The Dolcera Blog

Case background    Avandia is the popular drug name marketed by GSK had strong sales of 2.3 billion USD in 2007 till reports of its cardiovascular risks came out in the market place (forcing lots of physicians to change prescriptions to their patients, though the data was proclaimed as inconclusive by FDA).
    Avandia finds strong applications for glycemic control or in others words for diabetes type II treatment. Its active ingredient is a compound called Rosiglitazone, and a variant of this chemical compound was patented by GSK with expiry in 2005  (US5741803).

GSK Indian strategy

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Per change in the Indian patent act in 2005, GSK filed a patent for the same active ingredient as disclosed in US 5002953 as an Indian patent 00295/DELNP/2003 trying to claim the ethanesulfonate salt of the active ingredient. This patent was subsequently rejected by the India Patent office citing no evidence of the complex showing substantially different clinical efficacy than the available pharmaceutical version of Rosiglitazone.

However, it is interesting to note that GSK has not given up. It has at least three more pending application before the IPO for the same compound Rosiglitazone and we will have to see how the IPO deals with that. These applications are:- 
    a) IN3546/DELNP/2004 in which GSK has tried to patent a cyclodextrin complex of rosiglitazone and

    b) IN4030/DELNP/2005 in which GSK has tried to patent the process for manufacture of a rosiglitazone polymorph (the maleic ester form as patented in US7358366)
    c) IN6569/DELNP/2007 in which GSK has tried to patent a novel method of delivering rosiglitazone (enmeshed in nanofibres)

To counter this threat, Cadila and Dr. Reddys have also filed process patents for manufacture of amorphous Rosiglitazone maleate.

Only time will tell, who will win the Rosiglitazone turf war in India.

Source:

FDA Orange book - http://www.accessdata.fda.gov/scripts/cder/ob/docs/patexclnew.cfm?Appl_No=021071&Product_No=002&table1=OB_Rx

Indian Patent office

US Patent Office

Economic times

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Lakshmikant Goenka

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Claims 1,4,15 & 18-21 of US Patent Application No. 10/346,493(”Appln. 493″) filed by “Gleave”(Martin Gleave and Maxim Signaevsky)  were rejected by the examiner as anticipated or obvious under 35 U.S.C 102/103. Gleave appealed against the decision but the Federal circit affirmed the rejection.

Appln. 493(titled “Bispecific Antisense Oligonucleotides that inhibit  IGFBP-2 and IGFBP-5 and Methods of Using the same”) claims antisense oligodeoxynucleotides, pharmaceutical compositions containing them and method of treating cancer by using them.

The claims rejected by the examiner included Composition claims consisting of these antisense oligodeoxynucleotides, which were claimed to be complementary to a portion of a gene encoding human IGFBP-2/ IGFBP-5, “wherein the oligodeoxynucleotide is of sufficient length to act as an antisense inhibitor of human IGFBP-2 and human IGFBP-5″.

The examiner rejected the present claims over anticipation by prior art PCT Publication of Wraight et al. (WO 00/78341).This publication disclosed every fifteen-base long sense oligodeoxynucleotide in the IGFBP-2 gene and further also disclosed that these oligodeoxynucleotides may be bispecific(capable of acting as a inhibitor of IGFBP such as IGFBP-2 and/or IGFBP-3).

For a reference/document to be anticipatory, the following requirements should be satisfied:

1.     The reference should disclose each and every element of the claimed invention, explicitly or inherently. Those elements must be combined or arranged in the same way as in the claim.

2.     The reference must enable “one of ordinary skill in the art to make the invention without undue experimentation”.

Gleave claims that Wraight does not describe any particular individual antisense species, there are no particular selections and no understanding of what targets would be useful. Thus Gleave primarily argues that although a large and exhaustive list was disclosed to the public, no basis was provided for selecting some individual members over the others. In effect, he argues that what is actually disclosed is not more than a generic concept underlying the list.

However, the court held that Gleave’s argument failed for two reasons. The list disclosed in Wraight’s  application anticipates Gleave’s claims. Secondly, Gleave’s argument that Wraight’s application is a generic concept stating that one could make antisense constructs that target IGBFP, was also nullified as court held that a person of ordinary skill in the art having the IGFBP sequence is capable of envisioning how to make antisense sequences. Thus, Gleave does not hold right to patentability over Wraight.

In conclusion, the discovery of a new property/use of known composition even when the use/property are non-obvious over prior art cannot impart patentability to claims of the known composition. If a new use is  discovered, patentability can only be claimed for that method of use.

-Priyanka Goyal

Knowledge Scientist

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http://www.cafc.uscourts.gov/opinions/09-1001.pdf

It is our contention that in the globalized world of manufacturing, where most of the manufacturing activity happens outside the developed world, having legally valid patents in the manufacturing hubs of China, Mexico or India can pay off handsomely. A legal right in those countries can ease gathering of evidence as can be seen in the case below where video shots of manufacturing process used in Mexico is used as admissible evidence.

This case pertains to an infringement claim won by Gemtron Corp. against Saint Gobain for refrigerator shelf manufacturing method and design.

Background:
Saint Gobain manufactures refrigerator components in Mexico and sells them in the United Sates. Gemtron Corp. has a patent for manufacture of refrigerator shelves where by a glass portion of the shelf is held to a polymeric base using ‘fingers’ and not ‘adhesive’ ( a traditional method) filed in both USA and Mexico.

Gemtron Corp. alleged that Saint Gobain was infringing on its patents since it was using a similar method for manufacturing its shelves - in which a glass portion is held to its polymeric base using ‘fingers’. Saint Gobain was countering Gemtron Corp. allegation saying that the claim 23 of the ‘673 Gemtron patent was only a ‘process’ patent and hence the end result from the process (the end design or the structural component) was not claimed. The CAFC rejected Saint Gobain’s plea on the grounds that the result of a claimed process which lead to a unique structural change were also by default patentable subject matter.

In order to refute Saint Gobain’s claims that its manufacturing process was significantly different than claimed in the patent, Gemtron Corp. showed videos of the manufacturing process used at Saint Gobain’s manufacturing site in Mexico. The video clearly proved similarity in the process used at Saint Gobain manufacturing site.

In the overall case argument, while the moot point was the ’structural component’ or the design of the shelf, it can be argued that the video showing Saint Gobain’s manufacturing process was also helpful in winning a non-technical jury’s verdict to prove wilful infringement at the district court level.

- Lakshmikant Goenka

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http://www.cafc.uscourts.gov/opinions/07-1583.pdf

In this classic case of Friskit v/s Real networks, Friskit alleged Real networks media players had infringed its patents that claimed as its inventive the following (a) a media player with integrated search and playback features and (b) wher the entire control of the media player rest with the server side with no software (OS) from the client side assisting in the operation of the media player.

Real cited the following product and website evidence to counter Friskit. It cited the features available at www.iuma.com and Winamp to counter Friskit’s claims. In both cases of iuma.com and Winamp offered a media player interface with a search box. When a search was conducted, a new mini-browser window would pop up that would get populated with the search results. These search results could be dragged and dropped into the media player interface for immediate play-back with minimal intervention from the client side. Friskit’s only difference was the same interface (with no special mini-browser) window poping up providing this functionality.

The court cited KSR v/s Teleflex and found Friskit’s claims as obvious stating that as per the KSR case ‘predictable use of known elements according to their cited function’ results in obviousness.

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Mr. Mekete had filed the 5602905 patent in 1995 that allowed for a user to utilize commercial online services from a CPU, that had a modem and credit card reader coupled to the CPU, and where the CPU had a software installed to fulfil this transaction.

Later in August of 1998, Mr. Mekete filed for a reissue of his ‘905 patent since he believed he had severely limited his invention by not claiming the use of ‘online services perse’ from this CPU terminal.

Mr. Mekete’s patent is interesting since this ‘905 patent has 93 citations and hence is a seminal patent in that respect.
When Mr. Mekete filed for re-issuance of his patent, the BPAI rejected his assertion on grounds of obviousness. BPAI cited combination of 3 different references as a source to reject Mr. Meketes claim. Mr. Mekete appealed the BPAI decision with the CAFC that re-affirmed the BPAI decision.

Mr. Mekete’s arguments were that his invention was a commercial success since more than 50% of the internet kiosks were using the method he wished to Claim. However, the Board and the CAFC argued that when there is no-established co-relation between commercial success and the invention (in other words, the inventors commercialization efforts are not the reason for the success of the invention per-se) then the grounds to grant a patent based on utility is ‘weak’ - and also, that makes the BPAI argument to combine elements from ‘three’ different sources to reject the patent on ‘obviousness’ grounds as ’strong’.

- Lakshmikant

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http://www.cafc.uscourts.gov/opinions/08-1259.pdf

In an interesting case, bankrupt GM won a patent suit for its popular OnStar navigation system.
The OnStar navigation system acts like a warning system for manouever points that are going to come up within a certain pre-specified distance from the car. The calculations regarding the relative position of the car from the manouever point is done remotely, and the only information displayed in the device in the car is the ‘distance value’ to the manouever point.

VIP had filed a patent in which the co-ordinate of the manouever point is downloaded and compared with the car co-ordinates (obtained using GPS systems) on the mobile system. They do not represent the distance between the manouever point and the car co-ordinates as scalar values, but simply represent them on a scale ‘relative to each other’.

On this semantic difference VIP lost its case against GM in both the district court and the Federal Appeals court. The CAFC and district courts did not find any reference of possibility to display scalar values on the mobile device either in the Patent specification or at anytime during the patent prosecution history.

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Ariad filed a claim of infringement against Amgen for its drug Ender.

Ariad’s ‘516 patent claims “A method for diminishing induced NF-kB mediated intracellular signaling comprising reducing NF-kb activity in cells such that NF-kB mediated intracellular signaling is diminished”.

NF-kB activity can be mitigated through two methods: (a) Inside the cells - by modifying the signaling pathway. This is specified in the Ariad patent as done by using decoy molecules and other methods and (b) Outside the cells - by modifying the inducing action of Tumor Necrosis Alpha (TNF-Alpha) that in turn effects the signaling pathway inside the cell which in turn affects the NF-kB activity.

The court in its judgment pronounced Ariad’s claims as invalid. It maintained that the Ariad’s ‘516 patent does not state in its specification any modification of NF-kB activity by preventing the ‘external influencing’ activity of TNF-Alpha. Citing the Philips v/s AWH Corp, the court argued that “a person with ordinary skill in the art, is deemed to read the claim not only in context of the particular claim, but in the context of the entire patent, including the specification”. The court further cited that the patent prosecution history informs ‘how the inventor understood the invention, and whether the inventor narrowed his/her claim during the course of prosecution”.

Going forward, it is going to be imperative for inventors to disclose as broadly as possible the scientific and technical ramifications of their inventions, and ensure that each ramification is well spelt out in the specification of the patent. Failing which, the legal validity of such patents in the court of law will be easily challenged.

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- Lakshmikant Goenka
MD, Dolcera

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The US Patent 6,048,850 held by University of Rochester was found to be invalid for failing to comply with the written description requirement of 35 U.S.C. § 112.

University of Rochester sued G.D. Searle & Co. Inc., Monsanto Co., Pharmacia Corp. and Pfizer Inc. alleging that Pfizer’s sale of its COX-2 inhibitors Celebrex (R) and Bextra (R) infringed the ‘850 patent. The pharmaceutical companies counterclaimed that the patent is invalid.

Traditional non-steroidal anti-inflammatory drugs (“NSAIDs”) such as aspirin, ibuprofen, ketoprofen, and naproxen are believed to function by inhibiting the activity of enzymes called cyclooxygenases which are of two types COX-1/ PGHS-1 and COX-2/ PGHS-2. COX-1 is involved in the production of prostaglandins that serve a beneficial role while COX-2 is expressed in response to inflammatory stimuli, and is thought to be responsible for the inflammation. NSAIDs inhibit both COX-1 and COX-2 and hence are thought to result in undesirable side effects apart from reducing inflammation.

The ‘850 patent claims for the use of a “non-steroidal compound that selectively inhibits activity of the PGHS-2 gene.”

The ’850 patent however was not found to disclose any such compound nor provide any suggestion as to how such a compound could be made or otherwise obtained other than by trial-and-error research.

Three requirements referred to as the “written description requirement,” the “enablement requirement,” and the “best mode requirement” need to be satisfied to claim patentability of an invention disclosed in a patent.

Claims of the ’850 patent were thus found to be invalid as the specification did not describe in detail the method to manufacture or obtain the compound so that a person ordinarily skilled in the art could practice it.

The litigation case brings forward the concept of Reach-through claims seeks to protect things that have not yet been discovered by an inventor, but which might be discovered in the future by making use of their invention. When an invention is made in a widely applicable basic research technology (referred to herein as an “upstream” technology), it is often possible to envisage future technologies (referred to as “downstream” technology) which might be developed using the basic research technology. If the inventor of an upstream invention files a patent application for the upstream invention and attempts to claim downstream inventions which they have not as yet actually made, then the claims to those downstream inventions are referred to as “reach-through” claims.

Source 1 Source 2

- Priyanka Goyal
Knowledge Scientist
Dolcera

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AstraZeneca’s patent on Toprol-XL® was judged to be invalid by Court of Appeals for the Federal Circuit (CAFC). The seeding of the case way backs to 1971. The final judgment is in favor of opponents of Astra as Astra filled double patents for the same drug salts of Metoprolol. This is one amongst most talked about IP cases in world. Read on the complete article and understand how tides turned against Astra in this historic case.

1. 1971: Astra Sweden employee, named Toivo Nitenberg synthesized metoprolol succinate as well as the tartrate and sulfate salts of metoprolol.

2. 1982: Another Astra Sweden employee Lars Lilljequist synthesized a number of metoprolol salts, including metoprolol succinate.

3. 1982: Same year, The parties submitted conflicting evidence as to whether two other Astra employees in Sweden, Curt Appelgren and Christina Eskilsson, had directed Lilljequist to synthesize metoprolol succinate.

4. 1983: Appelgren and Eskilsson left Astra to join another company, Lejus Medical AB (“Lejus”).

5. Jan 1984: Lejus Medical filed a patent application (SE 8400085) with the Swedish Patent Office, describing “delayed and extended release dosage forms of pharmaceutical compositions, including metoprolol succinate” and naming Appelgren and Eskilsson as the inventors.

6. Jan 1985: Lejus Medical filed U.S. application Ser. No. 690,197 (the ’197 Application), claiming priority from the Swedish application filled in Jan 1984.

7. Oct 1985: In the settlement agreement, Lejus agreed to divide claims to “metoprolol succinate” and to a “pharmaceutical composition, characterized in that the active substance is metoprolol succinate” from the ’197 Application and to assign the divided claims to Astra. The settlement agreement listed Appelgren and Eskilsson as the inventors of the divided metoprolol succinate claims. Astra agreed that Lejus retained the rights to the ’197 Application that did not include the divided claims.

8. Mar 1988: In accordance with the settlement agreement, Lejus filed U.S. application Ser. No. 172,897 (the ’897 Application), which was a continuation-in-part of the ’197 Application. Lejus filed the ’897 Application with Appelgren and Eskilsson as the named inventors and Astra as assignee.

9. Jan 1989: Astra’s in-house counsel asserted to Astra’s outside U.S. patent counsel that “there remains an open question who is the proper inventor.” The last mention of this issue in the record is a phone call between Astra’s in-house counsel and outside U.S. patent counsel

10. Mar 1991: The ’897 Application (filled in Mar 1988 by Lejus) get issued as U.S. Patent No. 5,001,161 (the ’161 Patent). The only claim of the ’161 Patent reads: “A pharmaceutical composition comprising metoprolol succinate together with a sustained release pharmaceutically acceptable carrier.”

11. Jan 1992: A continuation of the ’897 Application issued as U.S. Patent No. 5,081,154 (the ’154 Patent). The only claim of the ’154 Patent simply reads, “Metoprolol succinate.”

12. 1992: The ’161 (Mar, 1991) and ’154 (Jan 1992) Patents both list Appelgren and Eskilsson as the inventors, and Astra as the assignee. Astra never revealed the inventorship issue to the U.S. Patent & Trademark Office during the prosecution of the two patents.

13 1992: During the same time period, Lejus’s ’197 Application issued as U.S. Patent No. 4,780,318 (the ’318 Patent) in October 1988.

14. District court invalidated Astra’s ’161 and ’154 Patents as double patenting over Lejus’s ’318 Patent.

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- Lakshmikant Goenka
MD, Dolcera

AND

- Harit Mohan
Knowledge Scientist,
Dolcera

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The case refers to a specific compound called Risedronate (3 pyr EHDP), a bisphosphonate.

PnG had filed for a patent ‘406 which genreally talked of bisphosphonates and their role in aiding bone mineralization. Teva’s contention was that Risdronate has significant structural similarities with 2 pyr EHDP, a compound mentioned by Png in its ‘406 patent.

Court ruled in PnG’s favor stating “unexpected results of risedronate’s potency and toxicity rebut a claim of obviousness”. Takedas argument was that homologs, analogs and isomers of known chemical compounds are obvious to a person knowing the arts. However, the court believed that even if this were true, there has to be adequate motivation for a person knowing the arts to modify a known chemical compound. PnG’s argument was that to predict the toxicity and benevolent effects of Risendorate in 1985 when the ‘406 patent was filed was very difficult, since each bisphosphonate shows different chemical and toxicity properties. They also contended that prediction of ‘chemical properties’ based on structural similarities can be highly misleading.

The court ruled that in the light of KSR, and given the unpredictable nature of chemical compounds, Teva failed to prove that an ordinary person skilled in the art could prove predictably that the 3 pyr isomer could have been thought off in 1985.
- Lakshmikant Goenka
MD, Dolcera
For complete article click here

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