US Supreme Court Overturns Federal Circuit’s Ruling Regarding Validity of Patent for Teva’s Copaxone

January 21, 2015

copaxone

Copaxone is a blockbuster drug based on the glatiramer acetate copolymer which was patented by Yeda (the Tech Transfer Company of the Weizman Institute) and licensed exclusively to Teva to manufacture.

On Tuesday 20 January 2014 the U.S. Supreme Court reversed an appeals court ruling that invalidated Teva Pharmaceutical Industries patent on the blockbuster multiple-sclerosis drug Copaxone, giving the drug maker a new opportunity to forestall generic competition.

The claims specify a particular molecular weight range but do not specify what method was used to measure the molecular weight. Sandoz argued that this is a fatal flaw and the claims are indefinite under §112. The District Court found for Teva, and was convinced by Teva’s argument that the claim clearly meant the “peak average molecular weight”, and not either of the two alternatives of “number average molecular weight” or “weight average molecular weight”.

On appeal, the Federal Circuit held to the contrary and found the patent invalid for indefiniteness. In reaching this conclusion, the Federal Circuit reviewed de novo all aspects of the District Court’s claim construction, including the District Court’s determination of subsidiary facts. The issue before the Supreme Court was whether that was permissible, or whether the Federal Circuit had impermissibly set aside the District Court’s findings of fact without the requisite finding of clear error on the part of the District Court (in violation of Federal Rule of Civil Procedure 52(a)(6), for what it is worth). The Supreme Court of the USA accepted TEVA’s appeal that found that the Federal Circuit had indeed impermissibly conducted a de novo factual review. So the Federal Circuit’s decision was vacated and the case remanded.

The Supreme Court Decision ruling was made by seven judges with two dissenting. Justice Breyer gave the Opinion with Justices Roberts, Scalia, Kennedy, Ginsburg, Sotomayor and Kagan affirming. Justice Thomas filed a dissenting opinion which Justice Alito concurred with. According the majority opinion the Federal Circuit had indeed impermissibly conducted a de novo factual review. So the Federal Circuit’s decision was vacated and the case remanded. In the dissenting view, the opinion was that the Federal Circuit had not overturned findings of fact, but had instead formed a different conclusion of law as to the claim construction. Therefore, there had been no breach of the Federal Rules of Civil Procedure. The case has been referred back to the Federal Circuit Court of Appeals.

COMMENT

The ruling will help TEVA prevent generic competitors from entering the Copaxone market until the patent expires in September. There seems to be a power struggle going on in the US court system with the Supreme Court reprimanding the Federal Circuit for assuming powers that are not rightfully theirs.


Nos

January 19, 2015

NOS

A Turkish company called GÜNEYSI IÇ VE DIS TICARET ANONIM SIRKETI filed an International Trademark Application as shown, for chemical preparations for medical purposes, chemico-pharmaceutical preparations, dietetic foods adapted for medical purposes, medical preparations for slimming purposes, food for babies, material for stopping teeth, dental wax; disinfectants; preparations for destroying noxious plants, materials for dressings, preparations for destroying vermin; fungicides, air freshening preparations, antiseptics – in class 5; Meat, fish, poultry and game; meat extracts; beans, preserved, soups, preparations for making bouillon, olives, preserved, milk and milk products, butter, edible oils and fats, preserved, frozen, dried and cooked fruits and vegetables, nuts, prepared, peanut butter, tahini (sesame seed paste), eggs and powdered eggs, non-medical foods use for supplementary purposes (including pollens, proteins, carbonate), potato chips in class 29; Coffee, cocoa, coffee substitutes, coffee or cocoa based beverages, chocolate based beverages, macaroni, ravioli, vermicelli, pastry and bakery products, desserts, honey, royal jelly, propolis (bee gum), condiments for foodstuff, yeasts, baking powder, natural substances for improving shape and color of bread and retarding its period of getting stale, all kinds of flour, semolina, corn starch, crystal sugar, cubed sugar, powdered sugar, tea, ice tea, confectionery, chocolates, biscuits, crackers; waffles, chewing gums, ice creams, edible ice, salt, grain (cereals) and products made from cereal, treacle in class 30 and Beers, preparations for making beer, mineral waters, spring waters, table water, soda waters, tonic waters, vegetable and fruit juices, their concentrations and extracts, beverages in class 32.

The mark received Israel Trademark Number 251385 and during the three-month period “Holley Performance Products, Inc” opposed the mark in Israel, and the Israel Patent Office informed the International Madrid Mechanism. Since Applicant did not respond to the Opposition, the mark has been canceled.

COMMENT

I suspect that with the mark filed for an enormous range of goods it is more than likely that the mark and Holley Performance could have hammered out a coexistence agreement.


Israel Patent Office Closures Due to Snow

January 6, 2015

snow in Israel

Snow is expected.  Living at 940 m above sea level, we had over half a meter last year, with power cuts, water pipes frozen, etc. I must admit, therefore, that I am rather less excited and enthusiastic about this than my 12-year-old son.

The Israel Patent Office has announced that it will be closed on 7th and 8th January 2014. All deadlines are extended to the next working day.

They say that “It’s an ill wind that does nobody any good.”

The Israel Patent Office is closed on Friday and Saturday anyway. This means that Applicants with a patent, design or trademark deadline of 7th or 8th January can file on Sunday 11th January 2015.

This works for the Paris deadline for filing PCT applications as well, but it should be noted that the USPTO may have a problem with a national phase of a PCT application that claims priority from a US provisional application.

 

 

 


European and Israel Patent Offices Sign a Bilateral PPH

December 10, 2014

pph

The European Patent Office (EPO) and the Israel Patent Office (IPO) have agreed a patent deal set to speed up examinations at both offices. Starting next month, the Patent Prosecution Highway (PPH) will allow applicants to request accelerated examination of a patent at either office provided the claims have been previously deemed acceptable by the other. The agreement was signed on December 4 by heads of both offices in Brussels, Belgium.

Apparently Asa Kling, director of the IPO, said the programme would “enhance co-operation between the offices” and further strengthen the economic and technological relations between Israel and Europe.

COMMENT
We see this as a great development, not least because Israel Applications may be accelerated fairly easily under a variety of routes including Section 17c of the Israel Patent Law 1967 and relevant patent office circulars. European Applications can linger in the queue for examination for quite a while, and incur annual maintenance fees. Then again, once allowed, a European patent has to be ratified and is then subject to renewal fees in the countries where it is ratified. The main thing is that this gives applicants choice and flexibility.


Orbotech Challenges Cost Ruling, but too Late

December 8, 2014

missed opportunity

Back on 9th November 2014, I reported that after finally ruling on the Camtek – Orbotech patent Opposition, the Israel Patent Office ruled very large costs to Adi Levit, mostly because he’d detailed his cost calculation and it was unchallenged by Orbotech who’d lost the case.

Camtek requested 302,895 Shekels costs (including VAT).  The request for costs were supported by an affidavit from Camtek’s IP manager Michael Lev. The sum includes legal fees of 288,687 Shekels to outside counsel, Adi Levit, 8208 Shekels to the witness Mr Golan, and 6000 Shekels for intermediate costs awarded. All cost requests were supported by documentary evidence such as invoices from outside counsel and salary slips from the witness. Orbotech, represented by Reuven Borchowski, did not counter the request for costs.

In her ruling, Ms Jacqueline Bracha reviewed the intermediate costs to see whether they were affected by the final decision and came to the conclusion that where she had ruled that the costs were incurred by Opposer unnecessarily, they should be discounted.  The costs awarded were 296,895 Shekels.

Apparently, on the day that the cost ruling issued, Orbotech requested that the ruling be canceled, arguing that because of industrial action in the courts, they were unable to respond on the last day as they had intended.

Camtek responded that they could have filed a notice of intent to challenge, the court strike was actually the day after, and a response could have been submitted despite the strike. They requested that Orbotech’s lawyer file an affidavit testifying to why he was unable to respond, and to be prepared to be cross-examined on it.

Ms Bracha decided that the ruling was given fairly and there was no reason to cancel it. The issue was not whether Reuven Borchovsky, attorney for Orbotech had intended filing a response, but whether there were counter-arguments on file when she made her ruling. As there weren’t, she was entitled to simply check the calculation submitted by Adv. Levit. Consequently, she saw no reason to cancel her decision to award the actual legal costs + witness fee – intermediate costs that were unnecessary.


Requests for Costs Must be Timely Filed

November 19, 2014

missed

Back in June 2014, I reported on a decision by the Israel Commissioner of Patents and Trademarks that the Chinese brand Lovol and the older and more established Swedish brand Volvo are not confusingly similar. Having persuaded the Israel Patent Office that their mark was registered in good faith and was not confusing, Hebei Aulion Heavy Industries LTD, who own the Lovol mark, were entitled to file a request for costs.

The request for costs should have been filed within two months, as per Patent Office Circular M.N. 80. Hebei missed this deadline and, three and a half months after the hearing, they filed a late request for an extension to file costs.

Volvo opposed this request.

Hebei argued that the delay was caused because they waited to see whether the ruling would be appealed. The Commissioner did not see that connection between a possible Appeal and the right to file, and the right to costs for one proceeding is quite independent of whether the ruling may eventually be appealed or overturned. Furthermore, appeals should be filed within one month of a trademark ruling, whereas a request for costs may be filed within two months of a ruling. Where an extension is requested in an ex-partes proceeding it should be requested in advance and not retroactively.

A further consideration submitted by Hebei’s agent-of-record (Wolf Bregman Goler) was that they were unaware of the Circular and their client should not be penalized for their ignorance in this manner.  The Commissioner noted that the Circular issued back in February 2010 and that the agent-of-record was experienced and regularly appeared before the patent office in hearings and the like.

Citing A. Goren on Civil Procedure, the Commissioner noted that ignorance of the Law may be an excuse if objectively the Law is unclear and there hasn’t been any case-law, or, if subjectively, the legal representative had made efforts to avoid the mistake. In this instance, no evidence or arguments were submitted to establish objective or subjective grounds for clemency.

The agent of record argued that his client had a basic right to costs, that the Trademark Ordinance and regulations doesn’t establish a deadline, and so the Circular should not be considered binding. The Commissioner rejected this argument, considering that the Circular filled a lacuna and gave certainty as to whether costs would be requested or not. He considered that different practitioners should be held to the same standards. Costs should be requested at the end of a proceeding and not any time thereafter. There were no good reasons to consider the two month period insufficient, so the request was thrown out.


Forcing Foreign Witnesses to Attend Hearings In Jerusalem When There is a Difficult Security Situation

November 19, 2014

Courage under fire

It is very unfortunate that Israel in general and Jerusalem in particular suffers from terrorist attacks. The situation is not, of course, limited to Israel.

EBay Inc. is opposing Israel trademark application No. 243223 that was filed by Dotcom Retail LTD for the mark BEAUTYBAY.

Arguing that the US Government has warned its citizens not to travel to Israel, e-Bay Inc has asked to postpone a hearing that was scheduled for 3 November 2014 since it is a US company and one of their witnesses is prevented from coming to Israel because of the security situation. They requested a postponement until January 2015 and were willing to pay any costs caused by the delay. Alternatively, they suggested allowing the witness to testify by video-conference.

Dotcom Retail LTD objects to both requests. They claim that the current warning regarding the security situation in Israel has remained the same for decades, and submitted copies of the US Government’s warnings from 2010 – 2012. They claim that the decision against travel to Israel is an internal policy of eBay and is not an acceptable reason for delaying the hearing, as, say, the state of health of a witness might be. They supported their opposition to the request with reference to 2668/03 Etrade Group vs. Karden technologies LTD.

EBay noted that following the Protective Edge Campaign (War with Hamastan – Gaza) earlier this year, the situation in Israel is not normal and that they have forbidden their employees to travel to Israel. They suggested that the hearing could be held by video conference and noted that the Israel Supreme Court had upheld the possibility of conducting a hearing by video conferencing.

REGARDING DELAYING THE HEARING
In her ruling, the Deputy Commissioner, Ms Jacqueline Bracha, noted that the opposer had already postponed the hearing once and had tried to find someone willing to attend a hearing in November. Not being able to, they were requesting a second postponement.

She noted that in an Opposition to patent application number IL 107741 Unipharm vs. Merck & Co., the then Commissioner ruled that parties wishing to obtain IP rights in Israel or to oppose such rights should be willing to testify and to be cross-examined in Israel.

M Bracha accepted eBay was willing to participate in legal proceedings in Israel, but merely felt that the current time was too dangerous. However, she noted that there is no state of war at present that prevents hearings from taking place in Jerusalem. She noted that in 2006, then Commissioner Noam rejected ‘security considerations’ when there was no actual war taking place, and pointed out that a witness can arrive in an Israel Airport, travel to the Patent Office, give evidence and return on the same day. EBay cannot know from day to day or from month to month what the security situation is and therefore cannot guarantee that any postponement will suffice to reschedule a hearing under better circumstances.

The restriction was an internal decision of the eBay and was not a decision by the US government. It had no legal significance and one cannot simply create travel restrictions and expect the Israel Courts to uphold them.

VIDEO-CONFERENCING
Regarding the Supreme Court precedent regarding video conferencing, Ms Bracha noted that in extreme circumstances where a hearing was postponed four times due to a party being in ill-health, hearings have been held outside of a court room. Where the court sits in a court room but a witness testifies or is cross-examined by video conference, the situation is less than ideal in that the testimony is indirect when compared to a witness in the court room. It may be permitted in some circumstances, but use should be limited, particularly if the other party does not willingly consent.

In 3005/02 SmithKline vs. Unipharm testimony over a video link was allowed since the party could not force the witness to travel to Israel. The current case is different in that eBay is the source of the travel restriction, and can lift it as easily as they imposed it.

Referring back to 2668/03 Etrade Group vs. Karden technologies LTD, Ms Bracha ruled that there is a difference between a minor witness and a major one. The courts have rejected ‘security considerations’ as justification for a witness not turning up in court. Both the request for postponement and the request for video conferencing were both rejected.

COMMENT
I think this decision is correct. Formally, Israel is in an ongoing state of War with various Arab neighbours and has been since 1948. Hamas certainly see themselves as in a perpetual state of war, and at best, accept temporary cease-fires as restraint. The case-law that deals with this issue shows that security problems are ongoing and may be considered a fact of life in Israel.

That said, we note that Operation Protective Edge was not declared as being a war, probably since Hamas are not recognized as being a State. It is not clear, therefore, that when there were rockets hitting the country, and occasionally hitting Jerusalem, that the Patent Office would have recognized a state of war. Security fears may be real and not merely a delaying tactic. On a daily basis there are terrorist attacks and many of these are in Jerusalem. I don’t have enough experience of testimony and cross-examination by video conferencing to know if it is a reasonable alternative to standard cross-examination conditions.

As an Israel citizen working and living here it is difficult for me to put myself in the position of an American. I am sure that things are better here than in Syria, Iraq and Iran. I suspect that they are safer than in Egypt, Lebanon and Jordan as well. Let us hope and pray that the security situation in Israel approves.


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