The Dolcera Blog

Oracle sued Google on its famous operating system ‘Android’. Oracle says Google infringed patents on its Java software platform while developing Android and also violated the copyrights owned for Java platform (including without limitation code, specifications, documentation and other materials) by Oracle.

The following is a brief background on this news and a summary along with patent numbers to digest.

Oracle acquired Sun Microsystems on January 27, 2010. Sun is now Oracle America, a subsidiary of Oracle. Oracle acquired the Java technology from Sun. Android competes with Java as “an operating system software platform for cellular telephones and other mobile devices” and that the Android stack employs Java apps running on a Java-based object oriented application framework and core libraries running on a “Dalvik” virtual machine that features just in time (JIT) compilation.
Android (including without limitation of the Dalvik virtual machine and the Android software development kit) and devices that operate Android infringe one or more claims of each of the following US patents.
US6125447A-Protection domains to provide security in a computer system
US6192476B1-Controlling access to a resource
US6192476B1-Method and apparatus for pre-processing and packaging class files
US7426720B1-System and method for dynamic preloading of classes through memory space cloning of a master run-time system process
USRE38104E1-Method and apparatus for resolving data references in generated code
US6910205B2-Interpreting functions utilizing a hybrid of virtual and native machine instructions
US6061520A-Method and system for performing static initialization

Source: Oracle Google Complaint

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Shall we say the era of complete information disclosure has just begun? and hence the importance of full text patent searching. This blog post is subsequent to our recent post where we cited a classic patent suit where the ‘test of enablement’ was exercised.
Under section US112, the test of enablement requires the claims to be backed by full disclosure of the preferred embodiment in the specification. This tactic has been used by lawyers extensively to invalidate patents in the courts of law.
Hence, as a commercial information service provider the provision of the full text data becomes extremely important to search and analyze since the import of the inventive step may not be fully available from the claims.
In other words, there is potent challenge to perform a thorough patent search given the commercial patent database providers providing just the thumb nail view of the first page. My random informal meetings with Dolcera’s analysts go on to concur on one simple fact that in order to understand the utility of an invention, it is highly advised that a patent search is done on the full specifications of the patent.  They believe that the title, abstract and claims typically make one to understand the novelty and non obviousness while most patents have their utility residing in the full specification.
Further, it is only prudent to have a thorough patent search involving full specifications of the patents where the purpose of patent search is for litigations involving invalidation / infringement and also while searching the prior art. Time and again, it has become a thumb rule for a patent searcher to understand that the patents are often written with a purpose to obscure the patented invention.  We believe that the above reiterates the need to search on the full text and hence the key for future patent searches.
Alternately, the patent dashboard’s new version allows searching the full text of the patent even with simple boolean operators. The search snippets provided beside the pdf documents of patents is where the searched keyword is highlighted on the full text.

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Test of enablement - “Any analysis of whether a particular claim is supported by the disclosure in an application requires a determination of whether that disclosure, when filed, contained sufficient information regarding the subject matter of the claims as to enable one skilled in the pertinent art to make and use the claimed invention.”  Source
I have always considered the CAFC judgments as one of the best repository to learn intellectual property. I happened to come across a very interesting case.
Janssen Enablement Alzheimers (pdf) - This case (relating to US Patent No. 4,663,318) goes to prove the necessity of writing very detailed specifications backed with strong experimental data for claims to be upheld in the court of law. In this case, Janssen claimed use of a certain drug ‘galanthamine’ for treating Alzheimers. At the time of submitting the patent for review, the inventor who later on licensed the granted patent to Jansen, did not have sufficient experimental data proving direct probable linkage to use of galanthamine for Alzheimers treatment. USPTO examiner also cited this point, yet issued the patent (this part is weird). Eventually, the claims of this patent were held invalid due to an ‘enablement’ clause - in simple terms, enablement here means the specification did not directly support the claims of the inventor.
The discussions were also adverting to the utility requirement which prevents mere ideas from being patented. As noted in Genentech, Inc. v. Novo Nordisk A/S, 108 F.3d 1361, 1366 (Fed. Cir. 1997), “[p]atent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable.
Being an inventor myself, this case intrigues me that if we find a novel use for a patented compound, we can get a patent for it. From a business perspective, I feel that it would be prudent that pharmaceutical firms keep track of formulation patents/method of use patents filed by competitors over its own molecule portfolio. This is on the assumption that the competitors are trying to find novel uses of a compound patented by the inventing pharmaceutical firm. If successful, the competition would need to pay royalties to the patent holder of the novel compound (assuming the patent holder is willing to license it on fair terms).
For the patent searching fraternity, the hypothesis of determining patent quality based on disclosed experimental data is quite sound. However, it becomes difficult to retrieve if the experimental data paragraphs are added during the later stages of patent prosecution. The US PAIR information workaround to access the office actions will be of little help especially if the number of patents to be examined is large.

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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

—————————–

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

—

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

Source

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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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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.

Click here for source

- 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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