Category Archives: USPTO

U.S. District Court Confirms Validity of Patent For UCB Pharma’s Vimpat®

UCB Pharma, a Belgian pharmaceutical company, announced on 14th August 2016 that the U.S. District Court for the District of Delaware confirmed the validity of its U.S. reissued patent RE38551 related to anti-epileptic drug Vimpat® (lacosamide). The patent challenge was brought by generic drug makers who had questioned the validity of the UCB’s patent which is scheduled to expire in March 2022.

Vimpat®, one of four key products for UCB Pharma, generated net sales of 379 million euros ($423.7 million) in the first half of 2016. Vimpat® is indicated for use alone or as add-on therapy in the treatment of partial-onset seizures in patients with epilepsy who are 17 years of age or older.

In 2013, UCB had sued numerous generic drug companies, including New York-based generics maker Argentum Pharmaceuticals, after they applied ANDA application to market a generic version of Vimpat® in the United States. In late May, Argentum Pharmaceuticals won an inter partes review of UCB’s patent by the USPTO’s Patent Trial and Appeal Board (PTAB).

The Delaware district court has ruled that UCB’s patent covering the epilepsy drug Vimpat® is valid. The Court upheld the validity of the UCB’s patent after issuing a sealed opinion on the patent. The court’s favorable decision for UCB now guarantees patent protection for Vimpat® until 2022.

Anna S. Richo, executive vice president and general counsel for UCB stated “We are pleased with Delaware Chief Judge Stark’s decision”. “This confirms the strength of our intellectual property for Vimpat®”.

The decision is currently under seal and will be released following an order from the court.

About the Author: Antony David, Senior Patent Associate at Khurana & Khurana, Advocates and IP Attorneys and can be reached at:antony@khuranaandkhurana.com.

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Post Prosecution Pilot Program (P3): A Commendable Decision by USPTO

On Monday 11 July, USPTO announced a new pilot program (P3), intended to boost the prosecution efficiency. Under the P3 program, an applicant can file a request for consideration after final rejection, statement that he is willing and available to participate in the event, along with copy of response to a final rejection, and optionally proposed non-broadening amendment to the one or more claims. The program provides an opportunity to the applicant to make an oral prosecution to a panel of examiners, and then receive a written decision from the panel.

Duration of the initiative:

The P3 pilot is scheduled to start from 11 July 2016 and will continue till earlier of 12 January 2017 or receipt of 1,600 compliant requests by USPTO. There are multiple technology centres involved in this initiative and one or more of them shall stop accepting further requests as soon as their counter reaches 200.

Eligibility:

To participate in the P3 pilot program, applicant has to file a request within 2 months from the mailing date of final rejection, and before applying a notice of appeal. USPTO is providing facility to the applicant, to present an oral presentation to a panel of 3 examiners, during the conference. To apply for P3 Pilot program the requirements are as follows:

  • A request form to apply under P3 pilot program;
  • A statement within the Request Form that the applicant is willing and available to participate in a P3 conference with the panel of examiners;
  • A response under 37 C.F.R. 1.116 comprising no more than 5 pages of arguments (exclusive of amendments) to final rejection; and
  • Optionally a proposed non-broadening amendment to one or more claims.

There is no fee required to participant in the program. The goal of the P3 pilot program is to reduce the number of appeals take to patent trial and appeal board. It will also hopefully reduce the request for continued examination (RCE) filing after final rejection.

The USPTO is also requesting comments from the public, and suggestion to improve the prosecution process. The patent office plans to evaluate the public feedback to the pilot program so as to achieve its goals. Comments and suggestion can be sent by email on: afterfinalpractice@USPTO.gov, or by post to: USPTO, mail stop comments patents, office of commissioner for patents, P.O. Box 1450, Alexandria, VA 22313 – 1450. View the USPTO Notice for more details.

About the Author: Saurabh Kumar Jain, Patent Associate at Khurana & Khurana, Advocates and IP Attorneys and can be reached at: Saurabh@khuranaandkhurana.com.

Part 3 of 3: Patent Term Extension laws for Europe and the United States of America: compared and contrasted

This is third and last part of the three part series dedicated to the discussion on the comparison of the Patent Term Extension laws of Europe and the United States of America (USA). While part one of three, which discussed the comparison of terms used for the extension of patent term in Europe and the USA, relevant regulations, effective date of the regulations, authority to grant extension, and provisions of negative or zero extension, was more a kind of introductory one, second part took care of comparison on the basis of statutory requirements for the grant of extension along with possible interpretations of the relevant terms, scope of protection during the extended period of term, maximum number of extensions per product, maximum number of extensions per patent, calculation of period of extension, and this part is giving comparison of the total combined duration of market exclusivity of a general patent and extension, further extension of ‘extension of patent term’, patent term adjustment (PTA), period within which request for extension should be made, interim extension, application fees/ renewal fees, combination product, provision which may reduce the period of extension, terminal disclaimer and extension of patent term.

This table is continuation of the table 1 from part 1 and part 2

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About the Author: Swapnil Patil, Patent Associate at Khurana & Khurana, Advocates and IP Attorneys and can be reached at: swapnil@khuranaandkhurana.com

Part 2 of 3: Patent Term Extension laws for Europe and the United States of America: compared and contrasted

This is second part of the three part series dedicated to the discussion on the comparison of the Patent Term Extension laws of Europe and the United States of America (USA). While part one of three, which discussed the comparison of terms used for the extension of patent term in Europe and the USA, relevant regulations, effective date of the regulations, authority to grant extension, and provisions of negative or zero extension, was more a kind of introductory one, this part takes care of comparison on the basis of statutory requirements for the grant of extension along with possible interpretations of the relevant terms, scope of protection during the extended period of term, maximum number of extensions per product, maximum number of extensions per patent, calculation of period of extension, and third and last part of the series will give comparison of the total combined duration of market exclusivity of a general patent and extension, further extension of ‘extension of patent term’, patent term adjustment (PTA), period within which request for extension should be made, interim extension, application fees/ renewal fees, combination product, provision which may reduce the period of extension, terminal disclaimer and extension of patent term.

This table is continuation of the table 1 from part 1

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About the Author: Swapnil Patil, Patent Associate at Khurana & Khurana, Advocates and IP Attorneys and can be reached at: swapnil@khuranaandkhurana.com

Part 1 of 3: Patent Term Extension laws for Europe and the United States of America: compared and contrasted

Many people love comparing and contrasting and I am one of those (at least for study purposes). This time, I am comparing Patent Term Extension laws for Europe and the United States of America (USA). Though there are other provisions that may extend the life of patent such as patent term adjustment to compensate the delays due to patent offices, and paediatric exclusivity, I am specifically focusing on the patent term extension intended when the patent owner loses patent term during the early years of the patent because the product cannot be commercially marketed without approval from a regulatory agencies. Though Patent Term Extension laws in both the USA and Europe serve the same purpose, you will agree with me when I say that there are notable differences in the provisions of both. Products eligible for extension of patent term are not limited to human drug products, but this blog focuses more on them, somewhere references may also be found to medical devices, food additives, or color additives, animal drug products, and plant protection products. Unless otherwise specified, details discussed in this blog are related to human drug products/medicine products.  In the table 1, the Patent Term Extension laws for Europe and the USA are compared for easy understanding. Table 2 is for regulations governing Supplementary Protection Certificate and Table 3 is for calculation of extension period for the USA. As the discussion of this topic is quite lengthy one, I thought it fit to post it in series of three. While part one of three, which discusses the comparison of terms used for the extension of patent term in Europe and the USA, relevant regulations, effective date of the regulations, authority to grant extension, and provisions of negative or zero extension, is more a kind of introductory one, part two will take care of comparison on the basis of statutory requirements for the grant of extension along with possible interpretations of the relevant terms, scope of protection during the extended period of term, maximum number of extensions per product, maximum number of extensions per patent, calculation of period of extension, and third and last part of the series will give comparison of the total combined duration of market exclusivity of a general patent and extension, further extension of ‘extension of patent term’, patent term adjustment (PTA), period within which request for extension should be made, interim extension, application fees/ renewal fees, combination product, provision which may reduce the period of extension, terminal disclaimer and extension of patent term.

Table 1: Comparison Patent Term Extension laws for Europe and the USA

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Table 2: Regulations governing Supplementary Protection Certificate
 

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Table 3*: Calculation of extension period for the USA
 

*This table is for other than animal drug or veterinary biological products. Term of the patent shall be extended from the original expiration date of the patent, which shall include any patent term adjustment (PTA) granted under section 154 (b)

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The patent term extension of a patents that were issued before September 24, 1984, where the regulatory review period began and ended before September 24, 1984, were only function of the regulatory review period could be extended for more than five years.

About the Author: Swapnil Patil, Patent Associate at Khurana & Khurana, Advocates and IP Attorneys and can be reached at: swapnil@khuranaandkhurana.com

Vacation of injunction upon invalidation of patent by USPTO ePlus. v. Lawson Software

In a recent judgment, The U.S. Court of Appeals for the Federal Circuit on July 25, 2014, vacated the U.S. District Court’s decision on injunction and contempt orders against Lawson Software and instructed the lower court to dismiss the patent litigation case brought by ePlus, Inc. This decision mainly pertains totwo main issues. Firstly, whether an injunction can continue after the USPTO has cancelled the only claim on which the injunction was based. Secondly, whether the civil contempt remedies based on violation of an injunction are appropriate when the injunction itself has been overturned on direct appeal. The decision can be found here.

 Background of the case:

 ePlus, Inc.,an IT assets selling and financing company, and assignee of U.S. Patent Nos. 6,023,683 (”683 patent hereinafter) and 6,505,172 (”172 patent hereinafter), sued Lawson Software, Inc. (“Lawson”) for infringementin the year 2009 in a district court. The district court found two of the asserted system claims and three of the asserted method claims not invalid, and a jury found that Lawson infringed those claims. The defendant then appealed in Court of Appeals for the Federal Circuit (CAFC) where it was decided that the two asserted system claims (claim 1 of the ′172 patent and claim 3 of the ′683 patent) were invalid, and that two of the three asserted method claims (claims 28 and 29 of the ′683 patent) were not infringed.

It further affirmed infringement of method claim 26. So CAFC remanded the district court to consider what changes are required to the terms of the injunction, consistent with the opinion. On remand, in addition to reconsidering the injunction, the district court also instituted contempt proceedings for the reason that Lawson had redesigned its software against which the injunction order was passed. The district court held Lawson in contempt for violating the injunction, finding that the redesigned products were no more than colorably different.The court ordered Lawson to pay a compensatory fine of $18,167,950 and coercive daily fines of $62,362 until it could show compliance with the injunction.Thus being aggrieved by such order, Lawson appealed the district court’s modified injunction and contempt order in CAFC.In the meantime during proceeding of validity of the said patent claim, USPTO held Claim 26 as invalid during reexamination procedure. Armed with UPSTO decision the defendant Lawson Inc. further appealed in CAFC against the decision given by district court on injunction and contempt of court.

 Decisions given by CAFC

Issue 1

Whether the district court’s modified injunction against Lawson must be set aside now that the USPTO has cancelled the patent claim on which it is based.

 It is well established principle of law that an injunction must be set aside when the legal basis for it has ceased to exist.Citing case of Mendenhall v. Barber–Greene Co. the court recognized that upholding injunctions would be “anomalous in the extreme in connection with patents this court has just held invalid.” Under these authorities, there is no longer any legal basis to enjoin Lawson’s conduct based on rights that claim 26 of the ′683 patent previously conferred as those rights have ceased to exist. Since USPTO found claim 26 invalid, claim 26 no longer confered any rights that support an injunction against infringement. Hence cancellation of claim 26 by the USPTO required vacation of the injunction.

 Issue 2

Whether the civil contempt remedies based on the violation of an injunction are appropriate when the injunction has been overturned on direct appeal?

 It was held that the case is not distinguishable on the ground that the injunction has been set aside as the result of the USPTO proceeding rather than a court judgment. Citing the case of Fresenius USA, Inc. v. Baxter International, Inc. whereit was held that a non-final money judgment of damages for infringement must be set aside where the judgment rested on a patent claim that the USPTO later cancelled. It was held that the cancellation of a patent requires that non-final judgments be set aside because the “cancelled claims are void ab initio,” Similarly, relying on these underlined principle the civil contempt sanctions in this case must be set aside.

 There would not have been any need to decide about the survival of the civil contempt sanctions in case the injunction had been final at the time the district court imposed civil contempt sanctions. Pertinently, the injunction here was not final even though claim 26 had been held infringed. The court unanimously held in Fresenius that even if the court has rejected an invalidity defense to infringement, an “intervening decision invalidating the patents unquestionably applies” as long as “the judgment in [the present] litigation is not final.” In Fresenius, the federal court had previously reviewed the district court’s rulings on infringement and invalidity and remanded the case to the district court to determine the scope of damages and injunctive relief. When reviewing the judgment reached by the district court on remand, the federal court held that the original district court judgment, while “final for purposes of appeal was not sufficiently final to preclude application of the intervening judgment” that led to the cancellation of the patent. It was concluded that the compensatory award for the violation of the injunction must be set aside in light of the cancellation of claim 26. Finally the CAFC remanded the lower court with instruction to dismiss.

 Conclusion:

Thus it can be concluded that the decision is based on the  valid principles of law that when the main subject matter i.e. Claim 26 is itself void ab initio then the order of injunction and the civil contempt to protect such claim cannot exist or say continue to exist and needed to be set aside. Thus the validity of any patent claims per se plays utmost importance in order to determine the rights and liabilities of the parties to the dispute.

About the Author: Mr Sitanshu singh, Patent Associate at Khurana & Khurana and can be reached at:  sitanshu@khuranaandkhurana.com