benefit analysis and to ascertain if Indonesia remains a country of commercial value to seek patent protection in the future.
Please continue watch BRICS & Beyond for further updates on annuity payments in Indonesia.
This post was written by Lisa Mueller and Adam Denley, Desmond Tan and Karen Bentley of FPA Patent Attorneys.
On September 27, 2018, the National Institute of Industrial Property in Argentina issued Resolution No. 250/2018 (Resolution) implementing certain changes to Argentine Patent Law that have been awaiting resolution as a result of Law No. 27.444 (Debureaucratization and Simplification Law for the Productive Development of the Nation).
The main change addressed by Resolution relates to the requirement for sworn Spanish translations of patent priority documents. Specifically, for any patent applications filed after October 1, 2018, a sworn Spanish translation of any priority documents will be required within three (3) months from the date of filing. Failure to submit a translation within this time frame will result in a loss of the priority right.
Moreover, on October 9, 2018, the National Patent Administration issued Circular No. 4/2018 requiring the submission of sworn Spanish translations of priority documents for patent and utility model applications filed in the Argentine Patent Office between January 12, 2018 and October 1, 2018. Applicants have three (3) months beginning October 1, 2018, namely, until January 1, 2019, to submit these translations. Please note that the January 1, 2019 deadline is not extendible. Failure to submit a sworn translation by this date will result in a loss of a priority right for an application.
Other changes resulting from the Resolution include:
- The implementation of electronic filing for all intellectual property matters (trademarks, patents, industrial models and designs, technology transfer, etc.), which will simplify and expedite the prosecution of proceedings.
- An increase in official fees for assignment and change of name proceedings for trademarks, patents, industrial models and designs (from ARS 1200 to ARS 1700).
- The incorporation of official fees for renewal proceedings of industrial models and designs within the grace period, namely, six (6) months after the expiration date (ARS 4200).
Written by Lisa Mueller and Martin Bechara Arcuri, Clarke, Modet & Co.
Post grant review (PGR) is a trial proceeding conducted at the Patent Trial and Appeal Board (PTAB or Board) to review the patentability of one or more claims in a patent on any ground that could be raised under 35 U.S.C. §282(b)(2) or (3) (e.g., §§101, 102, 103 or 112). The procedure for conducting post grant review took effect on September 16, 2012, and generally applies to patents issuing from applications subject to first-inventor-to-file provisions of the American Invents Act.
The PGR process begins with a third party filing a petition on or prior to the date that is 9 months after the grant of the patent or issuance of a reissue patent. The patent owner may file a preliminary response to the petition. A PGR may be instituted upon a showing that, it is more likely than not that at least one claim challenged is unpatentable. If the proceeding is instituted and not dismissed, a final determination by the PTAB will be issued within 1 year (extendable for good cause by 6 months).
We have been monitoring the PGRs filed in U.S. PTO Tech Center (TC) 1600 and a summary of the PGRs filed to date is shown in the attached table: PGRCHARTTC1600_09_28_2018. We will continue to update this table in future posts as new PGRs are filed against patents issued from this TC.
As of September 27, 2018, 39 PGRs have been filed in TC 1600. Twenty-three of these PGRs have involved transitional applications. Five different drugs listed in the electronic Orange Book have been the subject of one or more PGRs (namely, Aloxi®, phenylephrine hydrochloride, Copaxone®, Jakafi® and Qbrelis®).
A summary of the grounds alleged in the 39 PGRs is provided in the below table.
§112 (Written Description)
*Other grounds raised under §101 included lack of inventorship and practical utility.
A summary of the status of the 39 PGRs is provided in the below table.
Final Written Decision
The four written decisions issued thus far have been in Altaire Pharmaceuticals, Inc. v. Paragon BioTeck, Inc. (PGR2015-00011), Grünenthal GmBH v. Antecip Bioventures II LLC (PGR2017-0008), L’Oréal USA, Inc. v. Liqwd, Inc. (PGR2017-00012) and KVK-Tech, Inc. v. Silvergate Pharmaceuticals, Inc. (PGR2017-00039). A brief summary of each of the final written decisions is provided in the attached table. Particularly noteworthy is the decision in Grünenthal which is the first final written decision involving a patent in TC 1600 that focuses solely on written description. This decision is helpful in that it provides insight on how the PTAB analyzes written description in such proceedings. Given its importance, Grünenthal is discussed in more detail below.
Grünenthal GmBH v. Antecip Bioventures II LLC
Grünenthal requested post-grant review of claims 1-17 of U.S. Patent No. 9,283,239 (the ‘239 patent) owned by Antecip. In a final written decision entered on June 22, 2018, the PTAB held that Grünenthal had demonstrated by a preponderance of the evidence that claims 1-17 of the ‘239 patent were unpatentable for a lack of written description.
The ‘239 patent is directed to oral dosage forms of bisphosphonate compounds, such as zoledronic acid, that can be used to alleviate pain or related conditions. One such condition, complex regional pain syndrome (CRPS), is a debilitating pain syndrome that is characterized by severe pain in a limb that is accompanied by edema, and autonomic, motor and sensory changes. Because bisphosphonates generally have low oral bioavailability, the ‘239 patent describes enhancing oral bioavailability of zoledronic acid by administering the compound in its disodium salt form.
Claims of the ‘293 patent
The ‘293 patent issued with 17 claims. Claim 1, the only independent claim, is reproduced below:
- A method of treating complex regional pain syndrome comprising orally administering zoledronic acid to a human being in need thereof, wherein the human being receives about 80 to about 500 mg of zoledronic acid within a period of six months.
Dependent claim 17, which also discussed in the PTAB’s decision, is reproduced below:
- The method of claim 1, wherein the zoledronic acid is orally administered in a dosage form containing at least 10% zoledronic acid.
Written Description of the ‘293 patent
According to the specification, the monthly dose of zoledronic acid:
. . . is about 5000 mg or less, about 4000 mg or less, about 3000 mg or less, about 2000 mg or less, about 1000 mg or less, about 700 mg or less, about 600 mg or less, about 1 mg to about 4,000 mg, about 1 mg to about 1,000 mg, about 10 mg to about 1000 mg, about 50 mg to about 1000 mg, about 10 mg to about 600 mg, about 40 mg to about 600 mg, about 50 mg to about 600 mg, or about 100 mg to about 600 mg, about 40 mg to about 2000 mg, about 40 mg to about 800 mg, about 50 mg to about 800 mg, or about 100 mg to about 800 mg, about 40 mg to about 1000 mg, about 50 mg to about 1000 mg, or about 100 mg to about 1000 mg, or any monthly dose in a range bounded by, or between, any of these values. Column 11, lines 33-48.
…may be administered for only 1 month, or may be repeatedly administered for 2 or more months. Column 12, lines 2-3.
Additionally, the specification, in column 10, lines 40-63, provides following guidance with regard to dosing regimens:
Any suitable amount of zoledronic acid may be used. Some solid or liquid oral dosage forms, or units of oral dosage forms (referred to collectively herein as ‘oral dosage form(s)’) may contain about 0.005 mg to about 20 mg, about 0.1 mg to about 10 mg, about 0.5 mg to about 10 mg, about 0.2 mg to about 5 mg, about 1 mg to about 500 mg, about 1 mg to about 50 mg, about 10 mg to about 250 mg, about 100 mg to about 300 mg, about 20 mg to about 200 mg, about 20 mg to about 150 mg, about 30 mg to about 100 mg, about 1 mg to about 1,000 mg, about 10 mg to about 50 mg, about 10 mg to about 300 mg, about 10 mg to about 150 mg, about 10 mg to about 100 mg, about 40 mg to about 150 mg, about 10 mg to about 600 mg, about 40 mg to about 600 mg, about 40 mg to about 2000 mg, about 40 mg to about 800 mg, about 25 mg to about 800 mg, about 30 mg to about 800 mg, about 10 mg to about 500 mg, about 50 mg to about 150 mg, about 50 mg, about 100 mg, about 50 mg to about 500 mg, about 100 mg to about 2000 mg, about 300 mg to about 1500 mg, about 200 mg to about 1000 mg, about 100 mg to about 500 mg, or about 150 mg of zoledronic acid, or any amount of zoledronic in a range bounded by, or between, any of these values. In some embodiments, the oral zoledronic acid is administered daily, weekly, monthly, every two or three months, once a year, or twice a year. (Emphasis added).
Moreover, the specification in column 13, lines 34-40, provides the following guidance with regard to dosing regimens:
In some embodiments, an oral dosage form comprises about 10 mg to about 150 mg or about 10 mg to about 100 mg of zoledronic acid, and is administered daily for about 5 to about 10 consecutive days. This regimen may be repeated once monthly, once every two months, once every three months, once every four months, once every five months, once every six months, once yearly, or once every two years. (Emphasis added).
With respect to the examples, example 3 describes treatment of CRPS with orally administered zoledronic acid in a rat tibia fracture model. According to this example, CRPS was induced by fracturing the right distal tibias of the animals, then casting the fractured hindpaws for four weeks. The animals were orally administered either a vehicle (control) or 18 mg/m2/day of zoledronic acid for 28 days. After 28 days, the casts were removed and the animals tested for hindpaw pain, edema, and warmth. Additionally, Figures 3–6 depict the results of the treatment. The ’239 patent states that “a daily dose of 18 mg/m2 corresponds to a monthly dose of about 500–560 mg/m2 or a human dose of about 800–900 mg”.
PTAB’s Analysis and Decision
Claim 1 – “about 80 to about 500 mg of zoledronic acid within a period of six months”
The PTAB first considered whether the specification provided written description support for the range of “about 80 to about 500 mg of zoledronic acid” as recited in the claims. The PTAB acknowledged the Antecip’s argument that column 10 of the ’239 patent specification disclosed ranges that would encompass the claimed range. Specifically, the PTAB noted that this portion of the specification disclosed the range of “about 50 mg to about 500 mg,” thereby giving literal support to the range and to the endpoint of “about 500 mg.” The Board also noted that although the endpoint of “about 80 mg” was not expressly disclosed in combination with the 500 mg endpoint, that the Federal Circuit had explained
If lack of literal support alone were enough to support a rejection under § 112, then the statement of In re Lukach . . . that ‘the invention claimed does not have to be described in ipsis verbis in order to satisfy the description requirement of § 112,’ is empty verbiage.
Thus, according to the PTAB, the issue was whether the description “clearly allowed persons of ordinary skill in the art to recognize” the claimed invention. The PTAB stated that in this case, the ’239 patent specification clearly did not allow persons of ordinary skill in the art to recognize the “about 80 mg” endpoint as part of invention described in the ’239 patent. Specifically, the Board noted that there was no disclosure of “about 80 mg” as a preferred endpoint, no disclosure of a specific embodiment including a dose of 80 mg, nor any other description suggesting the importance or criticality of the “about 80 mg” endpoint.
As a result, the Board concluded:
In view of the lack of any explicit disclosure for ‘about 80 mg’ endpoint, Patent Owner suggests that the ‘about 80 mg’ endpoint may be derived from the specification in numerous ways. PO Resp. 13–33; Ex. 2015 ¶¶ 26, 28. For example, Patent Owner argues that the endpoint of 80 mg finds support in column 13 of the specification, which discloses a range of ‘about 10 mg to about 100 mg’ administered over the course of 5 to 10 consecutive days, thereby essentially disclosing a list six different ranges that includes the ranges of about 50 mg to about 500 mg and about 80 mg to about 800 mg. PO Resp. 14 (citing Ex. 2015 ¶¶ 18, 26–29); Tr. 24:8–25:7, 30:16–33:11, 45:3–46:22.
We are aware of cases indicating that the written description analysis requires consideration as to whether one of skill in the art could derive the claimed ranges from the specification. See e.g., Purdue Pharma L.P. v. Faulding Inc., 230 F.3d at 1327; Vas–Cath Inc. v. Mahurkar, 935 F.2d at 1563–64; Ralston Purina Co. v. Far–Mar–Co, Inc., 772 F.2d at 1575; In re Wertheim, 541 F.2d at 264–65. For example, we note that ‘ranges found in applicant’s claims need not correspond exactly to those disclosed in [the specification, so long as] one skilled in the art could derive the claimed ranges from the [ ] disclosure’. Vas–Cath, 935 F.2d at 1566. However, none of the cases concluding that sufficient written description existed such that a person of ordinary skill in the art could derive a claimed range from a specification are factually equivalent to the present case, where, as here, a non-original claim recites a dosage regimen range with endpoints derived from an inordinate amount of picking and choosing from disparate disclosures of various embodiments reciting broader ranges. For example, in Ralston, the Federal Circuit held that the disclosure of 25%–27% water in a soybean mixture did not support broader claims to ‘at least 20%’, ‘between 20% and 40%’, or ‘in the range of 20%–30%’ moisture levels, but did support moisture levels of ‘at least about 25% by weight’ and ‘at least 25% by weight’, reasoning that the open-ended claims would be limited by what a person skilled in the art would understand to be workable. 772 F.2d at 1576; see also, In re Wertheim, 541 F.2d at 264–65 (discussed hereinabove).
Furthermore, we note that the disparate disclosures of the ’239 patent specification upon which Patent Owner relies may very well render the ‘about 80 mg’ endpoint of the claimed ranges obvious to a person having ordinary skill in the art. Obviousness, however, is an inappropriate standard to measure a claim’s compliance with the description requirement. Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572 (Fed. Cir. 1997) (‘One shows that one is ‘in possession’ of the invention by describing the invention, with all its claimed limitations, not that which makes it obvious’.) Moreover, we note that the claims do not merely require administration of a dose of about 80 mg to about 500 mg of zoledronic acid, they also require that dose to be administered ‘within a six month period’. The ’239 patent specification does not use the phrase ‘within a six month period’, but rather discloses that the various described dosage amounts may be administered, for example, ‘monthly, every two or three months, once a year, or twice a year’ or may be ‘repeated . . . once every six months’. Ex. 1003, 10:40–63, 13:27–33. To the extent the specification does describe periods of six months, it also does not specify the administration of the recited doses over six months. Thus, a person of ordinary skill in the art must further derive from the language of the ’239 patent specification the time frame of ‘within a period of six months’ to administer the recited dose of ‘about 80 to about 500 mg of zoledronic acid’, thereby further complicating the process necessary to derive the recited dosing regimen from the ’239 patent specification. We thus, conclude that the ’239 patent specification does not clearly allow persons of ordinary skill in the art to recognize nor derive the recited dosing regimen of ‘about 80 to about 500 mg of zoledronic acid within a period of six months’. (Emphasis added).
Claim 17 – “orally administered in a dosage form containing at least 10% zoledronic acid”
With respect to claim 17, Grünenthal acknowledged that the ’239 patent described liquid compositions containing from 0.0001 % to about 50% (w/v) zoledronic acid, and solid compositions containing from 5% up to about 90% (w/w) zoledronic acid. However, Grünenthal argued that because formulations containing more than 90% zoledronic acid were not described in the specification but would be within the scope of claim 17, the written description requirement was not satisfied. Interestingly, Antecip did not specifically address Grünenthal’s arguments regarding claim 17. Nonetheless, the PTAB was not persuaded by Grünenthal’s contentions. Instead, it found that the ’239 patent contained a sufficient written description of an oral dosage form containing “at least 10% zoledronic acid”. Specifically, according to the PTAB, the specification described a “full panoply of zoledronic acid concentrations” citing to column 10, lines 17-28 which recited that the liquid compositions may contain:
…about 10% (w/v) to about 15% (w/v), about 15% (w/v) to about 20% (w/v), about 20% (w/v) to about 30% (w/v), about 30% (w/v) to about 40% (w/v), or about 40% (w/v) to about 50% (w/v) of zoledronic acid.
Additionally, with respect to solid dosage forms, the PTAB referred to column 10, lines 29-32 which recited that such solid forms “may contain at least about 10% (w/w), at least about 20% (w/w) . . .” up to “at least about 80% [w/w]” zoledronic acid. Moreover, solid dosage forms were also described in this same section of the specification as containing zoledronic acid in ranges beginning from “about 10% (w/w) to about 30% (w/w), about 10% (w/w) to about 20% (w/w) . . .” all the way up to a range of “about 80% (w/w) to about 90% (w/w)” (See, column 10, lines 32-39). Therefore, according to the PTAB, the breadth of zoledronic acid concentration ranges disclosed in the specification was more comprehensive than, and therefore distinguishable from, the more limited concentration ranges disclosed in Wertheim (where the claimed range of “at least 35%” was not supported by disclosure of 25% to 60% range disclosed in priority application). In short, the PTAB determined that a person of ordinary skill in the art, namely, a medical doctor with experience treating CRPS, would have recognized that the “inventor invented what is claimed” and did not overreach in claiming “at least 10% zoledronic acid” in an orally administered dosage form for treating CRPS.
This post was written by Lisa Mueller.
Article 20 of Indonesia’s Patent Law requires patent owners to either manufacture their patented products in Indonesia or use their patented processes in the country. Although controversial, the purpose of this working requirement is to drive foreign technology transfer, investment, and stimulate local employment opportunities within the country.
If an invention is not worked within thirty-six (36) months of grant, a third party can file an application for a compulsory license pursuant to Article 82, which is reproduced below:
(1) A compulsory license shall constitute license to implement a patent granted by the Minister upon request by reason of:
a. Patent holder does not fulfill the obligation to make the product or using the process in Indonesia as referred to in Article 20 (1) within a period of 36 (thirty-six) months after being granted patent;
b. Patents have been implemented by the patent holder or licensee in the form and manner that is detrimental to the public interest; or
c. A patent resulting from the development of a patent that has been previously granted cannot be implemented without using another party’s patent that is still under protection.
(2) An application for a compulsory license referred to in paragraph (1) is free of charge.
As discussed above, an application for a compulsory license for failure to work an invention can be filed immediately after the expiration of 36 months from grant. However, an application for a compulsory license can be filed at any time if the patent owner implements the patent in a form and manner that is detrimental to the public interest or if the development of a patented product could not be implemented without the use of another party’s patent which is still under protection. According to Article 96, any person may apply for a compulsory license.
According to Article 83, examination of an application for a compulsory license is done by a team of experts assembled ad-hoc by the Ministry of Law. Once the experts provide the results of their examination, the patent owner is given a period of time to respond. When providing its response, the patent owner is afforded an opportunity to provide its own experts. If the patent owner does not respond to the opinion of the experts, or does not do so timely, then the compulsory license will be approved.
On July 11, 2018, Implement Regulations were issued by the Indonesian Patent Office to provide more clarity on the working requirement. Specifically, these regulations allow patent owners that are not yet able to work their inventions to postpone the obligation to do so for a maximum period of five years by submitting an application to the Ministry of Law along with the reason(s) for postponement. Additionally, further postponement beyond the maximum period of five years may be granted upon request. A fee may be required for filing a request for postponement. However, whether a fee will be required and, if so, the exact amount, have not yet be announced.
Procedurally, according to Indonesian Patent Law No. 13 (2016), an initial request for postponement must be submitted by a patent owner within three years from the date of grant. Because the working requirement just recently came into effect on August 26, 2016, the three-year period to submit a request for postponement would be (at the earliest), August 26, 2019. However, the Indonesian Patent Office appears to have a different opinion regarding the date for the filing of such postponements. Specifically, according to the Indonesian Patent Office, because the Implementing Regulations are effective from the date of promulgation (namely, July 11, 2018), a patent owner can file a request for postponement beginning July 11, 2018. What this means is that all patents having a grant date after July 11, 2015 are subject to this requirement. However, readers should be aware that the procedures for filing such a request are still under discussion.
While it is presently unknown what language will be accepted when filing a request for postponement, some examples of suggested wording to consider is provided below:
- If the product/process of the patent has not been used at all in Indonesia: “The patented product or process needs further development.”
- If the product of the patent has been imported or distributed in Indonesia but has not been manufactured domestically: “The patented product has been imported and distributed in Indonesia. However, taking into consideration the value of our product sales so far, the patent owner has not been able to make investment to bring the manufacturing technology into Indonesia.”
- If the patent relates to a process or method: “The patent owner does not have the facilities to implement the patented process, and until now, they do not have any cooperation or agreements with any local companies that are interested in using their patented process.”
Unlike the working requirement in India where patent owners and licensees are required to submit Form 27 by the March 31st every year detailing whether a patent was worked in India, there is no requirement under Indonesian Patent Law for patent owners and licensees to provide the Indonesian Patent Office/Ministry of Law with evidence that a patent is being implemented in the country. However, a patent owner will be expected to prove that his invention has been implemented in the event that an application for a compulsory license is filed by a third party. Therefore, it is important for patent owners to keep track and docket the 36 month deadline for working and timely request postponement of this requirement if necessary.
There are other consequences for not complying with the working requirement as well. According to Article 132, a patent can be revoked for non-compliance with the working requirement. However, only a public prosecutor or “other party that represents national interests” (and no other person) can request revocation if an invention is not worked. Interestingly, it appears that not working an invention will not automatically result in a revocation. Moreover, it seems unlikely that a public prosecutor will bring a revocation action against a patent unless it is against public interest. Nonetheless, it will be interesting to watch the case law develop in this area.
Please continue to watch BRICS & Beyond for an update on the working requirements in Indonesia.
This post was written by Lisa Mueller and Indah Handayani of Tilleke & Gibbins.
The Canadian Patent Office (CPO) is seeking comments on its proposed revisions to Chapter 17 of the Manual of Patent Office Practice (MOPOP) as it relates to pharmaceutical solid forms (namely, polymorphs, salts, hydrates, solvates, desolvates and co-crystals). In this post, we will examine various section of this amended chapter in detail.
Considerations Respecting Anticipation and Obviousness (Chapter 17.08.01)
This section of amended Chapter 17 describes the considerations to be used in assessing anticipation and obviousness of pharmaceutical solid forms. According to this section, where a particular crystalline form (such as a polymorph) of a small chemical molecule has not been disclosed and enabled in the prior art, either explicitly or inherently, a claim to that crystalline form is considered to be novel and satisfy subsection 28.2(1) of the Canadian Patent Act (Patent Act). However, if a polymorph is disclosed and enabled in the prior art, a claim encompassing that polymorph is considered to be anticipated. Thus, a known polymorph will not be novel simply by making it dependent on a new process. Nonetheless, a claim to a process used to prepare a polymorph may be novel if it can be distinguished over the prior art.
When assessing obviousness of a new crystalline form, the chapter notes that one factor to be considered is the process by which the new form is produced. Inventiveness may be acknowledged for a form that can only be produced using an inventive process (such a process is considered to go beyond the mere application of common general knowledge and routine experimentation).
Nevertheless, the chapter further states that even if a process used to prepare a new solid form relies on basic crystallization techniques that are standard in the field, the solid form may still be non-obviousness. Specifically, inventiveness may be acknowledged if the originally-filed application discloses that the form provides an unexpected benefit, such as a beneficial physicochemical property that is attributable to the form itself. Specifically, the chapter further notes that:
Only benefits disclosed in the originally-filed application will be taken into account during an obviousness assessment. The disclosure of the benefit may be either explicit (e.g., direct statements) or implicit (e.g. supportive data provided in the application). In a patent application the most persuasive disclosure is one that provides data comparing the form of the invention to the prior art form (or all of the closest prior art forms when more than one exist) and confirms that there is a significant difference or improvement in one or more physicochemical properties compared to the prior art form(s) of the same chemical molecule. Where the specification comprises statements indicating a solid form ‘may’ have a particular benefit or ‘has at least one’ benefit selected from a list of benefits (without clearly stating which it has), this amounts to an inexplicit indication of potential benefit. Unless the benefit would be implicit from data provided in the application, such statements would not be considered during an obviousness assessment. Likewise, a benefit that is recognized subsequent to the filing of the original application would be given no weight in the assessment.
It is important to note that the person skilled in the art would generally expect or predict that a crystalline form will have certain benefits over an amorphous form of the same small chemical molecule, including easier isolating, purifying, drying, and in batch processes, easier handling and formulating. However, such expected are generally not sufficient, when taken alone, to support a finding of non-obviousness.
Considerations Respecting Utility (Chapter 17.08.02)
This portion of amended Chapter 17 states that although the utility of a polymorph does not need to be expressly set out in the application, the subject matter must have utility. Moreover, a person skilled in the art would reasonably expect that polymorphs of a known small chemical molecule that have a previously established utility (either pharmacological or therapeutic) would also possess the same activity. In such cases, because the utility of the polymorph will generally be self-evident to the skilled person, the utility requirement of section 2 of the Patent Act would be satisfied.
A utility defect will be made if the specification is silent regarding the utility of the claimed polymorph and the utility of other known forms of the same small chemical molecule are neither disclosed in the specification or common general knowledge to a skilled person in the art.
In instances where the claimed crystal form has a utility different from other known form(s) of the small chemical molecule, the utility must be established by demonstration or sound prediction. However, if the utility relies on a physicochemical property that was not established and could not have been predicted, then the utility of the subject-matter of the invention cannot be established by sound prediction. Specifically, this portion of the chapter states, “[R]ecall that the specific physicochemical properties of a particular crystalline form are generally considered as unpredictable since the crystal form must be prepared and tested before its properties can be ascertained (see 17.08.01). Given that such properties cannot be predicted and would not be implicit to the skilled person, in order to establish utility the applicant must be in a position to show that the property associated with the utility was demonstrated no later than the filing date of the application.”
Defining a polymorph in the claims (Chapter 17.08.03)
This portion of amended Chapter 17 states that with respect to claiming polymorphs, that the polymorph must be defined in terms of physical characterization data and/or physicochemical properties that are specific to its solid state structure and which serve to distinctly and explicitly distinguish it from all other forms of that molecule or in terms of the process by which it is made.
Polymorphs can be defined in a claim by: (1) the physical parameters relevant to its particular crystal structure; (2) spectral analysis parameters (such as X-ray powder diffraction (XRPD) pattern, Raman spectrum and/or solid-state nuclear magnetic resonance (NMR)); or (3) parameters associated with methods of thermal analysis (such as infrared (IR) absorption, differential scanning calorimetry (DSC), thermogravimetric analysis (TGA), melting point or combinations thereof). Polymorphs should not be defined by an internal designation (such as Form I, polymorph B, etc.), molecular formula or chemical name.
Examples (Chapter 17.08.05)
This portion of amended Chapter 17 provides two hypothetical examples involving claiming strategies for polymorphs and the application of the anticipation, obviousness and utility requirements discussed previously. These examples are very useful from a practical perspective in understanding how the CPO will examine these claims.
Considerations relating to particular solid forms (Chapter 17.08.06)
This portion of amended Chapter 17 notes that the patentability of pharmaceutical salts, hydrates, solvates, desolvates and co-crystals involve the same considerations as those described earlier with respect to polymorphs.
Salts (Chapter 17.08.06a)
With respect to assessing whether claims to a novel salt are inventive, this portion of amended Chapter 17 notes that the process used to prepare a salt and any unexpected beneficial properties of the salt may be informative. Where the originally-filed application discloses that a salt can only be produced using an inventive process that goes beyond routine methodologies or that the salt has a beneficial property that is unexpected, the claimed salt is inventive and complies with section 28.3 of the Patent Act. Additionally, a person skilled in the art would reasonably expect that salts of known small chemical molecule having a previously established utility would also possess the same utility despite incorporation of a counterion in its structure.
In terms of defining a salt in the claims, inclusion of the counterion in the structure of the molecule is often sufficient to satisfy the requirements of subsection 27(4) of the Patent Act (such as, for example, by claiming “A besylate salt of compound of Formula (I)…”). In cases where the claim is directed to a specific polymorph of a salt, the physical parameters relevant to the polymorph’s particular crystal structure must also be defined in order to satisfy the requirements of subsection 27(4) of the Patent Act.
Hydrates, solvates and desolvates (Chapter 17.08.06b)
With respect to assessing whether claims to a novel solvate or desolvate are inventive, the amended chapter notes that the process used for the preparation and any unexpected benefits of the particular entity may be informative. As with novel salts, where the originally-filed application discloses that a solvate or desolvate can only be produced using an inventive process that goes beyond routine methodologies or that the solvate or desolvate crystalline form has a beneficial property that is unexpected, the claimed solvate or desolvate is inventive and complies with section 28.3 of the Patent Act. Additionally, a person skilled in the art would reasonably expect that solvates and desolvates of known small chemical molecule having a previously established utility would also possess the same utility despite incorporation of a solvent into the crystal lattice (solvate) or the removal of a solvate form the solvated form (desolvate).
In terms of defining a solvate in the claims, inclusion of the number of solvent molecules per small chemical molecule is often sufficient to satisfy the requirements of subsection 27(4) of the Patent Act (such as, for example, by claiming, “A dihydrate of the compound of formula (I)”). In cases where the claim is directed to a specific polymorph of a solvate, the physical parameters relevant to the polymorph’s particular crystal structure must also be defined in order to satisfy the requirements of subsection 27(4) of the Patent Act.
With respect to defining a desolvate in the claims, inclusion of the physical parameters relevant to its particular crystal structure are often sufficient to satisfy the requirements of subsection 27(4) of the Patent Act.
Co-crystals (Chapter 17.08.06c)
With respect to assessing whether claims to a novel co-crystal are inventive, as with salts, solvates and desolvates, the amended chapter notes that the process used for the preparation and any unexpected benefits of the particular co-crystal may be informative. Specifically, the chapter notes that “[G]iven the state of the art and recognizing the extensive number of potential co-crystal formers that can be used, screening for co-crystals may involve an inventive process and co-crystals produced by such an inventive process would also be inventive”. Additionally, a person skilled in the art would reasonably expect that co-crystals of known small chemical molecule having a previously established utility would also possess the same utility despite incorporation of a co-crystal in its structure.
In terms of defining a co-crystal in the claims, like polymorphs, inclusion of the relevant physical parameters to the particular crystal structure of the co-crystal are often sufficient to satisfy the requirements of subjection 27(4) of the Patent Act.
The deadline for submitting comments to CIPO on the above amended Chapter 17 is August 17, 2018.
This post was written by Lisa Mueller.
On July 24, 2018, the Instituto Nacional da Propriedade Industrial (INPI) published Rule #222/2018 implementing the Patent Prosecution Highway (PPH) Pilot program (PPH program) with the United Kingdom patent and trademark Office (UKIPO). Implementation of this PPH program may expedite the examination of pending Brazilian patent applications which have received a “Notification to Grant” or “Intention to Grant” issued by the UKIPO in counterpart applications. This is good news for biotechnology Applicants as discussed further below.
The program will accept applications belonging to patent families whose earliest application has been filed with INPI or the UKIPO, or for PCT applications containing no priority claim(s), those filed using INPI or the UKIPO as the receiving office.
Applications eligible for the PPH program include:
- Electric apparatus and machines and power;
- Audiovisual technology;
- Digital communications;
- Communication basic processes;
- Computer technology;
- Information technology methods and management; and
Additionally, the application must also be specifically classified under the IPC codes listed in the table below to be accepted:
IPC Code (Includes all subcategories within an indicated classification unless otherwise noted)
|Biotechnology||C07G, C07K, C12M, C12N, C12P, C12Q, C12R, C12S (except for A61K (drug-related patent applications))|
|Electric apparatus and machines and power||F21#, H01B, H01C, H01F, H01G, H01H, H01J, H01K, H01M, H01R, H01T, H02#, H05B, H05C, H05F, H99Z|
|Audiovisual technology||G09F, G09G, G11B, H04N-003, H04N-005, H04N-009, H04N-013, H04N-015, H04N-017, H04R, H04S, H05K|
|Telecommunications||G08C, H01P, H01Q, H04B, H04H, H04J, H04K, H04M, H04N-001, H04N-007, H04N-011, H04Q|
|Communication basic processes||H03#|
|Computer technology||G06# (G06Q not included), G11C, G10L|
|Information technology methods and management||G06Q|
To be accepted into the PPH Pilot program, the Brazilian patent application must:
- Have been filed in Brazil for more than eighteen months or requested anticipated publication by INPI (as provided for in Article 30 Paragraph 1 of the Brazilian Patent Statute); or, for PCT national phase applications, the corresponding PCT application must have already been published by WIPO;
- A request for examination submitted to INPI; and
- Have not been accepted in any other fast-track examination program.
Divisional and their corresponding original applications may be eligible for the program provided that the PPH is requested for each application independently.
In terms of mechanics, participation in the PPH Pilot program must be requested electronically. Documents that must be submitted along with the request include: (1) documents evidencing that the application meets the above requirements; (2) a table demonstrating the correspondence between the pending claims in the Brazilian application and those allowed by the UKIPO; and (3) a copy of any non-patent literature deemed to be prior art by the UKIPO. A translation must be submitted for any documents not in Portuguese, English or Spanish.
It is important to note that an application will be removed from the PPH program if the Applicant voluntarily (1) divides the application; or (2) submits any amendments before issuance of a first technical opinion on the application by INPI.
INPI will evaluated applications submitted for compliance with the requirements of the PPH program according to the date the request is made. Applications that fail to meet the requirements will either be (1) given an opportunity to correct any defects or irregularities within 60 days after issuance of an Office Action; or (2) denied participation in the PPH program. Applicants may appeal any decision denying participation in the PPH program within 60 days of notification thereof, provided that all the requisite documents and information required for participation in the program and a brief are submitted within this period.
The PPH program will be limited to 100 applications per year (for a total of 200 applications at most over the life of the program). An Applicant will be limited to one application per calendar month except during the last month of the program, when this limitation will not be applied. Request for participation in the PPH program with the UKIPO will be accepted from August 1, 2018 until July 31st, 2020. Rule #222/2018 will remain in force until a final decision is reached for each application accepted into the program.
This post was written by Lisa Mueller.
Eli Lilly and Company (Eli Lilly) globally markets its product tadalafil (Cialis®) a PDE5 inhibitor, for use in the treatment of erectile (or sexual) dysfunction as well as for treating the signs and symptoms of benign prostatic hyperplasia. Tadalafil is available as a tablet in four strengths – 2.5 mg, 5 mg, 10 mg and 20 mg, respectively. Not surprisingly, worldwide, Eli Lilly has several issued patents covering tadalafil. One such patent, European Patent No. 1 173 181 T6 (the ‘181 patent), covers a pharmaceutical unit dosage composition comprising 1 to 5 mg of tadalafil that is suitable for oral administration up to a maximum of 5 mg per day.
Over the last several years, there has been significant interest by generic manufacturers in developing a generic version of tadalafil. As a result, in Europe, the ‘181 patent has already been litigated in several countries and been found to be invalid by courts in the Netherlands, Great Britain (on appeal to the Supreme Court) and Germany. In Belgium, a nullity action is currently pending (despite the fact that a trial took place a few months ago, the parties are still waiting to receive a judgment).
Sandoz has launched a generic version of tadalafil in a few countries around the world, most recently in Denmark, where the product was made available in all strengths. As a result, Eli Lilly filed a patent litigation action and a request for preliminary injunction with respect to the 2.5 mg, 5 mg and 10 mg tablets. On June 15, 2018, the Danish Maritime and Commercial High Court, in Eli Lilly and Company, ICOS Corporation, and Eli Lilly Danmark A/S v. Sandoz A/S found the Danish equivalent of the ‘181 patent valid and issued the injunction.
During the proceeding, Sandoz argued that the preliminary injunction should not be granted because the ‘181 patent was invalid for added subject matter, lack of priority, lack of novelty and lack of inventive step. However, the main focus of Sandoz’s arguments during the proceeding centered on lack of inventive step. Specifically, Sandoz argued that the ‘181 patent was obvious in view of WO 97/03675 (Daugen II) and Viagra® (a well known PDG5 inhibitor). In finding that the ‘181 patent was likely valid, the Court described the objective problem to be solved as providing a selective, potent tetracyclic derivative as described in Daugen II for the inhibition of PDE5 for treating erectile dysfunction as well as providing an improved dosing regimen. According to the Court, the “skilled person” would have consisted of a “team”, namely, a clinician as well as persons with knowledge about toxicology, pharmacokinetics, urology and pharmaceutical formulations. Eli Lily argued that this team would have been lead by a clinician. In contrast, Sandoz argued that the team would have been lead by a clinical pharmacologist.
According to the Court, the ‘181 patent solved the problem through the use of a unit dosage comprising 1 to 5 mg of tadalafil in the manufacture of a medicament for administration up to a maximum total dose of 5 mg tadalafil per day in a method of treating sexual dysfunction. Specifically, the Court said that the general route of determining the optimal dose of a drug to administer does not in and of itself constitute inventive step. However, this simply was not the case here. Instead, the Court found that the recitation in the claims of a unit dose comprising 1 to 5 tadalafil up to a maximum of 5 mg daily did not lack inventive step in view of Daugan II. Therefore, based on the evidence presented, the Court stated that one could not determine in advance of the clinical trials that a skilled person would have been lead to the claimed invention, and moreover, a computer model could not have sufficiently described the complicated conditions of the patent including the physical and psychological factors that can play a role in erectile dysfunction. In fact, in view of what was known about Viagra®, the skilled person would have concluded that the higher the dose of tadalafil used the better the effect (in treating sexual dysfunction). As a result, a skilled person would not have included a 5 mg or less dose in a dose response study and therefore would not have tried to develop a daily dosing regimen for treating sexual dysfunction. Additionally, the Court found it surprising that tadalafil could be use daily at such an effective low dose with minimum side effects.
This post was written by Lisa Mueller and Verena Simpson of Guardian IP.